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

Incomplete Abortion Clinical Trial

Official title:

Misoprostol for Treatment of Incomplete Abortion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00674232
• Other study ID #: 2.2.0
• Status: Completed
• Phase: N/A
• First received: April 28, 2008
• Last updated: May 5, 2008
• Start date: May 2006
• Est. completion date: October 2007

Study information

• Verified date: May 2008
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ecuador: Hospital Gineco-obstetrico Isidro AyoraVenezuela: Hospital Maternidad Concepcion Palacios
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 311
• Est. completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abortion, Incomplete
• Incomplete Abortion

Intervention

Drug:
• 600 mcg misoprostol
single dose of misoprostol taken orally

Procedure:
• Surgical treatment
Either dilation and curettage or manual vacuum aspiration, as per local protocol

Locations

Country	Name	City	State
Ecuador	Hospital del Dia, CEMOPLAF	Quito
Ecuador	Hospital Gineco-obstetrico Isidro Ayora	Quito
Venezuela	Hospital Maternidad Concepcion Palacios	Caracas

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Countries where clinical trial is conducted

Ecuador,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete resolution of signs/symptoms of incomplete abortion without recourse to surgery at any point for any reason		one week after initial treatment
Secondary	side effects		measured at follow up visit one week after initial treatment	No
Secondary	acceptability		measured at follow up visit one week after initial treatment	No

External Links

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