38 results on '"van der Voet, L. F."'
Search Results
2. Re: Risk of Cesarean scar defect following single‐ vs double‐layer uterine closure
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Huirne, J. A. F., Stegwee, S. I., van der Voet, L. F., de Groot, C. J. M., Hehenkamp, W. J. K., and Brölmann, H. A. M.
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- 2017
- Full Text
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3. Economic evaluation of endometrial scratching before the second IVF/ICSI treatment:a cost-effectiveness analysis of a randomized controlled trial (SCRaTCH trial)
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van Hoogenhuijze, N. E., van Eekelen, R., Mol, F., Schipper, I., Groenewoud, E. R., Traas, M. A.F., Janssen, C. A.H., Teklenburg, G., de Bruin, J. P., van Oppenraaij, R. H.F., Maas, J. W.M., Moll, E., Fleischer, K., van Hooff, M. H.A., de Koning, C. H., Cantineau, A. E.P., Lambalk, C. B., Verberg, M., van Heusden, A. M., Manger, A. P., van Rumste, M. M.E., van der Voet, L. F., Pieterse, Q. D., Visser, J., Brinkhuis, E. A., den Hartog, J. E., Glas, M. W., Klijn, N. F., van der Zanden, M., Bandell, M. L., Boxmeer, J. C., van Disseldorp, J., Smeenk, J., van Wely, M., Eijkemans, M. J.C., Torrance, H. L., Broekmans, F. J.M., van Hoogenhuijze, N. E., van Eekelen, R., Mol, F., Schipper, I., Groenewoud, E. R., Traas, M. A.F., Janssen, C. A.H., Teklenburg, G., de Bruin, J. P., van Oppenraaij, R. H.F., Maas, J. W.M., Moll, E., Fleischer, K., van Hooff, M. H.A., de Koning, C. H., Cantineau, A. E.P., Lambalk, C. B., Verberg, M., van Heusden, A. M., Manger, A. P., van Rumste, M. M.E., van der Voet, L. F., Pieterse, Q. D., Visser, J., Brinkhuis, E. A., den Hartog, J. E., Glas, M. W., Klijn, N. F., van der Zanden, M., Bandell, M. L., Boxmeer, J. C., van Disseldorp, J., Smeenk, J., van Wely, M., Eijkemans, M. J.C., Torrance, H. L., and Broekmans, F. J.M.
- Abstract
STUDY QUESTION: Is a single endometrial scratch prior to the second fresh IVF/ICSI treatment cost-effective compared to no scratch, when evaluated over a 12-month follow-up period? SUMMARY ANSWER: The incremental cost-effectiveness ratio (ICER) for an endometrial scratch was €6524 per additional live birth, but due to uncertainty regarding the increase in live birth rate this has to be interpreted with caution. WHAT IS KNOWN ALREADY: Endometrial scratching is thought to improve the chances of success in couples with previously failed embryo implantation in IVF/ICSI treatment. It has been widely implemented in daily practice, despite the lack of conclusive evidence of its effectiveness and without investigating whether scratching allows for a cost-effective method to reduce the number of IVF/ICSI cycles needed to achieve a live birth. STUDY DESIGN, SIZE, DURATION: This economic evaluation is based on a multicentre randomized controlled trial carried out in the Netherlands (SCRaTCH trial) that compared a single scratch prior to the second IVF/ICSI treatment with no scratch in couples with a failed full first IVF/ICSI cycle. Follow-up was 12 months after randomization.Economic evaluation was performed from a healthcare and societal perspective by taking both direct medical costs and lost productivity costs into account. It was performed for the primary outcome of biochemical pregnancy leading to live birth after 12 months of follow-up as well as the secondary outcome of live birth after the second fresh IVF/ICSI treatment (i.e. the first after randomization). To allow for worldwide interpretation of the data, cost level scenario analysis and sensitivity analysis was performed. PARTICIPANTS/MATERIALS, SETTING, METHODS: From January 2016 until July 2018, 933 women with a failed first IVF/ICSI cycle were included in the trial. Data on treatment and pregnancy were recorded up until 12 months after randomization, and the resulting live birth outcomes (even if after 12 mo
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- 2022
4. Economic evaluation of endometrial scratching before the second IVF/ICSI treatment: a cost-effectiveness analysis of a randomized controlled trial (SCRaTCH trial)
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MS VPG/Gynaecologie, Infection & Immunity, Biostatistiek Onderzoek, Child Health, Circulatory Health, JC onderzoeksprogramma Infectieziekten, JC onderzoeksprogramma Methodologie, van Hoogenhuijze, N. E., van Eekelen, R., Mol, F., Schipper, I., Groenewoud, E. R., Traas, M. A.F., Janssen, C. A.H., Teklenburg, G., de Bruin, J. P., van Oppenraaij, R. H.F., Maas, J. W.M., Moll, E., Fleischer, K., van Hooff, M. H.A., de Koning, C. H., Cantineau, A. E.P., Lambalk, C. B., Verberg, M., van Heusden, A. M., Manger, A. P., van Rumste, M. M.E., van der Voet, L. F., Pieterse, Q. D., Visser, J., Brinkhuis, E. A., den Hartog, J. E., Glas, M. W., Klijn, N. F., van der Zanden, M., Bandell, M. L., Boxmeer, J. C., van Disseldorp, J., Smeenk, J., van Wely, M., Eijkemans, M. J.C., Torrance, H. L., Broekmans, F. J.M., MS VPG/Gynaecologie, Infection & Immunity, Biostatistiek Onderzoek, Child Health, Circulatory Health, JC onderzoeksprogramma Infectieziekten, JC onderzoeksprogramma Methodologie, van Hoogenhuijze, N. E., van Eekelen, R., Mol, F., Schipper, I., Groenewoud, E. R., Traas, M. A.F., Janssen, C. A.H., Teklenburg, G., de Bruin, J. P., van Oppenraaij, R. H.F., Maas, J. W.M., Moll, E., Fleischer, K., van Hooff, M. H.A., de Koning, C. H., Cantineau, A. E.P., Lambalk, C. B., Verberg, M., van Heusden, A. M., Manger, A. P., van Rumste, M. M.E., van der Voet, L. F., Pieterse, Q. D., Visser, J., Brinkhuis, E. A., den Hartog, J. E., Glas, M. W., Klijn, N. F., van der Zanden, M., Bandell, M. L., Boxmeer, J. C., van Disseldorp, J., Smeenk, J., van Wely, M., Eijkemans, M. J.C., Torrance, H. L., and Broekmans, F. J.M.
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- 2022
5. Definition and sonographic reporting system for Cesarean scar pregnancy in early gestation: modified Delphi method
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Jordans, I. P. M., primary, Verberkt, C., additional, De Leeuw, R. A., additional, Bilardo, C. M., additional, Van Den Bosch, T., additional, Bourne, T., additional, Brölmann, H. A. M., additional, Dueholm, M., additional, Hehenkamp, W. J. K., additional, Jastrow, N., additional, Jurkovic, D., additional, Kaelin Agten, A., additional, Mashiach, R., additional, Naji, O., additional, Pajkrt, E., additional, Timmerman, D., additional, Vikhareva, O., additional, Van Der Voet, L. F., additional, and Huirne, J. A. F., additional
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- 2022
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6. Word Catheter and Marsupialisation in Women With a Cyst or Abscess of the Bartholin Gland (WoMan-Trial): A Randomised Clinical Trial
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Kroese, J. A., van der Velde, M., Morssink, L. P., Zafarmand, M. H., Geomini, P., van Kesteren, P. J. M., Radder, C. M., van der Voet, L. F., Roovers, J. P. W. R., Graziosi, G. C. M., van Baal, W. M., van Bavel, J., Catshoek, R., Klinkert, E. R., Huirne, J. A. F., Clark, T. J., Mol, B. W. J., and Reesink-Peters, N.
