Optimal Interval Between Consecutive Cesarean Sections

NCT06491368 | Completed

• 1 other identifier: Obstet30624
• Study Type: observational
• Target: 201
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section Complications

Keywords

Elective cesarean section; Time interval between consecutive cesarean sections

Outcome Measures

Primary Outcomes (1)

• Intraoperative complications

  Occurrences of injuries to the bladder or bowel during surgery, injury of uterine artery, extension of uterine incision.

  Withen the surgery.

Secondary Outcomes (7)

• Intraoperative and postoperative bleeding (quantify blood loss

  withen the surgery and up to 24 hours after the sutgery.

• Blood transfusions

  withen the surgery and up to 24 hours after the sutgery.

• ICU admissions

  1 week after the surgery.

• Fetal distress

  during and 24 hours after the surgery.

• Neonatal Apgar scores

  5 minutes after birth.

Study Arms (5)

Less than 18 months

This group consists of women who have had their previous cesarean section less than 12 months before the current scheduled elective cesarean section.

Procedure: Cesarean Delivery

18-24 months

This group includes women whose previous cesarean section was 12 to 24 months before their current scheduled elective cesarean section.

Procedure: Cesarean Delivery

25-36 months

This group is comprised of women who had their last cesarean section between 25 and 36 months prior to the current scheduled elective cesarean section.

Procedure: Cesarean Delivery

37-48 months

This group consists of women whose previous cesarean section occurred 37 to 48 months before the current scheduled elective cesarean section.

Procedure: Cesarean Delivery

More than 48 months

This group includes women who had their last cesarean section more than 48 months before their current scheduled elective cesarean section.

Procedure: Cesarean Delivery

Interventions

Cesarean Delivery PROCEDURE

A Pfannenstiel abdominal incision is made. The skin and rectus sheath are transversely opened using sharp dissection, and the rectus sheath is separated from the underlying rectus abdominis muscles. The peritoneum is then longitudinally opened using sharp dissection. A transverse incision is made in the lower segment of the uterus, which is subsequently closed with two layers of continuous sutures. Both peritoneal layers are closed with continuous sutures. The fascia is closed using either continuous or interrupted sutures. Finally, the skin is closed with either interrupted sutures or a continuous intracutaneous suture.

18-24 months; 25-36 months; 37-48 months; Less than 18 months; More than 48 months

Eligibility Criteria

• Age: 20 Years - 42 Years
• Gender Eligibility Details: Female participants who have undergone previous Cesarean section(s) and are scheduled for elective Cesarean section(s) as part of the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study population consists of 200 women who have undergone previous Cesarean sections and are scheduled for elective Cesarean sections. Participants are categorized into five groups based on the time interval since their last Cesarean section: Less than 18 months, 18-24 months, 25-36 months, 37-48 months, and more than 48 months. This study aims to compare maternal and neonatal outcomes across these different interval groups to determine the optimal interval between consecutive Cesarean sections for improving maternal and neonatal health outcomes.

You may qualify if:

• Age between 20-42 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.

You may not qualify if:

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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Hussein University Hospital

Cairo, 11633, Egypt

Location

MeSH Terms

Interventions

Cesarean Section

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obstetrics and Gynecology

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 9, 2024
• Study Start: July 10, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD will be made available after completion of the primary analysis and publication of the study results. Data sharing will commence within 6 months of publication and remain accessible for a minimum of 5 years to allow for secondary analyses and replication studies.
• Access Criteria: Researchers interested in accessing IPD must submit a formal request detailing their research objectives, proposed analyses, and ethical approval from their institution's review board. Access will be granted based on the scientific merit of the proposed study and its alignment with the original research aims. Requests should be sent to the corresponding author.

Locations

EG (1)