Trial | NCT00670761  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    misoprostol ...

  • Study Participants

    720
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:

600 mcg of oral misoprostol in one dose, or
Standard surgical treatment (MVA)

In Moldova and Madagascar:

600 mcg of oral misoprostol in one dose, or
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.
Study Started
Jul 31
2004
Primary Completion
Apr 30
2010
Study Completion
Dec 31
2010
Last Update
Jul 27
2016
Estimate

Drug misoprostol

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

  • Other names: Cytotec

Procedure MVA

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

1 Active Comparator

treatment with 600mcg oral misoprostol

2 Active Comparator

treatment with 400mcg sublingual misoprostol

3 Active Comparator

treatment with Manual Vacuum Aspiration (MVA)

  • Procedure MVA

Criteria 

Inclusion Criteria:

If no ultrasound used:

Past or present history of vaginal bleeding during pregnancy; and
Open cervical os.

If ultrasound used:

Past or present history of vaginal bleeding during pregnancy; and
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:

foul smelling discharge,
fever > 39 degrees C ,
pulse >110/min;
No Results Posted