Progesterone and Doppler in Recurrent Abortion

Phase 4

• Conditions: Abortion in First Trimester
• Interventions: Drug: Dydrogesterone Oral Tablet; Drug: Progesterone Suppositories Vaginal; Device: doppler ultrasound

• Registration Number: NCT03267771
• Lead Sponsor: Assiut University

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 .

Study Timeline

• Study First Submitted: 2017-06-05
• Study First Submitted QC: 2017-08-29
• Study First Posted: 2017-08-30
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-06
• Last Update Posted: 2017-09-08
• Study Start: 2017-10-01
• Primary Completion: 2019-08-05
• Study Completion: 2019-12-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

1. pregnant 7-12 weeks documented by pregnancy test &/or ultrasaound.
2. History of at least 2 prior spontaneous abortion before 12 weeks of gestation.
3. Age: 18-35 years
4. Willing and able to give informed consent.
5. Rh +ve patient
6. BMI: 18-32
7. Viable pregnancy through the detection of fetal pulsations by ultrasound
8. Singleton pregnancy
9. Apparently stable pregnancy (no history of vaginal bleeding in this current pregnancy or signs of sac separation in ultrasound)

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Exclusion Criteria

1. Patients diagnosed to have Anti-phospholipid syndrome or another recognised thrombophilic or autoimmune conditions.
2. Pregnant > 12 weeks.
3. Contraindication to progesterone use.
4. Diabetic patients, have glucose intolerance.
5. Multiple pregnancies.
6. Thyroid disorder

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dydrogesterone oral tablets group	doppler ultrasound	20 mg tablets (Duphaston ®), 2 tablets orally twice daily through 18 weeks of gestation.
Dydrogesterone oral tablets group	Dydrogesterone Oral Tablet	20 mg tablets (Duphaston ®), 2 tablets orally twice daily through 18 weeks of gestation.
progesterone suppositories vaginal group	Progesterone Suppositories Vaginal	vaginal micronized progesterone suppositories (prontogest®) 400 mg, one vaginal suppository twice daily through 18 weeks of gestation.
progesterone suppositories vaginal group	doppler ultrasound	vaginal micronized progesterone suppositories (prontogest®) 400 mg, one vaginal suppository twice daily through 18 weeks of gestation.

Primary Outcome Measures

Name	Time	Method
number of Live births after 28 weeks of gestation	28 weeks gestation	Live births that survive and continue beyond 28 weeks of gestation

Secondary Outcome Measures

Name	Time	Method
Number of patients who Tolerable with the treatment	12 weeks	efficacy of treatment on patients

Trial Locations

Locations (1)

Gehad Elsherief; 🇪🇬 Assiut, Egypt