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

The costeffectiveness of double layer closure of the caesarean (uterine) scar in the prevention of gynaecological symptoms in relation to niche development. - 2Close study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47638

Enrollment

2290

Registered

2015-12-10

Start date

2016-05-25

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

CS scar defect Isthmocele

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 cont

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

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.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)