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CompletedNCT01939457Updated Sep 11, 2013

400mcg Sublingual Misoprostol as First Line Treatment

An interventional study of Misoprostol in Incomplete Abortion, sponsored by Gynuity Health Projects. Completed at 1 site in Senegal. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-09-11.

Sponsored by Gynuity Health Projects · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
641
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Incomplete Abortion

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03

In context

Abortion, Incomplete

24 studies on the registry are indexed under Abortion, Incomplete; 5 are open to participants now.

This study's enrollment of 641 is above the median of 311 across 21 interventional studies indexed under Abortion, Incomplete.

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Lead sponsor

Gynuity Health Projects is the lead sponsor of 113 studies on the registry; 2 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

  • 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

Exclusion criteria

Exclusion Criteria:

  • suspicion of ectopic pregnancy
  • intrauterine device in place
  • bad general health (infection, anemia, shoc)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
641 participants (actual)

Study arms

  • Experimental
    misoprostol

    400 mcg misoprostol sublingually

    Drug: Misoprostol

Interventions

06

What researchers measure

Primary outcomes

  1. complete abortion

    number of complete abortion with misoprostol treatment alone

    Time frame: 1 year

07

Study locations

1 site
  • Guediawaye Health Center
    Guediawaye, Senegal
08

References and documents

Publications

  • 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. PubMed 24893962 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2011, a primary completion of Aug 2012 and a completion of Aug 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 7, 2013
First posted
Sep 11, 2013
Start
Sep 2011
Primary completionActual
Aug 2012
CompletionActual
Aug 2012
Last update
Sep 11, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01939457
Lead sponsor
Gynuity Health Projects
Responsible party
Sponsor
First posted
Sep 11, 2013
Start date
Sep 2011
Primary completion
Aug 2012
Completion
Aug 2012
Last update
Sep 11, 2013

Study contacts

Beverly Winikoff, MD MPH
principal investigator · Gynuity Health Projects

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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