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Repeated Doses of Misoprostol for Medical Treatment of Missed Miscarriage

NCT ID: NCT01615224

Last Updated: 2019-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2019-10-30

Brief Summary

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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.

Detailed Description

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Conditions

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Missed Abortion

Keywords

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missed abortion miscarriage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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single dose

Patients receive the standard treatment with 800mcg of vaginal misoprostol

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

misoprostol

Intervention Type DRUG

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

Interventions

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misoprostol

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

Intervention Type DRUG

Other Intervention Names

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Cytotec 200mcg Pfizer

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kristina Gemzell Danielsson

OTHER

Sponsor Role lead

Responsible Party

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Kristina Gemzell Danielsson

professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Kristina Gemzell Danielsson, professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Dept of Obstetrics and Gynecology, Danderyd Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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WMA11

Identifier Type: -

Identifier Source: org_study_id