Status:
UNKNOWN
Progesterone to Prevent Preterm Delivery
Lead Sponsor:
The University of Hong Kong
Conditions:
Preterm Birth
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Preterm birth (PTB) is a major challenge to perinatal health. It is defined as delivery before 37 completed gestational weeks. It accounts for 75% of perinatal deaths and more than 50% of long-term ne...
Eligibility Criteria
Inclusion
- All women age ≥ 18 years old
- Confirmed intrauterine singleton pregnancy
- Gestational age less than 14 completed weeks as defined by pelvic ultrasound
Exclusion
- Silent miscarriage: mean gestational sac diameter ≥25 mm without fetal pole, or embryo with crown rump length ≥7 mm and no heartbeat, or no interval growth
- Suspected ectopic pregnancy
- Multiple pregnancy with silent miscarriage of one twin
- Heavy vaginal bleeding requiring surgical intervention
- Severe abdominal pain requiring surgical intervention
- Presence of fever
- History of adverse reaction to progesterone
- History of breast or genital tract malignancy
- History of suspected thromboembolic disease
- Congenital uterine anomaly
- Unwillingness or inability to comply with study procedures
- Known paternal or maternal abnormal karyotype
Key Trial Info
Start Date :
January 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2023
Estimated Enrollment :
1714 Patients enrolled
Trial Details
Trial ID
NCT03428685
Start Date
January 15 2019
End Date
January 1 2023
Last Update
April 10 2019
Active Locations (1)
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1
Department of Obstetrics and Gynaecology
Hong Kong, Hong Kong, China, 852