Progesterone and Doppler in Recurrent Abortion

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

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.

Study Overview

• Status: Unknown
• Conditions: Abortion in First Trimester
• Intervention / Treatment: Drug: Progesterone Suppositories Vaginal; Device: doppler ultrasound; Drug: Dydrogesterone Oral Tablet

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ahmed Ibrahim; Phone Number: 01000024321; Email: ahmedibrahimhas@yahoo.com
• Study Contact Backup: Name: Hesham Abu taleb; Phone Number: 01003332139; Email: Hishamaboutaleb1@yahoo.com

Study Locations

• Egypt
  • Assiut, Egypt
    • Gehad Elsherief
    • Contact: gehad elsherief

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: progesterone suppositories vaginal group; vaginal micronized progesterone suppositories (prontogest®) 400 mg, one vaginal suppository twice daily through 18 weeks of gestation.	Drug: Progesterone Suppositories Vaginal; progesterone vaginal suppository; Other Names: Prontogest; Device: doppler ultrasound; pulsed doppler ultrasound; Other Names: Gomez et al
Experimental: Dydrogesterone oral tablets group; 20 mg tablets (Duphaston ®), 2 tablets orally twice daily through 18 weeks of gestation.	Device: doppler ultrasound; pulsed doppler ultrasound; Other Names: Gomez et al; Drug: Dydrogesterone Oral Tablet; oral progesterone drug; Other Names: Duphaston

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of Live births after 28 weeks of gestation	Live births that survive and continue beyond 28 weeks of gestation	28 weeks gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients who Tolerable with the treatment	efficacy of treatment on patients	12 weeks

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2017
• Primary Completion (Anticipated): August 5, 2019
• Study Completion (Anticipated): December 5, 2019

Study Registration Dates

• First Submitted: June 5, 2017
• First Submitted That Met QC Criteria: August 29, 2017
• First Posted (Actual): August 30, 2017

Study Record Updates

• Last Update Posted (Actual): September 8, 2017
• Last Update Submitted That Met QC Criteria: September 6, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone; Dydrogesterone
• Other Study ID Numbers: gehad elsherief

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No