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- 2017
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7. Economic evaluation of endometrial scratching before the second IVF/ICSI treatment: a cost-effectiveness analysis of a randomized controlled trial (SCRaTCH trial)
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van Hoogenhuijze, N E, primary, van Eekelen, R, additional, Mol, F, additional, Schipper, I, additional, Groenewoud, E R, additional, Traas, M A F, additional, Janssen, C A H, additional, Teklenburg, G, additional, de Bruin, J P, additional, van Oppenraaij, R H F, additional, Maas, J W M, additional, Moll, E, additional, Fleischer, K, additional, van Hooff, M H A, additional, de Koning, C H, additional, Cantineau, A E P, additional, Lambalk, C B, additional, Verberg, M, additional, van Heusden, A M, additional, Manger, A P, additional, van Rumste, M M E, additional, van der Voet, L F, additional, Pieterse, Q D, additional, Visser, J, additional, Brinkhuis, E A, additional, den Hartog, J E, additional, Glas, M W, additional, Klijn, N F, additional, van der Zanden, M, additional, Bandell, M L, additional, Boxmeer, J C, additional, van Disseldorp, J, additional, Smeenk, J, additional, van Wely, M, additional, Eijkemans, M J C, additional, Torrance, H L, additional, and Broekmans, F J M, additional
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- 2021
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8. Effect of single- versus double-layer uterine closure during caesarean section on postmenstrual spotting (2Close): multicentre, double-blind, randomised controlled superiority trial
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Stegwee, S. I., van der Voet, L. F., Ben, A. J., de Leeuw, R. A., van de Ven, P. M., Duijnhoven, R. G., Bongers, M. Y., Lambalk, C. B., de Groot, C. J. M., Huirne, J. A. F., Papatsonis, Dimitri N. M., Pajkrt, Eva, Hehenkamp, Wouter J. K., Oei, Angèle L. M., Bekker, Mireille N., Schippers, Daniela H., van Vliet, Huib A. AM, van der Voet, Lucet, Schuitemaker, Nico W. E., Hemelaar, Majoie, van Baal, W. M., Huisjes, Anjoke J. M., Meijer, Wouter J., Janssen, C. A. H., Hermes, Wietske, Feitsma, A. H., van Eijndhoven, Hugo W. F., Rijnders, Robbert J. P., Sueters, Marieke, Scheepers, H. C. J., van Laar, Judith O. EH, Boormans, Elisabeth M. A., van Kesteren, Paul J. M., Radder, Celine M., Hink, Esther, Kapiteijn, Kitty, de Boer, Karin, Kaplan, Mesrure, van Beek, Erik, de Vleeschouwer, L. H. M., Visser, Harry, Bosmans, Judith E., el Alili, Mohamed, Langenveld, Josje, RS: GROW - R4 - Reproductive and Perinatal Medicine, Obstetrie & Gynaecologie, MUMC+: MA Medische Staf Obstetrie Gynaecologie (9), Health Economics and Health Technology Assessment, Amsterdam Public Health, Science and Society, APH - Mental Health, APH - Methodology, Obstetrics and Gynaecology, APH - Personalized Medicine, APH - Quality of Care, ARD - Amsterdam Reproduction and Development, Obstetrics and gynaecology, Amsterdam Reproduction & Development (AR&D), Epidemiology and Data Science, ACS - Heart failure & arrhythmias, APH - Societal Participation & Health, Other Research, and Cardiology
- Subjects
SYMPTOMS ,medicine.medical_treatment ,CORONIS ,Postoperative Complications ,0302 clinical medicine ,Superiority Trial ,Pregnancy ,uterine closure technique ,Medicine and Health Sciences ,Caesarean section ,Menstruation Disturbances ,media_common ,education.field_of_study ,OUTCOMES ,030219 obstetrics & reproductive medicine ,Obstetrics ,NICHE ,Obstetrics and Gynecology ,PREVALENCE ,Treatment Outcome ,Female ,Adult ,medicine.medical_specialty ,INCISION ,media_common.quotation_subject ,Population ,TERM ,Postmenstrual spotting ,Double blind ,03 medical and health sciences ,single layer ,Double-Blind Method ,medicine ,Humans ,Closure (psychology) ,education ,Menstrual cycle ,Cesarean Section ,business.industry ,Suture Techniques ,Perioperative ,SCAR ,FACTORIAL ,Linear Models ,RISK-FACTORS ,double layer ,postmenstrual spotting ,business ,Follow-Up Studies - Abstract
Objective To evaluate whether double-layer uterine closure after a first caesarean section (CS) is superior compared with single-layer uterine closure in terms of postmenstrual spotting and niche development in the uterine caesarean scar.Design Multicentre, double-blind, randomised controlled superiority trial.Setting Thirty-two hospitals in the Netherlands.Population A total of 2292 women aged >= 18 years undergoing a first CS were randomly assigned to each procedure (1:1): 1144 women were assigned to single-layer uterine closure and 1148 women were assigned to double-layer uterine closure.Methods Single-layer unlocked closure and double-layer unlocked closure, with the second layer imbricating the first.Main outcome measures Number of days with postmenstrual spotting during one menstrual cycle 9 months after CS. Secondary outcomes: perioperative and menstrual characteristics; transvaginal ultrasound measurements.Results A total of 774 (67.7%) women from the single-layer group and 770 (67.1%) women from the double-layer group were evaluable for the primary outcome, as a result of drop-out and amenorrhoea. The mean number of postmenstrual spotting days was 1.33 (bootstrapped 95% CI 1.12-1.54) after single-layer closure and 1.26 (bootstrapped 95% CI 1.07-1.45) after double-layer closure (adjusted mean difference -0.07, 95% CI -0.37 to 0.22, P = 0.810). The operative time was 3.9 minutes longer (95% CI 3.0-4.9 minutes, P < 0.001) and niche prevalence was 4.7% higher (95% CI 0.7-8.7%, P = 0.022) after double-layer closure.Conclusions The superiority of double-layer closure compared with single-layer closure in terms of postmenstrual spotting after a first CS was not shown. Long-term obstetric follow-up of our trial is needed to assess whether uterine caesarean closure guidelines should be adapted.Tweetable abstract Double-layer uterine closure is not superior for postmenstrual spotting after a first caesarean; single-layer closure performs slightly better on other outcomes.
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- 2021
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9. Reply: Niche risk factor for uterine rupture?
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Bij de Vaate, A. J.M., van der Voet, L. F., Naji, O., Witmer, M., Veersema, S., Brölmann, H. A.M., Bourne, T., and Huirne, J. A.F.
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- 2014
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10. Prevalence, potential risk factors for development and symptoms related to the presence of uterine niches following Cesarean section: systematic review
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Bij de Vaate, A. J. M., van der Voet, L. F., Naji, O., Witmer, M., Veersema, S., Brölmann, H. A. M., Bourne, T., and Huirne, J. A. F.
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- 2014
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11. Endometrial scratching in women with one failed IVF/ICSI cycle-outcomes of a randomised controlled trial (SCRaTCH)
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MS VPG/Gynaecologie, Infection & Immunity, Biostatistiek Onderzoek, Child Health, Circulatory Health, JC onderzoeksprogramma Infectieziekten, JC onderzoeksprogramma Methodologie, van Hoogenhuijze, N E, Mol, F, Laven, J S E, Groenewoud, E R, Traas, M A F, Janssen, C A H, Teklenburg, G, de Bruin, J P, van Oppenraaij, R H F, Maas, J W M, Moll, E, Fleischer, K, van Hooff, M H A, de Koning, C H, Cantineau, A E P, Lambalk, C B, Verberg, M, van Heusden, A M, Manger, A P, van Rumste, M M E, van der Voet, L F, Pieterse, Q D, Visser, J, Brinkhuis, E A, den Hartog, J E, Glas, M W, Klijn, N F, van der Meer, S, Bandell, M L, Boxmeer, J C, van Disseldorp, J, Smeenk, J, van Wely, M, Eijkemans, M J C, Torrance, H L, Broekmans, F J M, MS VPG/Gynaecologie, Infection & Immunity, Biostatistiek Onderzoek, Child Health, Circulatory Health, JC onderzoeksprogramma Infectieziekten, JC onderzoeksprogramma Methodologie, van Hoogenhuijze, N E, Mol, F, Laven, J S E, Groenewoud, E R, Traas, M A F, Janssen, C A H, Teklenburg, G, de Bruin, J P, van Oppenraaij, R H F, Maas, J W M, Moll, E, Fleischer, K, van Hooff, M H A, de Koning, C H, Cantineau, A E P, Lambalk, C B, Verberg, M, van Heusden, A M, Manger, A P, van Rumste, M M E, van der Voet, L F, Pieterse, Q D, Visser, J, Brinkhuis, E A, den Hartog, J E, Glas, M W, Klijn, N F, van der Meer, S, Bandell, M L, Boxmeer, J C, van Disseldorp, J, Smeenk, J, van Wely, M, Eijkemans, M J C, Torrance, H L, and Broekmans, F J M
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- 2021
12. Minimally invasive therapy for gynaecological symptoms related to a niche in the caesarean scar: a systematic review
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van der Voet, L F, Vervoort, A J, Veersema, S, BijdeVaate, A J, Brölmann, H AM, and Huirne, J AF
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- 2014
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13. Long-term complications of caesarean section. The niche in the scar: a prospective cohort study on niche prevalence and its relation to abnormal uterine bleeding
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van der Voet, L F, Bij de Vaate, A M, Veersema, S, Brölmann, H AM, and Huirne, J AF
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- 2014
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14. Ultrasound evaluation of the Cesarean scar: relation between a niche and postmenstrual spotting
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Bij de Vaate, A. J. M., Brölmann, H. A. M., van der Voet, L. F., van der Slikke, J. W., Veersema, S., and Huirne, J. A. F.
