Evening Primrose Oil Efficacy in Second Trimester Abortion

October 4, 2018 updated by: Radwa Rasheedy Ali, Ain Shams University

Effect of Adding Evening Primrose Oil to Misoprostol in Second Trimester Abortion

efficacy of evening primrose oil in shortening the duration of induction in 2nd trimesteric missed abortion

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • 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
    • Abbassya
      • Cairo, Abbassya, Egypt, 11566
        • Recruiting
        • AinShams university maternity hospital
        • Contact:
          • Ahmed K Maklad, MD

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

16 years to 33 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Primiparous women

Exclusion Criteria:

  • Previous uterine incision( Cs, myomectomy,)
  • Contraindications to medical or surgical uterine evacuations (eg, hemodynamically unstable, coagulopathy)
  • Evidence of intra-uterine infection
  • Rupture of fetal membranes.
  • Intrauterine device in place.
  • Allergy to prostaglandins or EPO

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: Placebo - Cap
primiparous women with missed abortion between(13 to 24 weeks) will receive 1 capsule of placebo in addition to misopristol
Active Comparator: Evening primrose oil
Drug: Evening primrose oil(EPO)
primiparous women with missed abortion between(13 to 24 weeks) will receive 1 capsule of EPO( 1000mg) in addition to misopristol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of medical induction of abortion
Time Frame: up to 1 week
time needed for complete expulsion of fetus and placenta
up to 1 week

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 (Anticipated)

November 1, 2018

Primary Completion (Anticipated)

November 1, 2019

Study Completion (Anticipated)

November 1, 2019

Study Registration Dates

First Submitted

October 4, 2018

First Submitted That Met QC Criteria

October 4, 2018

First Posted (Actual)

October 9, 2018

Study Record Updates

Last Update Posted (Actual)

October 9, 2018

Last Update Submitted That Met QC Criteria

October 4, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASU obstetrics hosp

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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