Cesarean Section ComplicationsNCT06491368
Optimal Interval Between Consecutive Cesarean Sections
An observational study of Cesarean Section Complications, run by Al-Azhar University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 42 years, women only
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- Cesarean Delivery
- Type of treatment
- Surgery or procedure
- How many people
- 201 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jul 2024to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 42 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- Women with contraindications to cesarean section
- Those with emergency indications
- Multiple pregnancies
- Pre-existing maternal or fetal conditions affecting outcomes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read more
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
- Being tested
- Cesarean Delivery
- Keywords
- Elective cesarean section, Time interval between consecutive cesarean sections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cesarean DeliveryProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Procedure: Cesarean Delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative complications
Occurrences of injuries to the bladder or bowel during surgery, injury of uterine artery, extension of uterine incision.
Measured: Withen the surgery.
Secondary outcomes (7)
Intraoperative and postoperative bleeding (quantify blood loss
Measurement of blood loss before and after surgery using complete blood count (CBC).
Measured: withen the surgery and up to 24 hours after the sutgery.
Blood transfusions
Instances of maternal blood transfusions during or after surgery.
Measured: withen the surgery and up to 24 hours after the sutgery.
ICU admissions
Number of mothers admitted to the Intensive Care Unit (ICU) postoperatively.
Measured: 1 week after the surgery.
Fetal distress
Instances of fetal distress noted during labor or delivery
Measured: during and 24 hours after the surgery.
Neonatal Apgar scores
Apgar scores measured at 1 minute and 5 minutes after birth, assessing newborn health.
Measured: 5 minutes after birth.
NICU admissions
Number of neonates admitted to the Neonatal Intensive Care Unit (NICU).
Measured: 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.
Measured: during and 2 weeks after the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start10 Jul 2024
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491368
- Sponsor's protocol ID
- Obstet30624
- Status last verified
- Jan 2026
- First submitted
- 1 Jul 2024
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Interval Between Consecutive Cesarean Sections: A Comparative Study on Maternal and Neonatal Outcomes
- ClinicalTrials.gov ID
- NCT06491368
- Acronym / sponsor ID
- Obstet30624
- Conditions
- Cesarean Section Complications
- Keywords
- Elective cesarean section, Time interval between consecutive cesarean sections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Less than 18 months | – | Procedure: Cesarean DeliveryThis group consists of women who have had their previous cesarean section less than 12 months before the current scheduled elective cesarean section. |
| 18-24 months | – | Procedure: Cesarean DeliveryThis group includes women whose previous cesarean section was 12 to 24 months before their current scheduled elective cesarean section. |
| 25-36 months | – | Procedure: Cesarean DeliveryThis group is comprised of women who had their last cesarean section between 25 and 36 months prior to the current scheduled elective cesarean section. |
| 37-48 months | – | Procedure: Cesarean DeliveryThis group consists of women whose previous cesarean section occurred 37 to 48 months before the current scheduled elective cesarean section. |
| More than 48 months | – | Procedure: Cesarean DeliveryThis group includes women who had their last cesarean section more than 48 months before their current scheduled elective cesarean section. |
Who may qualify
- Ages
- 20 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Women with contraindications to cesarean section
- Those with emergency indications
- Multiple pregnancies
- Pre-existing maternal or fetal conditions affecting outcomes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cesarean DeliveryA 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. | Procedure or surgery | 18-24 months, 25-36 months, 37-48 months, Less than 18 months, More than 48 months |
Primary outcome
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.
7 secondary outcomes
Intraoperative and postoperative bleeding (quantify blood loss
Time frame: withen the surgery and up to 24 hours after the sutgery.
Blood transfusions
Time frame: withen the surgery and up to 24 hours after the sutgery.
ICU admissions
Time frame: 1 week after the surgery.
Fetal distress
Time frame: during and 24 hours after the surgery.
Neonatal Apgar scores
Time frame: 5 minutes after birth.
NICU admissions
Time frame: during and 24 hours after the surgery.
Neonatal morbidity and mortality
Time frame: during and 2 weeks after the surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Cesarean Section Complications
Recruiting
Reducing Chronic Pain Following Cesarean Delivery
Chronic Pain, Cesarean Section Complications
Not yet recruiting
Empowered Relief for Severe Pain After Cesarean Delivery During the Inpatient Period
Severe Pain, Cesarean Section Complications
Recruiting
Platelet Rich Plasma for Uterine Scar
Cesarean Section Complications, Uterine Bleeding
Enrolling by invitation
Using Empowered Relief and Education To Help Postpartum Women Recover After Cesarean Delivery
Cesarean Section Complications, Postpartum Care
Recruiting
Personalized Perioperative Analgesia Platform (PPAP) for Cesarean Section
Cesarean Section Complications, Opioid Use
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section Complications, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative complications (time frame: Withen the surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026; AzTrials last refreshed its copy on 1 Nov 2026.