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- 2011
15. Endometrial scratching in women with one failed IVF/ICSI cycle—outcomes of a randomised controlled trial (SCRaTCH)
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van Hoogenhuijze, N E, primary, Mol, F, additional, Laven, J S E, additional, Groenewoud, E R, additional, Traas, M A F, additional, Janssen, C A H, additional, Teklenburg, G, additional, de Bruin, J P, additional, van Oppenraaij, R H F, additional, Maas, J W M, additional, Moll, E, additional, Fleischer, K, additional, van Hooff, M H A, additional, de Koning, C H, additional, Cantineau, A E P, additional, Lambalk, C B, additional, Verberg, M, additional, van Heusden, A M, additional, Manger, A P, additional, van Rumste, M M E, additional, van der Voet, L F, additional, Pieterse, Q D, additional, Visser, J, additional, Brinkhuis, E A, additional, den Hartog, J E, additional, Glas, M W, additional, Klijn, N F, additional, van der Meer, S, additional, Bandell, M L, additional, Boxmeer, J C, additional, van Disseldorp, J, additional, Smeenk, J, additional, van Wely, M, additional, Eijkemans, M J C, additional, Torrance, H L, additional, and Broekmans, F J M, additional
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- 2020
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16. Single- versus double-layer closure of the caesarean (uterine) scar in the prevention of gynaecological symptoms in relation to niche development - the 2Close study: a multicentre randomised controlled trial
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Arts-assistenten Kinderen, Orthopaedie Opleiding, Regenerative Medicine and Stem Cells, MS Reumatologie/Immunologie/Infectie, Infection & Immunity, MS Verloskunde, Child Health, Arts-assistenten DV&B, Stegwee, S I, Jordans, I P M, van der Voet, L F, Bongers, M Y, de Groot, C J M, Lambalk, C B, de Leeuw, R A, Hehenkamp, W J K, van de Ven, P M, Bosmans, J E, Pajkrt, E, Bakkum, E A, Radder, C M, Hemelaar, M, van Baal, W M, Visser, H, van Laar, J O E H, van Vliet, H A A M, Rijnders, R J P, Sueters, M, Janssen, C A H, Hermes, W, Feitsma, A H, Kapiteijn, K, Scheepers, H C J, Langenveld, J, de Boer, K, Coppus, S F P J, Schippers, D H, Oei, A L M, Kaplan, M, Papatsonis, D N M, de Vleeschouwer, L H M, van Beek, E, Bekker, M N, Huisjes, A J M, Meijer, W J, Deurloo, K L, Boormans, E M A, van Eijndhoven, H W F, Huirne, J A F, Arts-assistenten Kinderen, Orthopaedie Opleiding, Regenerative Medicine and Stem Cells, MS Reumatologie/Immunologie/Infectie, Infection & Immunity, MS Verloskunde, Child Health, Arts-assistenten DV&B, Stegwee, S I, Jordans, I P M, van der Voet, L F, Bongers, M Y, de Groot, C J M, Lambalk, C B, de Leeuw, R A, Hehenkamp, W J K, van de Ven, P M, Bosmans, J E, Pajkrt, E, Bakkum, E A, Radder, C M, Hemelaar, M, van Baal, W M, Visser, H, van Laar, J O E H, van Vliet, H A A M, Rijnders, R J P, Sueters, M, Janssen, C A H, Hermes, W, Feitsma, A H, Kapiteijn, K, Scheepers, H C J, Langenveld, J, de Boer, K, Coppus, S F P J, Schippers, D H, Oei, A L M, Kaplan, M, Papatsonis, D N M, de Vleeschouwer, L H M, van Beek, E, Bekker, M N, Huisjes, A J M, Meijer, W J, Deurloo, K L, Boormans, E M A, van Eijndhoven, H W F, and Huirne, J A F
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- 2019
17. Sonographic examination of uterine niche in non‐pregnant women: a modified Delphi procedure
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Jordans, I. P. M., primary, de Leeuw, R. A., additional, Stegwee, S. I., additional, Amso, N. N., additional, Barri‐Soldevila, P. N., additional, van den Bosch, T., additional, Bourne, T., additional, Brölmann, H. A. M., additional, Donnez, O., additional, Dueholm, M., additional, Hehenkamp, W. J. K., additional, Jastrow, N., additional, Jurkovic, D., additional, Mashiach, R., additional, Naji, O., additional, Streuli, I., additional, Timmerman, D., additional, van der Voet, L. F., additional, and Huirne, J. A. F., additional
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- 2019
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18. Endometrial scratching in women with implantation failure after a first IVF/ICSI cycle; does it lead to a higher live birth rate? The SCRaTCH study: a randomized controlled trial (NTR 5342)
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van Hoogenhuijze, N. E., primary, Torrance, H. L., additional, Mol, F., additional, Laven, J. S. E., additional, Scheenjes, E., additional, Traas, M. A. F., additional, Janssen, C., additional, Cohlen, B., additional, Teklenburg, G., additional, de Bruin, J. P., additional, van Oppenraaij, R., additional, Maas, J. W. M., additional, Moll, E., additional, Fleischer, K., additional, van Hooff, M. H., additional, de Koning, C., additional, Cantineau, A., additional, Lambalk, C. B., additional, Verberg, M., additional, Nijs, M., additional, Manger, A. P., additional, van Rumste, M., additional, van der Voet, L. F., additional, Preys-Bosman, A., additional, Visser, J., additional, Brinkhuis, E., additional, den Hartog, J. E., additional, Sluijmer, A., additional, Jansen, F. W., additional, Hermes, W., additional, Bandell, M. L., additional, Pelinck, M. J., additional, van Disseldorp, J., additional, van Wely, M., additional, Smeenk, J., additional, Pieterse, Q. D., additional, Boxmeer, J.C., additional, Groenewoud, E.R., additional, Eijkemans, M. J. C., additional, Kasius, J. C., additional, and Broekmans, F. J. M., additional
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- 2017
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19. Endometrial scratching in women with implantation failure after a first IVF/ICSI cycle; does it lead to a higher live birth rate? The SCRaTCH study : A randomized controlled trial (NTR 5342)
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van Hoogenhuijze, N. E., Torrance, H. L., Mol, F., Laven, Joop S E, Scheenjes, E., Traas, M.A.F., Janssen, Bert J C, Cohlen, B., Teklenburg, G., Bruin, Jacob P, van Oppenraaij, R., Maas, J. W M, Moll, Etelka, Fleischer, K., van Hooff, Marcel H, de Koning, C., Cantineau, A., Lambalk, Cornelis B., Verberg, M.F.G., Nijs, M. M., Manger, A. P., Van Rumste, M. M., Van der Voet, L F, Preys-Bosman, A., Visser, J., Brinkhuis, E.A., den Hartog, J. E., Sluijmer, A., Jansen, F. W., Hermes, W., Bandell, M. L., Pelinck, M. J., van Disseldorp, J., Wely, M., Smeenk, J., Pieterse, Q.D., Boxmeer, J.C., Groenewoud, Eva R., Eijkemans, M. J.C., Kasius, J. C., Broekmans, F. J.M., van Hoogenhuijze, N. E., Torrance, H. L., Mol, F., Laven, Joop S E, Scheenjes, E., Traas, M.A.F., Janssen, Bert J C, Cohlen, B., Teklenburg, G., Bruin, Jacob P, van Oppenraaij, R., Maas, J. W M, Moll, Etelka, Fleischer, K., van Hooff, Marcel H, de Koning, C., Cantineau, A., Lambalk, Cornelis B., Verberg, M.F.G., Nijs, M. M., Manger, A. P., Van Rumste, M. M., Van der Voet, L F, Preys-Bosman, A., Visser, J., Brinkhuis, E.A., den Hartog, J. E., Sluijmer, A., Jansen, F. W., Hermes, W., Bandell, M. L., Pelinck, M. J., van Disseldorp, J., Wely, M., Smeenk, J., Pieterse, Q.D., Boxmeer, J.C., Groenewoud, Eva R., Eijkemans, M. J.C., Kasius, J. C., and Broekmans, F. J.M.
