Progesterone and Doppler in Recurrent Abortion

Study Overview
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Brief Summary
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Recurrent pregnancy loss is classically defined as the occurrence of three or more consecutive pregnancy loss. The American Society of Reproductive Medicine has recently redefined recurrent pregnancy loss as two or more pregnancy losses. A pregnancy loss is defined as a clinically-recognized pregnancy means that the pregnancy has been visualized on an ultrasound or that pregnancy tissue was identified after a pregnancy loss.

Detailed Description
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Spontaneous pregnancy loss is a surprisingly common occurrence. Whereas approximately 15% of all clinically recognized pregnancies result in spontaneous loss, there are many more pregnancies that fail prior to being clinically recognized. Only 30% of all conceptions result in a live birth. Although no reliable published data have estimated the probability of finding an etiology for recurrent pregnancy loss in a population with 2 versus 3 or more miscarriages, the best available data suggest that the risk of miscarriage in subsequent pregnancies is 30% after 2 losses, compared with 33% after 3 losses among patients without a history of a live birth. This strongly suggests a role for evaluation after just 2 losses in patients with no prior live births. An earlier evaluation may be further indicated if fetal cardiac activity was identified prior to a loss .

Official Title
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Role of Serum Progesterone and Doppler Ultrasound in Prediction of Pregnancy Outcome in Women With Recurrent Unexplained Abortion

Conditions
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Abortion in First Trimester

Intervention / Treatment
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* Drug: Progesterone Suppositories Vaginal
* Drug: Dydrogesterone Oral Tablet
* Device: doppler ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pregnant 7-12 weeks documented by pregnancy test &/or ultrasaound. History of at least 2 prior spontaneous abortion before 12 weeks of gestation. Age: 18-35 years Willing and able to give informed consent. Rh +ve patient BMI: 18-32 Viable pregnancy through the detection of fetal pulsations by ultrasound Singleton pregnancy Apparently stable pregnancy (no history of vaginal bleeding in this current pregnancy or signs of sac separation in ultrasound) Exclusion Criteria: Patients diagnosed to have Anti-phospholipid syndrome or another recognised thrombophilic or autoimmune conditions. Pregnant > 12 weeks. Contraindication to progesterone use. Diabetic patients, have glucose intolerance. Multiple pregnancies. Thyroid disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: progesterone suppositories vaginal group<br>vaginal micronized progesterone suppositories (prontogest®) 400 mg, one vaginal suppository twice daily through 18 weeks of gestation. | Drug: Progesterone Suppositories Vaginal<br>* progesterone vaginal suppository<br>* Other names: Prontogest;Device: doppler ultrasound<br>* pulsed doppler ultrasound<br>* Other names: Gomez et al;|
| Experimental: Dydrogesterone oral tablets group<br>20 mg tablets (Duphaston ®), 2 tablets orally twice daily through 18 weeks of gestation. | Drug: Dydrogesterone Oral Tablet<br>* oral progesterone drug<br>* Other names: Duphaston;Device: doppler ultrasound<br>* pulsed doppler ultrasound<br>* Other names: Gomez et al;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of Live births after 28 weeks of gestation | Live births that survive and continue beyond 28 weeks of gestation | 28 weeks gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who Tolerable with the treatment | efficacy of treatment on patients | 12 weeks |