Search

Study Question: Are the long-term reproductive outcomes following recurrent dilatation and curettage (D&C) for miscarriage in women with identified and treated intrauterine adhesions (IUAs) comparable to women without IUAs.Summary Answer: Reproductive outcomes in women with identified and treated IUAs following recurrent D&C for miscarriage are impaired compared to women without IUAs; fewer ongoing pregnancies and live births are achieved with a prolonged time to a live birth.What Is Known Already: The Prevention of Adhesions Post Abortion (PAPA) study showed that application of auto-crosslinked hyaluronic acid (ACP) gel, an absorbable barrier in women undergoing recurrent D&C for miscarriage resulted in a lower rate of IUAs, 13% versus 31% (relative risk 0.43, 95% CI 0.22 to 0.83), lower mean adhesion score and significant less moderate to severe IUAs. It is unclear what the impact is of IUAs on long-term reproductive performance.Study Design, Size, Duration: This was a follow-up of the PAPA study, a multicenter randomized controlled trial evaluating the application of ACP gel in women undergoing recurrent D&C for miscarriage. All included women received a diagnostic hysteroscopy 8-12 weeks after randomization to evaluate the uterine cavity and for adhesiolysis if IUAs were present. Here, we present the reproductive outcomes in women with identified and treated IUAs versus women without IUAs, 46 months after randomization.Participants/materials, Setting, Methods: Between December 2011 and July 2015, 152 women with a first-trimester miscarriage with at least one previous D&C, were randomized for D&C alone or D&C with immediate intrauterine application of ACP gel. Participants were approached at least 30 months after randomization to evaluate reproductive performance, obstetric and neonatal outcomes and cycle characteristics. Additionally, the medical files of all participants were reviewed. Main outcome was ongoing pregnancy. Outcomes of subsequent pregnancies, time to conception and time to live birth were also recorded.Main Results and the Role Of Chance: In women pursuing a pregnancy, 14/24 (58%) ongoing pregnancies were recorded in women with identified and treated IUAs versus 80/89 (90%) ongoing pregnancies in women without IUAs odds ratio (OR) 0.18 (95% CI 0.06 to 0.50, P-value <0.001). Documented live birth was also lower in women with IUAs; 13/24 (54%) with versus 75/89 (84%) without IUAs, OR 0.22 (95% CI: 0.08 to-0.59, P-value 0.004). The median time to conception was 7 months in women with identified and treated IUAs versus 5 months in women without IUAs (hazard ratio (HR) 0.84 (95% CI 0.54 to 1.33)) and time to conception leading to a live birth 15 months versus 5.0 months (HR 0.54 (95% CI: 0.30 to 0.97)). In women with identified and treated IUAs, premature deliveries were recorded in 3/16 (19%) versus 4/88 (5%) in women without IUAs, P-value 0.01. Complications were recorded in respectively 12/16 (75%) versus 26/88 (30%), P-value 0.001. No differences were recorded in mean birth weight between the groups.Limitations, Reasons For Caution: In the original PAPA study, randomization was applied for ACP gel application. Comparing women with and without IUAs is not in line with the randomization and therefore confounding of the results cannot be excluded. IUAs, if visible during routine hysteroscopy after randomization were removed as part of the study protocol; the influence of IUAs on reproductive outcome may therefore be underestimated. Women undergoing a recurrent D&C for miscarriage were included, a specific group likely to generate clinically significant adhesions. The findings should therefore not be generalized to all women undergoing D&C for miscarriage.Wider Implications Of the Findings: As IUAs have an impact on reproductive performance, even after hysteroscopic adhesiolysis, primary prevention is essential. Expectative and medical management should therefore be considered as serious alternatives for D&C in women with a miscarriage. In case D&C is necessary, application of ACP gel should be considered.Study Funding/competing Interest(s): The original PAPA study (NTR 3120) was an investigator initiated study that was funded by the Foundation for scientific investigation in Obstetrics and Gynaecology of the Saint Lucas Andreas Hospital (currently renamed OLVG Oost), SWOGA. The syringes containing ACP gel were received from Anika Therapeutics, the manufacturer of Hyalobarrier® Gel Endo. The current follow-up study was also an investigator-initiated study without funding. The funder and sponsor had no role in the design of this follow-up study, data collection, data analysis, data interpretation, trial design, patient recruitment, writing of the report or any aspect pertinent to the study. ABH, RAL, JAFH and JWRT have no conflict to declare. HAMB reports being a member of safety board research Womed.Trial Registration Number: Netherlands Trial Register NTR 3120. [ABSTRACT FROM AUTHOR]

