The costeffectiveness of double layer closure of the caesarean (uterine) scar in the prevention of gynaecological symptoms in relation to niche development.

Completed

• Conditions: CS scar defect; Isthmocele; 10013326

• Registration Number: NL-OMON47638
• Lead Sponsor: VUmc Gynaecologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 2290

Inclusion Criteria

• Patients undergoing their first CS (planned or emergency)
• >=18 years old
• Sufficient command of the Dutch language

Exclusion Criteria

• Patients with an indication for an emergency CS (suspicion of fetal distress)
• Inadequate possibility for counseling (e.g. patients in heavy pain without
accurate therapy, insufficient language comprehension) who were not asked to
sign informed consent earlier in the pregnancy
• Previous uterine major surgery (e.g. laparoscopic or laparotomic fibroid
resection, septum resection)
• Patients with known causes of menstrual disorders (known cervical dysplasia,
communicating hydrosalpinx, uterine anomaly or endocrine disorders disturbing
ovulation)
• Placenta percreta during the current pregnancy
• >= 3 fetus during the current pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome: post- and intermenstrual spotting 9 months after<br /><br>randomization. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome: menstrual pattern (score card) and dysmenorhoe (VAS),<br /><br>Quality of life (SF36 & EQ-5D-5L), societal reintegration (PROMIS), sexual<br /><br>function (FSFI), Niche (characteristics), complications, surgery time and<br /><br>costs, % of ongoing pregnancies, life birth rate and time to conceive in women<br /><br>willing to conceive. </p><br>