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- 2017
20. Diagnostic workup for postmenopausal bleeding : a randomised controlled trial
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van Hanegem, N., Breijer, M. C., Slockers, S. A., Zafarmand, M. H., Geomini, P. M A J, Catshoek, R., Pijnenborg, J. M A, van der Voet, L. F., Dijkhuizen, F. P H L J, van Hoecke, G. C R, Reesink-Peters, N., Veersema, S., van Hooff, M. H A, van Kesteren, P. J M, Huirne, J. A., Opmeer, B. C., Bongers, M. Y., Mol, B. W J, Timmermans, A., van Hanegem, N., Breijer, M. C., Slockers, S. A., Zafarmand, M. H., Geomini, P. M A J, Catshoek, R., Pijnenborg, J. M A, van der Voet, L. F., Dijkhuizen, F. P H L J, van Hoecke, G. C R, Reesink-Peters, N., Veersema, S., van Hooff, M. H A, van Kesteren, P. J M, Huirne, J. A., Opmeer, B. C., Bongers, M. Y., Mol, B. W J, and Timmermans, A.
- Published
- 2017
21. Endometrial scratching in women with implantation failure after a first IVF/ICSI cycle; does it lead to a higher live birth rate? The SCRaTCH study: A randomized controlled trial (NTR 5342)
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UMC Utrecht, MS VPG/Gynaecologie, Fertiliteitartsen, Child Health, Infection & Immunity, Biostatistiek Onderzoek, Circulatory Health, JC onderzoeksprogramma Methodologie, JC onderzoeksprogramma Infectieziekten, Arts-assistenten DV&B, van Hoogenhuijze, N. E., Torrance, H. L., Mol, F., Laven, Joop S E, Scheenjes, E., Traas, M.A.F., Janssen, Bert J C, Cohlen, B., Teklenburg, G., Bruin, Jacob P, van Oppenraaij, R., Maas, J. W M, Moll, Etelka, Fleischer, K., van Hooff, Marcel H, de Koning, C., Cantineau, A., Lambalk, Cornelis B., Verberg, M.F.G., Nijs, M. M., Manger, A. P., Van Rumste, M. M., Van der Voet, L F, Preys-Bosman, A., Visser, J., Brinkhuis, E.A., den Hartog, J. E., Sluijmer, A., Jansen, F. W., Hermes, W., Bandell, M. L., Pelinck, M. J., van Disseldorp, J., Wely, M., Smeenk, J., Pieterse, Q.D., Boxmeer, J.C., Groenewoud, Eva R., Eijkemans, M. J.C., Kasius, J. C., Broekmans, F. J.M., UMC Utrecht, MS VPG/Gynaecologie, Fertiliteitartsen, Child Health, Infection & Immunity, Biostatistiek Onderzoek, Circulatory Health, JC onderzoeksprogramma Methodologie, JC onderzoeksprogramma Infectieziekten, Arts-assistenten DV&B, van Hoogenhuijze, N. E., Torrance, H. L., Mol, F., Laven, Joop S E, Scheenjes, E., Traas, M.A.F., Janssen, Bert J C, Cohlen, B., Teklenburg, G., Bruin, Jacob P, van Oppenraaij, R., Maas, J. W M, Moll, Etelka, Fleischer, K., van Hooff, Marcel H, de Koning, C., Cantineau, A., Lambalk, Cornelis B., Verberg, M.F.G., Nijs, M. M., Manger, A. P., Van Rumste, M. M., Van der Voet, L F, Preys-Bosman, A., Visser, J., Brinkhuis, E.A., den Hartog, J. E., Sluijmer, A., Jansen, F. W., Hermes, W., Bandell, M. L., Pelinck, M. J., van Disseldorp, J., Wely, M., Smeenk, J., Pieterse, Q.D., Boxmeer, J.C., Groenewoud, Eva R., Eijkemans, M. J.C., Kasius, J. C., and Broekmans, F. J.M.
- Published
- 2017
22. Diagnostic workup for postmenopausal bleeding: a randomised controlled trial
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MS VPG/Gynaecologie, van Hanegem, N., Breijer, M. C., Slockers, S. A., Zafarmand, M. H., Geomini, P. M A J, Catshoek, R., Pijnenborg, J. M A, van der Voet, L. F., Dijkhuizen, F. P H L J, van Hoecke, G. C R, Reesink-Peters, N., Veersema, S., van Hooff, M. H A, van Kesteren, P. J M, Huirne, J. A., Opmeer, B. C., Bongers, M. Y., Mol, B. W J, Timmermans, A., MS VPG/Gynaecologie, van Hanegem, N., Breijer, M. C., Slockers, S. A., Zafarmand, M. H., Geomini, P. M A J, Catshoek, R., Pijnenborg, J. M A, van der Voet, L. F., Dijkhuizen, F. P H L J, van Hoecke, G. C R, Reesink-Peters, N., Veersema, S., van Hooff, M. H A, van Kesteren, P. J M, Huirne, J. A., Opmeer, B. C., Bongers, M. Y., Mol, B. W J, and Timmermans, A.
- Published
- 2017
23. Uterine caesarean closure techniques affect ultrasound findings and maternal outcomes: a systematic review and meta-analysis.
