ClinicalTrials.gg
CompletedNCT00466999Updated Mar 30, 2012

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

An interventional study of misoprostol and surgery in Incomplete Abortion, sponsored by Gynuity Health Projects. Completed at 6 sites in 5 countries. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-03-30.

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

Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Sex
Female
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Study summary

In this study, we will compare the safety and efficacy of 400 mcg sublingually administered misoprostol alone to standard surgical care for the treatment of incomplete abortion. This study will provide important data on the role of misoprostol in health services offering an array of treatments for incomplete abortion. Women could significantly benefit from a non-invasive treatment option for incomplete abortion. While safe surgical services are becoming more widespread, there is still a serious risk of complications from these procedures. Especially in developing countries, infection, hemorrhage and uterine damage are still too common. Medical treatment of incomplete abortion using misoprostol would be a tremendous step to reducing morbidity and mortality due to abortion complications.

02

Conditions studied

  • Incomplete Abortion

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Keywords

  • misoprostol
  • incomplete abortion
  • PAC
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 1,000 is above 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
Child (0–17), Adult (18–64), Older adult (65+)
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 no larger than 12 weeks LMP at time of presentation for care.
  • Past or present history of vaginal bleeding during pregnancy.
  • Open cervical os.
  • If ultrasound used evidence of incomplete abortion with substantial debris in the uterus.
  • All women would have been advised to have surgical evacuation of the uterus if misoprostol was not available.
  • General good health.
  • Willing to provide contact information for purposes of follow-up.
  • Also in Egypt: 21 years of age or over or parental permission (there is no minimum age requirement in Niger, Mauritania and Senegal).

Exclusion criteria

Exclusion Criteria:

  • to study drug
  • Signs of severe infection, defined as at least one of the following: 1) foul smelling discharge, 2) fever > 38 degrees C , 3) uterine tenderness
  • Hemodynamic disturbances (pulse >110/min and systolic bp \<100)
  • Have an IUD in place; (the IUD may be removed making the woman eligible)
  • Suspected ectopic pregnancy
Terms in these criteria, in plain language(1)

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
1,000 participants (actual)

Study arms

  • Active comparator
    surgery

    standard surgical treatment (either dilation and curettage or manual vacuum aspiration)

    Procedure: surgery

  • Active comparator
    misoprostol

    400 mcg misoprostol

    Drug: misoprostol

Interventions

  • single dose of 400 mcg misoprostol administered sublingually

  • Proceduresurgery

    standard surgical treatment (dilation and curettage or manual vacuum aspiration)

06

What researchers measure

Primary outcomes

  1. Complete abortion without recourse to surgical intervention.

    Time frame: follow up visit 7 days after initial treatment

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Study locations

6 sites
  • Dandé District Hospital/Ziniaré District Hospital
    Dande/Ziniare, Burkina Faso
  • El-Galaa Teaching Hospital
    Cairo, Egypt
  • Shatby Maternity Hospital/Alexandria University
    Shatby, Alexandria, Egypt
  • Cheikh Zayed Hospital
    Nouakchott, Mauritania
  • Maternite Issaka Gazobi
    Niamey, Niger
  • Centre de Sante Le Roi Baudouin
    Guediawaye, Senegal
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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 ↗
  • Blandine T, Ouattara AZ, Coral A, Hassane C, Clotaire H, Dao B, Lankoande J, Diop A, Blum J. Sublingual [corrected] misoprostol as first-line care for incomplete abortion in Burkina Faso. Int J Gynaecol Obstet. 2012 Nov;119(2):166-9. doi: 10.1016/j.ijgo.2012.05.036. Epub 2012 Aug 28. Erratum In: Int J Gynaecol Obstet. 2013 May;121(2):194. PubMed 22935621 ↗
  • Dabash R, Ramadan MC, Darwish E, Hassanein N, Blum J, Winikoff B. A randomized controlled trial of 400-mug sublingual misoprostol versus manual vacuum aspiration for the treatment of incomplete abortion in two Egyptian hospitals. Int J Gynaecol Obstet. 2010 Nov;111(2):131-5. doi: 10.1016/j.ijgo.2010.06.021. PubMed 20801444 ↗

Related links

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00466999
Responsible party
Sponsor
First posted
Apr 27, 2007
Start date
Feb 2007
Primary completion
Nov 2009
Completion
Nov 2009
Last update
Mar 30, 2012

Study contacts

Beverly Winikoff, MD, MPH
principal investigator · Gynuity Health Projects
Rasha Dabash, MPH
study director · Gynuity Health Projects
Ayisha Diop, MPH
study director · 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 Mar 2012. You cannot join it, but the record below documents what was studied.

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