Optimal Treatment of Miscarriage
This study is currently recruiting participants.
Verified February 2013 by Region Skane
Sponsor:
Region Skane
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01033903
First received: December 16, 2009
Last updated: February 12, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Abortion, Spontaneous |
Drug: misoprostol |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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? |
Resource links provided by NLM:
MedlinePlus related topics:
Miscarriage
Drug Information available for:
Misoprostol
U.S. FDA Resources
Further study details as provided by Region Skane:
Primary Outcome Measures:
- complete miscarriage [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- complete miscarriage [ Time Frame: 17 days, 24 days, 31 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 240 |
| Study Start Date: | October 2008 |
| Estimated Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Misoprostol 800 micrograms intravaginally |
Drug: misoprostol
800 micrograms intravaginally ONCE
|
| No Intervention: expectant managment |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01033903
Contacts
| Contact: Lil Valentin, MD, PhD | +4640332149 | lil.valentin@med.lu.se |
Locations
| Sweden | |
| Region Skane, Kvinnokliniken, University Hopsital MAS | Recruiting |
| Malmö, Sweden, SE 20502 | |
| Contact: Lil Valentin, MD, PhD +4640332149 lil.valentin@med.lu.se | |
| Principal Investigator: Lil Valentin, MD, PhD | |
Sponsors and Collaborators
Region Skane
More Information
No publications provided
| Responsible Party: | Region Skane |
| ClinicalTrials.gov Identifier: | NCT01033903 History of Changes |
| Other Study ID Numbers: | EudraCT 2007-007661-20 |
| Study First Received: | December 16, 2009 |
| Last Updated: | February 12, 2013 |
| Health Authority: | Sweden: Medical Products Agency |
Keywords provided by Region Skane:
|
Abortion, Spontaneous Randomized Controlled Trial |
Additional relevant MeSH terms:
|
Abortion, Spontaneous Pregnancy Complications Misoprostol Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses |
Pharmacologic Actions Oxytocics Reproductive Control Agents Physiological Effects of Drugs Abortifacient Agents, Nonsteroidal Abortifacient Agents |
ClinicalTrials.gov processed this record on May 21, 2013