Misoprostol for the Treatment of Incomplete Abortion

Misoprostol for the Treatment of Incomplete Abortion: Comparison of Treatment Options

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00670761

Enrollment

720

Registered

2008-05-02

Start date

2004-07-31

Completion date

2010-12-31

Last updated

2016-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abortion, Incomplete

Keywords

misoprostol, incomplete abortion, sublingual, postabortion care, MVA

Brief summary

This randomized study will examine the efficacy, safety and acceptability of misoprostol for treatment of incomplete abortion. Women diagnosed with incomplete abortion will be randomized to receive one of the following regimens: In Tanzania and Mozambique: 1. 600 mcg of oral misoprostol in one dose, or 2. Standard surgical treatment (MVA) In Moldova and Madagascar: 1. 600 mcg of oral misoprostol in one dose, or 2. 400 mcg of sublingual misoprostol in one dose. In Burkina Faso and Vietnam: 1\. 400 mcg of sublingual misoprostol in one dose. We hypothesize that treatment of incomplete abortion with either 400 mcg sublingual misoprostol, 600 mcg oral misoprostol or MVA are equally effective in evacuating the uterus.

Interventions

DRUGmisoprostol

comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA)

PROCEDUREMVA

comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* If no ultrasound used: 1. Past or present history of vaginal bleeding during pregnancy; and 2. Open cervical os. * If ultrasound used: 1. Past or present history of vaginal bleeding during pregnancy; and 2. 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. * Willing to provide contact information for purposes of follow-up. * In Tanzania: 18 years of age or over or parental permission * In Mozambique: 21 years of age or over or parental permission * In Moldova: 18 years of age or over * In Madagascar: 18 years of age or parental permission * In Vietnam: reproductive age

Exclusion criteria

* Contraindications to the study drug; * Uterine size larger than 12 weeks L.M.P. at time of presentation for care. * Signs of severe infection, defined as at least one of the following of: 1. foul smelling discharge, 2. fever \> 39 degrees C , 3. pulse \>110/min;

Design outcomes

Primary

Measure	Time frame
complete resolution of signs/symptoms of incomplete abortion without recourse to surgery at any point for any reason	one week after initial treatment with the option of an additional week

Countries

Burkina Faso, Madagascar, Moldova, Mozambique, Tanzania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026