Repeated Doses of Misoprostol for Medical Treatment of Missed Miscarriage

Kristina Gemzell Danielsson

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Missed Abortion

Treatments: Drug: misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT01615224

WMA11

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

single dose

No Intervention group

Description:

Patients receive the standard treatment with 800mcg of vaginal misoprostol

repeated doses

Experimental group

Description:

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.

Treatment:

Drug: misoprostol