60 Participants Needed

Progesterone for Pre-eclampsia

(PROGRESS Trial)

BL
LM
Overseen ByLorena M Amaral, Ph.D.
Age: 18 - 65
Sex: Female
Trial Phase: Phase 2
Sponsor: Babbette Lamarca
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if 17-hydroxyprogesterone caproate (17 OHPC), a form of progesterone, can improve outcomes for mothers and babies when the mother has preeclampsia, a pregnancy complication causing high blood pressure, diagnosed before 34 weeks. Participants will either receive 17 OHPC or join a control group with no added treatment. The trial seeks pregnant individuals between 23 and 34 weeks with preeclampsia who can understand the study and provide consent. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

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.

Is there any evidence suggesting that 17 OHPC is likely to be safe for humans?

Research has shown that 17-hydroxyprogesterone caproate (17 OHPC) is usually well-tolerated. A safety review found its safety comparable to a placebo, indicating it is generally safe to use. However, some studies noted a slight increase in certain pregnancy-related issues compared to control groups.

This treatment has been studied in various contexts, and despite some concerns, it maintains a good overall safety record. For those considering participation in a trial with 17 OHPC, these findings suggest it is generally safe but not without some risks.12345

Why do researchers think this study treatment might be promising for pre-eclampsia?

Most treatments for pre-eclampsia focus on managing symptoms and delaying delivery, often using medications like antihypertensives to control blood pressure. But 17 OHPC, a form of progesterone, offers a different approach by potentially improving both maternal and perinatal outcomes. Researchers are excited about 17 OHPC because it targets hormonal pathways that could stabilize and improve conditions for both the mother and baby, unlike traditional options that primarily address symptoms. This novel mechanism may provide a more comprehensive management strategy for severe pre-eclampsia diagnosed before 34 weeks of gestation.

What evidence suggests that 17 OHPC might be an effective treatment for pre-eclampsia?

Research has shown that 17-hydroxyprogesterone caproate (17 OHPC) might help with preeclampsia, a condition in pregnant women that leads to high blood pressure and can harm organs. Animal studies, such as those conducted on rats, have found that 17 OHPC can reduce high blood pressure, a major issue in preeclampsia. These studies also suggest that 17 OHPC may improve health outcomes for both the mother and baby. In this trial, participants in the experimental arm will receive 17 OHPC to determine if it improves maternal and perinatal outcomes in cases of severe preeclampsia diagnosed before 34 weeks gestation. While these results are encouraging, studies in humans are needed to confirm its effectiveness in pregnant women.16789

Who Is on the Research Team?

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Sheila S Belk

Principal Investigator

UMMC Pharmacology and Toxicology

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Babbette LaMarca, PhD

Principal Investigator

University of Missisippi Medical Center

Are You a Good Fit for This Trial?

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

UMMC antepartum patients with preterm PE between 23 0/7ths and 34 0/7ths weeks gestation when initially evaluated
Willing and able to understand study procedures and to provide informed consent

Exclusion Criteria

Gestational age >33 weeks or <23 weeks
Fetal compromise requiring emergent delivery (fetal bradycardia, recurrent late fetal heart rate decelerations, minimal to absent fetal heart rate variability)
Eclampsia
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Treatment

Participants receive 17 OHPC, 250mg IM at admission and every 7 days thereafter until delivery

Until delivery
Weekly visits for 17 OHPC administration

Monitoring

Blood samples collected at baseline, 24 hours after first dose, every 72 hours until delivery, and 24 hours after delivery

Until delivery
Multiple visits for blood sampling

Follow-up

Participants are monitored for safety and effectiveness after treatment

Until discharge
In-hospital monitoring until discharge

What Are the Treatments Tested in This Trial?

