Evening Primrose Oil Efficacy in Second Trimester Abortion
Sponsor
Ain Shams University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03698734
Collaborator
(none)
100
1
2
12
8.3
Study Details
Study Description
Brief Summary
efficacy of evening primrose oil in shortening the duration of induction in 2nd trimesteric missed abortion
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Effect of Adding Evening Primrose Oil to Misoprostol in Second Trimester Abortion
Anticipated Study Start Date
:
Nov 1, 2018
Anticipated Primary Completion Date
:
Nov 1, 2019
Anticipated Study Completion Date
:
Nov 1, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Evening primrose oil
|
Drug: Evening primrose oil(EPO)
primiparous women with missed abortion between(13 to 24 weeks) will receive 1 capsule of EPO( 1000mg) in addition to misopristol
|
| Placebo Comparator: placebo
|
Drug: Placebo - Cap
primiparous women with missed abortion between(13 to 24 weeks) will receive 1 capsule of placebo in addition to misopristol
|
Outcome Measures
Primary Outcome Measures
- duration of medical induction of abortion [up to 1 week]
time needed for complete expulsion of fetus and placenta
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 35 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Primiparous women
Exclusion Criteria:
-
Previous uterine incision( Cs, myomectomy,)
-
Contraindications to medical or surgical uterine evacuations (eg, hemodynamically unstable, coagulopathy)
-
Evidence of intra-uterine infection
-
Rupture of fetal membranes.
-
Intrauterine device in place.
-
Allergy to prostaglandins or EPO
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | AinShams university maternity hospital | Cairo | Abbassya | Egypt | 11566 |
Sponsors and Collaborators
- Ain Shams University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Radwa Rasheedy Ali,
Principal Investigator,
Ain Shams University
ClinicalTrials.gov Identifier:
NCT03698734
Other Study ID Numbers:
- ASU obstetrics hosp
First Posted:
Oct 9, 2018
Last Update Posted:
Oct 9, 2018
Last Verified:
Oct 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: