RecruitingPhase 2NCT02989025

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


Sponsor

University of Mississippi Medical Center

Enrollment

60 participants

Start Date

May 22, 2017

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria2

  • 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 Criteria16

  • \>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

Interventions

DRUG17 OHPC

The study participant will be given 17 OHPC, 250mg IM at admission and every 7 days thereafter.


Locations(1)

Winfred L. Wiser Hospital

Jackson, Mississippi, United States

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NCT02989025


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