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1. Well being of obstetric patients on minimal blood transfusions (WOMB trial)

Author

Bloemenkamp Kitty WM, Schippers Daniela H, Spaanderman Marc EA, Rijnders Robbert JP, Porath Martina, van Alphen Marcel, van der Post Joris AM, Stigter Rob H, van Loon Aren J, Bremer Henk A, Metz Godfried CH, Akerboom Bettina MC, Papatsonis Dimitri NM, Uyl-de Groot Carin A, Peters Nina CJ, Essink-Bot Marie-Louise, Hop Wim CJ, Jansen AJ Gerard, Steegers Eric AP, Prick Babette W, Boers Kim E, Scheepers Hubertina CJ, Roumen Frans JME, Kwee Anneke, Schuitemaker Nico WE, Mol Ben Willem J, van Rhenen Dick J, and Duvekot Johannes J

Subjects
Gynecology and obstetrics, RG1-991
Abstract

Abstract Background Primary postpartum haemorrhage is an obstetrical emergency often causing acute anaemia that may require immediate red blood cell (RBC) transfusion. This anaemia results in symptoms such as fatigue, which may have major impact on the health-related quality of life. RBC transfusion is generally thought to alleviate these undesirable effects although it may cause transfusion reactions. Moreover, the postpartum haemoglobin level seems to influence fatigue only for a short period of time. At present, there are no strict transfusion criteria for this specific indication, resulting in a wide variation in postpartum policy of RBC transfusion in the Netherlands. Methods/Design The WOMB trial is a multicentre randomised non-inferiority trial. Women with acute anaemia due to postpartum haemorrhage, 12-24 hours after delivery and not initially treated with RBC transfusion, are eligible for randomisation. Patients with severe physical complaints are excluded. Patients are randomised for either RBC transfusion or expectant management. Health related quality of life (HRQoL) will be assessed at inclusion, at three days and one, three and six weeks postpartum with three validated measures (Multi-dimensional Fatigue Inventory, ShortForm-36, EuroQol-5D). Primary outcome of the study is physical fatigue three days postpartum. Secondary outcome measures are general and mental fatigue scores and generic health related quality of life scores, the number of RBC transfusions, length of hospital stay, complications and health-care costs. The primary analysis will be by intention-to-treat. The various longitudinal scores will be evaluated using Repeated Measurements ANOVA. A costs benefit analysis will also be performed. The power calculation is based on the exclusion of a difference in means of 1.3 points or greater in favour of RBC transfusion arm regarding physical fatigue subscale. With missing data not exceeding 20%, 250 patients per arm have to be randomised (one-sided alpha = 0.025, power = 80%). Discussion This study will provide evidence for a guideline regarding RBC transfusion in the postpartum patient suffering from acute anaemia. Equivalence in fatigue score, remaining HRQoL scores and physical complications between both groups is assumed, in which case an expectant management would be preferred to minimise transfusion reactions and costs. Trial registration ClinicalTrials.gov NCT00335023, Nederlands Trial Register NTR335

Published
2010
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2. Prognostic model on niche development after a first caesarean section: development and internal validation

Author

Papatsonis, Dimitri N.M., Pajkrt, Eva, Hehenkamp, Wouter J.K., Oei, Angèle L.M., Bekker, Mireille N., Schippers, Daniela H., van Vliet, Huib A.A.M., van der Voet, Lucet, WE Schuitemaker, Nico, Hemelaar, Majoie, van Baal, W.M. (Marchien), Huisjes, Anjoke J.M., Meijer, Wouter J., Janssen, C.A.H. (Ineke), Hermes, Wietske, Feitsma, A.H. (Hanneke), van Eijndhoven, Hugo W.F., Rijnders, Robbert J.P., Sueters, Marieke, Scheepers, H.C.J. (Liesbeth), van Laar, Judith O.E.H., 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. (Marloes), Visser, Harry, Langenveld, Josje, Stegwee, Sanne I., van der Voet, L.F. (Lucet), Heymans, Martijn W., de Groot, Christianne J.M., and Huirne, Judith A.F.

