Septum resection in women with a septate uterus: a cohort study.

STUDY QUESTION: Does septum resection improve reproductive outcomes in women with a septate uterus? SUMMARY ANSWER: In women with a septate uterus, septum resection does not increase live birth rate nor does it decrease the rates of pregnancy loss or preterm birth, compared with expectant management. WHAT IS KNOWN ALREADY: The septate uterus is the most common uterine anomaly with an estimated prevalence of 0.2-2.3% in women of reproductive age, depending on the classification system. The definition of the septate uterus has been a long-lasting and ongoing subject of debate, and currently two classification systems are used worldwide. Women with a septate uterus may be at increased risk of subfertility, pregnancy loss, preterm birth and foetal malpresentation. Based on low quality evidence, current guidelines recommend removal of the intrauterine septum or, more cautiously, state that the procedure should be evaluated in future studies. STUDY DESIGN, SIZE, DURATION: We performed an international multicentre cohort study in which we identified women mainly retrospectively by searching in electronic patient files, medical records and databases within the time frame of January 2000 until August 2018. Searching of the databases, files and records took place between January 2016 and July 2018. By doing so, we collected data on 257 women with a septate uterus in 21 centres in the Netherlands, USA and UK. PARTICIPANTS/MATERIALS, SETTING, METHODS: We included women with a septate uterus, defined by the treating physician, according to the classification system at that time. The women were ascertained among those with a history of subfertility, pregnancy loss, preterm birth or foetal malpresentation or during a routine diagnostic procedure. Allocation to septum resection or expectant management was dependent on the reproductive history and severity of the disease. We excluded women who did not have a wish to conceive at time of diagnosis. The primary outcome was live birth. Secondary outcomes included pregnancy loss, preterm birth and foetal malpresentation. All conceptions during follow-up were registered but for the comparative analyses, only the first live birth or ongoing pregnancy was included. To evaluate differences in live birth and ongoing pregnancy, we used Cox proportional regression to calculate hazard rates (HRs) and 95% CI. To evaluate differences in pregnancy loss, preterm birth and foetal malpresentation, we used logistic regression to calculate odds ratios (OR) with corresponding 95% CI. We adjusted all reproductive outcomes for possible confounders. MAIN RESULTS AND THE ROLE OF CHANCE: In total, 257 women were included in the cohort. Of these, 151 women underwent a septum resection and 106 women had expectant management. The median follow-up time was 46 months. During this time, live birth occurred in 80 women following a septum resection (53.0%) compared to 76 women following expectant management (71.7%) (HR 0.71 95% CI 0.49-1.02) and ongoing pregnancy occurred in 89 women who underwent septum resection (58.9%), compared to 80 women who had expectant management (75.5%) (HR 0.74 (95% CI 0.52-1.06)). Pregnancy loss occurred in 51 women who underwent septum resection (46.8%) versus 31 women who had expectant management (34.4%) (OR 1.58 (0.81-3.09)), while preterm birth occurred in 26 women who underwent septum resection (29.2%) versus 13 women who had expectant management (16.7%) (OR 1.26 (95% CI 0.52-3.04)) and foetal malpresentation occurred in 17 women who underwent septum resection (19.1%) versus 27 women who had expectant management (34.6%) (OR 0.56 (95% CI 0.24-1.33)). LIMITATIONS, REASONS FOR CAUTION: Our retrospective study has a less robust design compared with a randomized controlled trial. Over the years, the ideas about the definition of the septate uterus has changed, but since the 257 women with a septate uterus included in this study had been diagnosed by their treating physician according to the leading classification system at that time, the data of this study reflect the daily practice of recent decades. Despite correcting for the most relevant patient characteristics, our estimates might not be free of residual confounding. WIDER IMPLICATIONS OF THE FINDINGS: Our results suggest that septum resection, a procedure that is widely offered and associated with financial costs for society, healthcare systems or individuals, does not lead to improved reproductive outcomes compared to expectant management for women with a septate uterus. The results of this study need to be confirmed in randomized clinical trials. STUDY FUNDING/COMPETING INTEREST(S): A travel for JFWR to Chicago was supported by the Jo Kolk Studyfund. Otherwise, no specific funding was received for this study. The Department of Obstetrics and Gynaecology, University Medical Centre, Groningen, received an unrestricted educational grant from Ferring Pharmaceutical Company unrelated to the present study. BWM reports grants from NHMRC, personal fees from ObsEva, personal fees from Merck, personal fees from Guerbet, other payment from Guerbet and grants from Merck, outside the submitted work. The other authors declare no conficts of interest. TRIAL REGISTRATION NUMBER: N/A.

Interventions to support shared decision-making for women with heavy menstrual bleeding: A systematic review.

This review studies women's preferences for shared decision-making about heavy menstrual bleeding treatment and evaluates interventions that support shared decision-making and their effectiveness. PubMed, Cochrane, Embase, Medline and ClinicalTrials.gov were searched. Three research questions were predefined: 1) What is the range of perspectives gathered in studies that examine women facing a decision related to heavy menstrual bleeding management?; 2) What types of interventions have been developed to support shared decision-making for women experiencing heavy menstrual bleeding?; and 3) In what way might women benefit from interventions that support shared decision-making? All original studies were included if the study population consisted of women experiencing heavy menstrual bleeding. We used the TIDieR (Template for Intervention: Description and Replication) checklist to assess the quality of description and the reproducibility of interventions. Interventions were categorized using Grande et al. guidelines and collated and summarized outcomes measures into three categories: 1) patient-reported outcomes; 2) observer-reported outcomes; and 3) doctor-reported outcomes. Fifteen studies were included. Overall, patients preferred to decide together with their doctor (74%). Women's previsit preference was the strongest predictor for treatment choice in two studies. Information packages did not have a statistically significant effect on treatment choice or satisfaction. However, adding a structured interview or decision aid to increase patient involvement did show a positive effect on treatment choice and results, patient satisfaction and shared decision-making related outcomes. In conclusion shared decision-making is becoming more important in the care of women with heavy menstrual bleeding. Structured interviews or well-designed (computerized) tools such as decision aids seem to facilitate this process, but there is room for improvement. A shared treatment choice is only possible after careful provision of information, elicitation of patients' preferences and integrating those preferences. Interventions should be designed accordingly.

Efficacy and safety of uterine manipulators in laparoscopic surgery: a review.

PURPOSE: This review aims to objectively assess the efficacy and safety of uterine manipulators as reported in scientific literature. Furthermore, it evaluates as to which manipulator best suits which surgical procedure. METHODS: PubMed, Embase, Web of Science, COCHRANE, CINAHL, Academic Search Premier, Science Direct and the MAUDE database were searched. Technical information was retrieved from the manufacturers. RESULTS: 25 articles covering 10 uterine manipulators were found. Studies regarding implementation and use of manipulators are scarce; only two surveys were found comparing different manipulators. Moreover, clinical evidence proving the efficacy of manipulators with respect to prevention of complications, inherent to laparoscopic surgery, does not exist. CONCLUSION: The use of uterine manipulators is well established and it is clear that uterine manipulators offer the easiest way to handle the uterus during surgery. However, detailed information regarding efficacy and safety is scarce. Clinical evidence substantiating the assumed mechanism of prevention of ureter injuries was not found. Our review did not find the optimal manipulator. Some are more versatile than others and not all instruments are appropriate for all types of surgery. Therefore, gynecologists should choose the manipulator that best suits the type of surgery that is performed.