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

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ClinicalTrials.gov Identifier: NCT03584698
Recruitment Status : Not yet recruiting
First Posted : July 12, 2018
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Abbas, Assiut University

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

Condition or disease Intervention/treatment Phase
Missed Abortion Drug: Misoprostol 100Mcg Tab Drug: Evening Primrose Oil 1000 MG Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of Adding Vaginal Evening Primrose Oil to Misoprostol During Induction of Second-trimester Missed Miscarriage; a Randomized Controlled Trial
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Miscarriage
Drug Information available for: Misoprostol

Arm Intervention/treatment
Experimental: study group
Misoprostol + Evening primrose oil group
Drug: Misoprostol 100Mcg Tab
women will receive misoprostol 100 mcg (Misotac, Sigma Pharmaceuticals, Egypt) vaginally applied every 6 hours till cervical dilatation.

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.

Active Comparator: control group
Misoprostol only group
Drug: Misoprostol 100Mcg Tab
women will receive misoprostol 100 mcg (Misotac, Sigma Pharmaceuticals, Egypt) vaginally applied every 6 hours till cervical dilatation.




Primary Outcome Measures :
  1. The induction to fetal expulsion time. [ Time Frame: 24 hours ]
    Duration of delivery of fetus



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584698


Locations
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Egypt
Assiut Faculty of Medicine
Assiut, Egypt
Sponsors and Collaborators
Assiut University

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Responsible Party: Ahmed Mohamed Abbas, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03584698     History of Changes
Other Study ID Numbers: EPOM
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Abortion, Spontaneous
Abortion, Missed
Pregnancy Complications
Misoprostol
Evening primrose oil
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Dermatologic Agents