Evening Primrose Oil to Misoprostol During Induction of Second-trimester Missed Miscarriage
The Effect of Adding Vaginal Evening Primrose Oil to Misoprostol During Induction of Second-trimester Missed Miscarriage; a Randomized Controlled Trial
1 other identifier
interventional
144
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2018
CompletedFirst Posted
Study publicly available on registry
July 12, 2018
CompletedStudy Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2021
CompletedApril 26, 2021
April 1, 2021
1.4 years
June 30, 2018
April 22, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
The induction to fetal expulsion time.
Duration of delivery of fetus
24 hours
Study Arms (2)
study group
EXPERIMENTALMisoprostol + Evening primrose oil group
control group
ACTIVE COMPARATORMisoprostol only group
Interventions
women will receive misoprostol 100 mcg (Misotac, Sigma Pharmaceuticals, Egypt) vaginally applied every 6 hours till cervical dilatation.
women will receive 4 capsules evening primrose oil 1000 mg (Primrose plus, Ema Pharm, Egypt) vaginally applied every 6 hours till cervical dilatation.
Eligibility Criteria
You may qualify if:
- Nullipara or previous vaginal delivery only
- Bishop score was ≤ 5
- Women who will accept to participate in the study
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut Faculty of Medicine
Asyut, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
June 30, 2018
First Posted
July 12, 2018
Study Start
September 1, 2019
Primary Completion
January 15, 2021
Study Completion
March 31, 2021
Last Updated
April 26, 2021
Record last verified: 2021-04