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Completed

NCT Number: NCT06491368

Optimal Interval Between Consecutive Cesarean Sections

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.

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Key information

Conditions

Cesarean Section Complications

Age range

20 year–42 year

Sex eligibility

Female

Study type

Observational

Primary location

Al-Hussein University Hospital

Cairo, 11633, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Intraoperative complications

    Time frame: Withen the surgery.

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

Secondary outcomes

  1. Intraoperative and postoperative bleeding (quantify blood loss

    Time frame: withen the surgery and up to 24 hours after the sutgery.

    Measurement of blood loss before and after surgery using complete blood count (CBC).

  2. Blood transfusions

    Time frame: withen the surgery and up to 24 hours after the sutgery.

    Instances of maternal blood transfusions during or after surgery.

  3. ICU admissions

    Time frame: 1 week after the surgery.

    Number of mothers admitted to the Intensive Care Unit (ICU) postoperatively.

  4. Fetal distress

    Time frame: during and 24 hours after the surgery.

    Instances of fetal distress noted during labor or delivery

  5. Neonatal Apgar scores

    Time frame: 5 minutes after birth.

    Apgar scores measured at 1 minute and 5 minutes after birth, assessing newborn health.

  6. NICU admissions

    Time frame: during and 24 hours after the surgery.

    Number of neonates admitted to the Neonatal Intensive Care Unit (NICU).

  7. Neonatal morbidity and mortality

    Time frame: during and 2 weeks after the surgery.

    Incidence of health issues and deaths among newborns within a specific timeframe post-delivery.

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 9, 2024
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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