Aim: To study changes in a ceasarean section (CS) scar during the first year after a CS using gel installation sonography (GIS).Methods: Proof-of-concept study, prospective cohort study. Twenty women who delivered by their first CS were evaluated by both transvaginal sonography and GIS 2 months and 1 year after CS. A niche was defined as an anechogenic space at the uterine caesarean scar with a depth >2 mm. The primary outcome was any change in the thickness of the residual myometrium (RMT) as evaluated by GIS.Results: Mean RMT changed in time from 11.9 mm at 2 months to 6.5 mm at 12 months after the CS (p < 0.001). Niche prevalence did not change. The adjacent myometrium (AM) reduced from 15 to 12.4 mm (p = 0.04). The ratio between RMT and AM with GIS decreased from 0.80 at 2 months to 0.54 at 12 months (p = 0.002).Conclusion: RMT thickness, the adjacent myometium and the ratio between the RMT and AM reduces from 2 to 12 months after a CS. The prevalence did not change. This needs to be taken into account when deciding on the timing of niche measurement and the interpretation of the RMT. [ABSTRACT FROM AUTHOR]

We describe our experience with the treatment of 4 caesarean scar pregnancies and provide an overview of current literature. Four women diagnosed with a caesarean scar pregnancy in our hospital between 1996 and 2007 were treated with local or systemic methotrexate and had a steady decline of the serum beta-hCG level. The uterus was preserved in all women and 3 of them had an uneventful subsequent pregnancy and delivery. We suggest that transcervical needle aspiration of amniotic fluid followed by intra-amniotic injection of methotrexate should be the treatment of choice, followed by surgical treatment only if methotrexate fails. [ABSTRACT FROM AUTHOR]

Background: Full recovery after gynecological surgery takes much longer than expected regardless of surgical technique or the level of invasiveness. After discharge, detailed convalescence recommendations are not provided to patients typically, and postoperative care is fragmented, poorly coordinated, and given only on demand. For patients, this contributes to irrational beliefs and avoidance of resumption of activities and can result in a prolonged sick leave. Objective: To develop an eHealth intervention that empowers gynecological patients during the perioperative period to obtain timely return to work (RTW) and prevent work disability. Methods: The intervention mapping (IM) protocol was used to develop the eHealth intervention. A literature search about behavioral and environmental conditions of prolonged sick leave and delayed RTW in patients was performed. Patients' needs, attitudes, and beliefs regarding postoperative recovery and resumption of work were identified through focus group discussions. Additionally, a literature search was performed to obtain determinants, methods, and strategies for the development of a suitable interactive eHealth intervention to empower patients to return to normal activities after gynecological surgery, including work. Finally, the eHealth intervention was evaluated by focus group participants, medical doctors, and eHealth specialists through questionnaires. Results: Twenty-one patients participated in the focus group discussions. Sufficient, uniform, and tailored information regarding surgical procedures, complications, and resumption of activities and work were considered most essential. Knowing who to contact in case of mental or physical complaints, and counseling and tools for work reintegration were also considered important. Finally, opportunities to exchange experiences with other patients were a major issue. Considering the determinants of the Attitude-Social influence-self-Efficacy (ASE) model, various strategies based on a combination of theory and evidence were used, resulting in an eHealth intervention with different interactive functionalities including tailored convalescence recommendations and a video to communicate the most common pitfalls during the perioperative period to patients and employers. Fifteen patients in the focus groups, 11 physicians, and 3 eHealth specialists suggested points for improvement to optimize the usability of the eHealth intervention and judged it an approachable, appropriate, and attractive eHealth intervention to empower gynecological patients. Conclusions: The IM protocol was a useful method to develop an eHealth intervention based on both theory and evidence. All patients and stakeholders judged the eHealth intervention to be a promising tool to empower gynecological patients during the perioperative period and to help them to return to normal activities and work. [ABSTRACT FROM AUTHOR]