Published
2023
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3. Single-layer vs double-layer uterine closure during cesarean delivery: 3-year follow-up of a randomized controlled trial (2Close study)

Author

van Baal, Marchien, Klerkx, Wenche, Bekker, Mireille N., de Boer, Karin, Boormans, Elisabeth M.A., van Eijndhoven, Hugo W.F., Feitsma, Hanneke, Hehenkamp, Wouter J.K., Hemelaar, Majoie, Hermes, Wietske, Hink, Esther, Huisjes, Anjoke J.M., Janssen, Ineke, Kapiteijn, Kitty, Wüst, Monique D., van Kesteren, Paul J.M., van Laar, Judith O.E.H., Langenveld, Josje, Meijer, Wouter J., Oei, Angèle L.M., Pajkrt, Eva, Papatsonis, Dimitri N.M., Radder, Celine M., Rijnders, Robbert J.P., Scheepers, Hubertina, Schippers, Daniela H., Schuitemaker, Nico W.E., Sueters, Marieke, Visser, Harry, van Vliet, Huib A.A.M., de Vleeschouwer, Marloes, Verberkt, Carry, Stegwee, Sanne I., Van der Voet, Lucet F., Van Baal, W. Marchien, Geomini, Peggy M.A.J., Van Eekelen, Rik, de Groot, Christianne J.M., de Leeuw, Robert A., and Huirne, Judith A.F.

Published
2024
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5. Effect of single- versus double-layer uterine closure during caesarean section on postmenstrual spotting (2Close): multicentre, double-blind, randomised controlled superiority trial

Author

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.

Published
2021

6. SUGAR-DIP trial: oral medication strategy versus insulin for diabetes in pregnancy, study protocol for a multicentre, open-label, non-inferiority, randomised controlled trial

Author

de Wit, Leon, Rademaker, Doortje, Voormolen, Daphne N, Akerboom, Bettina M C, Kiewiet-Kemper, Rosalie M, Soeters, Maarten R, Verwij-Didden, Marion A L, Assouiki, Fahima, Schippers, Daniela H, Vermeulen, Mechteld A R, Kuppens, Simone M I, Oosterwerff, Mirjam M, Zwart, Joost J, Diekman, Mattheus J M, Vogelvang, Tatjana E, Gallas, P Rob J, Galjaard, Sander, Visser, Willy, Horree, Nicole, Klooker, Tamira K, Laan, Rosemarie, Heijligenberg, Rik, Huisjes, Anjoke J M, van Bemmel, Thomas, van Meir, Claudia A, van den Beld, Annewieke W, Hermes, Wietske, Vidarsdottir, Solrun, Veldhuis-Vlug, Anneke G, Dullemond, Remke C, Jansen, Henrique J, Sueters, Marieke, de Koning, Eelco J P, van Laar, Judith O E H, Wouters-van Poppel, Pleun, Sanson-van Praag, Marina E, van den Akker, Eline S, Brouwer, Catherine B, Hermsen, Brenda B, Potter van Loon, Bert Jan, van der Heijden, Olivier W H, de Galan, Bastiaan E, van Leeuwen, Marsha, Wijbenga, Johanna A M, de Boer, Karin, van Bon, Arianne C, van der Made, Flip W, Eskes, Silvia A, Zandstra, Mirjam, van Houtum, William H, Braams-Lisman, Babette A M, Daemen-Gubbels, Catharina R G M, Wouters, Maurice G A J, IJzerman, Richard G, Mensing van Charante, Nico A, Zwertbroek, Rolf, Bosmans, Judith E, Evers, Inge M, Mol, Ben Willem, de Valk, Harold W, Groenendaal, Floris, Naaktgeboren, Christiana A, Painter, Rebecca C, deVries, J Hans, Franx, Arie, van Rijn, Bas B, de Wit, Leon, Rademaker, Doortje, Voormolen, Daphne N, Akerboom, Bettina M C, Kiewiet-Kemper, Rosalie M, Soeters, Maarten R, Verwij-Didden, Marion A L, Assouiki, Fahima, Schippers, Daniela H, Vermeulen, Mechteld A R, Kuppens, Simone M I, Oosterwerff, Mirjam M, Zwart, Joost J, Diekman, Mattheus J M, Vogelvang, Tatjana E, Gallas, P Rob J, Galjaard, Sander, Visser, Willy, Horree, Nicole, Klooker, Tamira K, Laan, Rosemarie, Heijligenberg, Rik, Huisjes, Anjoke J M, van Bemmel, Thomas, van Meir, Claudia A, van den Beld, Annewieke W, Hermes, Wietske, Vidarsdottir, Solrun, Veldhuis-Vlug, Anneke G, Dullemond, Remke C, Jansen, Henrique J, Sueters, Marieke, de Koning, Eelco J P, van Laar, Judith O E H, Wouters-van Poppel, Pleun, Sanson-van Praag, Marina E, van den Akker, Eline S, Brouwer, Catherine B, Hermsen, Brenda B, Potter van Loon, Bert Jan, van der Heijden, Olivier W H, de Galan, Bastiaan E, van Leeuwen, Marsha, Wijbenga, Johanna A M, de Boer, Karin, van Bon, Arianne C, van der Made, Flip W, Eskes, Silvia A, Zandstra, Mirjam, van Houtum, William H, Braams-Lisman, Babette A M, Daemen-Gubbels, Catharina R G M, Wouters, Maurice G A J, IJzerman, Richard G, Mensing van Charante, Nico A, Zwertbroek, Rolf, Bosmans, Judith E, Evers, Inge M, Mol, Ben Willem, de Valk, Harold W, Groenendaal, Floris, Naaktgeboren, Christiana A, Painter, Rebecca C, deVries, J Hans, Franx, Arie, and van Rijn, Bas B

