Evening Primrose Oil to Misoprostol During Induction of Second-trimester Missed Miscarriage
Primary Purpose
Missed Abortion
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Misoprostol 100Mcg Tab
Evening Primrose Oil 1000 MG
Sponsored by
About this trial
This is an interventional treatment trial for Missed Abortion
Eligibility Criteria
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)
Sites / Locations
- Assiut Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
study group
control group
Arm Description
Misoprostol + Evening primrose oil group
Misoprostol only group
Outcomes
Primary Outcome Measures
The induction to fetal expulsion time.
Duration of delivery of fetus
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03584698
Brief Title
Evening Primrose Oil to Misoprostol During Induction of Second-trimester Missed Miscarriage
Official Title
The Effect of Adding Vaginal Evening Primrose Oil to Misoprostol During Induction of Second-trimester Missed Miscarriage; a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
January 15, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
144 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
Misoprostol + Evening primrose oil group
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Misoprostol only group
Intervention Type
Drug
Intervention Name(s)
Misoprostol 100Mcg Tab
Intervention Description
women will receive misoprostol 100 mcg (Misotac, Sigma Pharmaceuticals, Egypt) vaginally applied every 6 hours till cervical dilatation.
Intervention Type
Drug
Intervention Name(s)
Evening Primrose Oil 1000 MG
Intervention Description
women will receive 4 capsules evening primrose oil 1000 mg (Primrose plus, Ema Pharm, Egypt) vaginally applied every 6 hours till cervical dilatation.
Primary Outcome Measure Information:
Title
The induction to fetal expulsion time.
Description
Duration of delivery of fetus
Time Frame
24 hours
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Assiut Faculty of Medicine
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Evening Primrose Oil to Misoprostol During Induction of Second-trimester Missed Miscarriage
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