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400mcg Sublingual Misoprostol as First Line Treatment

NCT ID: NCT01939457

Last Updated: 2013-09-11

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

NA

Total Enrollment

641 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-08-31

Brief Summary

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Women presenting with incomplete abortion and eligible for treatment with misoprostol were offered 400mcg sublingual misoprostol for treatment. Based on existing literature, the study hypothesises that women can successfully be treated with misoprostol alone as first line treatment.

Detailed Description

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Conditions

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Incomplete Abortion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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misoprostol

400 mcg misoprostol sublingually

Group Type EXPERIMENTAL

Misoprostol

Intervention Type DRUG

Interventions

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Misoprostol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* uterine size less than 12 weeks lmp
* open cervical os
* current or past vaginal bleeding
* willing to provide contact information for follow-up
* over 18 or with guardian consent

Exclusion Criteria

* suspicion of ectopic pregnancy
* intrauterine device in place
* bad general health (infection, anemia, shoc)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Gynuity Health Projects

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Beverly Winikoff, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Gynuity Health Projects

Locations

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Guediawaye Health Center

Guédiawaye, , Senegal

Site Status

Countries

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Senegal

References

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Gaye A, Diop A, Shochet T, Winikoff B. Decentralizing postabortion care in Senegal with misoprostol for incomplete abortion. Int J Gynaecol Obstet. 2014 Sep;126(3):223-6. doi: 10.1016/j.ijgo.2014.03.028. Epub 2014 May 15.

Reference Type DERIVED
PMID: 24893962 (View on PubMed)

Other Identifiers

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2.2.4

Identifier Type: -

Identifier Source: org_study_id