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Efficacy of Misoprostol Administration before Elective Cesarean Section to Reduce the Risk of Neonatal Respiratory Morbidity: A Randomized Controlled Trial

Misoprostol Administration before Elective Cesarean Section to Reduce the Risk of Neonatal Respiratory Morbidity

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
PACTR
Registry ID
PACTR202512711709610
Enrollment
160
Registered
2025-12-10
Start date
2024-06-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy and Childbirth

Interventions

Misoprostol vaginal tables
No treatment

Sponsors

Ahmed Soliman
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Women aged under 35 years who were scheduled for an elective cesarean section and met the following criteria: (1) had a gestational age of less than 38 weeks, (2) were carrying a singleton pregnancy without any fetal anomalies. Gestational age was precisely confirmed through a reliable early ultrasound measurement of crown-rump length or the last menstrual period.

Exclusion criteria

Exclusion criteria: Patients were excluded if they had a history of two or more previous cesarean sections, Any pre-existing obstetric disorders such as preeclampsia or diabetes, or If their fetus had been diagnosed with any fetal anomalies, oligohydramnios, or intrauterine growth restriction. Other reasons for exclusion also included any contraindications to misoprostol, such as a history of allergic reactions or hypersensitivity to prostaglandins, hemorrhagic disorders, or severe anemia.

Design outcomes

Primary

MeasureTime frame
The main study outcome was the incidence of neonatal respiratory distress, characterized by a respiratory rate above 60 cycles per minute, the manifestation of RD symptoms, or a combination of both.

Secondary

MeasureTime frame
The secondary outcomes encompassed Apgar scores at 5 minutes, the newborn's respiratory rate, the occurrence of apnea, the prevalence of transient tachypnea of the newborn (TTN), the necessity for mechanical ventilation (via Ambu-bag resuscitator or endotracheal intubation), the rate of admission to the NICU, the length of NICU stay, and the neonatal mortality rate.

Countries

Egypt

Contacts

Public ContactMerna Farid

Kafr Elsheikh University

drahmedsoliman1998@gmail.com02201550071055

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026