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

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.

The effect of laparoscopic resection of large niches in the uterine caesarean scar on symptoms, ultrasound findings and quality of life: a prospective cohort study.

OBJECTIVE: To evaluate the effectiveness of a laparoscopic niche resection on niche-related symptoms and/or fertility-related problems, ultrasound findings and quality of life. DESIGN: Prospective cohort study. SETTING: University hospital. POPULATION: Women with a large niche (residual myometrium <3 mm) and complaints of either postmenstrual spotting, dysmenorrhoea, intrauterine fluid accumulation and/or difficulties with embryo transfer due to distorted anatomy. METHODS: Women filled out questionnaires and a validated menstrual score chart at baseline and 6 months after the laparoscopic niche resection. At baseline and between 3 and 6 months follow up niches were evaluated by transvaginal ultrasound. MAIN OUTCOME MEASURES: The primary outcome was reduction of the main problem 6 months after the intervention. Secondary outcomes were complications, menstrual characteristics, dysmenorrhoea, niche measurements, intrauterine fluid, surgical outcomes, satisfaction and quality of life. RESULTS: In all, 101 women underwent a laparoscopic niche resection. In 80 women (79.2%) the main problem was improved or resolved. Postmenstrual spotting was significantly reduced by 7 days at 6 months follow up compared with baseline. Dysmenorrhoea and discomfort related to spotting was also significantly reduced. The residual myometrium was increased significantly at follow up. The intrauterine fluid was resolved in 86.9% of the women with intrauterine fluid at baseline; 83.3% of women were (very) satisfied. The physical component of quality of life increased, the mental component did not change. CONCLUSIONS: A laparoscopic niche resection reduced postmenstrual spotting, discomfort due to spotting, dysmenorrhoea and the presence of intrauterine fluid in the majority of women and increased the residual myometrium. TWEETABLE ABSTRACT: Laparoscopic niche resection reduces niche-related problems and enlarges the residual myometrium.

Fibroid vascularisation assessed with three-dimensional power Doppler ultrasound is a predictor for uterine fibroid growth: a prospective cohort study.

OBJECTIVE: To analyse fibroid vascularisation measured with three-dimensional (3D) power Doppler in relation to absolute fibroid volume change during 12 months of follow up and in relation to fibroid growth rate per year. DESIGN: A prospective cohort study was performed between March 2012 and March 2014. SETTING: Outpatient clinic of the VU medical centre, Amsterdam. POPULATION OR SAMPLE: All premenopausal women diagnosed with a maximum of two fibroids with expectant management were consecutively included. METHODS: Three-dimensional ultrasound including power Doppler was performed at baseline, 3, 6 and 12 months. Volume and vascular parameters were calculated using VOCAL software. MAIN OUTCOME MEASURES: The relationship between vascular index (VI) at baseline and fibroid volume over time was analysed using linear mixed model analyses for repeated measurements. Second, the relationship between VI at baseline and fibroid growth rate per year was calculated using linear regression analyses. Analyses were adjusted for possible confounders. RESULTS: In all, 66 women (mean age 42 years) completed 12 months of follow up without treatment. Baseline fibroid vascularisation (VI) measured with 3D power Doppler is correlated with fibroid volume at 12 months (P = 0.02 ). An increase of 1% in VI at baseline was associated with a 7.00-cm3 larger fibroid volume at 12 months. Furthermore, vascularisation was also associated with fibroid growth rate per year (P = 0.04). CONCLUSION: In women with uterine fibroids without therapy, baseline vascularisation (VI) measured with 3D power Doppler is correlated with absolute fibroid volume change at 12 months and with fibroid growth rate per year. TWEETABLE ABSTRACT: Fibroid vascularisation correlates with absolute fibroid volume change and fibroid growth rate per year.

Uterine caesarean closure techniques affect ultrasound findings and maternal outcomes: a systematic review and meta-analysis.

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.

Hysteroscopic resection of a uterine caesarean scar defect (niche) in women with postmenstrual spotting: a randomised controlled trial.

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.

Word catheter and marsupialisation in women with a cyst or abscess of the Bartholin gland (WoMan-trial): a randomised clinical trial.

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.

Fertility outcomes after hysteroscopic niche resection compared with expectant management in women with a niche in the uterine cesarean scar.

OBJECTIVE: To determine whether hysteroscopic niche resection (HNR) and expectant management are suitable in women with fertility desire and a niche with a residual myometrium thickness (RMT) ≥ 2.5 mm. STUDY DESIGN: This retrospective cohort study was conducted at International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China between September 2016 and December 2021. We reported the fertility outcomes between women (with fertility desire and a niche with RMT ≥ 2.5 mm) who received HNR or expectant management. RESULTS: We studied 166 women, of whom 72 accepted HNR and 94 accepted expectant management. The HNR group included more symptomatic women, in terms of postmenstrual spotting or infertility. No differences were found regarding niche measures before treatment. The live birth rate was comparable in both groups (HNR versus expectant management as 55.5% versus 45.7%, risk ratio = 1.48, 95% Cl 0.80-2.75, p = 0.21). The pregnancy rate was higher in HNR group than that in expectant management group (n = 72.2% versus n = 56.4%, risk ratio = 2.01, 95% CI 1.04-3.88, p = 0.04). In a subgroup of women with infertility before entry in the study, HNR resulted in a significant higher live birth rate (p = 0.04) and pregnancy rate (p = 0.01). CONCLUSION: In women with infertility with a symptomatic niche with RMT ≥ 2.5 mm, HNR may be superior to expectant management. This retrospective cohort biased selection against a randomized study, our results still need to be validated in the future with larger clinical multicenter randomized controlled trials.