Treatment of Incomplete Abortion With 600 Mcg Oral Misopr... | NCT00674232

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

NCT00674232

Sponsor

Gynuity Health Projects

Status

Completed

Last Update Posted

May 7, 2008Estimated

Enrollment

311Actual

Phase

Not Applicable

Conditions

Incomplete Abortion

Interventions

600 mcg misoprostol
Surgical treatment

Countries

Ecuador
Venezuela

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2006

Primary Completion Date

Not provided

Completion Date

Oct 2007Actual

First Submitted Date

Apr 28, 2008

First Submission Date that Met QC Criteria

May 5, 2008

First Posted Date

May 7, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2008

Last Update Posted Date

May 7, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

311Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Misoprostol	Experimental	Group 1 randomized to take single dose of 600 mcg oral misoprostol	Drug: 600 mcg misoprostol
Surgical treatment	Other	Group 2 randomized to receive standard surgical treatment as per local protocol (D&C or MVA)	Procedure: Surgical treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
600 mcg misoprostol	Drug	single dose of misoprostol taken orally	Misoprostol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
complete resolution of signs/symptoms of incomplete abortion without recourse to surgery at any point for any reason		one week after initial treatment

Secondary Outcomes

Measure	Description	Time Frame
side effects		measured at follow up visit one week after initial treatment
acceptability		measured at follow up visit one week after initial treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Melanie Peña, MPH, MA	Gynuity Health Projects	Study Director
Jill Durocher	Gynuity Health Projects	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital del Dia, CEMOPLAF		Quito			Ecuador
Hospital Gineco-obstetrico Isidro Ayora

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21872244	Derived	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.

ID	Term
D000022	Abortion, Spontaneous
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

ID	Term
D016595	Misoprostol
D013514	Surgical Procedures, Operative
D004107	Dilatation and Curettage

ID	Term
D011459	Prostaglandins E, Synthetic
D011465	Prostaglandins, Synthetic
D011453	Prostaglandins
D015777	Eicosanoids