Efficacy of Misoprostol in Prevention of Neonatal Respiratory Morbidity in Parturient at Early Term Elective Caesarian Section

Phase 3

• Conditions: Transient Tachypnea of the Newborn; Neonatal Respiratory Distress
• Interventions: Drug: Placebo; Drug: Misoprostol

• Registration Number: NCT04780412
• Lead Sponsor: Ain Shams University

Brief Summary

Neonatal respiratory morbidities represent a common group of post natal complications including respiratory distress syndrome, transient tachypnea of newborn, and persistent pulmonary hypertension of newborn.

It is thought that preoperative vaginal misoprostol administration may decrease the incidence of neonatal respiratory morbidity especially transient tachypnea of newborn. And therefore, it may decrease the incidence of admission to neonatal intensive care units for respiratory causes.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2021-02-24
• Status Verified: 2021-03
• Primary Completion: 2021-03
• Study Completion: 2021-03
• Study First Submitted QC: 2021-03-02
• Last Update Submitted: 2021-03-02
• Study First Posted: 2021-03-03
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 210

Inclusion Criteria

• Age: 18 years or more.
• Early term singleton pregnancy.
• Elective caesarian section at (37 - 38+6) weeks of gestation.
• Any indication for lower uterine segment caesarian section other than labor (as malpresentations, severe preeclampsia, placenta previa with no previous bleeding attacks, Diabetes Mellitus, macrosomic fetus, non reassuring cardiotocogram (CTG), and fetal growth restriction).
• Informed written consent signed by the participating pregnant woman.

Exclusion Criteria

• Women having any contraindication to Prostaglandin E1 as hypersensitivity, respiratory disease (especially bronchial asthma), or glaucoma.
• Any mental problems that block understanding of the nature and all the possible consequences of the procedure and the study.
• Pregnancies of known fetal diseases or chromosomal abnormalities.
• Non-singleton pregnancies.
• Emergency caesarian section as in ruptured membrane and women in labor pain.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo	-
Misoprostol Group	Misoprostol	-

Primary Outcome Measures

Name	Time	Method
incidence of neonatal respiratory morbidity (NRM)	up to 24 hours after birth	The incidence of neonatal respiratory morbidity, especially transient tachypnea of newborn, in early term neonates born to elective caesarian section.

Secondary Outcome Measures

Name	Time	Method
Neonatal intensive care unit (NICU) admission	up to 24 hours after birth	The incidence of the need for neonatal intensive care unit admission during the first ten days after delivery in early term neonates born to elective caesarian section.

Trial Locations

Locations (1)

Ain Shams University - Faculty of Medicine; 🇪🇬 Cairo, Egypt