Oral Progesterone for Prevention of Miscarriage in Threatened Abortion

Study Overview
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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.

Official Title
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Oral Progesterone for Prevention of Miscarriage in Threatened Abortion: a Randomized, Double-blinded, Placebo-controlled Trial

Conditions
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Threatened Abortion

Intervention / Treatment
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* Drug: Dydrogesterone
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dydrogesterone<br>dydrogesterone 10 mg by mouth every 12 hours until 1 week after bleeding stops or until 6 weeks. | Drug: Dydrogesterone<br>* Dydrogesterone tablet<br>|
| Placebo Comparator: Placebo<br>placebo by mouth every 12 hours until 1 week after bleeding stops or until 6 weeks. | Drug: Placebo<br>* Placebo tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| continue pregnancy more than 20 weeks gestation | percentage of cases with continue pregnancy more than 20 weeks gestation | at 20 weeks gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| preterm delivery less than 34 weeks | percentage of delivery less than 34 weeks | at 34 weeks gestation | 
| preterm delivery less than 37 weeks | percentage of delivery less than 37 weeks | at 37 weeks gestation | 
| placenta previa | percentage of placenta previa | 31 weeks | 
| abruptio placenta | percentage of abruptio placenta | 31 weeks | 
| Intrauterine growth restriction | percentage of intrauterine growth restriction | 31 weeks | 
| neonatal complications | percentage of newborn with respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, death | 31 weeks | 
| side effects | percentage of side effects such as headache, nausea/vomiting | 6 weeks | 
| compliance | percentage of complete drug use | 6 weeks | 
| maternal satisfaction | percentage of good satisfaction | 6 weeks | 
| time until bleeding stops | time from first bleeding until bleeding stops | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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threatened abortion