Optimal Interval Between Consecutive Cesarean Sections

Recruiting

• Conditions: Cesarean Section Complications

• Registration Number: NCT06491368
• Lead Sponsor: Al-Azhar University

Brief Summary

The goal of this observational study is to determine the best time interval between consecutive cesarean sections and compare maternal and neonatal outcomes in women with a history of previous cesarean sections. The main questions it aims to answer are:

* What is the optimal time interval between consecutive cesarean sections for minimizing maternal intraoperative complications, blood transfusions, and intra- and postoperative bleeding?

* What are the differences in fetal and neonatal outcomes based on different time intervals between cesarean sections?

Participants will be divided into five subgroups based on the time interval since their last cesarean section: 0-12 months, 12-24 months, 25-36 months, 37-48 months, and more than 48 months. Each participant will undergo an elective cesarean section and provide data on maternal and neonatal outcomes.

Researchers will compare these subgroups to see if varying time intervals between consecutive cesarean sections affect maternal and neonatal outcomes.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-01
• Study First Submitted QC: 2024-07-01
• Study First Posted: 2024-07-09
• Study Start: 2024-07-10
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-07
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Age between 20-40 years.
• Full-term pregnant women more than 37 weeks gestation.
• Women with a history of at least one previous cesarean section, planning an elective repeated cesarean section.

Exclusion Criteria

• Women with contraindications to cesarean section
• Those with emergency indications
• Multiple pregnancies
• Pre-existing maternal or fetal conditions affecting outcomes.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intraoperative complications	Withen the surgery.	Occurrences of injuries to the bladder or bowel during surgery, injury of uterine artery, extension of uterine incision.

Secondary Outcome Measures

Name	Time	Method
Blood transfusions	withen the surgery and up to 24 hours after the sutgery.	Instances of maternal blood transfusions during or after surgery.
Neonatal Apgar scores	5 minutes after birth.	Apgar scores measured at 1 minute and 5 minutes after birth, assessing newborn health.
NICU admissions	during and 24 hours after the surgery.	Number of neonates admitted to the Neonatal Intensive Care Unit (NICU).
Intraoperative and postoperative bleeding (quantify blood loss	withen the surgery and up to 24 hours after the sutgery.	Measurement of blood loss before and after surgery using complete blood count (CBC).
Neonatal morbidity and mortality	during and 2 weeks after the surgery.	Incidence of health issues and deaths among newborns within a specific timeframe post-delivery.
Fetal distress	during and 24 hours after the surgery.	Instances of fetal distress noted during labor or delivery
ICU admissions	1 week after the surgery.	Number of mothers admitted to the Intensive Care Unit (ICU) postoperatively.

Trial Locations

Locations (1)

Al-Hussein University Hospital; 🇪🇬 Cairo, Egypt