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Progesterone and Doppler in Recurrent Abortion

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03267771
Enrollment
50
Registered
2017-08-30
Start date
2017-10-01
Completion date
2019-12-05
Last updated
2017-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abortion in First Trimester

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 .

Interventions

DRUGProgesterone Suppositories Vaginal

progesterone vaginal suppository

oral progesterone drug

DEVICEdoppler ultrasound

pulsed doppler ultrasound

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
number of Live births after 28 weeks of gestation28 weeks gestationLive births that survive and continue beyond 28 weeks of gestation

Secondary

MeasureTime frameDescription
Number of patients who Tolerable with the treatment12 weeksefficacy of treatment on patients

Countries

Egypt

Contacts

Primary ContactAhmed Ibrahim
ahmedibrahimhas@yahoo.com01000024321
Backup ContactHesham Abu taleb
Hishamaboutaleb1@yahoo.com01003332139

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026