Back to resultsOptimal Treatment of Miscarriage
Primary Purpose
Abortion, Spontaneous
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
misoprostol
Sponsored by
About this trial
This is an interventional treatment trial for Abortion, Spontaneous focused on measuring Abortion, Spontaneous, Randomized Controlled Trial
Eligibility Criteria
Inclusion Criteria:
- nonviable intrauterine pregnancy with retained gestational sac in the uterus
- the embryo if visible 5 to 35 mm without a heart beat
- vaginal bleeding
- circulatory stable
- hemoglobin at least 80 g/L
Exclusion Criteria:
- contraindications against misoprostol
Sites / Locations
- Region Skane, Kvinnokliniken, University Hopsital MAS
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Misoprostol 800 micrograms intravaginally
expectant managment
Arm Description
Outcomes
Primary Outcome Measures
complete miscarriage
Secondary Outcome Measures
complete miscarriage
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01033903
Brief Title
Optimal Treatment of Miscarriage
Official Title
Which is the Optimal Treatment for Miscarriage With a Gestational ac in the Uterus and Which Factors Can Predict if the Treatment Will be Successful?
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2008 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
March 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main objective of the study is to determine if there is a difference in the number of women with a complete miscarriage after 10 days between expectant management versus treatment with 800 micrograms of misoprostol intravaginally in women with an an incomplete miscarriage before 14 weeks and a gestational sac retained in the uterus.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abortion, Spontaneous
Keywords
Abortion, Spontaneous, Randomized Controlled Trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
190 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Misoprostol 800 micrograms intravaginally
Arm Type
Experimental
Arm Title
expectant managment
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
misoprostol
Intervention Description
800 micrograms intravaginally ONCE
Primary Outcome Measure Information:
Title
complete miscarriage
Time Frame
10 days
Secondary Outcome Measure Information:
Title
complete miscarriage
Time Frame
17 days, 24 days, 31 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
nonviable intrauterine pregnancy with retained gestational sac in the uterus
the embryo if visible 5 to 35 mm without a heart beat
vaginal bleeding
circulatory stable
hemoglobin at least 80 g/L
Exclusion Criteria:
contraindications against misoprostol
Facility Information:
Facility Name
Region Skane, Kvinnokliniken, University Hopsital MAS
City
Malmö
ZIP/Postal Code
SE 20502
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
29072372
Citation
Fernlund A, Jokubkiene L, Sladkevicius P, Valentin L. Misoprostol treatment vs expectant management in women with early non-viable pregnancy and vaginal bleeding: a pragmatic randomized controlled trial. Ultrasound Obstet Gynecol. 2018 Jan;51(1):24-32. doi: 10.1002/uog.18940. Epub 2017 Dec 5.
Results Reference
derived
Learn more about this trial
Optimal Treatment of Miscarriage
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