NCT05900492

Brief Summary

To assess the incidence of cesarean scar niche and its risk factors in a prospectively collected population.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

9 months

First QC Date

June 4, 2023

Last Update Submit

June 11, 2023

Conditions

Cesarean SectionDehiscence

Outcome Measures

Primary Outcomes (1)

  • the incidence of cesarean scar niche among cesarean deliveries

    number of cases develop cesarean scar niche after cesarean deliveries

    6 months after delivery

Secondary Outcomes (1)

  • risk factors that affect the development of the niche.

    within 1 month of delivery

Study Arms (3)

previous 1 cesarean section

patient who had her first Cesarean section

Procedure: cesarean section

previous 2 cesarean sections

patient who had her second Cesarean sections

Procedure: cesarean section

previous 3 or more cesarean sections

patient who had 3 or more Cesarean sections

Procedure: cesarean section

Interventions

cesarean sectionPROCEDURE

caesarean delivery, is the surgical procedure by which one or more babies are delivered through an incision in the mother's abdomen

previous 1 cesarean sectionprevious 2 cesarean sectionsprevious 3 or more cesarean sections

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The study population will include women recruited from the outpatient obstetrics clinic or emergency room after proper counseling.

You may qualify if:

  • Delivery by cesarean section.
  • More than 6 months after delivery.
  • Cesarean section by senior resident or assistant lecturer.

You may not qualify if:

  • Single layer technique in uterine closure.
  • Uterine anomaly.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni-suef university Hospital

Banī Suwayf, Beni Suweif Governorate, 62521, Egypt

Location

MeSH Terms

Interventions

Cesarean Section

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • sara M salem, MD

    Faculty of Medicine Beni-Suef University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Study Record Dates

First Submitted

June 4, 2023

First Posted

June 12, 2023

Study Start

January 1, 2023

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

June 13, 2023

Record last verified: 2023-06

Locations

EG(1)