Completed

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

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What is being tested

Misoprostol 100Mcg Tab

+ Evening Primrose Oil 1000 MG

Drug
Who is being recruted

Abortion, Spontaneous+2

+ Abortion, Missed

+ Urogenital Diseases

+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: September 2019
See protocol details

Summary

Principal SponsorAssiut University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2019

Actual date on which the first participant was enrolled.

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

Official TitleThe Effect of Adding Vaginal Evening Primrose Oil to Misoprostol During Induction of Second-trimester Missed Miscarriage; a Randomized Controlled Trial
NCT03584698
Principal SponsorAssiut University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

144 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Abortion, SpontaneousAbortion, MissedUrogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsPregnancy Complications

Criteria

3 inclusion criteria required to participate
Bishop score was ≤ 5
Nullipara or previous vaginal delivery only
Women who will accept to participate in the study
6 exclusion criteria prevent from participating
Multiple gestations
Rupture of fetal membranes
Previous cesarean sections
Women with heavy bleeding
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Misoprostol only group

Group II

Experimental
Misoprostol + Evening primrose oil group

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Assiut Faculty of Medicine

Asyut, EgyptOpen Assiut Faculty of Medicine in Google Maps
CompletedOne Study Center