Treatment of Incomplete Abortion With 600 Mcg Oral Misoprostol Compared to Standard Surgical Treatment

NCT ID: NCT00674232

Last Updated: 2008-05-07

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

311 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-10-31

Brief Summary

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This study aims to compare the efficacy, side effects profile and acceptability of a single dose of 600mcg misoprostol taken orally compared to standard surgical treatment as per local protocols for the treatment of incomplete abortion.

Detailed Description

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Conditions

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Incomplete Abortion

Keywords

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incomplete abortion spontaneous miscarriage

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

Group 1 randomized to take single dose of 600 mcg oral misoprostol

Group Type EXPERIMENTAL

600 mcg misoprostol

Intervention Type DRUG

single dose of misoprostol taken orally

Surgical treatment

Group 2 randomized to receive standard surgical treatment as per local protocol (D\&C or MVA)

Group Type OTHER

Surgical treatment

Intervention Type PROCEDURE

Either dilation and curettage or manual vacuum aspiration, as per local protocol

Interventions

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600 mcg misoprostol

single dose of misoprostol taken orally

Intervention Type DRUG

Surgical treatment

Either dilation and curettage or manual vacuum aspiration, as per local protocol

Intervention Type PROCEDURE

Other Intervention Names

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Cytotec D&C, MVA

Eligibility Criteria

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Inclusion Criteria

* past or present history of vaginal bleeding during pregnancy
* open cervical os
* evidence of incomplete abortion with substantial debris in the uterus (if using ultrasound)
* surgical evacuation of the uterus would be advised as course of action if misoprostol was not available
* generally in good health
* woman lives or works within one hour of study site
* woman willing to provide contact information for follow up purposes
* informed consent given

Exclusion Criteria

* contraindications to study drug
* uterine size larger than 12 weeks LMP
* signs of severe infection
Minimum Eligible Age

14 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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Gynuity Health Projects

Principal Investigators

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Melanie Peña, MPH, MA

Role: STUDY_DIRECTOR

Gynuity Health Projects

Jill Durocher

Role: STUDY_DIRECTOR

Gynuity Health Projects

Locations

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Hospital del Dia, CEMOPLAF

Quito, , Ecuador

Site Status

Hospital Gineco-obstetrico Isidro Ayora

Quito, , Ecuador

Site Status

Hospital Maternidad Concepcion Palacios

Caracas, , Venezuela

Site Status

Countries

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Ecuador Venezuela

References

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Montesinos R, Durocher J, Leon W, Arellano M, Pena M, Pinto E, Winikoff B. Oral misoprostol for the management of incomplete abortion in Ecuador. Int J Gynaecol Obstet. 2011 Nov;115(2):135-9. doi: 10.1016/j.ijgo.2011.06.015. Epub 2011 Aug 26.

Reference Type DERIVED
PMID: 21872244 (View on PubMed)

Related Links

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Other Identifiers

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2.2.0

Identifier Type: -

Identifier Source: org_study_id