NCT01939457

Brief Summary

Women presenting with incomplete abortion and eligible for treatment with misoprostol were offered 400mcg sublingual misoprostol for treatment. Based on existing literature, the study hypothesises that women can successfully be treated with misoprostol alone as first line treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
641

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 7, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 11, 2013

Completed
Last Updated

September 11, 2013

Status Verified

September 1, 2013

Enrollment Period

11 months

First QC Date

August 7, 2013

Last Update Submit

September 6, 2013

Conditions

Incomplete Abortion

Outcome Measures

Primary Outcomes (1)

  • complete abortion

    number of complete abortion with misoprostol treatment alone

    1 year

Study Arms (1)

misoprostol

EXPERIMENTAL

400 mcg misoprostol sublingually

Drug: Misoprostol

Interventions

MisoprostolDRUG
misoprostol

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • uterine size less than 12 weeks lmp
  • open cervical os
  • current or past vaginal bleeding
  • willing to provide contact information for follow-up
  • over 18 or with guardian consent

You may not qualify if:

  • suspicion of ectopic pregnancy
  • intrauterine device in place
  • bad general health (infection, anemia, shoc)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guediawaye Health Center

Guédiawaye, Senegal

Location

Related Publications (1)

  • Gaye A, Diop A, Shochet T, Winikoff B. Decentralizing postabortion care in Senegal with misoprostol for incomplete abortion. Int J Gynaecol Obstet. 2014 Sep;126(3):223-6. doi: 10.1016/j.ijgo.2014.03.028. Epub 2014 May 15.

    PMID: 24893962DERIVED

MeSH Terms

Conditions

Abortion, Incomplete

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Abortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Beverly Winikoff, MD MPH

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2013

First Posted

September 11, 2013

Study Start

September 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

September 11, 2013

Record last verified: 2013-09

Locations

SE(1)