Randomized Double-blind Controlled Trial of Use of Dydrogesterone in Threatened Miscarriage

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

PHASE3

Total Enrollment

406 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-05-31

Brief Summary

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The aim of this study is to determine whether the dydrogesterone therapy is associated with reduction in miscarriage in women with first trimester threatened miscarriage. The hypothesis is that the dydrogesterone therapy will significantly reduce the risk of miscarriage in women with threatened miscarriage.

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Detailed Description

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Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dydrogesterone

Patients allocated to the dydrogesterone group will receive oral dydrogesterone 40mg stat, followed by 10mg orally three times a day, and placebo will be used in the control group accordingly. Patients will be followed up with weekly pelvic ultrasound till 12 completed weeks of gestation or 1 week after the bleeding stopped, whichever is longer.

Group Type ACTIVE_COMPARATOR

Dydrogesterone

Intervention Type DRUG

Placebo pill

Patients allocated to the dydrogesterone group will receive oral dydrogesterone 40mg stat, followed by 10mg orally three times a day, and placebo will be used in the control group accordingly. Patients will be followed up with weekly pelvic ultrasound till 12 completed weeks of gestation or 1 week after the bleeding stopped, whichever is longer.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Dydrogesterone

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Duphaston

Eligibility Criteria

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Inclusion Criteria

* Age of women from 18-40 years at the time of recruitment (not beyond 40th birthday)
* Absence of fever
* Gestation less than 12 completed weeks as defined by pelvic ultrasound
* Presence of intrauterine gestational sac(s) if an urine pregnancy test is first positive within past 2 weeks
* Presence of intrauterine fetus(es) with crown-rump length of \<7mm and no fetal pulsation, or presence of intrauterine fetus(es) with positive fetal heart pulsation confirmed on pelvic scanning

Exclusion Criteria

* Age of women \>40 years at the time of recruitment
* History of recurrent miscarriage defined as at least three consecutive spontaneous miscarriages
* History of known parental chromosomal abnormalities
* Heavy vaginal bleeding requiring surgical intervention
* Severe abdominal pain requiring surgical intervention
* Absence of cardiac pulsation in a fetal pole with crown-rump length of \>=7mm on transvaginal scanning
* Use of hCG or progesterone treatment for threatened miscarriage prior to recruitment

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No