Repeated Doses of Misoprostol for Medical Treatment of Missed Miscarriage
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|ClinicalTrials.gov Identifier: NCT01615224|
Recruitment Status : Suspended (No funding)
First Posted : June 8, 2012
Last Update Posted : March 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Missed Abortion||Drug: misoprostol||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Repeated Doses of Misoprostol for Treatment of Missed Abortion|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2020|
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
- Efficacy [ Time Frame: 1 day ]Complete abortion as judged by ultrasound
- Acceptability [ Time Frame: 1 day, 1 week, 2 weeks, 3 weeks, 5 weeks ]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?
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01615224
|Dept of Obstetrics and Gynecology, Danderyd Hospital|
|Stockholm, Sweden, 18288|
|Principal Investigator:||Kristina Gemzell Danielsson, professor||Karolinska Institutet|