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Repeated Doses of Misoprostol for Medical Treatment of Missed Miscarriage

This study is currently recruiting participants.
Verified June 2012 by Karolinska Institutet
Sponsor:
Information provided by (Responsible Party):
Kristina Gemzell Danielsson, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01615224
First received: June 4, 2012
Last updated: June 7, 2012
Last verified: June 2012
History of Changes
  Purpose

Missed abortion is a condition where the fetus has perished but the miscarriage is not expelled. Women often present at a routine ultrasound or with a slight brownish discharge. Traditionally this condition has been treated with curettage or vacuum aspiration. Lately, medical treatment has become more common due to less risk of infection and other complications. The routine medical treatment is 800mcg of misoprostol administered vaginally. We wish to examine of repeated doses of 400mcg misoprostol after the initial 800mcg vaginal misoprostol increases efficacy of the treatment.


Condition Intervention Phase
Missed Abortion
 Drug: misoprostol
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Repeated Doses of Misoprostol for Treatment of Missed Abortion

Resource links provided by NLM:

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

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Complete abortion as judged by ultrasound


Secondary Outcome Measures:
  • Acceptability [ Time Frame: 1 day, 1 week, 2 weeks, 3 weeks, 5 weeks ] [ Designated as safety issue: No ]
    questionnaire on future choice of treatment method. Surgical or medical treatment if free choice. If having to have medical would she choose repeated doses or single dose?


Estimated Enrollment: 140
Study Start Date: May 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: single dose
Patients receive the standard treatment with 800mcg of vaginal misoprostol
Experimental: repeated doses
patients receive 800mcg of vaginal misoprostol. In addition to this they receive repeated doses of 400mcg oral misoprostol after 3 and 5 hours. Women of more than 9 weeks pregnancy according to last menstrual period will be given a choice of vacuum aspiration or further medical treatment with 2 additional doses of misoprostol given after 7 and 9 hours after the initial vaginal treatment.
 Drug: misoprostol
repeated doses of misoprostol. 400mcg of oral misoprostol given at 3, 5, 7 and 9 hours.
Other Name: Cytotec 200mcg Pfizer

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • over 18 years of age healthy no contraindication to medical treatment visible fetal structures such as yolk sac or fetus

Exclusion Criteria:

  • empty gestational sac more than sparse bleeding or dilated cervix mental instability after diagnosis contraindication to medical treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01615224

Contacts
Contact: Kristina Gemzell Danielsson, professor +47-8-51772128 kristina.gemzell@ki.se
Contact: Helena Kopp Kallner, MD +46-70-440 2070 helena.kopp-kallner@ds.se

Locations
Sweden
Dept of Obstetrics and Gynecology, Danderyd Hospital Recruiting
Stockholm, Sweden, 18288
Contact: Helena Kopp Kallner, MD     +46-70-402070        
Principal Investigator: Helena Kopp Kallner, MD            
Sponsors and Collaborators
Kristina Gemzell Danielsson
Investigators
Principal Investigator: Kristina Gemzell Danielsson, professor Karolinska Institutet
  More Information

No publications provided

Responsible Party: Kristina Gemzell Danielsson, professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01615224     History of Changes
Other Study ID Numbers: WMA11
Study First Received: June 4, 2012
Last Updated: June 7, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska Institutet:
missed abortion
miscarriage

Additional relevant MeSH terms:
Abortion, Spontaneous
Abortion, Missed
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 19, 2013