Treatment of Incomplete Abortion With 600 Mcg Oral Misoprostol Compared to Standard Surgical Treatment
Misoprostol for Treatment of Incomplete Abortion
1 other identifier
interventional
311
2 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2006
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 28, 2008
CompletedFirst Posted
Study publicly available on registry
May 7, 2008
CompletedMay 7, 2008
May 1, 2008
April 28, 2008
May 5, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (2)
side effects
measured at follow up visit one week after initial treatment
acceptability
measured at follow up visit one week after initial treatment
Study Arms (2)
Misoprostol
EXPERIMENTALGroup 1 randomized to take single dose of 600 mcg oral misoprostol
Surgical treatment
OTHERGroup 2 randomized to receive standard surgical treatment as per local protocol (D\&C or MVA)
Interventions
Either dilation and curettage or manual vacuum aspiration, as per local protocol
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- contraindications to study drug
- uterine size larger than 12 weeks LMP
- signs of severe infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Hospital del Dia, CEMOPLAF
Quito, Ecuador
Hospital Gineco-obstetrico Isidro Ayora
Quito, Ecuador
Hospital Maternidad Concepcion Palacios
Caracas, Venezuela
Related Publications (1)
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.
PMID: 21872244DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Melanie Peña, MPH, MA
Gynuity Health Projects
- STUDY DIRECTOR
Jill Durocher
Gynuity Health Projects
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 28, 2008
First Posted
May 7, 2008
Study Start
May 1, 2006
Study Completion
October 1, 2007
Last Updated
May 7, 2008
Record last verified: 2008-05