Progesterone in Expectantly Managed Early-onset Preeclampsia

NCT04077853 | Completed Phase 4

• 1 other identifier: PPET
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Preeclampsia

Outcome Measures

Primary Outcomes (1)

• The mean difference between blood pressure measurements in both groups

  blood pressure measured by mercury sphygmomanometer

  one month

Study Arms (2)

study group

EXPERIMENTAL

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

control group

NO INTERVENTION

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

Interventions

17 Hydroxyprogesterone Capronate DRUG

Intramuscular injection 250 mg

study group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Gestational age between 20+0 and 33+6 weeks.
• Singleton pregnancy.
• Willing to participate in the study and sign the informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Location

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

17 alpha-Hydroxyprogesterone Caproate

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

17-alpha-Hydroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Progesterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: September 1, 2019
• First Posted: September 4, 2019
• Study Start: December 15, 2019
• Primary Completion: October 30, 2021
• Study Completion: January 15, 2022
• Last Updated: May 9, 2022

Record last verified: 2022-05

Locations

EG (1)