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

Background: The rising rate of cesarean deliveries has led to an increased incidence of long long-term complications, including niche formation in the uterine scar. Niche development is associated with various gynecologic complaints and complications in subsequent pregnancies, such as uterine rupture and placenta accreta spectrum disorders. Although uterine closure technique is considered a potential risk factor for niche development, consensus on the optimal technique remains elusive. Objective: We aimed to evaluate the effect of single-layer vs double-layer closure of the uterine incision on live birth rate at a 3-year follow-up with secondary objectives focusing on gynecologic, fertility, and obstetrical outcomes at the same follow-up. Study Design: A multicenter, double-blind, randomized controlled trial was performed at 32 hospitals in the Netherlands. Women ≥18 years old undergoing a first cesarean delivery were randomly assigned (1:1) to receive either single-layer or double-layer closure of the uterine incision. The primary outcome of the long-term follow-up was the live birth rate; with secondary outcomes, including pregnancy rate, the need for fertility treatment, mode of delivery, and obstetrical and gynecologic complications. This trial is registered on the International Clinical Trials Registry Platform www.who.int (NTR5480; trial finished). Results: Between 2016 and 2018, the 2Close study randomly assigned 2292 women, with 830 of 1144 and 818 of 1148 responding to the 3-year questionnaire in the single-layer and double-layer closure. No differences were observed in live birth rates; also there were no differences in pregnancy rate, need for fertility treatments, mode of delivery, or uterine ruptures in subsequent pregnancies. High rates of gynecologic symptoms, including spotting (30%–32%), dysmenorrhea (47%–49%), and sexual dysfunction (Female Sexual Function Index score, 23) are reported in both groups. Conclusion: The study did not demonstrate the superiority of double-layer closure over single-layer closure in terms of reproductive outcomes after a first cesarean delivery. This challenges the current recommendation favoring double-layer closure, and we propose that surgeons can choose their preferred technique. Furthermore, the high risk of gynecologic symptoms after a cesarean delivery should be discussed with patients.</p

Levonorgestrel-releasing intrauterine system versus endometrial ablation for heavy menstrual bleeding

Acknowledgments: We thank all the women who participated in this trial; the participating general practitioners, gynecologists, and hospitals; the research nurses; and the staff of the Dutch Consortium for Studies in Women’s Health and Reproduction.Peer reviewedPublisher PD

Niche-related outcomes after caesarean section and quality of life: a focus group study and review of literature

Background: A niche in the uterus, present in 60% of women after caesarean section (CS), is associated with several gynaecological symptoms and possibly with subfertility. Studies that focus on quality of life (QoL) in relation to a niche are lacking. Purpose: To identify niche-related outcomes that influence QoL and to compare patient-reported outcomes with outcomes studied in the literature. Methods: Two focus group discussions (FGDs, N = 8 and 5) were conducted in Amsterdam UMC—location VUmc. Participants were Dutch patients with a large niche, with (planned) surgical treatment for their symptoms. Niche-related symptoms and impact on functioning or participation were fixed topics. The transcripts of the FGDs were coded into outcomes, themes and domains of QoL according to the WHOQOL model. Additionally, participants created a top five important outcomes. Next, we performed a systematic review (SR) on niche-related outcomes and compared the FGDs with niche-related outcomes from the SR. Results: In four domains (physical health, psychological domain, social relationships and environment), fifteen themes were reported in the FGDs. Abnormal uterine bleeding (AUB), subfertility, sexual activity, abdominal pain and self-esteem were themes prioritised by participants. In the literature, gynaecological symptoms and reproductive outcomes were predominantly studied. Sexuality and self-esteem were prioritised in the FGDs but hardly or never studied in the literature. Conclusion: We found a broad range of niche-related outcomes influencing QoL. Apart from symptoms evaluated in the literature such as AUB, abdominal pain and subfertility, clinicians and researchers should be more aware of sexual activity and self-esteem in this population

Prognostic Factors for Niche Development in the Uterine Caesarean Section Scar

In a prospective study on 134 women after their first cesarean section prognostic factors for developing an uterine niche (scar defect) measured with sonohysterography were evaluated. With multivariable logistic regression anlaysis the following prognostic factors were identified; enlarged cervical dilatation and induction of labour. Contractions before labour reduced the risk for niche development. The predictive value of the model made with this prognostic factors was low. The development of a niche is a multifactorial proces and more studies are needed

Niches after cesarean section in a population seeking hysteroscopic sterilization

