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OpenTrials
Completed

NCT Number: NCT04077853

Progesterone in Expectantly Managed Early-onset Preeclampsia

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

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

17 Hydroxyprogesterone Capronate

Drug

Intramuscular injection 250 mg

Primary outcomes

  1. The mean difference between blood pressure measurements in both groups

    Time frame: one month

    blood pressure measured by mercury sphygmomanometer

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Sep 4, 2019
Registry last updated
May 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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