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

Launched by UNIVERSITY OF MISSISSIPPI MEDICAL CENTER · Dec 9, 2016

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called 17-hydroxyprogesterone caproate (17 OHPC) can help improve outcomes for mothers and babies when preeclampsia is diagnosed before 34 weeks of pregnancy. Preeclampsia is a condition that can cause high blood pressure and other health issues during pregnancy. The researchers want to see if this treatment can make a positive difference for mothers and their babies who are being monitored instead of receiving immediate delivery.

To participate in this study, women need to be between 23 and 34 weeks pregnant and diagnosed with preeclampsia. They must also be able to understand the study and agree to participate. If a woman has certain serious health concerns, such as severe high blood pressure that doesn’t improve with medication or signs that the baby is not doing well, she won’t be able to join the trial. Participants will receive the medication and be closely monitored, and the study is currently looking for volunteers. This research could potentially lead to better management of preeclampsia and improve health outcomes for both mothers and their babies.

Gender

FEMALE

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