Evening Primrose Oil to Misoprostol During Induction of Second-trimester Missed Miscarriage

April 22, 2021 updated by: Ahmed Mohamed Abbas, Assiut University

The Effect of Adding Vaginal Evening Primrose Oil to Misoprostol During Induction of Second-trimester Missed Miscarriage; a Randomized Controlled Trial

Termination of pregnancy is an important subject that has complex and emotional controversies. The most common time of termination of pregnancy is the mid-trimester which has two-thirds of all serious abortion-related complications. There are many indications for mid trimester termination of pregnancy such as missed abortion, serious fetal abnormalities and lastly some women do not wish to continue a pregnancy and will often request termination of pregnancy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

144

Phase

  • Phase 4

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
      • Assiut, Egypt
        • Assiut Faculty of Medicine

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Nullipara or previous vaginal delivery only
  • Bishop score was ≤ 5
  • Women who will accept to participate in the study

Exclusion Criteria:

  • Multiple gestations
  • Rupture of fetal membranes
  • Previous cesarean sections
  • Women with heavy bleeding
  • Evidence of low implanted placenta by US
  • Evidence of intra-uterine infection (either clinical or laboratory)

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: study group
Misoprostol + Evening primrose oil group
Drug: Misoprostol 100Mcg Tab
women will receive misoprostol 100 mcg (Misotac, Sigma Pharmaceuticals, Egypt) vaginally applied every 6 hours till cervical dilatation.
Drug: Evening Primrose Oil 1000 MG
women will receive 4 capsules evening primrose oil 1000 mg (Primrose plus, Ema Pharm, Egypt) vaginally applied every 6 hours till cervical dilatation.
Active Comparator: control group
Misoprostol only group
Drug: Misoprostol 100Mcg Tab
women will receive misoprostol 100 mcg (Misotac, Sigma Pharmaceuticals, Egypt) vaginally applied every 6 hours till cervical dilatation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The induction to fetal expulsion time.
Time Frame: 24 hours
Duration of delivery of fetus
24 hours

Collaborators and Investigators

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

Sponsor

Assiut 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)

September 1, 2019

Primary Completion (Actual)

January 15, 2021

Study Completion (Actual)

March 31, 2021

Study Registration Dates

First Submitted

June 30, 2018

First Submitted That Met QC Criteria

June 30, 2018

First Posted (Actual)

July 12, 2018

Study Record Updates

Last Update Posted (Actual)

April 26, 2021

Last Update Submitted That Met QC Criteria

April 22, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPOM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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