Back to resultsRepeated Doses of Misoprostol for Medical Treatment of Missed Miscarriage
Primary Purpose
Missed Abortion
Status
Terminated
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
misoprostol
Sponsored by
About this trial
This is an interventional treatment trial for Missed Abortion focused on measuring missed abortion, miscarriage
Eligibility Criteria
Inclusion Criteria:
- over 18 years of age healthy no contraindication to medical treatment visible fetal structures such as yolk sac or fetus
Exclusion Criteria:
- empty gestational sac more than sparse bleeding or dilated cervix mental instability after diagnosis contraindication to medical treatment
Sites / Locations
- Dept of Obstetrics and Gynecology, Danderyd Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
single dose
repeated doses
Arm Description
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.
Outcomes
Primary Outcome Measures
Efficacy
Complete abortion as judged by ultrasound
Secondary Outcome Measures
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?
Full Information
NCT ID
NCT01615224
First Posted
June 4, 2012
Last Updated
December 14, 2019
Sponsor
Kristina Gemzell Danielsson
1. Study Identification
Unique Protocol Identification Number
NCT01615224
Brief Title
Repeated Doses of Misoprostol for Medical Treatment of Missed Miscarriage
Official Title
Repeated Doses of Misoprostol for Treatment of Missed Abortion
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
No funding
Study Start Date
May 2012 (undefined)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kristina Gemzell Danielsson
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Missed Abortion
Keywords
missed abortion, miscarriage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single dose
Arm Type
No Intervention
Arm Description
Patients receive the standard treatment with 800mcg of vaginal misoprostol
Arm Title
repeated doses
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
misoprostol
Other Intervention Name(s)
Cytotec 200mcg Pfizer
Intervention Description
repeated doses of misoprostol. 400mcg of oral misoprostol given at 3, 5, 7 and 9 hours.
Primary Outcome Measure Information:
Title
Efficacy
Description
Complete abortion as judged by ultrasound
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Acceptability
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
over 18 years of age healthy no contraindication to medical treatment visible fetal structures such as yolk sac or fetus
Exclusion Criteria:
empty gestational sac more than sparse bleeding or dilated cervix mental instability after diagnosis contraindication to medical treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristina Gemzell Danielsson, professor
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of Obstetrics and Gynecology, Danderyd Hospital
City
Stockholm
ZIP/Postal Code
18288
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Repeated Doses of Misoprostol for Medical Treatment of Missed Miscarriage
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