Vaginal Estradiol Pretreatment in Labour Induction With Misoprostol

February 14, 2016 updated by: Mohamed S Sweed, MD, Ain Shams University
To assess the effect of vaginal estradiol pretreatment before vaginal misoprostol on labor induction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A prospective double blind randomized clinical trial. Conducted at Ain Shams University Maternity Hospital. Patients fulfilling inclusion and exclusion criteria will be divided into two groups. Group (A):

100 patient will receive single dose vaginal estradiol 50mcg tablet (Ethinyl Estradiol manufactured by KAHIRA Pharmaceutical company) and vaginal misoprostol 25mcg tablet (Vagiprost manufactured by ADWIA Pharmaceutical company), misoprostol alone will repeated every 6hours up to five doses.

Group (B):

100 patients will receive placebo vaginally and misoprostol 25 mcg which will be repeated every 6 hours up to five doses.

Primary Outcome

  • Measure the time to cervical ripening. Secondary Outcome
  • Measure the time to active labor.
  • Number of misoprostol doses.
  • Induction delivery time.
  • Time to achieve vaginal delivery.
  • Fetal outcome (Apgar score).

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2
  • Phase 3

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
      • Cairo, Egypt
        • Ain shams university

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:

  • Maternal age ≥ 18 years old.
  • Gestational age ≥ 37 wks to 41 wks.
  • BMI between 20 kg/m2 and 35kg/m2.
  • Vertex presentation.
  • Singleton pregnancy.

Exclusion criteria:

  • Multiple pregnancy.
  • Non vertex presentation.
  • Absolute or relative contraindication to vaginal delivery e.g. (Placenta previa, fibroid uterus, uterine anomalies, previous uterine surgery).
  • PROM.
  • IUFD.
  • Fetal distress.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Estradiol + Misoprostol
100 patient will receive single dose vaginal estradiol 50mcg tablet (Ethinyl Estradiol manufactured by KAHIRA Pharmaceutical company) and vaginal misoprostol 25mcg tablet (Vagiprost manufactured by ADWIA Pharmaceutical company), misoprostol alone will repeated every 6hours up to five doses.
Drug: Misoprostol
Other Names:
  • Vagiprost
Drug: Estradiol
Other Names:
  • Ethinyl Estradiol
Placebo Comparator: Placebo + Misoprostol
100 patients will receive placebo vaginally and misoprostol 25 mcg which will be repeated every 6 hours up to five doses.
Drug: Placebo
Drug: Misoprostol
Other Names:
  • Vagiprost

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to cervical ripening.
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to active labor
Time Frame: 30 hours
30 hours
Number of misoprostol doses
Time Frame: 24 hours
24 hours
Induction delivery time
Time Frame: 48 hours
48 hours

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Osama El-Kady, MD, AinShams university
  • Principal Investigator: AbdEl-Latif El-Kholy, MD, AinShams 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

June 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

June 19, 2015

First Submitted That Met QC Criteria

June 26, 2015

First Posted (Estimate)

June 30, 2015

Study Record Updates

Last Update Posted (Estimate)

February 17, 2016

Last Update Submitted That Met QC Criteria

February 14, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS39825273

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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