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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 18-24 months | This group includes women whose previous cesarean section was 12 to 24 months before their current scheduled elective cesarean section. |
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| 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. |
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| 37-48 months | This group consists of women whose previous cesarean section occurred 37 to 48 months before the current scheduled elective cesarean section. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Female participants who have undergone previous Cesarean section(s) and are scheduled for elective Cesarean section(s) as part of the study.
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al-Hussein University Hospital | Cairo | 11633 | Egypt |
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 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.
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.
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| ID | Term |
|---|---|
| D002585 | Cesarean Section |
| ID | Term |
|---|---|
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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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. |