ABSTRACT

BackgroundA caesarean section (CS) can cause a defect or disruption of the myometrium at the site of the uterine scar, called a niche. In recent years, an association between a niche and postmenstrual spotting after a CS has been demonstrated. Hysteroscopic resection of these niches is thought to reduce spotting and menstrual pain. However, there are no randomised trials assessing the effectiveness of a hysteroscopic niche resection.Methods/DesignWe planned a multicentre randomised trial comparing hysteroscopic niche resection to no intervention. We study women with postmenstrual spotting after a CS and a niche with a residual myometrium of at least 3 mm during sonohysterography. After informed consent is obtained, eligible women will be randomly allocated to hysteroscopic resection of the niche or expectant management for 6 months.The primary outcome is the number of days with postmenstrual spotting during one menstrual cycle 6 months after randomisation. Secondary outcomes are menstrual characteristics, menstruation related pain and experienced discomfort due to spotting or menstrual pain, quality of life, patient satisfaction, sexual function, urological symptoms, medical consultations, medication use, complications, lost productivity and medical costs. Measurements will be performed at baseline and at 3 and 6 months after randomisation. A cost-effectiveness analysis will be performed from a societal perspective at 6 months after randomisation.DiscussionThis trial will provide insight in the (cost)effectiveness of hysteroscopic resection of a niche versus expectant management in women who have postmenstrual spotting and a niche with sufficient residual myometrium to perform a hysteroscopic niche resection.Trial registrationDutch Trial Register NTR3269. Registered 1 February 2012. ZonMw Grant number 80-82305-97-12030

We thank Dr Gonser for his interest in our review. We reported that a single-layer myometrium closure is a potential risk factor for the presence of a niche based on three studies 1 -3 . One randomized controlled trial (RCT) 3 reported a lower frequency of a niche in women treated by full-thickness suturing (including the endometrial layer) in comparison with those treated with split-thickness suturing (excluding the endometrial layer). A prospective cohort study 1 reported a reduced risk of niche development after double-layer myometrium

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