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RecruitingPhase 2

Progesterone to Enhance the Efficacy and Success of Expectantly Managed Preterm Severe/Superimposed Preeclampsia

Progesterone to Enhance the Efficacy and Success of Expectantly Managed Preterm Severe/Superimposed Preeclampsia-The PROGRESS Pilot Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 45 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws, Ultrasound

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The treating physician will then immediately contact the MFM fellow on call and Research Division personnel to facilitate the initiation of study procedures, including the consent process and baseline blood tests."
  • "After the first 24 hours, blood samples will be collected every 72 hrs until delivery and again 24hrs (+- 2hrs) after delivery."
  • "Placentas will be collected at delivery and the investigators will also collect information of the mother and newborn while in the hospital and until discharge including de-identified routine ultrasound."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a drug called 17-hydroxyprogesterone caproate (17 OHPC) can improve health for mothers and babies. It is for pregnant patients with preeclampsia, a pregnancy condition involving high blood pressure, diagnosed before 34 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are a UMMC patient receiving care before birth, with preeclampsia at 23 to 34 weeks of pregnancy when first checked. The exclusion list gives a different upper limit: no more than 33 weeks.
  • You can understand the study steps and agree to take part.

Who can't join

  • You are more than 33 weeks or less than 23 weeks pregnant.
  • You need an emergency delivery because of serious problems, such as abnormal blood clotting. Fluid in the lungs or the placenta pulling away from the womb also rules you out.
  • Your baby needs an emergency delivery because of a slow heart rate, repeated heart rate drops, or too little change in heart rate.
  • Your water breaks early, before labor, after 34 weeks of pregnancy.
  • You have fewer than 100,000 platelets per microliter with signs of HELLP syndrome, a condition affecting blood and the liver. Platelets help blood clot. Liver enzyme levels that stay at least twice the normal upper limit also rule you out.
  • Your baby is much smaller than expected, there is very little fluid around the baby, or a blood-flow test shows blood moving backward in the cord artery.
  • You have repeated severe high blood pressure despite medicine, or eclampsia, which means seizures linked to preeclampsia.
  • Daily tests show signs your baby is not doing well, such as a well-being score below 4 out of 10 or repeated heart rate drops, or your baby has died in the womb.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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: * \>33 weeks gestational age or \<23 weeks gestation * Maternal compromise requiring emergent delivery (ongoing placental abruption, DIC, pulmonary edema). * Fetal compromise requiring emergent delivery (fetal bradycardia, recurrent late fetal heart rate decelerations, minimal to absent fetal heart rate variability). * Parameters according to current practice guidelines that exclude a patient from expectant management include the following: * Preterm premature rupture of membranes (PPROM) \> 34 weeks gestation; * Platelet count \< 100,000/microliter (thrombocytopenia) with evidence of HELLP syndrome; * Persistently abnormal hepatic enzyme concentrations (twice or more upper normal values); * Severe fetal growth restriction (ultrasound-estimated fetal weight less than fifth percentile); * Severe Oligohydramnios (AFI \< 5cm) * Reversal of end diastolic flow(REDF) in umbilical artery Doppler testing; * Recurrent (\> 2 readings \> 30 minutes apart) severe hypertension despite antihypertensive therapy; * Eclampsia; * Pulmonary edema; * Abruption placentae; * Nonreassuring fetal status during daily testing (biophysical profile \<4/10 and/or recurrent variable or late decelerations); * IUFD

Study sites (1)

MS