Oral Progesterone for Prevention of Miscarriage in Threatened Abortion

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

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-08-31

Brief Summary

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This study evaluates the effectiveness of oral dydrogesterone in preventing miscarriage in threatened abortion. Half of participants will receive oral dydrogesterone, while the other half will receive oral placebo.

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Detailed Description

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Conditions

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Threatened Abortion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dydrogesterone

dydrogesterone 10 mg by mouth every 12 hours until 1 week after bleeding stops or until 6 weeks.

Group Type ACTIVE_COMPARATOR

Dydrogesterone

Intervention Type DRUG

Dydrogesterone tablet

Placebo

placebo by mouth every 12 hours until 1 week after bleeding stops or until 6 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablet

Interventions

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Dydrogesterone

Dydrogesterone tablet

Intervention Type DRUG

Placebo

Placebo tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* singleton pregnancy with gestational age 6 - 20 weeks
* threatened abortion
* confirmed intrauterine pregnancy with a viable fetus by ultrasound

Exclusion Criteria

* history of recurrent miscarriage
* having endocervical polyp
* having infection such as pneumonia, pyelonephritis, septicemia
* having autoimmune diseases such as systemic lupus erythematosus, systemic sclerosis, rheumatoid arthritis
* having cancer
* having coagulation defect
* allergy to dydrogesterone

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes