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

The OBGYN house and attending staff on duty caring for the patient will determine
appropriateness for study inclusion. 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. Once enrolled with
informed consent, the participant will receive 17 OHPC, 250mg IM to be given at admission and
every 7 days thereafter. Blood sampling of approximately 1-2 teaspoons each will be collected
at baseline immediately prior to administration of 17 OHPC, then 24 hours (+-2hrs). 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.

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;

- New onset renal dysfunction or increasing renal dysfunction (serum creatinine > 1.1
mg/dL;

- 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