NCT07525362

Brief Summary

To determine if a short interpregnancy interval following a prior cesarean delivery is associated with an increased risk of intraoperative maternal morbidity (e.g., hemorrhage, visceral injury, prolonged surgery) during the next cesarean delivery.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
13mo left

Started Apr 2026

Status
not yet recruiting

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 Progress4%
Apr 2026Jun 2027

Study Start

First participant enrolled

April 1, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

April 7, 2026

Last Update Submit

April 7, 2026

Conditions

Keywords

Short interpregnancy interval after one prior cesarean delivery and risk of intraoperative maternal morbidity

Outcome Measures

Primary Outcomes (1)

  • Utrine rupture Bladder injury

    1year

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Maternal characteristics to be collected will include: Maternal age, Educational level, Marital status, Gestational diabetes mellitus, Pre-pregnancy hypertension , Gestational hypertension, body mass index at delivery (BMI, calculated as weight in kilograms divided by height in meters squared).

You may qualify if:

  • Pregnant women with history of one previous cesarean delivery Women admmitted for delivery by cesarean delivery during the study period Singleton pregnancy

You may not qualify if:

  • uterine malformation coagulation abnormalities, hypertension or diabetes before pregnancy, immune-related diseases, and chronic hepatic, renal orcardiac diseases Twin or multiple pregnancies Miscarriage before 28 weeks of gestation; Current placental previa or accrete and risk of PPH patients with medical morbid condition like diabetes, preeclampsia, hypertension, cardiac, renal diseases or patients having obstetrical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 1. Wahid N, Ullah I, Bibi H, Ali S, Batool A, Islam L, et al. Obstetric Study to Exploring the Prevalence and Determinants of Cesarean Sections at Timeragra Teaching Hospital Dir Lower. Indus J Biosci Res. 2025;3(2):25- 9. 2. Mazhar T, Ambareen A, Jabeen S. Effects Of Short Inter-Delivery Interval On Mode Of Delivery In Previous One Caesarean Section Cases. Khyber Med Univ J. 2022;14(2):128-31. 3. Umeh UA, Eleje GU, Onuh JU, Nwankwo OT, Ezeome IV, Ajah LO, et al. Comparison of Placenta Previa and Placenta Accreta Spectrum Disorder Following Previous Cesarean Section between Women with a Short and Normal Interpregnancy Interval. Obstet Gynecol Int. 2022;2022(1):8028639. 4. Garg B, Darney B, Pilliod RA, Caughey AB. Long and short interpregnancy intervals increase severe maternal morbidity. Am J Obstet Gynecol. 2021;225(3):331-e1

    BACKGROUND

Central Study Contacts

Hwayda Refaat Sayed, Lecturer

CONTACT

Diaa El- Din Mohamed Abdel -Aal, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

April 7, 2026

First Posted

April 13, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share