Abstract

INTRODUCTION: In women with gestational diabetes mellitus (GDM) requiring pharmacotherapy, insulin was the established first-line treatment. More recently, oral glucose lowering drugs (OGLDs) have gained popularity as a patient-friendly, less expensive and safe alternative. Monotherapy with metformin or glibenclamide (glyburide) is incorporated in several international guidelines. In women who do not reach sufficient glucose control with OGLD monotherapy, usually insulin is added, either with or without continuation of OGLDs. No reliable data from clinical trials, however, are available on the effectiveness of a treatment strategy using all three agents, metformin, glibenclamide and insulin, in a stepwise approach, compared with insulin-only therapy for improving pregnancy outcomes. In this trial, we aim to assess the clinical effectiveness, cost-effectiveness and patient experience of a stepwise combined OGLD treatment protocol, compared with conventional insulin-based therapy for GDM.METHODS: The SUGAR-DIP trial is an open-label, multicentre randomised controlled non-inferiority trial. Participants are women with GDM who do not reach target glycaemic control with modification of diet, between 16 and 34 weeks of gestation. Participants will be randomised to either treatment with OGLDs, starting with metformin and supplemented as needed with glibenclamide, or randomised to treatment with insulin. In women who do not reach target glycaemic control with combined metformin and glibenclamide, glibenclamide will be substituted with insulin, while continuing metformin. The primary outcome will be the incidence of large-for-gestational-age infants (birth weight >90th percentile). Secondary outcome measures are maternal diabetes-related endpoints, obstetric complications, neonatal complications and cost-effectiveness analysis. Outcomes will be analysed according to the intention-to-treat principle.ETHICS AND DISSEMINATION: The study protocol was approved

Published
2019

7. SUGAR-DIP trial:Oral medication strategy versus insulin for diabetes in pregnancy, study protocol for a multicentre, open-label, non-inferiority, randomised controlled trial

