Progesterone in Expectantly Managed Early-onset Preeclampsia

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

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

Study Overview

• Status: Completed
• Conditions: Preeclampsia
• Intervention / Treatment: Drug: 17 Hydroxyprogesterone Capronate

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

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Assiut, Cairo, Egypt, 002
      • Ahmed Abbas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study group; 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; Intramuscular injection 250 mg
No Intervention: control group; No intervention will be given apart from the usual conservative measures of early-onset PE

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2019
• Primary Completion (Actual): October 30, 2021
• Study Completion (Actual): January 15, 2022

Study Registration Dates

• First Submitted: September 1, 2019
• First Submitted That Met QC Criteria: September 1, 2019
• First Posted (Actual): September 4, 2019

Study Record Updates

• Last Update Posted (Actual): May 9, 2022
• Last Update Submitted That Met QC Criteria: May 6, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Estrogen Antagonists; Progestins; 17 alpha-Hydroxyprogesterone Caproate; 11-hydroxyprogesterone
• Other Study ID Numbers: PPET

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No