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Stegwee, S. I., Jordans, I. P. M., van der Voet, L. F., van de Ven, P. M., Ket, J. C. F., Lambalk, C. B., de Groot, C. J. M., Hehenkamp, W. J. K., Huirne, J. A. F., Jordans, Ipm, Ket, Jcf, de Groot, Cjm, Hehenkamp, Wjk, and Huirne, Jaf
- Subjects
CESAREAN section complications ,UTERINE surgery ,HEALTH outcome assessment ,RANDOMIZED controlled trials ,SYSTEMATIC reviews ,CESAREAN section ,CLINICAL trials ,DYSMENORRHEA ,LONGITUDINAL method ,META-analysis ,MYOMETRIUM ,SURGICAL complications ,OPERATIVE surgery ,SUTURING ,ULTRASONIC imaging ,UTERUS ,UTERINE rupture ,WOUND healing ,TREATMENT effectiveness - Abstract
Background: Caesarean section (CS) rates are rising globally. Long-term adverse outcomes after CS might be reduced when the optimal uterine closure technique becomes evident.Objective: To determine the effect of uterine closure techniques after CS on maternal and ultrasound outcomes.Search Strategy: Literature search in electronic databases.Selection Criteria: Randomised controlled trials (RCTs) or prospective cohort studies that evaluated uterine closure techniques and reported on ultrasound findings, perioperative or long-term outcomes.Data Collection and Analysis: Twenty studies (15 053 women) were included in our meta-analyses for various outcomes. We calculated pooled risk ratios (RR) and weighted mean differences (WMD) with 95% CI through random-effect analysis.Main Results: Residual myometrium thickness (RMT), reported in eight studies (508 women), decreased by 1.26 mm after single- compared with double-layer closure (95% CI -1.93 to -0.58), particularly when locked sutures were used. Healing ratio [RMT/adjacent myometrium thickness (AMT)] decreased after single-layer closure (WMD -7.74%, 95% CI -13.31 to -2.17), particularly in the case of locked sutures. Niche prevalence increased (RR 1.71, 95% CI 1.11-2.62) when the decidua was excluded. Dysmenorrhea occurred more often in the single-layer group (RR 1.23, 95% CI 1.01-1.48), whereas incidence of uterine rupture was similar (RR 1.91, 95% CI 0.63-5.74).Conclusion: Double-layer unlocked sutures are preferable to single-layer locked sutures regarding RMT, healing ratio and dysmenorrhoea. Excluding the decidua seems to result in higher niche prevalence. As thin residual myometrium or niches may serve as intermediates for gynaecological and reproductive outcomes, future studies should focus on these outcomes. TWEETABLE ABSTRACT: #Uterineclosuretechniques after #caesarean affect #longtermoutcomes. [ABSTRACT FROM AUTHOR]- Published
- 2018
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24. The HysNiche trial : hysteroscopic resection of uterine caesarean scar defect (niche) in patients with abnormal bleeding, a randomised controlled trial
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Vervoort, A J M W, Van der Voet, L F, Witmer, M, Thurkow, A L, Radder, C M, van Kesteren, P J M, Quartero, H W P, Kuchenbecker, W K H, Bongers, M Y, Geomini, P M A J, de Vleeschouwer, L H M, van Hooff, M H A, van Vliet, H A A M, Veersema, S, Renes, W B, van Meurs, H S, Bosmans, J, Oude Rengerink, K, Brölmann, H A M, Mol, B W J, Huirne, J A F, Vervoort, A J M W, Van der Voet, L F, Witmer, M, Thurkow, A L, Radder, C M, van Kesteren, P J M, Quartero, H W P, Kuchenbecker, W K H, Bongers, M Y, Geomini, P M A J, de Vleeschouwer, L H M, van Hooff, M H A, van Vliet, H A A M, Veersema, S, Renes, W B, van Meurs, H S, Bosmans, J, Oude Rengerink, K, Brölmann, H A M, Mol, B W J, and Huirne, J A F
- Published
- 2015
25. The HysNiche trial: hysteroscopic resection of uterine caesarean scar defect (niche) in patients with abnormal bleeding, a randomised controlled trial
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Arts-assistenten Kinderen, Epi Methoden Team 1, Vervoort, A J M W, Van der Voet, L F, Witmer, M, Thurkow, A L, Radder, C M, van Kesteren, P J M, Quartero, H W P, Kuchenbecker, W K H, Bongers, M Y, Geomini, P M A J, de Vleeschouwer, L H M, van Hooff, M H A, van Vliet, H A A M, Veersema, S, Renes, W B, van Meurs, H S, Bosmans, J, Oude Rengerink, K, Brölmann, H A M, Mol, B W J, Huirne, J A F, Arts-assistenten Kinderen, Epi Methoden Team 1, Vervoort, A J M W, Van der Voet, L F, Witmer, M, Thurkow, A L, Radder, C M, van Kesteren, P J M, Quartero, H W P, Kuchenbecker, W K H, Bongers, M Y, Geomini, P M A J, de Vleeschouwer, L H M, van Hooff, M H A, van Vliet, H A A M, Veersema, S, Renes, W B, van Meurs, H S, Bosmans, J, Oude Rengerink, K, Brölmann, H A M, Mol, B W J, and Huirne, J A F
- Published
- 2015
26. The HysNiche trial: hysteroscopic resection of uterine caesarean scar defect (niche) in patients with abnormal bleeding, a randomised controlled trial
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Vervoort, A. J. M. W., primary, Van der Voet, L. F., additional, Witmer, M., additional, Thurkow, A. L., additional, Radder, C. M., additional, van Kesteren, P. J. M., additional, Quartero, H. W. P., additional, Kuchenbecker, W. K. H., additional, Bongers, M. Y., additional, Geomini, P. M. A. J., additional, de Vleeschouwer, L. H. M., additional, van Hooff, M. H. A., additional, van Vliet, H. A. A. M., additional, Veersema, S., additional, Renes, W. B., additional, van Meurs, H. S., additional, Bosmans, J., additional, Rengerink, K. Oude, additional, Brölmann, H. A. M., additional, Mol, B. W. J., additional, and Huirne, J. A. F., additional
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- 2015
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27. Should endometrial polyps be removed in patients with postmenopausal bleeding?-an assessment of study designs and report of a failed randomised controlled trial (ISRCTN73825127)
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Timmermans, A., Veersema, S., van Kerkvoorde, T. C., van der Voet, L. F., Opmeer, B. C., Bongers, M. Y., Mol, B. W. J., Obstetrics and Gynaecology, Amsterdam Public Health, and Epidemiology and Data Science
- Abstract
We describe the design of a randomised controlled trial to evaluate the efficacy of endometrial polyp removal in women with postmenopausal bleeding. We designed a trial in which patients with postmenopausal bleeding and endometrial thickness >4 mm undergo hysteroscopy. If during hysteroscopy an endometrial polyp was diagnosed, patients were asked to participate in this trial and after informed consent allocated to immediate removal of the polyp or expectant management. This trial suffered from lack of recruitment related both to doctors seeking for informed consent as well as to patients' unwillingness to participate in this trial. However, a randomised controlled trial on this subject is still necessary to evaluate the efficacy of uterine cavity evaluation in the diagnostic work-up of women with postmenopausal bleeding, focussing on benign pathology. Therefore, we propose an alternative design, which might be more feasible
- Published
- 2009
28. Hysteroscopic resection of a uterine caesarean scar defect (niche) in women with postmenstrual spotting: a randomised controlled trial.
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Vervoort, A. J. M. W., van der Voet, L. F., Hehenkamp, W. J. K., Thurkow, A. L., van Kesteren, P. J. M., Quartero, H., Kuchenbecker, W., Bongers, M., Geomini, P., de Vleeschouwer, L. H. M., van Hooff, M. H. A., van Vliet, H., Veersema, S., Renes, W. B., Oude Rengerink, K., Zwolsman, S. E., Brölmann, H. A. M., Mol, B. W. J., Huirne, J. A. F., and Vervoort, Ajmw
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- *
HYSTEROSCOPIC surgery , *UTERINE surgery , *METRORRHAGIA , *CESAREAN section , *QUALITY of life , *DYSURIA , *MYOMETRIUM , *MYOMETRIUM surgery , *COMPARATIVE studies , *HYSTEROSCOPY , *RESEARCH methodology , *MEDICAL cooperation , *RESEARCH , *SCARS , *SURGICAL complications , *WOMEN'S health , *EVALUATION research , *RANDOMIZED controlled trials , *TREATMENT effectiveness , *REHABILITATION - Abstract
Objective: To compare the effectiveness of a hysteroscopic niche resection versus no treatment in women with postmenstrual spotting and a uterine caesarean scar defect.Design: Multicentre randomised controlled trial.Setting: Eleven hospitals collaborating in a consortium for women's health research in the Netherlands.Population: Women reporting postmenstrual spotting after a caesarean section who had a niche with a residual myometrium of ≥3 mm, measured during sonohysterography.Methods: Women were randomly allocated to hysteroscopic niche resection or expectant management for 6 months.Main Outcome Measures: The primary outcome was the number of days of postmenstrual spotting 6 months after randomisation. Secondary outcomes were spotting at the end of menstruation, intermenstrual spotting, dysuria, sonographic niche measurements, surgical parameters, quality of life, women's satisfaction, sexual function, and additional therapy. Outcomes were measured at 3 months and, except for niche measurements, also at 6 months after randomisation.Results: We randomised 52 women to hysteroscopic niche resection and 51 women to expectant management. The median number of days of postmenstrual spotting at baseline was 8 days in both groups. At 6 months after randomisation, the median number of days of postmenstrual spotting was 4 days (interquartile range, IQR 2-7 days) in the intervention group and 7 days (IQR 3-10 days) in the control group (P = 0.04); on a scale of 0-10, discomfort as a result of spotting had a median score of 2 (IQR 0-7) in the intervention group, compared with 7 (IQR 0-8) in the control group (P = 0.02).Conclusions: In women with a niche with a residual myometrium of ≥3 mm, hysteroscopic niche resection reduced postmenstrual spotting and spotting-related discomfort.Tweetable Abstract: A hysteroscopic niche resection is an effective treatment to reduce niche-related spotting. [ABSTRACT FROM AUTHOR]- Published
- 2018
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29. Ultrasound evaluation of the Cesarean scar: relation between a niche and postmenstrual spotting
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Bij de Vaate, A. J. M., primary, Brölmann, H. A. M., additional, van der Voet, L. F., additional, van der Slikke, J. W., additional, Veersema, S., additional, and Huirne, J. A. F., additional
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- 2010
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30. P06.10: Therapeutical options of Cesarean scar pregnancy: experience of a University Hospital
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Bij de Vaate, M., primary, Brölmann, H., additional, van der Slikke, J. W., additional, van der Voet, L. F., additional, Wouters, M., additional, Bartholomew, J., additional, and Huirne, J., additional
- Published
- 2009
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31. Structured hysteroscopic examination of uterine niches: a modified Delphi procedure.
