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Vaginal Misoprostol to Improve the Neonatal Respiratory Outcome

NCT03239327 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 292

Last updated 2018-01-08

No results posted yet for this study

Summary

Project summary:

Objective: To test the hypothesis that administration of vaginal Misoprostol before elective cesarean section will improve the neonatal respiratory outcomes in late preterm and early term neonates through induction of catecholamine surge.

Design: Randomized controlled clinical trial. Setting: Women health center ,Assiut university hospital. Patients: mothers planned for cesarean section at 34 - 37weeks. Intervention: two hundred and ninety two women will be randomly allocated to receive either 50 micrograms of Misoprostol per vagina within one hour before cesarean section (study group; n= 146) or receive nothing (control group; n = 146) .

Main outcome measure: Apgar score at 1 and 5 minutes.

Conditions

  • Neonatal Respiratory Distress

Interventions

DRUG

Misoprostol

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Ahmed Makhlouf, professor · women health center,Assiut university,Assiut,Egypt

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • Egypt

Study Locations

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Entities

Drugs

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 NCT03239327 on ClinicalTrials.gov