Misoprostol Before Caesarean Section
Miso/CS
Misoprostol Administration Before Elective Caesarean Section to Reduce the Risk of Respiratory Morbidity in Newborns
1 other identifier
interventional
160
1 country
1
Brief Summary
The aim of our study is to evaluate the efficacy of Misoprostol before elective cesarean section in pregnant women with gestational age less than 38 weeks for preventing the occurrence of neonatal respiratory morbidity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2024
CompletedFirst Submitted
Initial submission to the registry
April 21, 2025
CompletedFirst Posted
Study publicly available on registry
April 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2025
CompletedMay 13, 2025
April 1, 2025
1 year
April 21, 2025
May 8, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
the incidence of Transient tachypnea of the newborn which defined by increase respiratory rate more than 60 cycle per minute in pregnant women with gestational age less than 38 weeks before elective cesarean section
in the first 5 minute after delivery of fetus post operative
Study Arms (2)
Misoprostol before elective cesarean section .
ACTIVE COMPARATORcandidates will receive 100mcg Misoprostol one hour before elective caesarean section.
Giving no treatment before elective caesarean section.
PLACEBO COMPARATORcandidates will receive no treatment before elective caesarean section.
Interventions
administration of 100mg of misoprostol to evaluate the efficacy of Misoprostol before elective cesarean section in pregnant women with gestational age less than 38 weeks for preventing the occurrence of neonatal respiratory morbidity.
Eligibility Criteria
You may qualify if:
- Women with indication for elective caesarean section.
- Age less than 35 years old.
- Gestational age less than 38 weeks.
- Gestational age will be confirmed by certain LMP or reliable early ultrasound measurement of crown-rump length.
- Singleton pregnancy with no major anomalies
You may not qualify if:
- Any obstetric disorders as preeclampsia and diabetes.
- Fetus with oligohydramnios, intrauterine growth restriction.
- Any contraindications to misoprostol like those with previous allergic reaction or hypersensitivity to prostaglandin hemorrhagic disorders, and severe anemia.
- History of more than or equal 2 previous caesarean section.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kafr El-sheikh University Hospital
Kafr Ash Shaykh, Egypt, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- gynaecologist and obsteterician resident
Study Record Dates
First Submitted
April 21, 2025
First Posted
April 27, 2025
Study Start
June 1, 2024
Primary Completion
June 1, 2025
Study Completion
August 1, 2025
Last Updated
May 13, 2025
Record last verified: 2025-04