Progesterone for Pre-eclampsia
(PROGRESS Trial)
Trial Summary
Do I need to stop my current medications for this trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What evidence supports the effectiveness of the drug 17-OHPC for treating preeclampsia?
Is 17α-hydroxyprogesterone caproate generally safe for humans?
17α-hydroxyprogesterone caproate (17-OHPC) has been used since the 1950s for various conditions, but there are ongoing concerns about its safety, especially regarding long-term effects on children exposed in the womb. Additionally, the method of administration can pose risks like contamination and needlestick injuries.12678
How does the drug 17 OHPC differ from other treatments for pre-eclampsia?
What is the purpose of this trial?
The purpose of this study is to learn if giving 17-hydroxyprogesterone caproate (17 OHPC) to mothers with preeclampsia diagnosed before 34 weeks gestation improves mother and baby outcomes.
Research Team
Sheila S Belk
Principal Investigator
UMMC Pharmacology and Toxicology
Babbette LaMarca, PhD
Principal Investigator
University of Missisippi Medical Center
Eligibility Criteria
This trial is for pregnant patients at UMMC with preterm preeclampsia between 23 and 34 weeks of gestation, who can consent to study procedures. It excludes those with conditions like PPROM after 34 weeks, low platelets, liver issues, severe fetal growth restriction, eclampsia, or any maternal/fetal condition requiring urgent delivery.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 17 OHPC, 250mg IM at admission and every 7 days thereafter until delivery
Monitoring
Blood samples collected at baseline, 24 hours after first dose, every 72 hours until delivery, and 24 hours after delivery
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- 17 OHPC
17 OHPC is already approved in United States, European Union for the following indications:
- Prevention of preterm birth in high-risk pregnant individuals
- Advanced adenocarcinoma of the uterine corpus (Stage III or IV)
- Management of amenorrhea (primary and secondary) and abnormal uterine bleeding due to hormonal imbalance
- Habitual and imminent abortion
- Infertility due to corpus luteum insufficiency
- Primary and secondary amenorrhea
Find a Clinic Near You
Who Is Running the Clinical Trial?
Babbette Lamarca
Lead Sponsor