Repeated Doses of Misoprostol for Medical Treatment of Missed Miscarriage

Missed Abortion Clinical Trial

Official title:

Repeated Doses of Misoprostol for Treatment of Missed Abortion

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01615224
• Other study ID #: WMA11
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: May 2012
• Est. completion date: October 30, 2019

Study information

• Verified date: August 2019
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: October 30, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Missed
• Missed Abortion

Intervention

Drug:
• misoprostol
repeated doses of misoprostol. 400mcg of oral misoprostol given at 3, 5, 7 and 9 hours.

Locations

Country	Name	City	State
Sweden	Dept of Obstetrics and Gynecology, Danderyd Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Kristina Gemzell Danielsson

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy	Complete abortion as judged by ultrasound	1 day
Secondary	Acceptability	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?	1 day, 1 week, 2 weeks, 3 weeks, 5 weeks