Progesterone in Expectantly Managed Early-onset Preeclampsia

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04077853

Enrollment

Registered

2019-09-04

Start date

2019-12-15

Completion date

2022-01-15

Last updated

2022-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preeclampsia

Brief summary

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

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

Interventions

DRUG17 Hydroxyprogesterone Capronate

Intramuscular injection 250 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

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.

Design outcomes

Primary

Measure	Time frame	Description
The mean difference between blood pressure measurements in both groups	one month	blood pressure measured by mercury sphygmomanometer

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026