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

  • End date
    Jan 31, 2024
  • participants needed
  • sponsor
    Babbette Lamarca
Updated on 21 March 2022
Accepts healthy volunteers


The purpose of this study is to learn if giving 17-hydroxyporgesterone caproate (17 OHPC) to mothers with preeclampsia diagnosed before 34 weeks gestation improves mother and baby outcomes.


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.

Condition Pregnancy
Treatment 17 OHPC
Clinical Study IdentifierNCT02989025
SponsorBabbette Lamarca
Last Modified on21 March 2022


Yes No Not Sure

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
Pulmonary edema
Abruption placentae
Nonreassuring fetal status during daily testing (biophysical profile <4/10 and/or recurrent variable or late decelerations)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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