Misoprostol Before Elective Caesarean Section for Decreasing the Neonatal Respiratory Morbidity

May 24, 2018 updated by: Ahmed Mohamed El Kotb Abdel Fattah, Ain Shams University

Misoprostol Before Elective Caesarean Section for Decreasing the Neonatal Respiratory Morbidity: A Randomized Controlled Trial

Neonatal respiratory distress may occur in either term or preterm newborns with a higher relative risk in preterm, and whether born vaginally or through caesarean section, but in a higher percentage after elective caesarean section whose rate is rising.

Prostaglandins may be given about one hour before an elective caesarean section after excluding the presence of contraindication to their use to decrease the neonatal respiratory diseases and thus, the number of children who suffered from bronchopulmonary dysplasia that occurs frequently in children who had previously TTN will diminish.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Al Qahirah
      • Cairo, Al Qahirah, Egypt
        • Recruiting
        • Faculty of medicine, Ain Shams university
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age: 18 years or more.
  • Term singleton pregnancy (38 - 38+6 weeks gestation).
  • Planned for elective transverse lower segment caesarean section with an indication.

Exclusion Criteria:

  • Women with history of significant cardiac disease, eclampsia, pre eclampsia, epilepsy, severe asthma, severe allergic condition, vascular disease, renal or hepatic disease.
  • Women with contraindication to prostaglandins as Glucoma or known hypersensitivity to prostaglandins or specifically for misoprostol.
  • Psychological problem or mental disease that renders the patient not able to understand the nature, scope, and sequences of the study.
  • Pregnancies with known foetal malformation/s or chromosomal aberration.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Misoprostol
After preparing for elective caesarean section, the pessary will be given containing the misoprostol medication 1 hour before , women in the operating room, and the anaesthetic and surgical techniques will be standardized
Drug: Misoprostol
Misoprostol is given before elective cesarean section as prophylaxis against post partum hemorrhage
Other Names:
  • Mesotac
Active Comparator: Placebo
After preparing for elective caesarean section, the pessary will be given containing placebo 1 hour before , women in the operating room, and the anaesthetic and surgical techniques will be standardized
Drug: Placebos
placebos tablet will be given before elective Cesarean sections

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The need for admission to neonatal intensive care unit (NICU)
Time Frame: first 24 hours after delivery
Number of newborns admitted to NICU for respiratory morbidity
first 24 hours after delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
APGAR score below 6 at 5 minute
Time Frame: 5 minutes after delivery
number of newborns delivered with APGAR score below 6 at 5 minutes
5 minutes after delivery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
neonatal mortality
Time Frame: first month after delivery
number of neonates died from respiratory morbidity with one month of delivery
first month after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Anticipated)

May 1, 2018

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

November 27, 2016

First Submitted That Met QC Criteria

January 24, 2017

First Posted (Estimate)

January 25, 2017

Study Record Updates

Last Update Posted (Actual)

May 29, 2018

Last Update Submitted That Met QC Criteria

May 24, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AinShamsU103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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