Consensus between niche experts was achieved on all items regarding ultrasonographic niche measurement.

a,d for the 2Close study group*

Background Double-layer compared to single-layer closure of the uterus after a caesarean section (CS) leads to a thicker myometrial layer at the site of the CS scar, also called residual myometrium thickness (RMT). It possibly decreases the development of a niche, which is an interruption of the myometrium at the site of the uterine scar. Thin RMT and a niche are associated with gynaecological symptoms, obstetric complications in a subsequent pregnancy and delivery and possibly with subfertility. Methods Women undergoing a first CS regardless of the gestational age will be asked to participate in this multicentre, double blinded randomised controlled trial (RCT). They will be randomised to single-layer closure or double-layer closure of the uterine incision. Single-layer closure (control group) is performed with a continuous running, unlocked suture, with or without endometrial saving technique. Double-layer closure (intervention group) is performed with the first layer in a continuous unlocked suture including the endometrial layer and the second layer is also continuous unlocked and imbricates the first. The primary outcome is the reported number of days with postmenstrual spotting during one menstrual cycle nine months after CS. Secondary outcomes include surgical data, ultrasound evaluation at three months, menstrual pattern, dysmenorrhea, quality of life, and sexual function at nine months. Structured transvaginal ultrasound (TVUS) evaluation is performed to assess the uterine scar and if necessary saline infusion sonohysterography (SIS) or gel instillation sonohysterography (GIS) will be added to the examination. Women and ultrasound examiners will be blinded for allocation. Reproductive outcomes at three years follow-up including fertility, mode of delivery and complications in subsequent deliveries will be studied as well. Analyses will be performed by intention to treat. 2290 women have to be randomised to show a reduction of 15% in the mean number of spotting days. Additionally, a cost-effectiveness analysis will be performed from a societal perspective. Discussion This RCT will provide insight in the outcomes of single- compared to double-layer closure technique after CS, including postmenstrual spotting and subfertility in relation to niche development measured by ultrasound. Trial registration Dutch Trial Register ( NTR5480 ). Registered 29 October 2015. Electronic supplementary material The online version of this article (10.1186/s12884-019-2221-y) contains supplementary material, which is available to authorized users.

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.

ObjectiveTo evaluate the cost-effectiveness of double-layer compared with single-layer uterine closure after a first caesarean section (CS) from a societal and healthcare perspective.DesignEconomic evaluation alongside a multicentre, double-blind, randomised controlled trial.Setting32 hospitals in the Netherlands, 2016–2018.Participants2292 women ≥18 years undergoing a first CS were randomly assigned (1:1). Exclusion criteria were: inability for counselling, previous uterine surgery, known menstrual disorder, placenta increta or percreta, pregnant with three or more fetuses. 1144 women were assigned to single-layer and 1148 to double-layer closure. We included 1620 women with a menstrual cycle in the main analysis.InterventionsSingle-layer unlocked uterine closure and double-layer unlocked uterine closure with the second layer imbricating the first.Main outcome measuresSpotting days, quality-adjusted life-years (QALYs), and societal costs at 9 months of follow-up. Missing data were imputed using multiple imputation.ResultsNo significant differences were found between single-layer versus double-layer closure in mean spotting days (1.44 and 1.39 days; mean difference (md) −0.056, 95% CI −0.374 to 0.263), QALYs (0.663 and 0.658; md −0.005, 95% CI −0.015 to 0.005), total healthcare costs (€744 and €727; md €−17, 95% CI −273 to 143), and total societal costs (€5689 and €5927; md €238, 95% CI −624 to 1108). The probability of the intervention being cost-effective at willingness-to-pay of €0, €10 000 and €20 000/QALY gained was 0.30, 0.27 and 0.25, respectively, (societal perspective), and 0.55, 0.41 and 0.32, respectively, (healthcare perspective).ConclusionDouble-layer uterine closure is not cost-effective compared with single-layer uterine closure from both perspectives. If this is confirmed by our long-term reproductive follow-up, we suggest to adjust uterine closure technique guidelines.Trial registration numberNTR5480/NL5380.

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