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Optimal Treatment of Miscarriage

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ClinicalTrials.gov Identifier: NCT01033903
Recruitment Status : Unknown
Verified February 2016 by Region Skane.
Recruitment status was:  Active, not recruiting
First Posted : December 17, 2009
Last Update Posted : February 18, 2016
Sponsor:
Information provided by (Responsible Party):
Region Skane

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.

Condition or disease Intervention/treatment Phase
Abortion, Spontaneous Drug: misoprostol Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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?
Study Start Date : October 2008
Actual Primary Completion Date : December 2015
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Miscarriage
Drug Information available for: Misoprostol
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Misoprostol 800 micrograms intravaginally Drug: misoprostol
800 micrograms intravaginally ONCE
No Intervention: expectant managment



Primary Outcome Measures :
  1. complete miscarriage [ Time Frame: 10 days ]

Secondary Outcome Measures :
  1. complete miscarriage [ Time Frame: 17 days, 24 days, 31 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

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): NCT01033903


Locations
Sweden
Region Skane, Kvinnokliniken, University Hopsital MAS
Malmö, Sweden, SE 20502
Sponsors and Collaborators
Region Skane

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01033903     History of Changes
Other Study ID Numbers: EudraCT 2007-007661-20
First Posted: December 17, 2009    Key Record Dates
Last Update Posted: February 18, 2016
Last Verified: February 2016

Keywords provided by Region Skane:
Abortion, Spontaneous
Randomized Controlled Trial

Additional relevant MeSH terms:
Abortion, Spontaneous
Pregnancy Complications
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics