Using Misoprostol to Prevent Respiratory Issues in Newborns During Elective Cesarean Sections
Misoprostol Administration Before Elective Caesarean Section to Reduce the Risk of Respiratory Morbidity in Newborns
This study is testing if giving Misoprostol to pregnant women before planned cesarean sections can help reduce breathing problems in their newborns.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 20 Years to 35 Years |
| Sex | Female |
| Sponsor | Kafrelsheikh University Academic / other |
| Locations | 1 site (Kafr Ash Shaykh, Egypt) |
| Trial ID | NCT06946914 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of administering Misoprostol before elective cesarean sections in pregnant women under 38 weeks gestation to reduce neonatal respiratory morbidity. Given the high incidence of respiratory distress syndrome in newborns delivered via cesarean, the research aims to determine if Misoprostol can mitigate these risks. The study will include women with singleton pregnancies and no major anomalies, while excluding those with certain obstetric disorders or contraindications to Misoprostol. The findings could provide valuable insights into improving neonatal outcomes in cesarean deliveries.
Who should consider this trial
Good fit: Ideal candidates for this study are women under 35 years old, with singleton pregnancies, and scheduled for elective cesarean sections before 38 weeks of gestation.
Not a fit: Patients with obstetric disorders, contraindications to Misoprostol, or a history of multiple cesarean sections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of respiratory distress syndrome in newborns delivered by elective cesarean section.
How similar studies have performed: While the use of Misoprostol in obstetric settings is established, this specific application for preventing neonatal respiratory issues during elective cesarean sections is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Where this trial is running
Kafr Ash Shaykh, Egypt
- Kafr El-sheikh University Hospital — Kafr Ash Shaykh, Egypt, Egypt (Recruiting)
Study contacts
- Study coordinator: Merna Ashraf Ahmed farid, M.B.B.C.H
- Email: mernaashraf2551996@gmail.com
- Phone: 01093030236
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.