Progesterone in Expectantly Managed Early-onset Preeclampsia

Study Overview
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Brief Summary
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Preeclampsia is a disorder of widespread vascular endothelial malfunction and vasospasm that occurs after 20 weeks' gestation and can present as late as 4-6 weeks postpartum

Detailed Description
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Currently there is no effective treatment for early-onset preeclampsia except for early delivery of the fetus along with the placenta. Progesterone supplementation in the form of 17-alpha-hydroxyprogesterone caproate (17-OHPC) is currently used obstetrically to prevent recurrent preterm birth in patients with pregnancies not complicated by preeclampsia. Previous studies reported that patients with severe PE had significantly lower serum progesterone concentrations than gestational age- and race-matched non-preeclamptics. Moreover, supplementation of placental ischemic rats with 17-OHPC decreased blood pressure, inflammatory cytokines, and ET-1 within 24 hours of treatment

Official Title
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Efficacy of 17-Hydroxyprogesterone Caproate in Expectantly Managed Early-onset Preeclampsia: A Randomized Controlled Study

Conditions
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Preeclampsia

Intervention / Treatment
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* Drug: 17 Hydroxyprogesterone Capronate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age between 20+0 and 33+6 weeks. Singleton pregnancy. Willing to participate in the study and sign the informed consent. Exclusion Criteria: Maternal compromise requiring emergent delivery (ongoing placental abruption, DIC, pulmonary edema). Fetal compromise requiring emergent delivery (fetal bradycardia, recurrent late fetal heart rate decelerations). 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; Eclampsia; Nonreassuring fetal status during daily testing (biophysical profile <4/10 and/or recurrent variable or late decelerations); Intrauterine fetal death. Patient is unable or unwilling to give consent. Patients currently using progesterone for other indications.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>women will be given 17-OHPC 250 mg intra-muscular at admission and every 7 days thereafter in addition to other conservative measures of early-onset PE | Drug: 17 Hydroxyprogesterone Capronate<br>* Intramuscular injection 250 mg<br>|
| No Intervention: control group<br>No intervention will be given apart from the usual conservative measures of early-onset PE | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean difference between blood pressure measurements in both groups | blood pressure measured by mercury sphygmomanometer | one month |