The number of eligible publications on ICH in untreated FNAIT pregnancies is strikingly limited. The recurrence rate is high. As sufficient data on successive FNAIT cases without ICH are lacking, the occurrence of ICH in pregnancies with thrombocytopenia, but without ICH in a previous sibling, cannot be predicted. We estimate this risk to be 7%. This risk must be balanced against the risk of interventions in treatment strategies.
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
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.
Objective
To investigate whether laparoscopic sacrohysteropexy (LSH) is non‐inferior to vaginal sacrospinous hysteropexy (SSHP) in the surgical treatment of uterine prolapse.
Design
Multicentre randomised controlled, non‐blinded non‐inferiority trial.
Setting
Five non‐university teaching hospitals in the Netherlands, one university hospital in Belgium.
Population
126 women with uterine prolapse stage 2 or higher undergoing surgery without previous pelvic floor surgery.
Methods
Randomisation in a 1:1 ratio to LSH or SSHP, stratified per centre and severity of the uterine prolapse. The predefined inferiority margin was an increase in surgical failure rate of 10%.
Main outcome measures
Primary outcome was surgical failure, defined as recurrence of uterine prolapse (POP‐Q ≥ 2) with bothersome bulging/protrusion symptoms and/or repeat surgery or pessary at 12 months postoperatively. Secondary outcomes were anatomical recurrence (any compartment), functional outcome and quality of life.
Results
Laparoscopic sacrohysteropexy was non‐inferior for surgical failure (n = 1, 1.6%) compared with SSHP (n = 2, 3.3%, difference −1.7%, 95% CI: −7.1 to 3.7) 12 months postoperatively. Overall, anatomical recurrences and quality of life did not differ. More bothersome symptoms of overactive bladder (OAB) and faecal incontinence were reported after LSH. Dyspareunia was more frequently reported after SSHP.
Conclusion
Laparoscopic sacrohysteropexy was non‐inferior to SSHP for surgical failure of the apical compartment at 12 months’ follow up. Following LSH, bothersome OAB and faecal incontinence were more frequent, but dyspareunia was less frequent.
Tweetable abstract
Laparoscopic sacrohysteropexy and vaginal sacrospinous hysteropexy have equally good short‐term outcomes.
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