Objective To study the prevalence of hysteroscopically evaluated disruptions of the integrity of the uterine wall (‘niches’) in women with and without a previous cesarean section. Study design A prospective cohort study was performed in a teaching hospital in the Netherlands. Women seeking hysteroscopic sterilization were included. A hysteroscopic evaluation of the anterior wall of the uterus and cervix to identify the existence of disruptions (niches) was performed in a standard manner. Primary outcome was the presence of a uterine niche, defined as any visible defect, disruption, or concavity (gap) in the anterior wall. Secondary outcome was to develop a registration form of niche features for hysteroscopic evaluation. Results In total, 713 women were included, 603 without and 110 with a previous cesarean section. In women with a previous cesarean Section 83 (75%) niches were observed using hysteroscopy. Anterior wall disruptions were not observed in women without a cesarean section. The following niche features were identified and incorporated in a registration form: polyps, cysts, myometrium defect, fibrotic tissue, (abnormal) vascular pattern, lateral branches, mucus production inside the defect, and bleeding. Conclusion In a prospective cohort study among women undergoing hysteroscopic sterilization, a uterine niche could be detected by hysteroscopy in 75% of women with a previous cesarean section

Niches after cesarean section in a population seeking hysteroscopic sterilization

Objective To study the prevalence of hysteroscopically evaluated disruptions of the integrity of the uterine wall (‘niches’) in women with and without a previous cesarean section. Study design A prospective cohort study was performed in a teaching hospital in the Netherlands. Women seeking hysteroscopic sterilization were included. A hysteroscopic evaluation of the anterior wall of the uterus and cervix to identify the existence of disruptions (niches) was performed in a standard manner. Primary outcome was the presence of a uterine niche, defined as any visible defect, disruption, or concavity (gap) in the anterior wall. Secondary outcome was to develop a registration form of niche features for hysteroscopic evaluation. Results In total, 713 women were included, 603 without and 110 with a previous cesarean section. In women with a previous cesarean Section 83 (75%) niches were observed using hysteroscopy. Anterior wall disruptions were not observed in women without a cesarean section. The following niche features were identified and incorporated in a registration form: polyps, cysts, myometrium defect, fibrotic tissue, (abnormal) vascular pattern, lateral branches, mucus production inside the defect, and bleeding. Conclusion In a prospective cohort study among women undergoing hysteroscopic sterilization, a uterine niche could be detected by hysteroscopy in 75% of women with a previous cesarean section

Procedural sedation and analgesia versus general anesthesia for hysteroscopic myomectomy (PROSECCO trial) : a multicenter randomized controlled trial

BackgroundHysteroscopic resection is the first-choice treatment for symptomatic type 0 and 1 fibroids. Traditionally, this was performed under general anesthesia. Over the last decade, surgical procedures are increasingly being performed in an outpatient setting under procedural sedation and analgesia. However, studies evaluating safety and effectiveness of hysteroscopic myomectomy under procedural sedation are lacking. This study aims to investigate whether hysteroscopic myomectomy under procedural sedation and analgesia with propofol is noninferior to hysteroscopic myomectomy under general anesthesia.Methods and findingsThis was a multicenter, randomized controlled noninferiority trial conducted in 14 university and teaching hospitals in the Netherlands between 2016 and 2021. Inclusion criteria were age >= 18 years, maximum number of 3 type 0 or 1 fibroids, maximum fibroid diameter 3.5 cm, American Society of Anesthesiologists class 1 or 2, and having sufficient knowledge of the Dutch or English language. Women with clotting disorders or with severe anemia (Hb < 5.0 mmol/L) were excluded. Women were randomized using block randomization with variable block sizes of 2, 4, and 6, between hysteroscopic myomectomy under procedural sedation and analgesia (PSA) with propofol or under general anesthesia (GA).Primary outcome was the percentage of complete resections, assessed on transvaginal ultrasonography 6 weeks postoperatively by a sonographer blinded for the treatment arm and surgical outcome. Secondary outcomes were the surgeon's judgment of completeness of procedure, menstrual blood loss, uterine fibroid related and general quality of life, pain, recovery, hospitalization, complications, and surgical reinterventions. Follow-up period was 1 year.The risk difference between both treatment arms was estimated, and a Farrington-Manning test was used to determine the p-value for noninferiority (noninferiority margin 7.5% of incomplete resections). Data were analyzed according to the intention-to-treat principle, including a per-protocol analysis for the primary outcome.A total of 209 women participated in the study and underwent hysteroscopic myomectomy with PSA (n = 106) or GA (n = 103). Mean age was 45.1 [SD 6.4] years in the PSA group versus 45.0 [7.7] years in the GA group. For 98/106 women in the PSA group and 89/103 women in the GA group, data were available for analysis of the primary outcome.Hysteroscopic resection was complete in 86/98 women (87.8%) in the PSA group and 79/89 women (88.8%) in the GA group (risk difference -1.01%; 95% confidence interval (CI) -10.36 to 8.34; noninferiority, P = 0.09). No serious anesthesiologic complications occurred, and conversion from PSA to GA was not required. During the follow-up period, 15 serious adverse events occurred (overnight admissions). All were unrelated to the intervention studied. Main limitations were the choice of primary outcome and the fact that our study proved to be underpowered.ConclusionsNoninferiority of PSA for completeness of resection was not shown, though there were no significant differences in clinical outcomes and quality of life. In this study, hysteroscopic myomectomy for type 0 and 1 fibroids with PSA compared to GA was safe and led to shorter hospitalization. These results can be used for counseling patients by gynecologists and anesthesiologists. Based on these findings, we suggest that hysteroscopic myomectomies can be performed under PSA in an outpatient setting

