ClinicalTrials.gg
CompletedNCT01539408Updated Feb 27, 2012

Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion in Nigeria

A Phase 1 interventional study of Misoprostol and surgery Manual vacuum aspiration (MVA) in Incomplete Abortion, sponsored by Gynuity Health Projects. Completed at 2 sites in Nigeria. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-02-27.

Sponsored by Gynuity Health Projects · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

Women diagnosed with incomplete abortion in this health facility will be randomized to receive one of the following regimens: 400 mcg sublingual misoprostol in one dose or standard surgical treatment (MVA). The investigators hypothesize that treatment of incomplete abortion with misoprostol using 400 mcg administered sublingually will be as effective as surgical evacuation.

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 90 is below the median of 311 across 21 interventional studies indexed under Abortion, Incomplete.

Browse Abortion, Incomplete studies →

Lead sponsor

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

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
No

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

  • no to misoprostol
  • uterine size was not larger than 12 weeks
  • there were no signs of severe infection
  • haemodynamically stable
  • in general good health
  • willing to provide contact information

Exclusion criteria

Exclusion Criteria:

  • an IUD in place
  • ectopic pregnancy
  • aged below 18 years and had no accompanying adult to provide
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (actual)

Study arms

  • Active comparator
    Misoprostol

    400 mcg of sublingual misoprostol in one dose

    Drug: Misoprostol

  • Active comparator
    Manual vacuum aspiration (MVA)

    Standard surgical treatment (MVA)

    Procedure: surgery Manual vacuum aspiration (MVA)

Interventions

  • single dose of 400 mcg misoprostol administered sublingually

  • Proceduresurgery Manual vacuum aspiration (MVA)

    standard surgical treatment

06

What researchers measure

Primary outcomes

  1. Complete abortion without recourse to surgical intervention

    Time frame: follow up visit 7 days after initial treatment

07

Study locations

2 sites
  • Adeoyo Maternity Hospital
    Ibadan, Nigeria
  • University College Hospital, Ibadan
    Ibadan, Nigeria
08

References and documents

Publications

  • Ghosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tuncalp O, Lavelanet A, Gulmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6(6):CD012602. doi: 10.1002/14651858.CD012602.pub2. PubMed 34061352 ↗
  • Shochet T, Diop A, Gaye A, Nayama M, Sall AB, Bukola F, Blandine T, Abiola OM, Dao B, Olayinka O, Winikoff B. Sublingual misoprostol versus standard surgical care for treatment of incomplete abortion in five sub-Saharan African countries. BMC Pregnancy Childbirth. 2012 Nov 14;12:127. doi: 10.1186/1471-2393-12-127. PubMed 23150927 ↗
  • Fawole AO, Diop A, Adeyanju AO, Aremu OT, Winikoff B. Misoprostol as first-line treatment for incomplete abortion at a secondary-level health facility in Nigeria. Int J Gynaecol Obstet. 2012 Nov;119(2):170-3. doi: 10.1016/j.ijgo.2012.06.012. Epub 2012 Aug 27. PubMed 22935620 ↗
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Timeline

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

The record gives a start of Aug 2009, a primary completion of Oct 2010 and a completion of Oct 2010. 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
Feb 16, 2012
First posted
Feb 27, 2012
Start
Aug 2009
Primary completionActual
Oct 2010
CompletionActual
Oct 2010
Last update
Feb 27, 2012
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 Feb 27, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01539408
Responsible party
Sponsor
First posted
Feb 27, 2012
Start date
Aug 2009
Primary completion
Oct 2010
Completion
Oct 2010
Last update
Feb 27, 2012

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Misoprostol

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