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

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?

Research shows that 17-OHPC can improve conditions related to preeclampsia, such as reducing high blood pressure and inflammation in pregnant rats. It also helps manage certain inflammatory markers in women with early-onset preeclampsia.12345

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?

17 OHPC is unique because it not only helps reduce high blood pressure in pre-eclampsia but also improves blood flow and reduces inflammation by increasing nitric oxide levels. Unlike other treatments, it also balances immune cells, which may help improve pregnancy outcomes.123910

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

SS

Sheila S Belk

Principal Investigator

UMMC Pharmacology and Toxicology

BL

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

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

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

Treatment Details

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.
Participant Groups
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.

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

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

Trials
1
Recruited
60+

Findings from Research

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]
This study evaluated the pharmacokinetics of 17α-hydroxyprogesterone caproate (17-OHPC) in 61 pregnant women, showing that maternal body weight significantly affects the drug's clearance and distribution, which is crucial for optimizing treatment.
The findings indicate that 17-OHPC is absorbed and eliminated in a predictable manner during pregnancy, providing a foundational understanding for its use in preventing preterm birth.
Population pharmacokinetics of 17α-hydroxyprogesterone caproate in singleton gestation.Sharma, S., Caritis, S., Hankins, G., et al.[2021]
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]

References

17-hydroxyprogesterone caproate significantly improves clinical characteristics of preeclampsia in the reduced uterine perfusion pressure rat model. [2021]
Population pharmacokinetics of 17α-hydroxyprogesterone caproate in singleton gestation. [2021]
17-Hydroxyprogesterone caproate improves hypertension and renal endothelin-1 in response to sFlt-1 induced hypertension in pregnant rats. [2023]
Development and validation of a high-performance liquid chromatography-mass spectrometric assay for the determination of 17alpha-hydroxyprogesterone caproate (17-OHPC) in human plasma. [2019]
Effect of 17-Hydroxyprogesterone Caproate on Interleukin-6 and Tumor necrosis factor-alpha in expectantly managed early-onset preeclampsia. [2023]
In utero exposure to 17α-hydroxyprogesterone caproate and risk of cancer in offspring. [2023]
Development and usability of a new subcutaneous auto-injector device to administer hydroxyprogesterone caproate to reduce the risk of recurrent preterm birth. [2022]
Qualitative and quantitative measures of various compounded formulations of 17-alpha hydroxyprogesterone caproate. [2021]
Progesterone blunts vascular endothelial cell secretion of endothelin-1 in response to placental ischemia. [2021]
17-Hydroxyprogesterone caproate improves T cells and NK cells in response to placental ischemia; new mechanisms of action for an old drug. [2021]
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