Status:

RECRUITING

Niche In CEsarean Scar Trial (NICEST)

Lead Sponsor:

Nguyen Thi Thu Ha

Conditions:

Niche

Eligibility:

FEMALE

18-60 years

Phase:

NA

Brief Summary

Rationale: Cesarean delivery (CD) rates are increasing rapidly worldwide. The consequences of cesarean section not only affect the next pregnancies such as uterine rupture or malplacentation but also ...

Detailed Description

Pregnancies at term, indicated for cesarean delivery for the first time, will be fully consulted information related to this study before surgery. Written consent will be obtained from each eligible p...

Eligibility Criteria

Inclusion

  • Pregnant women who undergo a primary CD (planned or unplanned)
  • Age ≥ 18 years.
  • Gestational age ≥ 37 0/7 weeks

Exclusion

  • Previous major uterine surgery (e.g. laparoscopic or laparotomic fibroid resection, septum resection).
  • Women with abnormal menstrual bleeding (e.g. cervical dysplasia, communicating hydrosalpinx, uterine anomaly or endocrine disorders disturbing ovulation, drugs, polyps, fibroids, etc.).
  • Women with dysmenorrhea, dyspareunia, suprapubic pain.
  • Abnormal placenta: Placenta privia, Placenta percreta… in the current pregnancy.

Key Trial Info

Start Date :

May 1 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 1 2026

Estimated Enrollment :

938 Patients enrolled

Trial Details

Trial ID

NCT05312775

Start Date

May 1 2022

End Date

October 1 2026

Last Update

March 1 2024

Active Locations (1)

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Hanoi Obstetrics and Gynecology Hospital

Hanoi, Hanoi, Vietnam, 100000