Repeated Doses of Misoprostol for Medical Treatment of Missed Miscarriage
Missed abortion is a condition where the fetus has perished but the miscarriage is not expelled. Women often present at a routine ultrasound or with a slight brownish discharge. Traditionally this condition has been treated with curettage or vacuum aspiration. Lately, medical treatment has become more common due to less risk of infection and other complications. The routine medical treatment is 800mcg of misoprostol administered vaginally. We wish to examine of repeated doses of 400mcg misoprostol after the initial 800mcg vaginal misoprostol increases efficacy of the treatment.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Repeated Doses of Misoprostol for Treatment of Missed Abortion|
- Efficacy [ Time Frame: 1 day ] [ Designated as safety issue: No ]Complete abortion as judged by ultrasound
- Acceptability [ Time Frame: 1 day, 1 week, 2 weeks, 3 weeks, 5 weeks ] [ Designated as safety issue: No ]questionnaire on future choice of treatment method. Surgical or medical treatment if free choice. If having to have medical would she choose repeated doses or single dose?
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
No Intervention: single dose
Patients receive the standard treatment with 800mcg of vaginal misoprostol
Experimental: repeated doses
patients receive 800mcg of vaginal misoprostol. In addition to this they receive repeated doses of 400mcg oral misoprostol after 3 and 5 hours. Women of more than 9 weeks pregnancy according to last menstrual period will be given a choice of vacuum aspiration or further medical treatment with 2 additional doses of misoprostol given after 7 and 9 hours after the initial vaginal treatment.
repeated doses of misoprostol. 400mcg of oral misoprostol given at 3, 5, 7 and 9 hours.
Other Name: Cytotec 200mcg Pfizer
Please refer to this study by its ClinicalTrials.gov identifier: NCT01615224
|Contact: Kristina Gemzell Danielsson, firstname.lastname@example.org|
|Contact: Helena Kopp Kallner, MD||+46-70-440 email@example.com|
|Dept of Obstetrics and Gynecology, Danderyd Hospital||Recruiting|
|Stockholm, Sweden, 18288|
|Contact: Helena Kopp Kallner, MD +46-70-402070|
|Principal Investigator: Helena Kopp Kallner, MD|
|Principal Investigator:||Kristina Gemzell Danielsson, professor||Karolinska Institutet|