Optimal Treatment of Miscarriage

This study is currently recruiting participants.
Verified October 2013 by Region Skane
Sponsor:
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01033903
First received: December 16, 2009
Last updated: October 25, 2013
Last verified: October 2013
  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 ]

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: October 25, 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 April 15, 2014