Progesterone and Doppler in Recurrent Abortion

Assiut University

Status and phase: Unknown; Phase 4

Conditions: Abortion in First Trimester

Treatments: Device: doppler ultrasound; Drug: Progesterone Suppositories Vaginal; Drug: Dydrogesterone Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03267771

gehad elsherief

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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)

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

progesterone suppositories vaginal group

Active Comparator group

Description:

vaginal micronized progesterone suppositories (prontogest®) 400 mg, one vaginal suppository twice daily through 18 weeks of gestation.

Treatment:

Drug: Progesterone Suppositories Vaginal

Device: doppler ultrasound

Dydrogesterone oral tablets group

Experimental group

Description:

20 mg tablets (Duphaston ®), 2 tablets orally twice daily through 18 weeks of gestation.

Treatment:

Drug: Dydrogesterone Oral Tablet

Device: doppler ultrasound