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

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

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Key information

Conditions

Missed Abortion Abortion, Missed Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Assiut Faculty of Medicine

Asyut, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Misoprostol 100Mcg Tab

Drug

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

Evening Primrose Oil 1000 MG

Drug

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

Primary outcomes

The induction to fetal expulsion time.

Time frame: 24 hours

Duration of delivery of fetus

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Jul 12, 2018
Registry last updated: Apr 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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