Author

De Wit, Leon, Rademaker, Doortje, Voormolen, Daphne N., Akerboom, Bettina M.C., Kiewiet-Kemper, Rosalie M., Soeters, Maarten R., Verwij-Didden, Marion A.L., Assouiki, Fahima, Schippers, Daniela H., Vermeulen, Mechteld A.R., Kuppens, Simone M.I., Oosterwerff, Mirjam M., Zwart, Joost J., Diekman, Mattheus J.M., Vogelvang, Tatjana E., Gallas, P. Rob J., Galjaard, Sander, Visser, Willy, Horree, Nicole, Klooker, Tamira K., Laan, Rosemarie, Heijligenberg, Rik, Huisjes, Anjoke J.M., Van Bemmel, Thomas, Van Meir, Claudia A., Van Den Beld, Annewieke W., Hermes, Wietske, Vidarsdottir, Solrun, Veldhuis-Vlug, Anneke G., Dullemond, Remke C., Jansen, Henrique J., Sueters, Marieke, De Koning, Eelco J.P., Van Laar, Judith O.E.H., Wouters-Van Poppel, Pleun, Sanson-Van Praag, Marina E., Van Den Akker, Eline S., Brouwer, Catherine B., Hermsen, Brenda B., Potter Van Loon, Bert Jan, Van Der Heijden, Olivier W.H., De Galan, Bastiaan E., Van Leeuwen, Marsha, Wijbenga, Johanna A.M., De Boer, Karin, Van Bon, Arianne C., Van Der Made, Flip W., Eskes, Silvia A., Zandstra, Mirjam, Van Houtum, William H., Braams-Lisman, Babette A.M., Daemen-Gubbels, Catharina R.G.M., Wouters, Maurice G.A.J., Ijzerman, Richard G., Mensing Van Charante, Nico A., Zwertbroek, Rolf, Bosmans, Judith E., Evers, Inge M., Mol, Ben Willem, De Valk, Harold W., Groenendaal, Floris, Naaktgeboren, Christiana A., Painter, Rebecca C., Devries, J. Hans, Franx, Arie, Van Rijn, Bas B., De Wit, Leon, Rademaker, Doortje, Voormolen, Daphne N., Akerboom, Bettina M.C., Kiewiet-Kemper, Rosalie M., Soeters, Maarten R., Verwij-Didden, Marion A.L., Assouiki, Fahima, Schippers, Daniela H., Vermeulen, Mechteld A.R., Kuppens, Simone M.I., Oosterwerff, Mirjam M., Zwart, Joost J., Diekman, Mattheus J.M., Vogelvang, Tatjana E., Gallas, P. Rob J., Galjaard, Sander, Visser, Willy, Horree, Nicole, Klooker, Tamira K., Laan, Rosemarie, Heijligenberg, Rik, Huisjes, Anjoke J.M., Van Bemmel, Thomas, Van Meir, Claudia A., Van Den Beld, Annewieke W., Hermes, Wietske, Vidarsdottir, Solrun, Veldhuis-Vlug, Anneke G., Dullemond, Remke C., Jansen, Henrique J., Sueters, Marieke, De Koning, Eelco J.P., Van Laar, Judith O.E.H., Wouters-Van Poppel, Pleun, Sanson-Van Praag, Marina E., Van Den Akker, Eline S., Brouwer, Catherine B., Hermsen, Brenda B., Potter Van Loon, Bert Jan, Van Der Heijden, Olivier W.H., De Galan, Bastiaan E., Van Leeuwen, Marsha, Wijbenga, Johanna A.M., De Boer, Karin, Van Bon, Arianne C., Van Der Made, Flip W., Eskes, Silvia A., Zandstra, Mirjam, Van Houtum, William H., Braams-Lisman, Babette A.M., Daemen-Gubbels, Catharina R.G.M., Wouters, Maurice G.A.J., Ijzerman, Richard G., Mensing Van Charante, Nico A., Zwertbroek, Rolf, Bosmans, Judith E., Evers, Inge M., Mol, Ben Willem, De Valk, Harold W., Groenendaal, Floris, Naaktgeboren, Christiana A., Painter, Rebecca C., Devries, J. Hans, Franx, Arie, and Van Rijn, Bas B.

