NCT03698734

Brief Summary

efficacy of evening primrose oil in shortening the duration of induction in 2nd trimesteric missed abortion

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
23 days until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

1 year

First QC Date

October 4, 2018

Last Update Submit

October 4, 2018

Conditions

Missed Abortion

Outcome Measures

Primary Outcomes (1)

  • duration of medical induction of abortion

    time needed for complete expulsion of fetus and placenta

    up to 1 week

Study Arms (2)

Evening primrose oil

ACTIVE COMPARATOR
Drug: Evening primrose oil(EPO)

placebo

PLACEBO COMPARATOR
Drug: Placebo - Cap

Interventions

Evening primrose oil(EPO)DRUG

primiparous women with missed abortion between(13 to 24 weeks) will receive 1 capsule of EPO( 1000mg) in addition to misopristol

Evening primrose oil
Placebo - CapDRUG

primiparous women with missed abortion between(13 to 24 weeks) will receive 1 capsule of placebo in addition to misopristol

placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Primiparous women

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AinShams university maternity hospital

Cairo, Abbassya, 11566, Egypt

RECRUITING

MeSH Terms

Conditions

Abortion, Missed

Interventions

evening primrose oil

Condition Hierarchy (Ancestors)

Abortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Radwa R Ali, MD

CONTACT

01283492979radwaebed@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 4, 2018

First Posted

October 9, 2018

Study Start

November 1, 2018

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

October 9, 2018

Record last verified: 2018-10

Locations

EG(1)