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CompletedNCT03584698Updated Apr 26, 2021

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

A Phase 4 interventional study of Misoprostol 100Mcg Tab and Evening Primrose Oil 1000 MG in Missed Abortion, sponsored by Assiut University. Completed at 1 site in Egypt. Open to female participants. Per ClinicalTrials.gov, last updated 2021-04-26.

Sponsored by Assiut University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
144
Allocation
Randomized
Sex
Female
01

Study 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

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Conditions studied

  • Missed Abortion

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03

In context

Abortion, Missed

48 studies on the registry are indexed under Abortion, Missed; 10 are open to participants now.

This study's enrollment of 144 is above the median of 110 across 41 interventional studies indexed under Abortion, Missed.

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Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Nullipara or previous vaginal delivery only
  • Bishop score was ≤ 5
  • Women who will accept to participate in the study

Exclusion criteria

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)
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
144 participants (actual)

Study arms

  • Experimental
    study group

    Misoprostol + Evening primrose oil group

    Drug: Misoprostol 100Mcg Tab · Drug: Evening Primrose Oil 1000 MG

  • Active comparator
    control group

    Misoprostol only group

    Drug: Misoprostol 100Mcg Tab

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.

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What researchers measure

Primary outcomes

  1. The induction to fetal expulsion time.

    Duration of delivery of fetus

    Time frame: 24 hours

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Study locations

1 site
  • Assiut Faculty of Medicine
    Assiut, Egypt
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03584698
Lead sponsor
Assiut University
Responsible party
Ahmed Mohamed Abbas (Principal investigator, Assiut University) — Principal investigator
First posted
Jul 12, 2018
Start date
Sep 1, 2019
Primary completion
Jan 15, 2021
Completion
Mar 31, 2021
Last update
Apr 26, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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