Repeated Doses of Misoprostol for Medical Treatment of Missed Miscarriage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01615224
Recruitment Status : Suspended (No funding)
First Posted : June 8, 2012
Last Update Posted : March 3, 2017
Information provided by (Responsible Party):
Kristina Gemzell Danielsson, Karolinska Institutet

Brief Summary:
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 or disease Intervention/treatment Phase
Missed Abortion Drug: misoprostol Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Repeated Doses of Misoprostol for Treatment of Missed Abortion
Study Start Date : May 2012
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2020

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
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

Primary Outcome Measures :
  1. Efficacy [ Time Frame: 1 day ]
    Complete abortion as judged by ultrasound

Secondary Outcome Measures :
  1. Acceptability [ Time Frame: 1 day, 1 week, 2 weeks, 3 weeks, 5 weeks ]
    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?

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01615224

Dept of Obstetrics and Gynecology, Danderyd Hospital
Stockholm, Sweden, 18288
Sponsors and Collaborators
Kristina Gemzell Danielsson
Principal Investigator: Kristina Gemzell Danielsson, professor Karolinska Institutet

Responsible Party: Kristina Gemzell Danielsson, professor, Karolinska Institutet Identifier: NCT01615224     History of Changes
Other Study ID Numbers: WMA11
First Posted: June 8, 2012    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017

Keywords provided by Kristina Gemzell Danielsson, Karolinska Institutet:
missed abortion

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