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NCT03584698 Clinical Trial

Evening Primrose Oil to Misoprostol During Induction of Second-trimester Missed Miscarriage

Missed Abortion Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03584698
Other study ID # EPOM
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 1, 2019
Est. completion date March 31, 2021

Study information
Verified date April 2021
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 144
Est. completion date March 31, 2021
Est. primary completion date January 15, 2021
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Misoprostol 100Mcg Tab
women will receive misoprostol 100 mcg (Misotac, Sigma Pharmaceuticals, Egypt) vaginally applied every 6 hours till cervical dilatation.
• Evening Primrose Oil 1000 MG
women will receive 4 capsules evening primrose oil 1000 mg (Primrose plus, Ema Pharm, Egypt) vaginally applied every 6 hours till cervical dilatation.

Locations
Country Name City State
Egypt Assiut Faculty of Medicine Assiut

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary The induction to fetal expulsion time. Duration of delivery of fetus 24 hours
See also
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Recruiting NCT05342467 - Gemeprost Versus Dinoprostone in First Trimester Miscarriages Phase 2
Recruiting NCT03698734 - Evening Primrose Oil Efficacy in Second Trimester Abortion Phase 3
Terminated NCT01615224 - Repeated Doses of Misoprostol for Medical Treatment of Missed Miscarriage Phase 2/Phase 3
Completed NCT05216952 - Ulipristal Acetate for Use in Early Pregnancy Loss Phase 2
Recruiting NCT03081104 - Operative Hysteroscopy and Ultrasound Guided Vacuum Aspiration Versus Blind Vacuum Aspiration for the Treatment of Missed Abortion N/A
Completed NCT00892229 - Buccal Versus Vaginal Misoprostol in Surgical Termination of the First Trimester Missed Abortion in Erbil Phase 2
Active, not recruiting NCT04981457 - Comparative Study Between Combined Vaginal Misoprostol Phase 1
Recruiting NCT02573051 - Termination Of Anembryonic Pregnancy Phase 2
Not yet recruiting NCT04215835 - Letrozole Pretreatment With Misoprostol Induction of Abortion In First-Trimester Missed Miscarriage Phase 4
Not yet recruiting NCT04217265 - Letrozole Pretreatment With Misoprostol Versus Misoprostol Alone in Missed Abortion Phase 4
Recruiting NCT04705324 - Dilation and Curettage Versus Operative Hysteroscopy for Missed Abortion N/A
Completed NCT02686840 - Sublingual Versus Vaginal Misoprostol In Medical Treatment of First Trimestric Missed Miscarriage Phase 3
Terminated NCT02342002 - Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial Phase 4
Recruiting NCT01775917 - The Role of Uterine Artery Doppler Parameters in the Management of Retained Products of Conception. N/A
Active, not recruiting NCT04593108 - Misoprostol With or Without Letrozole in Treatment of Missed Miscarriage
Not yet recruiting NCT05001061 - Sublingual vs Vaginal Misoprostol for Termination of First Trimesteric Missed Abortion Early Phase 1