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Min N, de Leeuw RA, van der Voet LF, Di Spiezio Sardo A, Barri-Soldevila PN, Dueholm M, Donnez O, Saridogan E, Clark TJ, Brolmann HAM, Thurkow AL, Jurkovic D, van den Bosch T, Bourne T, Hehenkamp WJK, and Huirne JAF
- Abstract
Background: Uterine niches in the Caesarean section scar are seen in approximately half of women with a history of caesarean delivery. Whilst a structured ultrasound assessment of caesarean defects has been described, there is no consensus on a structured hysteroscopic evaluation., Objectives: To propose a methodology for a structured hysteroscopic evaluation of uterine niches., Materials and Methods: We conducted a modified Delphi procedure, including two online rounds and two face-to-face meetings of the members of the ESGE Uterine Niches Working Group. The taskforce members have extensive experience in hysteroscopic niche evaluation. The consensus was predefined as a Rate of Agreement of at least 75%., Results: Thirteen experts participated in this modified Delphi procedure. There was consensus on the need for a standardised methodology and the hysteroscopic definition of a niche as any indentation in the myometrium at the site of a previous CS. There was consensus that a hysteroscopic evaluation of a niche must be combined with ultrasound to measure the residual myometrial thickness. In addition, it was agreed that niches should be subclassified as 'simple', 'simple with one branch', or 'complex'. There was consensus that the following items should be described during a hysteroscopic niche evaluation: the number of niches, the size in relation to the size of cervical canal, the presence of polyps, crypts, cysts, fibrotic tissue, blood, mucus, placental remnants, a dynamic valve, the appearance of the endometrium, the number of blood vessels and bleeding from blood vessels within the defect., Conclusion: Using a modified Delphi procedure with international experts, consensus was achieved on the hysteroscopic evaluation and classification of niches in the uterine caesarean section scar., What Is New?: A structured registration form was developed to aid consistency in hysteroscopic niche reporting.
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- 2024
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32. Prognostic model on niche development after a first caesarean section: development and internal validation.
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Stegwee SI, van der Voet LFL, Heymans MW, Kapiteijn K, van Laar JOEH, van Baal WMM, de Groot CJM, and Huirne JAF
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- Female, Pregnancy, Humans, Prognosis, Uterus surgery, Myometrium pathology, Cesarean Section adverse effects, Cesarean Section methods, Cicatrix etiology
- Abstract
Objective: To develop and internally validate a prognostic prediction model for development of a niche in the uterine scar after a first caesarean section (CS)., Study Design: Secondary analyses on data of a randomized controlled trial, performed in 32 hospitals in the Netherlands among women undergoing a first caesarean section. We used multivariable backward logistic regression. Missing data were handled using multiple imputation. Model performance was assessed by calibration and discrimination. Internal validation using bootstrapping techniques took place. The outcome was 'development of a niche in the uterus', defined as an indentation of ≥ 2 mm in the myometrium., Results: We developed two models to predict niche development: in the total population and after elective CS. Patient related risk factors were: gestational age, twin pregnancy and smoking, and surgery related risk factors were double-layer closure and less surgical experience. Multiparity and Vicryl suture material were protective factors. The prediction model in women undergoing elective CS revealed similar results. After internal validation, Nagelkerke R
2 ranged from 0.01 to 0.05 and was considered low; median area under the curve (AUC) ranged from 0.56 to 0.62, indicating failed to poor discriminative ability., Conclusions: The model cannot be used to accurately predict the development of a niche after a first CS. However, several factors seem to influence scar healing which indicates possibilities for future prevention such as surgical experience and suture material. The search for additional risk factors that play a role in development of a niche should be continued to improve the discriminative ability., Competing Interests: Declaration of Competing Interest Judith Huirne received a grant from ZonMw for the conduction of the study; she received a grant from Samsung, PlantTec, and a fee from Olympus, all outside the submitted work. Christianne de Groot received a grant from ZonMw outside the submitted work. The remaining authors report no conflict of interest., (Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)- Published
- 2023
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33. Economic evaluation of endometrial scratching before the second IVF/ICSI treatment: a cost-effectiveness analysis of a randomized controlled trial (SCRaTCH trial).
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van Hoogenhuijze NE, van Eekelen R, Mol F, Schipper I, Groenewoud ER, Traas MAF, Janssen CAH, Teklenburg G, de Bruin JP, van Oppenraaij RHF, Maas JWM, Moll E, Fleischer K, van Hooff MHA, de Koning CH, Cantineau AEP, Lambalk CB, Verberg M, van Heusden AM, Manger AP, van Rumste MME, van der Voet LF, Pieterse QD, Visser J, Brinkhuis EA, den Hartog JE, Glas MW, Klijn NF, van der Zanden M, Bandell ML, Boxmeer JC, van Disseldorp J, Smeenk J, van Wely M, Eijkemans MJC, Torrance HL, and Broekmans FJM
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- Birth Rate, Cost-Benefit Analysis, Female, Humans, Live Birth, Male, Pregnancy, Pregnancy Rate, Fertilization in Vitro methods, Sperm Injections, Intracytoplasmic methods
- Abstract
Study Question: Is a single endometrial scratch prior to the second fresh IVF/ICSI treatment cost-effective compared to no scratch, when evaluated over a 12-month follow-up period?, Summary Answer: The incremental cost-effectiveness ratio (ICER) for an endometrial scratch was €6524 per additional live birth, but due to uncertainty regarding the increase in live birth rate this has to be interpreted with caution., What Is Known Already: Endometrial scratching is thought to improve the chances of success in couples with previously failed embryo implantation in IVF/ICSI treatment. It has been widely implemented in daily practice, despite the lack of conclusive evidence of its effectiveness and without investigating whether scratching allows for a cost-effective method to reduce the number of IVF/ICSI cycles needed to achieve a live birth., Study Design, Size, Duration: This economic evaluation is based on a multicentre randomized controlled trial carried out in the Netherlands (SCRaTCH trial) that compared a single scratch prior to the second IVF/ICSI treatment with no scratch in couples with a failed full first IVF/ICSI cycle. Follow-up was 12 months after randomization.Economic evaluation was performed from a healthcare and societal perspective by taking both direct medical costs and lost productivity costs into account. It was performed for the primary outcome of biochemical pregnancy leading to live birth after 12 months of follow-up as well as the secondary outcome of live birth after the second fresh IVF/ICSI treatment (i.e. the first after randomization). To allow for worldwide interpretation of the data, cost level scenario analysis and sensitivity analysis was performed., Participants/materials, Setting, Methods: From January 2016 until July 2018, 933 women with a failed first IVF/ICSI cycle were included in the trial. Data on treatment and pregnancy were recorded up until 12 months after randomization, and the resulting live birth outcomes (even if after 12 months) were also recorded.Total costs were calculated for the second fresh IVF/ICSI treatment and for the full 12 month period for each participant. We included costs of all treatments, medication, complications and lost productivity costs. Cost-effectiveness analysis was carried out by calculating ICERs for scratch compared to control. Bootstrap resampling was used to estimate the uncertainty around cost and effect differences and ICERs. In the sensitivity and scenario analyses, various unit costs for a single scratch were introduced, amongst them, unit costs as they apply for the United Kingdom (UK)., Main Results and the Role of Chance: More live births occurred in the scratch group, but this also came with increased costs over a 12-month period. The estimated chance of a live birth after 12 months of follow-up was 44.1% in the scratch group compared to 39.3% in the control group (risk difference 4.8%, 95% CI -1.6% to +11.2%). The mean costs were on average €283 (95% CI: -€299 to €810) higher in the scratch group so that the point average ICER was €5846 per additional live birth. The ICER estimate was surrounded with a high level of uncertainty, as indicated by the fact that the cost-effectiveness acceptability curve (CEAC) showed that there is an 80% chance that endometrial scratching is cost-effective if society is willing to pay ∼€17 500 for each additional live birth., Limitations, Reasons for Caution: There was a high uncertainty surrounding the effects, mainly in the clinical effect, i.e. the difference in the chance of live birth, which meant that a single straightforward conclusion could not be ascertained as for now., Wider Implications of the Findings: This is the first formal cost-effectiveness analysis of endometrial scratching in women undergoing IVF/ICSI treatment. The results presented in this manuscript cannot provide a clear-cut expenditure for one additional birth, but they do allow for estimating costs per additional live birth in different scenarios once the clinical effectiveness of scratching is known. As the SCRaTCH trial was the only trial with a follow-up of 12 months, it allows for the most complete estimation of costs to date., Study Funding/competing Interest(s): This study was funded by ZonMW, the Dutch organization for funding healthcare research. A.E.P.C., F.J.M.B., E.R.G. and C.B. L. reported having received fees or grants during, but outside of, this trial., Trial Registration Number: Netherlands Trial Register (NL5193/NTR 5342)., (© The Author(s) 2021. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology.)
