Evening Primrose Oil Efficacy in Second Trimester Abortion | NCT03698734

Studies
Evening Primrose Oil Efficacy in Second Trimester Abortion

NCT03698734

Sponsor

Ain Shams University

Status

Unknown status

Last Update Posted

Oct 9, 2018Actual

Enrollment

100Estimated

Phase

Phase 3

Conditions

Missed Abortion

Interventions

Evening primrose oil(EPO)
Placebo - Cap

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2018Estimated

Primary Completion Date

Nov 1, 2019Estimated

Completion Date

Nov 1, 2019Estimated

First Submitted Date

Oct 4, 2018

First Submission Date that Met QC Criteria

Oct 4, 2018

First Posted Date

Oct 9, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 4, 2018

Last Update Posted Date

Oct 9, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Evening primrose oil	Active Comparator		Drug: Evening primrose oil(EPO)
placebo	Placebo Comparator		Drug: Placebo - Cap

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
duration of medical induction of abortion	time needed for complete expulsion of fetus and placenta	up to 1 week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Radwa R Ali, MD	Contact	01283492979	02002	radwaebed@yahoo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AinShams university maternity hospital	Recruiting	Cairo	Abbassya	11566	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D000030	Abortion, Missed

Ancestor Terms

ID	Term
D000022	Abortion, Spontaneous
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C028498	evening primrose oil

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided