The cost effectiveness of surgical closure of the uterine scar during a caesarean section (CS) in 2 layers (compared with 1 layer closure) to prevent gynaecological symptoms associated with a defect in CS scar.
Completed
- Conditions
- Double layer closure, Caesarean sectio defect, niche, abnormal uterine bleeding2 lagen sluiten, Sectio caesarea litteken defect, niche, abnormaal uterien bloedverlies
- Registration Number
- NL-OMON28023
- Lead Sponsor
- VU medical centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2290
Inclusion Criteria
Women (18 years or older) undergoing their first caesarean section.
Exclusion Criteria
Exclusion criteria include patients with previous uterine surgery, patients with known other factors causing menstrual disorders and patients with placenta percreta.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome: post- and intermenstrual spotting 9 months after randomization.
- Secondary Outcome Measures
Name Time Method Secondary outcome: menstrual pattern (score card) and dysmenorhoe (VAS), Quality of life (SF36 & EQ-5D-5L), societal reintegration (PROMIS), sexual function (FSFI), Niche (characteristics), complications, surgery time and costs, % of ongoing pregnancies, life birth rate and time to conceive in women willing to conceive.