The (cost) effectiveness of procedural sedation and analgesia versus general anaesthesia for hysteroscopic myomectomy, a multicentre randomised controlled trial : PROSECCO trial, a study protocol

BACKGROUND: In women with abnormal uterine bleeding, fibroids are a frequent finding. In case of heavy menstrual bleeding and presence of submucosal type 0-1 fibroids, hysteroscopic resection is the treatment of first choice, as removal of these fibroids is highly effective. Hysteroscopic myomectomy is currently usually performed in the operating theatre. A considerable reduction in costs and a higher patient satisfaction are expected when procedural sedation and analgesia with propofol (PSA) in an outpatient setting is applied. However, both safety and effectiveness - including the necessity for re-intervention due to incomplete resection - have not yet been evaluated. METHODS: This study is a multicentre randomised controlled trial with a non-inferiority design and will be performed in the Netherlands. Women > 18 years with a maximum of 3 symptomatic type 0 or 1 submucosal fibroids with a maximum diameter of 3.5 cm are eligible to participate in the trial. After informed consent, 205 women will be randomised to either hysteroscopic myomectomy using procedural sedation and analgesia with propofol in an outpatient setting or hysteroscopic myomectomy using general anaesthesia in a clinical setting in the operating theatre. Primary outcome will be the percentage of complete resections, based on transvaginal ultrasonography 6 weeks postoperatively. Secondary outcomes are cost effectiveness, menstrual blood loss (Pictorial blood assessment chart), quality of life, pain, return to daily activities/work, hospitalization, (post) operative complications and re-interventions. Women will be followed up to one year after hysteroscopic myomectomy. DISCUSSION: This study may demonstrate comparable effectiveness of hysteroscopic myomectomy under procedural sedation and analgesia versus general anaesthesia in a safe and patient friendly environment, whilst achieving a significant cost reduction. TRIAL REGISTRATION: Dutch trial register, number NTR5357 . Registered 11th of August 2015

MisoREST: Surgical versus expectant management in women with an incomplete evacuation of the uterus after misoprostol treatment for miscarriage: A cohort study

Objective: To assess the effectiveness of curettage versus expectant management in women with an incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage. Study design: We conducted a multicenter cohort study alongside a randomized clinical trial (RCT) between June 2012 until July 2014. 27 Dutch hospitals participated. Women with an incomplete evacuation after misoprostol treatment for first trimester miscarriage who declined to participate in the RCT, received treatment of their preference; curettage (n = 65) or expectant management (n = 132). A successful outcome was defined as an empty uterus on sonography at six weeks or uneventful clinical follow-up. We furthermore assessed complication rate and (re)intervention rate Results: Of the 197 women who declined to participate in the RCT, 65 preferred curettage and 132 expectant management. A successful outcome was observed in 62/65 women (95%) in the surgical group versus 112/132 women (85%) in the expectant group (RR 1.1, 95% CI 1.03-1.2), with complication rates of 6.2% versus 2.3%, respectively (RR 2.7, 95% CI 0.6-12). Conclusion: In women with an incomplete evacuation of the uterus after misoprostol treatment, expectant management is an effective and safe option. This finding could restrain the use of curettage in women that have used misoprostol in the treatment of first trimester miscarriage. (C) 2017 Elsevier B.V. All rights reserved