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Optimal Treatment of Miscarriage

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01033903
First received: December 16, 2009
Last updated: February 17, 2016
Last verified: February 2016
  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:


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 ]

Enrollment: 190
Study Start Date: October 2008
Estimated Study Completion Date: February 2017
Primary Completion Date: December 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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01033903

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

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 17, 2016
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
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics

ClinicalTrials.gov processed this record on December 07, 2016