A Phase 2/3 interventional study of misoprostol in Missed Abortion, sponsored by Kristina Gemzell Danielsson. Terminated at 1 site in Sweden. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2019-12-18.
Sponsored by Kristina Gemzell Danielsson · Phase 2/3, Interventional, and Treatment
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.
48 studies on the registry are indexed under Abortion, Missed; 10 are open to participants now.
This study's enrollment of 23 is below the median of 110 across 41 interventional studies indexed under Abortion, Missed.
Browse Abortion, Missed studies →Kristina Gemzell Danielsson is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Patients receive the standard treatment with 800mcg of vaginal misoprostol
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.
Drug: misoprostol
repeated doses of misoprostol. 400mcg of oral misoprostol given at 3, 5, 7 and 9 hours.
Also known as: Cytotec 200mcg Pfizer
Efficacy
Complete abortion as judged by ultrasound
Time frame: 1 day
Acceptability
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?
Time frame: 1 day, 1 week, 2 weeks, 3 weeks, 5 weeks
The record gives a start of May 2012, a primary completion of Oct 2019 and a completion of Oct 2019. It does not say whether these dates are actual or estimated.
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This study is terminated, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Misoprostol
Kristina Gemzell Danielsson