Abstract

Introduction In women with gestational diabetes mellitus (GDM) requiring pharmacotherapy, insulin was the established first-line treatment. More recently, oral glucose lowering drugs (OGLDs) have gained popularity as a patient-friendly, less expensive and safe alternative. Monotherapy with metformin or glibenclamide (glyburide) is incorporated in several international guidelines. In women who do not reach sufficient glucose control with OGLD monotherapy, usually insulin is added, either with or without continuation of OGLDs. No reliable data from clinical trials, however, are available on the effectiveness of a treatment strategy using all three agents, metformin, glibenclamide and insulin, in a stepwise approach, compared with insulin-only therapy for improving pregnancy outcomes. In this trial, we aim to assess the clinical effectiveness, cost-effectiveness and patient experience of a stepwise combined OGLD treatment protocol, compared with conventional insulin-based therapy for GDM. Methods The SUGAR-DIP trial is an open-label, multicentre randomised controlled non-inferiority trial. Participants are women with GDM who do not reach target glycaemic control with modification of diet, between 16 and 34 weeks of gestation. Participants will be randomised to either treatment with OGLDs, starting with metformin and supplemented as needed with glibenclamide, or randomised to treatment with insulin. In women who do not reach target glycaemic control with combined metformin and glibenclamide, glibenclamide will be substituted with insulin, while continuing metformin. The primary outcome will be the incidence of large-for-gestational-age infants (birth weight >90th percentile). Secondary outcome measures are maternal diabetes-related endpoints, obstetric complications, neonatal complications and cost-effectiveness analysis. Outcomes will be analysed according to the intention-to-treat principle. Ethics and dissemination The study protocol was approved by the Ethics

Published
2019

8. SUGAR-DIP trial: oral medication strategy versus insulin for diabetes in pregnancy, study protocol for a multicentre, open-label, non-inferiority, randomised controlled trial

Author

de Wit, Leon, primary, Rademaker, Doortje, additional, Voormolen, Daphne N, additional, Akerboom, Bettina M C, additional, Kiewiet-Kemper, Rosalie M, additional, Soeters, Maarten R, additional, Verwij-Didden, Marion A L, additional, Assouiki, Fahima, additional, Schippers, Daniela H, additional, Vermeulen, Mechteld A R, additional, Kuppens, Simone M I, additional, Oosterwerff, Mirjam M, additional, Zwart, Joost J, additional, Diekman, Mattheus J M, additional, Vogelvang, Tatjana E, additional, Gallas, P Rob J, additional, Galjaard, Sander, additional, Visser, Willy, additional, Horree, Nicole, additional, Klooker, Tamira K, additional, Laan, Rosemarie, additional, Heijligenberg, Rik, additional, Huisjes, Anjoke J M, additional, van Bemmel, Thomas, additional, van Meir, Claudia A, additional, van den Beld, Annewieke W, additional, Hermes, Wietske, additional, Vidarsdottir, Solrun, additional, Veldhuis-Vlug, Anneke G, additional, Dullemond, Remke C, additional, Jansen, Henrique J, additional, Sueters, Marieke, additional, de Koning, Eelco J P, additional, van Laar, Judith O E H, additional, Wouters-van Poppel, Pleun, additional, Sanson-van Praag, Marina E, additional, van den Akker, Eline S, additional, Brouwer, Catherine B, additional, Hermsen, Brenda B, additional, Potter van Loon, Bert Jan, additional, van der Heijden, Olivier W H, additional, de Galan, Bastiaan E, additional, van Leeuwen, Marsha, additional, Wijbenga, Johanna A M, additional, de Boer, Karin, additional, van Bon, Arianne C, additional, van der Made, Flip W, additional, Eskes, Silvia A, additional, Zandstra, Mirjam, additional, van Houtum, William H, additional, Braams-Lisman, Babette A M, additional, Daemen-Gubbels, Catharina R G M, additional, Wouters, Maurice G A J, additional, IJzerman, Richard G, additional, Mensing van Charante, Nico A, additional, Zwertbroek, Rolf, additional, Bosmans, Judith E, additional, Evers, Inge M, additional, Mol, Ben Willem, additional, de Valk, Harold W, additional, Groenendaal, Floris, additional, Naaktgeboren, Christiana A, additional, Painter, Rebecca C, additional, deVries, J Hans, additional, Franx, Arie, additional, and van Rijn, Bas B, additional

Published
2019
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9. Well being of obstetric patients on minimal blood transfusions (WOMB trial)

