Role of Serum Progesterone and Doppler Ultrasound in Prediction of Pregnancy Outcome in Women With Recurrent Unexplained Abortion
Overview
- Phase
- Phase 4
- Intervention
- Progesterone Suppositories Vaginal
- Conditions
- Abortion in First Trimester
- Sponsor
- Assiut University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- number of Live births after 28 weeks of gestation
- Last Updated
- 8 years ago
Overview
Brief Summary
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
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 .
Investigators
GKElsherief
prinicipal investigator
Assiut University
Eligibility Criteria
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
- •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
Arms & Interventions
progesterone suppositories vaginal group
vaginal micronized progesterone suppositories (prontogest®) 400 mg, one vaginal suppository twice daily through 18 weeks of gestation.
Intervention: Progesterone Suppositories Vaginal
progesterone suppositories vaginal group
vaginal micronized progesterone suppositories (prontogest®) 400 mg, one vaginal suppository twice daily through 18 weeks of gestation.
Intervention: doppler ultrasound
Dydrogesterone oral tablets group
20 mg tablets (Duphaston ®), 2 tablets orally twice daily through 18 weeks of gestation.
Intervention: Dydrogesterone Oral Tablet
Dydrogesterone oral tablets group
20 mg tablets (Duphaston ®), 2 tablets orally twice daily through 18 weeks of gestation.
Intervention: doppler ultrasound
Outcomes
Primary Outcomes
number of Live births after 28 weeks of gestation
Time Frame: 28 weeks gestation
Live births that survive and continue beyond 28 weeks of gestation
Secondary Outcomes
- Number of patients who Tolerable with the treatment(12 weeks)