Optimal Interval Between Consecutive Cesarean Sections

Optimal Interval Between Consecutive Cesarean Sections: A Comparative Study on Maternal and Neonatal Outcomes

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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section Complications
• Intervention / Treatment: Procedure: Cesarean Delivery

• Study Type: Observational
• Enrollment (Actual): 201

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11633
    • Al-Hussein University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.
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; 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.
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; 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.
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; 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; This group includes women whose previous cesarean section was 12 to 24 months before their current scheduled elective cesarean section.	Procedure: Cesarean Delivery; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative complications	Occurrences of injuries to the bladder or bowel during surgery, injury of uterine artery, extension of uterine incision.	Withen the surgery.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2024
• Primary Completion (Actual): June 1, 2025
• Study Completion (Actual): June 1, 2025

Study Registration Dates

• First Submitted: July 1, 2024
• First Submitted That Met QC Criteria: July 1, 2024
• First Posted (Actual): July 9, 2024

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Elective cesarean section; Time interval between consecutive cesarean sections
• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Delivery, Obstetric; Obstetric Surgical Procedures; Cesarean Section
• Other Study ID Numbers: Obstet30624

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual Participant Data (IPD) from this study will be shared to facilitate transparency and further research. This includes anonymized data related to maternal and neonatal outcomes, as well as demographic and clinical variables collected during the study.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No