Evaluation of the caesarean section scar during pregnancies after uterine scar repair in comparison to controls without scar repair

Changes of the uterine niche during pregnancies after laparoscopic niche resection in comparison to controls without niche surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN10685540

Enrollment

100

Registered

2021-07-28

Start date

2012-02-01

Completion date

Unknown

Last updated

2022-09-05

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

Conditions

Subsequent pregnancy after previous niche resection Pregnancy and Childbirth

Interventions

An observational study of women with a niche after previous caesarean section, diagnosed before pregnancy, and followed up during subsequent pregnancy. There are two arms: women with a previous laparo

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Lapniche group: participants of the LapNiche trial (CCMO - NL37922.029.11) Expectant group: participants of the Niche Cohort study (https://www.trialregister.nl/, trial number NL6844)

Exclusion criteria

Exclusion criteria: Age <18 years or not able to understand Dutch

Design outcomes

Primary

Measure	Time frame
RMT obtained from the data of the Lapniche study and Niche cohort study before pregnancy and measured using transvaginal ultrasound (TVUS) in the first, second and third trimester of pregnancy	—

Secondary

Measure	Time frame
1. Niche presence and niche measurements obtained from the data of the Lapniche study and Niche cohort study before pregnancy and determined using TVUS in the first, second and third trimester of pregnancy 2. Obstetric outcomes (gestational age (GA) at time of delivery, obtained from medical files from time of delivery 3. Mode of delivery, obtained from medical files from time of delivery 4. Uterine dehiscence and rupture, obtained from medical files from time of delivery 5. Blood loss, obtained from medical files from time of delivery 6. Birth weight, obtained from medical files from time of delivery 7. Apgar score, obtained from medical files from time of delivery 8. Admission to neonatal care unit, obtained from medical files from time of delivery	—

Measure

Time frame

1. Niche presence and niche measurements obtained from the data of the Lapniche study and Niche cohort study before pregnancy and determined using TVUS in the first, second and third trimester of pregnancy 2. Obstetric outcomes (gestational age (GA) at time of delivery, obtained from medical files from time of delivery 3. Mode of delivery, obtained from medical files from time of delivery 4. Uterine dehiscence and rupture, obtained from medical files from time of delivery 5. Blood loss, obtained from medical files from time of delivery 6. Birth weight, obtained from medical files from time of delivery 7. Apgar score, obtained from medical files from time of delivery 8. Admission to neonatal care unit, obtained from medical files from time of delivery

—

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026