Progesterone and Doppler in Recurrent Abortion

Abortion in First Trimester Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03267771
• Other study ID #: gehad elsherief
• Status: Not yet recruiting
• Phase: Phase 4
• First received: June 5, 2017
• Last updated: September 6, 2017
• Start date: October 1, 2017
• Est. completion date: December 5, 2019

Study information

• Verified date: September 2017
• Source: Assiut University
• Contact: Ahmed Ibrahim
• Phone: 01000024321
• Email: ahmedibrahimhas[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 5, 2019
• Est. primary completion date: August 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Abortion in First Trimester

Intervention

Drug:
• Progesterone Suppositories Vaginal
progesterone vaginal suppository
• Dydrogesterone Oral Tablet
oral progesterone drug

Device:
• doppler ultrasound
pulsed doppler ultrasound

Locations

Country	Name	City	State
Egypt	Gehad Elsherief	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Macklon NS, Geraedts JP, Fauser BC. Conception to ongoing pregnancy: the 'black box' of early pregnancy loss. Hum Reprod Update. 2002 Jul-Aug;8(4):333-43. Review. — View Citation

Sotiriadis A, Papatheodorou S, Makrydimas G. Threatened miscarriage: evaluation and management. BMJ. 2004 Jul 17;329(7458):152-5. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of Live births after 28 weeks of gestation	Live births that survive and continue beyond 28 weeks of gestation	28 weeks gestation
Secondary	Number of patients who Tolerable with the treatment	efficacy of treatment on patients	12 weeks