Progesterone to Enhance the Efficacy and Success of Expectantly Managed Preterm Severe/Superimpos… (NCT02989025) | Clinical Trial Compass
RecruitingPhase 2
Progesterone to Enhance the Efficacy and Success of Expectantly Managed Preterm Severe/Superimposed Preeclampsia
United States60 participantsStarted 2017-05-22
Plain-language summary
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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.