Optimal Treatment of Miscarriage

NCT ID: NCT01033903

Last Updated: 2018-10-22

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

COMPLETED

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-01

Study Completion Date

2018-03-01

Brief Summary

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The main objective of the study is to determine if there is a difference in the number of women with a complete miscarriage after 10 days between expectant management versus treatment with 800 micrograms of misoprostol intravaginally in women with an an incomplete miscarriage before 14 weeks and a gestational sac retained in the uterus.

Detailed Description

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Conditions

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Abortion, Spontaneous

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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Misoprostol 800 micrograms intravaginally

Group Type EXPERIMENTAL

misoprostol

Intervention Type DRUG

800 micrograms intravaginally ONCE

expectant managment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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misoprostol

800 micrograms intravaginally ONCE

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* nonviable intrauterine pregnancy with retained gestational sac in the uterus
* the embryo if visible 5 to 35 mm without a heart beat
* vaginal bleeding
* circulatory stable
* hemoglobin at least 80 g/L

Exclusion Criteria

* contraindications against misoprostol
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Region Skane

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Region Skane, Kvinnokliniken, University Hopsital MAS

Malmo, , Sweden

Site Status

Countries

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Sweden

References

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Fernlund A, Jokubkiene L, Sladkevicius P, Valentin L. Misoprostol treatment vs expectant management in women with early non-viable pregnancy and vaginal bleeding: a pragmatic randomized controlled trial. Ultrasound Obstet Gynecol. 2018 Jan;51(1):24-32. doi: 10.1002/uog.18940. Epub 2017 Dec 5.

Reference Type DERIVED
PMID: 29072372 (View on PubMed)

Other Identifiers

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EudraCT 2007-007661-20

Identifier Type: -

Identifier Source: org_study_id

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