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

Gynuity Health Projects

Status and phase: Completed; Phase 1

Conditions: Incomplete Abortion

Treatments: Procedure: surgery Manual vacuum aspiration (MVA); Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT01539408

2.2.3

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• no contraindications 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

• an IUD in place
• ectopic pregnancy
• aged below 18 years and had no accompanying adult to provide informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Misoprostol

Active Comparator group

Description:

400 mcg of sublingual misoprostol in one dose

Treatment:

Drug: Misoprostol

Manual vacuum aspiration (MVA)

Active Comparator group

Description:

Standard surgical treatment (MVA)

Treatment:

Procedure: surgery Manual vacuum aspiration (MVA)