PEPPER-trial
EU CTIS ID: 2023-507763-18-01
What this study is testing
1. To assess the effectiveness of progesterone - started between 18- and 24-weeks of gestation, compared to no treatment - in the prevention of preterm birth in women with a placenta previa. We will assess total preterm birth rates and rates subdivided in spontaneous and iatrogenic preterm birth at different gestational age cut-offs, duration of pregnancy, neonatal mortality and morbidity, and maternal side effects. 2. The primary outcome measure will be the relative risk of preterm birth before 37 weeks of gestation.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, in utero, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.