Interventions

  • 17 OHPC
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: ExperimentalExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention

17 OHPC is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Makena for:
🇪🇺
Approved in European Union as Proluton for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Babbette Lamarca

Lead Sponsor

Trials
1
Recruited
60+

University of Mississippi Medical Center

Lead Sponsor

Trials
185
Recruited
200,000+

Published Research Related to This Trial

In a study involving pregnant rats, the administration of 17-hydroxyprogesterone caproate (17-OHPC) significantly reduced hypertension caused by elevated soluble fms-like tyrosine kinase-1 (sFlt-1), lowering mean arterial pressure from 115 mmHg to 102 mmHg.
17-OHPC also decreased elevated levels of preproendothelin-1 (PPET-1) mRNA in the kidneys, suggesting it may help mitigate some of the harmful effects of preeclampsia, although it did not affect pup or placental weights.
17-Hydroxyprogesterone caproate improves hypertension and renal endothelin-1 in response to sFlt-1 induced hypertension in pregnant rats.Amaral, LM., Cottrell, JN., Comley, KM., et al.[2023]
Women with preeclampsia (PE) have significantly lower levels of circulating progesterone compared to normal pregnant women, which is associated with increased levels of endothelin-1 (ET-1), a marker of endothelial dysfunction.
Treatment with 17-alpha-hydroxyprogesterone caproate (17-OHPC) in a rat model of preeclampsia significantly reduces hypertension and the elevated ET-1 levels, suggesting that progesterone may help mitigate the effects of placental ischemia and improve vascular function.
Progesterone blunts vascular endothelial cell secretion of endothelin-1 in response to placental ischemia.Kiprono, LV., Wallace, K., Moseley, J., et al.[2021]
In a study using a rat model of preeclampsia, 17-α-Hydroxyprogesterone caproate (17-OHPC) significantly reduced mean arterial pressure and inflammation, suggesting it may help manage preeclampsia symptoms.
17-OHPC improved nitric oxide levels and uterine artery resistance index, indicating its potential to enhance blood flow and reduce complications associated with preeclampsia during late gestation.
17-hydroxyprogesterone caproate significantly improves clinical characteristics of preeclampsia in the reduced uterine perfusion pressure rat model.Amaral, LM., Cornelius, DC., Harmon, A., et al.[2021]

Citations

17-Hydroxyprogesterone caproate improves hypertension ...This study was designed to test the hypothesis that 17-OHPC improves hypertension and ET-1 in response to elevated sFlt-1 in pregnant rats.
Study Details | NCT02989025 | Progesterone to Enhance ...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.
17-Hydroxyprogesterone caproate improves hypertension ...This study demonstrated that 17-OHPC improves hypertension in response to elevated sFlt-1 in pregnant rats. Furthermore, 17-OHPC improved renal cortex PPET-1 ...
17-HYDROXYPROGESTERONE CAPROATE ...17-HYDROXYPROGESTERONE CAPROATE SIGNIFICANTLY IMPROVES CLINICAL CHARACTERISTICS OF PREECLAMPSIA IN THE RUPP RAT MODEL. Lorena M Amaral. Lorena M Amaral. 1 ...
Continued Investigation Into 17-OHPCWe hypothesized that earlier administration of 17-OHPC on day 15 of gestation could improve pathophysiology of preeclampsia and fetal outcomes in response to ...
Safety review of hydroxyprogesterone caproate in women ...The integrated safety data demonstrates a favorable safety profile of 17P, which was comparable to placebo. References. ACOG. ACOG practice ...
The dosing regimen for 17-hydroxyprogesterone caproate ...Data from the Obstetrical-Fetal Pharmacology Research Centers study were used to determine the relationship between dose and safety outcomes.
17-α Hydroxyprogesterone Caproate Immunology, a ...17-α hydroxyprogesterone caproate (17-OHPC) could alter the immune response and inflammation, specifically affecting the risk of preterm labor and preeclampsia.
Makena (hydroxyprogesterone caproate) injection labelCertain pregnancy-related fetal and maternal complications or events were numerically increased in the Makena-treated subjects as compared to control subjects, ...
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