Progesterone in Expectantly Managed Early-onset Preeclampsia

Assiut University

Status and phase: Completed; Phase 4

Conditions: Preeclampsia

Treatments: Drug: 17 Hydroxyprogesterone Capronate

Study type: Interventional

Funder types: Other

Identifiers

NCT04077853

PPET

Details and patient eligibility

About

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

Full description

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

Enrollment: 80 patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

study group

Experimental group

Description:

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

Treatment:

Drug: 17 Hydroxyprogesterone Capronate

control group

No Intervention group

Description:

No intervention will be given apart from the usual conservative measures of early-onset PE