Objective: To examine whether intrauterine application of auto-cross-linked hyaluronic acid (ACP) gel after dilation and curettage (D&C) improves reproductive performance.Design: Multicenter prospective randomized trial.Setting: One university and seven university-affiliated teaching hospitals.Patient(s): A total of 149 women who have experienced a miscarriage at <14 weeks of gestation, with at least one previous D&C for miscarriage or termination of pregnancy, were randomly assigned to either D&C plus ACP gel (intervention group) or D&C alone (control group). A hysteroscopy was performed 8-12 weeks after the procedure. Where intrauterine adhesions (IUAs) were found, adhesiolysis was executed.Intervention(s): Participants received questionnaires 3, 6, and 12 months after the initial D&C procedure with questions regarding menstrual pattern, conception, and reproductive outcome.Main Outcome Measure(s): Reproductive outcomes during the 12 months after the D&C procedure.Result(s): Outcomes were available for 149 women: 77 in the intervention group and 72 in the control group. The conception rates were, respectively, 71% (46/64) and 59.7% (40/67). There was no significant difference in the miscarriage, ongoing pregnancy, and live birth rates. The median times to conception were 5.5 and 7.1 months, respectively.Conclusion(s): Reproductive performance was similar in both groups although there was a significant difference in the prevalence of IUAs. Given the favorable reproductive outcome in this underpowered study and the fact that adhesiolysis was executed, no solid conclusion can be drawn. Future studies are needed to evaluate the effect of ACP gel on fertility and reproductive outcomes.Clinical Trial Registration Number: NTR 3120. [ABSTRACT FROM AUTHOR]

Objective Purpose of this study is to determine the interobserver and intraobserver variability of 3D GIS in the assessment of intrauterine abnormalities. Study design Forty five 3D volumes were randomly selected from a larger prospective cohort study that studied the diagnostic accuracy of 3D GIS in addition to 2D GIS. To study interobserver agreement volumes were reviewed by two independent examiners. One examiner reviewed these samples twice with an interval of 1 month in a random order. Interobserver and intraobserver agreement were tested with Cohen's kappa coefficient and shown in Bland and Altman plots. Quality of the 3D volumes was evaluated. Results Cohen's kappa for interobserver variability for type of abnormalities (none, polyp, fibroid, other) was 0.64 and for presence of a fibroid (fibroid yes/no) 0.77. Agreement on type of fibroid was 0.59. Intraobserver agreement was almost perfect for type of abnormality (Cohen's kappa of 1.0) and good for fibroid diameter. Quality of the 3D volumes was poor in 11 out of 45 cases. Reproducibility increased when poor quality images were excluded. Conclusion Substantial interobserver and intraobserver agreement for 3D GIS in the diagnoses of intrauterine abnormalities was found. 3D GIS interobserver and intraobserver agreement are good for fibroid diameter and moderate for volume and protrusion. [ABSTRACT FROM AUTHOR]