- Published
- 2022
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34. Endometrial scratching in women with one failed IVF/ICSI cycle-outcomes of a randomised controlled trial (SCRaTCH).
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van Hoogenhuijze NE, Mol F, Laven JSE, Groenewoud ER, Traas MAF, Janssen CAH, Teklenburg G, de Bruin JP, van Oppenraaij RHF, Maas JWM, Moll E, Fleischer K, van Hooff MHA, de Koning CH, Cantineau AEP, Lambalk CB, Verberg M, van Heusden AM, Manger AP, van Rumste MME, van der Voet LF, Pieterse QD, Visser J, Brinkhuis EA, den Hartog JE, Glas MW, Klijn NF, van der Meer S, Bandell ML, Boxmeer JC, van Disseldorp J, Smeenk J, van Wely M, Eijkemans MJC, Torrance HL, and Broekmans FJM
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- Belgium, Birth Rate, Female, Fertilization in Vitro, Humans, Netherlands, Pregnancy, Pregnancy Rate, Live Birth, Sperm Injections, Intracytoplasmic
- Abstract
Study Question: Does endometrial scratching in women with one failed IVF/ICSI treatment affect the chance of a live birth of the subsequent fresh IVF/ICSI cycle?, Summary Answer: In this study, 4.6% more live births were observed in the scratch group, with a likely certainty range between -0.7% and +9.9%., What Is Known Already: Since the first suggestion that endometrial scratching might improve embryo implantation during IVF/ICSI, many clinical trials have been conducted. However, due to limitations in sample size and study quality, it remains unclear whether endometrial scratching improves IVF/ICSI outcomes., Study Design, Size, Duration: The SCRaTCH trial was a non-blinded randomised controlled trial in women with one unsuccessful IVF/ICSI cycle and assessed whether a single endometrial scratch using an endometrial biopsy catheter would lead to a higher live birth rate after the subsequent IVF/ICSI treatment compared to no scratch. The study took place in 8 academic and 24 general hospitals. Participants were randomised between January 2016 and July 2018 by a web-based randomisation programme. Secondary outcomes included cumulative 12-month ongoing pregnancy leading to live birth rate., Participants/materials, Setting, Methods: Women with one previous failed IVF/ICSI treatment and planning a second fresh IVF/ICSI treatment were eligible. In total, 933 participants out of 1065 eligibles were included (participation rate 88%)., Main Results and the Role of Chance: After the fresh transfer, 4.6% more live births were observed in the scratch compared to control group (110/465 versus 88/461, respectively, risk ratio (RR) 1.24 [95% CI 0.96-1.59]). These data are consistent with a true difference of between -0.7% and +9.9% (95% CI), indicating that while the largest proportion of the 95% CI is positive, scratching could have no or even a small negative effect. Biochemical pregnancy loss and miscarriage rate did not differ between the two groups: in the scratch group 27/153 biochemical pregnancy losses and 14/126 miscarriages occurred, while this was 19/130 and 17/111 for the control group (RR 1.21 (95% CI 0.71-2.07) and RR 0.73 (95% CI 0.38-1.40), respectively). After 12 months of follow-up, 5.1% more live births were observed in the scratch group (202/467 versus 178/466), of which the true difference most likely lies between -1.2% and +11.4% (95% CI)., Limitations, Reasons for Caution: This study was not blinded. Knowledge of allocation may have been an incentive for participants allocated to the scratch group to continue treatment in situations where they may otherwise have cancelled or stopped. In addition, this study was powered to detect a difference in live birth rate of 9%., Wider Implications of the Findings: The results of this study are an incentive for further assessment of the efficacy and clinical implications of endometrial scratching. If a true effect exists, it may be smaller than previously anticipated or may be limited to specific groups of women undergoing IVF/ICSI. Studying this will require larger sample sizes, which will be provided by the ongoing international individual participant data-analysis (PROSPERO CRD42017079120). At present, endometrial scratching should not be performed outside of clinical trials., Study Funding/competing Interest(s): This study was funded by ZonMW, the Dutch organisation for funding healthcare research. J.S.E. Laven reports grants and personal fees from AnshLabs (Webster, Tx, USA), Ferring (Hoofddorp, The Netherlands) and Ministry of Health (CIBG, The Hague, The Netherlands) outside the submitted work. A.E.P. Cantineau reports 'other' from Ferring BV, personal fees from Up to date Hyperthecosis, 'other' from Theramex BV, outside the submitted work. E.R. Groenewoud reports grants from Titus Health Care during the conduct of the study. A.M. van Heusden reports personal fees from Merck Serono, personal fees from Ferring, personal fees from Goodlife, outside the submitted work. F.J.M. Broekmans reports personal fees as Member of the external advisory board for Ferring BV, The Netherlands, personal fees as Member of the external advisory board for Merck Serono, The Netherlands, personal fees as Member of the external advisory for Gedeon Richter, Belgium, personal fees from Educational activities for Ferring BV, The Netherlands, grants from Research support grant Merck Serono, grants from Research support grant Ferring, personal fees from Advisory and consultancy work Roche, outside the submitted work. C.B. Lambalk reports grants from Ferring, grants from Merck, grants from Guerbet, outside the submitted work., Trial Registration Number: Registered in the Netherlands Trial Register (NL5193/NTR 5342)., Trial Registration Date: 31 July 2015., Date of First Patient’s Enrolment: 26 January 2016., (© The Author(s) 2020. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology.)
- Published
- 2021
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35. Diagnostic workup for postmenopausal bleeding: a randomised controlled trial.
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van Hanegem N, Breijer MC, Slockers SA, Zafarmand MH, Geomini P, Catshoek R, Pijnenborg J, van der Voet LF, Dijkhuizen F, van Hoecke G, Reesink-Peters N, Veersema S, van Hooff M, van Kesteren P, Huirne JA, Opmeer BC, Bongers MY, Mol B, and Timmermans A
- Subjects
- Biopsy, Female, Humans, Middle Aged, Polyps diagnosis, Precancerous Conditions complications, Precancerous Conditions diagnosis, Uterine Diseases complications, Uterine Hemorrhage diagnosis, Uterine Neoplasms complications, Uterine Neoplasms diagnosis, Uterus pathology, Watchful Waiting, Hysteroscopy statistics & numerical data, Polyps complications, Postmenopause, Uterine Diseases diagnosis, Uterine Hemorrhage etiology
- Abstract
Objective: To evaluate the effectiveness of hysteroscopy for the detection and treatment of endometrial polyps versus expectant management in women with postmenopausal bleeding (PMB), a thickened endometrium and benign endometrial sampling., Design: Multicentre, randomised controlled trial., Setting: Three academic hospitals and nine non-academic teaching hospitals in the Netherlands., Population: Women with PMB, an endometrial thickness >4 mm and benign result from endometrial sampling., Methods: Women were randomised to either further diagnostic workup by hysteroscopy (preceded by saline infusion sonography) or expectant management., Main Outcomes: The primary outcome measure was recurrence of PMB within a year after randomisation. Secondary outcome measures were time to recurrent bleeding and recurrent bleeding after more than 1 year. In the hysteroscopy group, the presence of polyps and the results of their histology were registered., Results: Between January 2010 and October 2013, 200 women were randomised; 98 to hysteroscopy and 102 to expectant management. Within 1 year a total of 15 women (15.3%) in the hysteroscopy group experienced recurrent bleeding, versus 18 (18.0%) in the expectant management group (relative risk 0.85 (95% CI 0.46-1.59). In the hysteroscopy group, 50/98 (51%) polyps were diagnosed of which 6/98 (6%) showed evidence of endometrial (pre)malignancy; final pathology results after hysterectomy showed three women with hyperplasia with atypia and three women with endometrial cancer., Conclusion: In women with PMB, a thickened endometrium and benign endometrial sampling, operative hysteroscopy does not reduce recurrent bleeding. Hysteroscopy detected focal endometrial (pre)malignancy in 6% of women who had benign endometrial sampling. This finding indicates that in these women, further diagnostic workup is warranted to detect focal (pre)malignancies, missed by blind endometrial sampling., Tweetable Abstract: In women with PMB, hysteroscopy does not reduce recurrent bleeding but is warranted to detect focal malignancy., (© 2016 Royal College of Obstetricians and Gynaecologists.)