Author

Prick, Babette W., Steegers, Eric A.P., Jansen, AJ Gerard, Hop, Wim C.J., Essink-Bot, Marie Louise, Peters, Nina C.J., Uyl-de Groot, Carin A., Papatsonis, Dimitri N.M., Akerboom, Bettina M.C., Metz, Godfried C.H., Bremer, Henk A., van Loon, Aren J., Stigter, Rob H., van der Post, Joris A.M., van Alphen, Marcel, Porath, Martina, Rijnders, Robbert J.P., Spaanderman, Marc E.A., Schippers, Daniela H., Bloemenkamp, Kitty W.M., Boers, Kim E., Scheepers, Hubertina C.J., Roumen, Frans J.M.E., Kwee, Anneke, Schuitemaker, Nico W.E., Mol, Ben Willem J., van Rhenen, Dick J., Duvekot, Johannes J., Prick, Babette W., Steegers, Eric A.P., Jansen, AJ Gerard, Hop, Wim C.J., Essink-Bot, Marie Louise, Peters, Nina C.J., Uyl-de Groot, Carin A., Papatsonis, Dimitri N.M., Akerboom, Bettina M.C., Metz, Godfried C.H., Bremer, Henk A., van Loon, Aren J., Stigter, Rob H., van der Post, Joris A.M., van Alphen, Marcel, Porath, Martina, Rijnders, Robbert J.P., Spaanderman, Marc E.A., Schippers, Daniela H., Bloemenkamp, Kitty W.M., Boers, Kim E., Scheepers, Hubertina C.J., Roumen, Frans J.M.E., Kwee, Anneke, Schuitemaker, Nico W.E., Mol, Ben Willem J., van Rhenen, Dick J., and Duvekot, Johannes J.

Abstract

Background: Primary postpartum haemorrhage is an obstetrical emergency often causing acute anaemia that may require immediate red blood cell (RBC) transfusion. This anaemia results in symptoms such as fatigue, which may have major impact on the health-related quality of life. RBC transfusion is generally thought to alleviate these undesirable effects although it may cause transfusion reactions. Moreover, the postpartum haemoglobin level seems to influence fatigue only for a short period of time. At present, there are no strict transfusion criteria for this specific indication, resulting in a wide variation in postpartum policy of RBC transfusion in the Netherlands.Methods/Design: The WOMB trial is a multicentre randomised non-inferiority trial. Women with acute anaemia due to postpartum haemorrhage, 12-24 hours after delivery and not initially treated with RBC transfusion, are eligible for randomisation. Patients with severe physical complaints are excluded. Patients are randomised for either RBC transfusion or expectant management. Health related quality of life (HRQoL) will be assessed at inclusion, at three days and one, three and six weeks postpartum with three validated measures (Multi-dimensional Fatigue Inventory, ShortForm-36, EuroQol-5D). Primary outcome of the study is physical fatigue three days postpartum. Secondary outcome measures are general and mental fatigue scores and generic health related quality of life scores, the number of RBC transfusions, length of hospital stay, complications and health-care costs.The primary analysis will be by intention-to-treat. The various longitudinal scores will be evaluated using Repeated Measurements ANOVA. A costs benefit analysis will also be performed. The power calculation is based on the exclusion of a difference in means of 1.3 points or greater in favour of RBC transfusion arm regarding physical fatigue subscale. With missing data not exceeding 20%, 250 patients per arm have to be randomised (one-sided alp

Published
2010

10. 64: RBC transfusion leads to an improvement of physical fatigue in women with acute postpartum anemia: the WOMB study (NCT00335023)

Author

Prick, Babette W., primary, Jansen, A.J. Gerard, additional, Steegers, Eric A.P., additional, Hop, Wim C.J., additional, Essink-Bot, Marie-Louise, additional, Uyl-de Groot, Carin A., additional, Papatsonis, Dimitri N.M., additional, Akerboom, Bettina M.C., additional, Metz, Godfried C.H., additional, Bremer, Henk A., additional, van Loon, Aren J., additional, Stigter, Rob H., additional, van der Post, Joris A.M., additional, van Alphen, Marcel, additional, Porath, Martina, additional, Rijnders, Robbert J.P., additional, Spaanderman, Marc E.A., additional, Schippers, Daniela H., additional, Bloemenkamp, Kitty W.M., additional, Boers, Kim E., additional, Scheepers, Hubertina C.J., additional, Roumen, Frans J.M.E., additional, Kwee, Anneke, additional, Schuitemaker, Nico W.E., additional, Mol, Ben Willem J., additional, van Rhenen, Dick J., additional, and Duvekot, Johannes J., additional

