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.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28023

Enrollment

2290

Registered

2015-10-29

Start date

2016-05-25

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Double layer closure, Caesarean sectio defect, niche, abnormal uterine bleeding 2 lagen sluiten, Sectio caesarea litteken defect, niche, abnormaal uterien bloedverlies

Interventions

Double layer closure (unlocked) continuous running suture of the uterus using multifilament material (instructed by e-learning) compared with usual (single layer) closure of the uterus, using a contin

Eligibility

Inclusion criteria

Inclusion criteria: Women (18 years or older) undergoing their first caesarean section.

Exclusion criteria

Exclusion criteria: Exclusion criteria include patients with previous uterine surgery, patients with known other factors causing menstrual disorders and patients with placenta percreta.

Design outcomes

Primary

Measure	Time frame
Primary outcome: post- and intermenstrual spotting 9 months after randomization.	—

Secondary

Measure	Time frame
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.	—

Contacts

Public ContactJ.A.F. Huirne

VU Medical Center Department of Obstetrics and Gynaecology Postbus 7057

j.huirne@vumc.nl+31 (0)20 4440090

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)