Clinical trial NCT06491368: Optimal Interval Between Consecutive Cesarean Sections
Official title: Optimal Interval Between Consecutive Cesarean Sections: A Comparative Study on Maternal and Neonatal Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cesarean Section Complications
Keywords: Elective cesarean section
Time interval between consecutive cesarean sections
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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 12 months, 12-24 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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Intraoperative complications
timeFrame: Withen the surgery.
Secondary outcomes:
measure: Intraoperative and postoperative bleeding (quantify blood loss
timeFrame: withen the surgery and up to 24 hours after the sutgery.
measure: Blood transfusions
timeFrame: withen the surgery and up to 24 hours after the sutgery.
measure: ICU admissions
timeFrame: 1 week after the surgery.
measure: Fetal distress
timeFrame: during and 24 hours after the surgery.
measure: Neonatal Apgar scores
timeFrame: 5 minutes after birth.
measure: NICU admissions
timeFrame: during and 24 hours after the surgery.
measure: Neonatal morbidity and mortality
timeFrame: during and 2 weeks after the surgery.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Hussein University Hospital
Study officials:
References: