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

NCT ID: NCT01539408

Last Updated: 2012-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Incomplete Abortion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Misoprostol

400 mcg of sublingual misoprostol in one dose

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

single dose of 400 mcg misoprostol administered sublingually

Manual vacuum aspiration (MVA)

Standard surgical treatment (MVA)

Group Type ACTIVE_COMPARATOR

surgery Manual vacuum aspiration (MVA)

Intervention Type PROCEDURE

standard surgical treatment

Interventions

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Misoprostol

single dose of 400 mcg misoprostol administered sublingually

Intervention Type DRUG

surgery Manual vacuum aspiration (MVA)

standard surgical treatment

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Gynuity Health Projects

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Adeoyo Maternity Hospital

Ibadan, , Nigeria

Site Status

University College Hospital, Ibadan

Ibadan, , Nigeria

Site Status

Countries

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Nigeria

References

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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.

Reference Type DERIVED
PMID: 34061352 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23150927 (View on PubMed)

Fawole AO, Diop A, Adeyanju AO, Aremu OT, Winikoff B. Misoprostol as first-line treatment for incomplete abortion at a secondary-level health facility in Nigeria. Int J Gynaecol Obstet. 2012 Nov;119(2):170-3. doi: 10.1016/j.ijgo.2012.06.012. Epub 2012 Aug 27.

Reference Type DERIVED
PMID: 22935620 (View on PubMed)

Other Identifiers

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2.2.3

Identifier Type: -

Identifier Source: org_study_id

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