Objective: To estimate the diagnostic accuracy and the interobserver reproducibility of pelvic x-rays in the diagnosis of successful bilateral sterilization with Essure after a 3-month follow-up period.Design: Interobserver study.Setting: Outpatient department of obstetrics and gynecology in a Dutch teaching hospital.Patient(s): Patients with successful bilateral Essure placement.Intervention(s): Hysteroscopic sterilization with Essure and pelvic x-ray and hysterosalpingography after a 3-month follow-up period.Main Outcome Measure(s): Six observers evaluations of 47 pelvic x-rays from 47 patients 3 months after a technical successful bilateral placement of microinserts to estimate the reliability of the sterilization. Diagnostic accuracy of pelvic x-ray per observer in detecting incorrectly positioned microinserts was expressed in terms of sensitivity and specificity, with hysterosalpingography as the reference strategy. Reproducibility of the interpretation of the pelvic x-ray was expressed as kappa-values.Result(s): The sensitivity and specificity for x-rays read by gynecologists was 0.67 (95% confidence interval [CI], 0.29-0.96) and 0.79 (95% CI, 0.58-1.00) and for radiologists 1.0 and 0.5 (95% CI, 0.36-0.64). The interobserver agreement in reliability of pelvic x-ray of hysteroscopic sterilization assessment with Essure ranged from slight (kappa-value=0.09) for gynecologists to moderate (kappa-value=0.52) for radiologists.Conclusion(s): Test characteristics of pelvic x-ray as the imaging technique to assess the position of the Essure microinserts and tubal patency were poor, as was the reproducibility, particularly if gynecologists performed the evaluation. We do not recommend the use of pelvic x-ray for the assessment of the positioning of microinserts after hysteroscopic sterilization. [ABSTRACT FROM AUTHOR]

Objective: To analyze the data of cases of unintended pregnancies after Essure sterilization. Design: Retrospective case series analysis. Setting: National multicenter. Patient(s): Ten cases of unintended pregnancies after Essure sterilization in the Netherlands were reported from August 2002 through May 2008. Intervention(s): Data on the hysteroscopic Essure sterilization procedures and postprocedure confirmation tests of the reported cases were reviewed and analyzed by two authors. The causes of the unintended pregnancies were determined in agreement with the physicians who performed the sterilizations. Main Outcome Measure(s): Most pregnancies occurred in patients with only one device placement and bilateral occlusion on hysterosalpingography (HSG). Other cases included misinterpretation of HSG, undetected abnormal device position by ultrasound, one undetected preprocedure pregnancy, and two patient failures to follow up with the physician advice. Conclusion(s): The risk of pregnancy after hysteroscopic sterilization may be reduced by strictly following the follow-up protocol, performing a urinary pregnancy test on the day of the procedure, and instructing the patient to return for the follow-up visit. A procedure with only a single device placement in a patient without a history of tubectomy of the heterolateral tube should be considered unsuccessful. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the reliability of pelvic X-ray and transvaginal ultrasound to localize Essure microinserts (Conceptus, San Carlos, California) after successful placement in both fallopian tubes 3 months after placement. Design: Prospective, observational study. Setting: Gynecology departments at two teaching hospitals. Patient(s): One hundred eighty-two patients who underwent hysteroscopic sterilization by placement of Essure microinserts between August 2002 and August 2004. Intervention(s): Transvaginal ultrasound, pelvic X-ray, and hysterosalpingography (HSG) 3 months after sterilization with Essure. Main Outcome Measure(s): Transvaginal ultrasound confirmation of correct localization of microinserts after a 3-month follow-up. Result(s): In 150 of 182 patients, confirmation of successful bilateral placement of two microinserts (300 devices) was possible. In 9 patients it was not possible to identify both devices with ultrasound, or there was doubt about the extension of the device through the uterotubal junction. The other 291 devices were identified as being in a good position. Conclusion(s): Hysterosalpingography at the 3-month follow-up after successful placement of Essure microinserts can be replaced by transvaginal ultrasonography. A 3-month follow-up with HSG after the Essure procedure is only required after unsatisfactory placements. In those patients in whom transvaginal ultrasonography cannot confirm satisfactory localization, a complementary pelvic X-ray should be performed. [ABSTRACT FROM AUTHOR]

