Progesterone and Doppler in Recurrent Abortion

NCT ID: NCT03267771

Last Updated: 2017-09-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2019-12-05

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 .

Conditions

Abortion in First Trimester

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

progesterone suppositories vaginal group

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

Group Type: ACTIVE_COMPARATOR

Progesterone Suppositories Vaginal

Intervention Type: DRUG

progesterone vaginal suppository

doppler ultrasound

Intervention Type: DEVICE

pulsed doppler ultrasound

Dydrogesterone oral tablets group

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

Group Type: EXPERIMENTAL

Dydrogesterone Oral Tablet

Intervention Type: DRUG

oral progesterone drug

doppler ultrasound

Intervention Type: DEVICE

pulsed doppler ultrasound

Interventions

Progesterone Suppositories Vaginal

progesterone vaginal suppository

Intervention Type: DRUG

Dydrogesterone Oral Tablet

oral progesterone drug

Intervention Type: DRUG

doppler ultrasound

pulsed doppler ultrasound

Intervention Type: DEVICE

Other Intervention Names

Prontogest; Duphaston; Gomez et al

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

GKElsherief

prinicipal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gehad Elsherief

Asyut, , Egypt

Countries

Egypt

Central Contacts

Ahmed Ibrahim

Role: CONTACT

ahmedibrahimhas@yahoo.com

01000024321

Hesham Abu taleb

Role: CONTACT

Hishamaboutaleb1@yahoo.com

01003332139

Facility Contacts

gehad elsherief

Role: primary

References

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. doi: 10.1093/humupd/8.4.333.

Reference Type: BACKGROUND

PMID: 12206468 (View on PubMed)

Sotiriadis A, Papatheodorou S, Makrydimas G. Threatened miscarriage: evaluation and management. BMJ. 2004 Jul 17;329(7458):152-5. doi: 10.1136/bmj.329.7458.152. No abstract available.

Reference Type: BACKGROUND

PMID: 15258071 (View on PubMed)

Other Identifiers

gehad elsherief

Identifier Type: -

Identifier Source: org_study_id