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- 2017
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36. Word catheter and marsupialisation in women with a cyst or abscess of the Bartholin gland (WoMan-trial): a randomised clinical trial.
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Kroese JA, van der Velde M, Morssink LP, Zafarmand MH, Geomini P, van Kesteren P, Radder CM, van der Voet LF, Roovers J, Graziosi G, van Baal WM, van Bavel J, Catshoek R, Klinkert ER, Huirne J, Clark TJ, Mol B, and Reesink-Peters N
- Subjects
- Adult, Catheterization methods, Female, Humans, Middle Aged, Treatment Outcome, Abscess surgery, Bartholin's Glands surgery, Catheterization instrumentation, Catheters, Cysts surgery, Gynecologic Surgical Procedures methods
- Abstract
Objective: To compare recurrence of a cyst or abscess of the Bartholin gland after surgical treatment using a Word catheter or marsupialisation., Design: Multicentre, open-label, randomised controlled trial., Setting: Eighteen hospitals in the Netherlands and one hospital in England., Population: Women with a symptomatic cyst or abscess of the Bartholin gland., Methods: Women were randomised to treatment with Word catheter or marsupialisation., Main Outcome Measures: The primary outcome was recurrence of the cyst or abscess within 1 year of treatment. The secondary outcomes included pain during and after treatment (measured on a 10-point scale), use of analgesics, and time from diagnosis to treatment. Analysis was by intention-to-treat. To assess whether marsupialisation would reduce the recurrence rate by 5% (from 20 to 15%) we needed to include 160 women (alpha error 0.05, beta error 0.2)., Results: One hundred and sixty-one women were randomly allocated to treatment by Word catheter (n = 82) or marsupialisation (n = 79) between August 2010 and May 2014. Baseline characteristics were comparable. Recurrence occurred in 10 women (12%) allocated to Word catheter versus eight women (10%) allocated to marsupialisation: relative risk (RR) 1.1, 95% confidence interval (CI) 0.64-1.91; P = 0.70. Pain scores after treatment were also comparable. In the first 24 hours after treatment, 33% used analgesics in the Word catheter group versus 74% in the marsupialisation group (P < 0.001). Time from diagnosis to treatment was 1 hour for placement of Word catheter versus 4 hours for marsupialisation (P = 0.001)., Conclusions: In women with an abscess or cyst of the Bartholin gland, treatment with Word catheter and marsupialisation results in comparable recurrence rates., Tweetable Abstract: Comparable recurrence rates for treatment of Bartholinic abscess/cyst with Word catheter and marsupialisation., (© 2016 Royal College of Obstetricians and Gynaecologists.)
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- 2017
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37. Minimally invasive therapy for gynaecological symptoms related to a niche in the caesarean scar: a systematic review.
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van der Voet LF, Vervoort AJ, Veersema S, BijdeVaate AJ, Brölmann HA, and Huirne JA
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- Contraceptives, Oral, Hormonal therapeutic use, Diagnostic Imaging, Female, Fertility, Humans, Hysteroscopy, Laparoscopy, Pain etiology, Pain surgery, Patient Satisfaction, Pregnancy, Pregnancy Outcome, Quality of Life, Sexuality, Cesarean Section, Cicatrix complications, Metrorrhagia etiology, Metrorrhagia therapy
- Abstract
Background: Various therapies are currently used to treat symptoms related to the niche (an anechoic area) in the caesarean scar, in particular to treat abnormal uterine bleeding (AUB)., Objective: To systematically review the available literature reporting on the effect of various therapies on niche-related symptoms., Search Strategy: A systematic search of MEDLINE, Embase, Cochrane, trial registers and congress abstracts from AAGL and ESGE was performed., Selection Criteria: Articles reporting on the effectiveness of therapies other than hysterectomy in women with niche-related symptoms were included. Studies were included if they reported one of the following outcomes: effect on AUB, pain relief, sexual function, quality of life (QOL), and surgical, anatomic, fertility, or pregnancy outcome., Data Collection and Analysis: Two authors independently selected the articles to be included. The Meta-analysis of Observational Studies in Epidemiology (MOOSE) guidelines were followed. A standardised checklist was used to score the methodological quality of the included studies., Main Results: Twelve studies were included, reporting on hysteroscopic niche resection (eight studies, 384 patients), laparoscopic repair (one study, 13 patients), (laparoscopic assisted) vaginal repair (two studies, 47 patients), and oral contraceptives (OCs) (one study, 11 patients). Reported AUB improved in the vast majority of the patients after these interventions, ranging from 87 to 100%. The rate of complications was low. Pregnancies were reported after therapy; however, sample sizes and follow-up were insufficient to study fertility or pregnancy outcome. The methodological quality of the selected papers was considered to be moderate to poor, and was therefore insufficient to make solid conclusions., Author's Conclusions: More evidence is needed before (surgical) niche interventions are implemented in daily practice., (© 2013 Royal College of Obstetricians and Gynaecologists.)
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- 2014
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38. Long-term complications of caesarean section. The niche in the scar: a prospective cohort study on niche prevalence and its relation to abnormal uterine bleeding.
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van der Voet LF, Bij de Vaate AM, Veersema S, Brölmann HA, and Huirne JA
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- Adult, Female, Follow-Up Studies, Humans, Myometrium diagnostic imaging, Pregnancy, Prevalence, Prospective Studies, Ultrasonography, Cesarean Section adverse effects, Cicatrix diagnostic imaging, Metrorrhagia epidemiology
- Abstract
Objective: To study the prevalence of niches in the caesarean scar in a random population, and the relationship with postmenstrual spotting and urinary incontinence., Design: A prospective cohort study., Setting: A teaching hospital in the Netherlands., Population: Non-pregnant women delivered by caesarean section., Methods: Transvaginal ultrasound (TVU) and gel instillation sonohysterography (GIS) were performed 6-12 weeks after caesarean section. Women were followed by questionnaire and menstruation score chart at 6-12 weeks, 6 months, and 12 months after caesarean section., Main Outcome Measures: Prevalence of a niche 6-12 weeks after caesarean section, using TVU and GIS., Secondary Outcomes: relation to postmenstrual spotting and urinary incontinence 6 and 12 months after caesarean section; and niche characteristics, evaluated by TVU and GIS., Results: Two hundred and sixty-three women were included. Niche prevalence was 49.6% on evaluation with TVU and 64.5% with GIS. Women with a niche measured by GIS reported more postmenstrual spotting than women without a niche (OR 5.48, 95% CI 1.14-26.48). Women with residual myometrium at the site of the uterine scar measuring <50% of the adjacent myometrial thickness had postmenstrual spotting more often than women with a residual myometrial thickness of >50% of the adjacent myometrial thickness (OR 6.13, 95% CI 1.74-21.63). Urinary incontinence was not related to the presence of a niche., Conclusions: A niche is present in 64.5% of women 6-12 weeks after caesarean section, when examined by GIS. Postmenstrual spotting is more prevalent in women with a niche and in women with a residual myometrial thickness of <50% of the adjacent myometrium., (© 2013 Royal College of Obstetricians and Gynaecologists.)
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- 2014
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