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

NCT ID: NCT03584698

Last Updated: 2021-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2021-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Missed Abortion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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study group

Misoprostol + Evening primrose oil group

Group Type EXPERIMENTAL

Misoprostol 100Mcg Tab

Intervention Type DRUG

women will receive misoprostol 100 mcg (Misotac, Sigma Pharmaceuticals, Egypt) vaginally applied every 6 hours till cervical dilatation.

Evening Primrose Oil 1000 MG

Intervention Type DRUG

women will receive 4 capsules evening primrose oil 1000 mg (Primrose plus, Ema Pharm, Egypt) vaginally applied every 6 hours till cervical dilatation.

control group

Misoprostol only group

Group Type ACTIVE_COMPARATOR

Misoprostol 100Mcg Tab

Intervention Type DRUG

women will receive misoprostol 100 mcg (Misotac, Sigma Pharmaceuticals, Egypt) vaginally applied every 6 hours till cervical dilatation.

Interventions

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Misoprostol 100Mcg Tab

women will receive misoprostol 100 mcg (Misotac, Sigma Pharmaceuticals, Egypt) vaginally applied every 6 hours till cervical dilatation.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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)
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed Abbas

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut Faculty of Medicine

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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EPOM

Identifier Type: -

Identifier Source: org_study_id

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