PEPPER-trial
Phase 1
- Conditions
- Placenta previa, preterm birthTherapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Registration Number
- CTIS2023-507763-18-01
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 142
Inclusion Criteria
Women pregnant of a singleton – without any other high-risk factor for preterm birth - diagnosed with a placenta previa diagnosed between 18- and 24 weeks of gestation.
Exclusion Criteria
1. Multiple pregnancy, 2. Major fetal congenital and/or chormosomal abnormalities, 3. Cervical cerclage or pessary in situ or planned to be placed, 4. Cervical dilation = 3cm, 5. Intra-uterine fetal death, 6. Women with an already existing indication for progesterone use per current guidelines, 7. (Suspected) placenta accreta spectrum disorder, 8. Contra-indication for progesterone use, 9. Inability to give informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method