Misoprostol for the Treatment of Incomplete Abortion

Gynuity Health Projects

Status: Completed

Conditions: Abortion, Incomplete

Treatments: Drug: misoprostol; Procedure: MVA

Study type: Interventional

Funder types: Other

Identifiers

NCT00670761

2.2.1

Details and patient eligibility

About

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.

Enrollment: 720 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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720 participants in 3 patient groups

1

Active Comparator group

Description:

treatment with 600mcg oral misoprostol

Treatment:

Drug: misoprostol

2

Active Comparator group

Description:

treatment with 400mcg sublingual misoprostol

Treatment:

Drug: misoprostol

3

Active Comparator group

Description:

treatment with Manual Vacuum Aspiration (MVA)

Treatment:

Procedure: MVA