Back to resultsEvening Primrose Oil Efficacy in Second Trimester Abortion
Primary Purpose
Missed Abortion
Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Evening primrose oil(EPO)
Placebo - Cap
Sponsored by
About this trial
This is an interventional treatment trial for Missed Abortion
Eligibility Criteria
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
Sites / Locations
- AinShams university maternity hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Evening primrose oil
placebo
Arm Description
Outcomes
Primary Outcome Measures
duration of medical induction of abortion
time needed for complete expulsion of fetus and placenta
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03698734
Brief Title
Evening Primrose Oil Efficacy in Second Trimester Abortion
Official Title
Effect of Adding Evening Primrose Oil to Misoprostol in Second Trimester Abortion
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2018 (Anticipated)
Primary Completion Date
November 1, 2019 (Anticipated)
Study Completion Date
November 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
efficacy of evening primrose oil in shortening the duration of induction in 2nd trimesteric missed abortion
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Missed Abortion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Evening primrose oil
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Evening primrose oil(EPO)
Intervention Description
primiparous women with missed abortion between(13 to 24 weeks) will receive 1 capsule of EPO( 1000mg) in addition to misopristol
Intervention Type
Drug
Intervention Name(s)
Placebo - Cap
Intervention Description
primiparous women with missed abortion between(13 to 24 weeks) will receive 1 capsule of placebo in addition to misopristol
Primary Outcome Measure Information:
Title
duration of medical induction of abortion
Description
time needed for complete expulsion of fetus and placenta
Time Frame
up to 1 week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Radwa R Ali, MD
Phone
01283492979
Ext
02002
Email
radwaebed@yahoo.com
Facility Information:
Facility Name
AinShams university maternity hospital
City
Cairo
State/Province
Abbassya
ZIP/Postal Code
11566
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed K Maklad, MD
12. IPD Sharing Statement
Learn more about this trial
Evening Primrose Oil Efficacy in Second Trimester Abortion
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