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Progesterone in Expectantly Managed Early-onset Preeclampsia

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ClinicalTrials.gov Identifier: NCT04077853
Recruitment Status : Recruiting
First Posted : September 4, 2019
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Abbas, Assiut University

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

Condition or disease Intervention/treatment Phase
Preeclampsia Drug: 17 Hydroxyprogesterone Capronate Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of 17-Hydroxyprogesterone Caproate in Expectantly Managed Early-onset Preeclampsia: A Randomized Controlled Study
Actual Study Start Date : December 15, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : October 2021


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



Primary Outcome Measures :
  1. The mean difference between blood pressure measurements in both groups [ Time Frame: one month ]
    blood pressure measured by mercury sphygmomanometer



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04077853


Locations
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Egypt
Ahmed Abbas Recruiting
Assiut, Cairo, Egypt, 002
Contact: ahmed abbas, MD    00201003385183    bmr90@hotmail.com   
Contact: ahmed abbas         
Sponsors and Collaborators
Assiut University
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Responsible Party: Ahmed Mohamed Abbas, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT04077853    
Other Study ID Numbers: PPET
First Posted: September 4, 2019    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
17 alpha-Hydroxyprogesterone Caproate
11-hydroxyprogesterone
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Progestins
Hormones