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

Study Overview
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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.

Official Title
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A Randomized Double-blind Controlled Trial of Use of Dydrogesterone in Women With Threatened Miscarriage in the First Trimester

Conditions
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Pregnancy

Intervention / Treatment
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* Drug: Dydrogesterone
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dydrogesterone<br>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. | Drug: Dydrogesterone<br> <br> * Other names: Duphaston;|
| Placebo Comparator: Placebo pill<br>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. | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The chance of miscarriage before 20 weeks of gestation |  | At 20 weeks of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth rate |  | At the time of delivery, from 24 weeks of gestation till term gestation | 
| The proportion of heavy vaginal bleeding or severe abdominal pain requiring surgical intervention (<20 weeks) |  | Before 20 weeks of gestation | 
| The incidence of antepartum hemorrhage | Any vaginal bleeding during pregnancy from the 24th week gestational age to term | From 24 weeks of gestation till term | 
| The incidence of placenta previa | Placenta is being inserted partially or wholly in the lower uterine segment and will be diagnosed by antenatal ultrasound at second and third trimesters | From 24 weeks of gestation till term | 
| The incidence of pregnancy-induced hypertension | Any development of newly-onset hypertension (blood pressure persistently >=140/90mmHg on two occasions at least 4 hours apart) during pregnancy after 20 weeks gestation, labour or the puerperium in a previously normotensive non-proteinuric women | From 20 weeks of gestation till term | 
| The incidence of intrauterine death | Fetus dies in uterus after 24 weeks gestation | After 24 weeks of gestation till term | 
| The incidence of preterm labour | Any premature spontaneous delivery from 24 weeks to 36 weeks gestation | From 24 weeks to 36 weeks gestation | 
| Low birth weight at term (grams) | Baby born with birth weight less than 2500g at or after 37 weeks gestation | After 37 weeks gestation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Threatened miscarriage, Dydrogesterone, Randomized controlled trial