Objectives: To assess the cost-effectiveness of transvaginal sonography (TVS) in the diagnostic work-up of women with postmenopausal bleeding.Methods: We performed a decision analysis in which we estimated life expectancy and cost of four strategies for the evaluation of postmenopausal bleeding: TVS (I), TVS and office endometrial biopsy (II), TVS and hysteroscopy (III), and endometrial biopsy (IV). In strategies incorporating TVS, calculations were performed for three different cut-off values between 3 and 9 mm double layer. Expectant management, i.e. no diagnosis or treatment was considered to be the reference strategy to which the other four strategies were compared. Data were obtained from the published literature. In extensive sensitivity analyses, we varied patient's age, discount rate, prevalence of endometrial carcinoma and atypical hyperplasia, and costs.Results: The strategy with endometrial biopsy and the strategy with TVS followed by endometrial biopsy in case of an increased endometrial thickness were the most cost-effective strategies. The strategy starting with endometrial biopsy was the most cost-effective when the prevalence of endometrial carcinoma was > or =15.3%, whereas the strategy with TVS and endometrial biopsy was the most cost-effective for women in which the prevalence of endometrial carcinoma was lower. In these strategies, a cut-off level for abnormality of 9 mm resulted in lowest cost per life-year gained.Conclusions: TVS is of use in women with postmenopausal bleeding and a probability of endometrial carcinoma below 15%. [ABSTRACT FROM AUTHOR]

Objective: To describe incorrect positions of Essure microinserts detected at 3 months' follow-up. Design: Case report. Setting: Outpatient department of obstetrics and gynecology in a Dutch teaching hospital. Patient(s): Initial series of 100 patients who underwent hysteroscopic sterilization using Essure between December 2003 and June 2004. Intervention(s): Hysteroscopic placement of the Essure System, follow-up at 3 months with transvaginal ultrasound (TVU), and hysterosalpingography. Main Outcome Measure(s): Bilateral placement rate, tubal obstruction, and detection of incorrect Essure microinsert localization at follow-up after apparent successful bilateral placement. Result(s): Bilateral placement of Essure microinserts in one session was successful in 93 women (93%). In 90 of these women (96.8%), tubal obstruction was proven at follow-up 3 months later. Three incorrect positions of an Essure insert were seen: two expulsions and one perforation into the abdominal cavity. Conclusion(s): Incorrect position of Essure microinserts was seen only when the initial placement procedure was difficult. When a placement procedure was difficult or other suboptimal conditions are present during the procedure, we advise performing a TVU or pelvic X-ray in these women 4 weeks after the procedure or after the first vaginal bleeding, instead of waiting for follow-up after 3 months. [ABSTRACT FROM AUTHOR]

Introduction: Pain experience, physical reaction, image quality and adverse events during Gel Instillation Sonohysterography (GIS) can differ using gels with different compositions. As a result, patient satisfaction can also be affected. The effect of two instillation gels, Endosgel versus ExEmgel, using both the Visual Analogue Scale (VAS) and a Continuous Pain Score Meter (CPSM) was therefore compared., Methods: This single centre double blind randomised controlled trial included 80 women planned for outpatient GIS, diagnosed with abnormal intrauterine bleeding or fertility disorders and suspicion on an intrauterine abnormality. Patients were randomly allocated to the instillation of Endosgel containing chlorhexidine or ExEmgel without chlorhexidine. Primary outcome was reported pain during the procedure using VAS. Secondary outcomes included pain score measured using CPSM, satisfaction to the procedure and preference at 3 weeks and 3 months after the procedure and image quality. A cost benefit analysis was also performed., Results: The reported median VAS concerning pain during gel instillation was comparable in the Endosgel and ExEmgel group, 2.50 (IQR 0.00-5.00) and 2.00 (IQR 0.00-5.75) respectively (p = 0.69). The median VAS of the entire procedure was also similar: both 2.00 (IQR 0.00-5.00) (p = 0.86). CPSM-scores were not significantly different either. Both groups were similar in image quality (p = 0.83) and patient's satisfaction (p = 0.36)., Conclusion: Concerning the pain experienced during a GIS procedure and patients' satisfaction, the ExEmgel was not proven to be superior to the Endosgel. Our advice is to use the gel that is available at the lowest costs, as the image quality is the same for both Endosgel and ExEmgel., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)