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

NCT04780412 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2021-03-03

No results posted yet for this study

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.

Conditions

  • Transient Tachypnea of the Newborn
  • Neonatal Respiratory Distress

Interventions

DRUG

Misoprostol

Vaginal Misoprostol tablets in a dose of 50 microgram given 90-120 minutes before an elective caesarian section.

DRUG

Placebo

Vaginal placebo pills given 90-120 minutes before an elective caesarian section.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Samar A. Kandeel · Ain Shams University - Faculty of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2021-03-31
Completion
2021-03-31

Countries

  • Egypt

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04780412 on ClinicalTrials.gov