Published
2012
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11. Well being of obstetric patients on minimal blood transfusions (WOMB trial)

Author

Prick, Babette W, primary, Steegers, Eric AP, additional, Jansen, AJ Gerard, additional, Hop, Wim CJ, additional, Essink-Bot, Marie-Louise, additional, Peters, Nina CJ, additional, Uyl-de Groot, Carin A, additional, Papatsonis, Dimitri NM, additional, Akerboom, Bettina MC, additional, Metz, Godfried CH, additional, Bremer, Henk A, additional, van Loon, Aren J, additional, Stigter, Rob H, additional, van der Post, Joris AM, additional, van Alphen, Marcel, additional, Porath, Martina, additional, Rijnders, Robbert JP, additional, Spaanderman, Marc EA, additional, Schippers, Daniela H, additional, Bloemenkamp, Kitty WM, additional, Boers, Kim E, additional, Scheepers, Hubertina CJ, additional, Roumen, Frans JME, additional, Kwee, Anneke, additional, Schuitemaker, Nico WE, additional, Mol, Ben Willem J, additional, van Rhenen, Dick J, additional, and Duvekot, Johannes J, additional

Published
2010
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12. Well being of obstetric patients on minimalblood transfusions (WOMB trial).

Author

Prick, Babette W., Steegers, Eric A. P., Jansen, A. J. Gerard, Hop, Wim C. J., Essink-Bot, Marie-Louise, Peters, Nina C. J., Groot, Carin A. Uyl-de, Papatsonis, Dimitri N. M., Akerboom, Bettina M. C., Metz, Godfried C. H., Bremer, Henk A., van Loon, Aren J., Stigter, Rob H., van der Post, Joris A. M., van Alphen, Marcel, Porath, Martina, Rijnders, Robbert J. P., Spaanderman, Marc E. A., Schippers, Daniela H., and Bloemenkamp, Kitty W. M.

Subjects
POSTNATAL care, HEMORRHAGE, ERYTHROCYTES, BLOOD transfusion, MEDICAL research
Abstract

Background: Primary postpartum haemorrhage is an obstetrical emergency often causing acute anaemia that may require immediate red blood cell (RBC) transfusion. This anaemia results in symptoms such as fatigue, which may have major impact on the health-related quality of life. RBC transfusion is generally thought to alleviate these undesirable effects although it may cause transfusion reactions. Moreover, the postpartum haemoglobin level seems to influence fatigue only for a short period of time. At present, there are no strict transfusion criteria for this specific indication, resulting in a wide variation in postpartum policy of RBC transfusion in the Netherlands. Methods/Design: The WOMB trial is a multicentre randomised non-inferiority trial. Women with acute anaemia due to postpartum haemorrhage, 12-24 hours after delivery and not initially treated with RBC transfusion, are eligible for randomisation. Patients with severe physical complaints are excluded. Patients are randomised for either RBC transfusion or expectant management. Health related quality of life (HRQoL) will be assessed at inclusion, at three days and one, three and six weeks postpartum with three validated measures (Multi-dimensional Fatigue Inventory, ShortForm-36, EuroQol-5D). Primary outcome of the study is physical fatigue three days postpartum. Secondary outcome measures are general and mental fatigue scores and generic health related quality of life scores, the number of RBC transfusions, length of hospital stay, complications and health-care costs. The primary analysis will be by intention-to-treat. The various longitudinal scores will be evaluated using Repeated Measurements ANOVA. A costs benefit analysis will also be performed. The power calculation is based on the exclusion of a difference in means of 1.3 points or greater in favour of RBC transfusion arm regarding physical fatigue subscale. With missing data not exceeding 20%, 250 patients per arm have to be randomised (one-sided alpha = 0.025, power = 80%). Discussion: This study will provide evidence for a guideline regarding RBC transfusion in the postpartum patient suffering from acute anaemia. Equivalence in fatigue score, remaining HRQoL scores and physical complications between both groups is assumed, in which case an expectant management would be preferred to minimise transfusion reactions and costs. Trial registration: ClinicalTrials.gov NCT00335023, Nederlands Trial Register NTR335. [ABSTRACT FROM AUTHOR]

Published
2010
Full Text
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