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Tests treatment safety and results for Pregnancy
Official title Progesterone to Enhance the Efficacy and Success of Expectantly Managed Preterm Severe/Superimposed Preeclampsia
ClinicalTrials.gov ID: NCT02989025
What this study is testing
What is 17 OHPC?
17 OHPC is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for pregnancy.
Also referred to as Study Drug.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join if
- 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
You likely can't join if
- \>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...
- 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;
See the full eligibility 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
- \>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
The study team makes the final eligibility decision.
Where it's taking place
- Jackson, Mississippi, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jackson, Mississippi, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.