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Progestogen
Progesterone for Pre-eclampsia (PROGRESS Trial)
Phase 2
Recruiting
Led By Babbette LaMarca, PhD
Research Sponsored by Babbette Lamarca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline until delivery
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if 17 OHPC given to preeclamptic mothers before 34 weeks improves mother and baby outcomes.
Who is the study for?
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.
What is being tested?
The study investigates whether the hormone medication called 17-hydroxyprogesterone caproate (17 OHPC) can improve outcomes for mothers and babies when preeclampsia occurs before the baby is full-term.
What are the potential side effects?
While specific side effects are not listed here, hormones like 17 OHPC could potentially cause injection site reactions, mood changes, headaches or increase the risk of certain pregnancy complications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ delivery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~delivery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Improvement of maternal and perinatal outcomes
Other study objectives
Assessment of APGAR score
Assessment of Acute Kidney Injury
Assessment of Biomarkers
+11 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ExperimentalExperimental Treatment1 Intervention
To determine if the addition of 17 OHPC to the management of Severe PE diagnosed prior to 34 weeks gestation improves maternal and perinatal outcomes.
Group II: ControlActive Control1 Intervention
To determine how close the molecular markers are with 17 OHPC added to the management protocol.
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Who is running the clinical trial?
Babbette LamarcaLead Sponsor
Sheila S BelkStudy DirectorUMMC Pharmacology and Toxicology
Babbette LaMarca, PhDPrincipal InvestigatorUniversity of Missisippi Medical Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- The mother is experiencing serious health issues that require immediate delivery of the baby.Your water broke too early, but you're more than 34 weeks pregnant.You had a baby that passed away before birth.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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