Back to resultsProgesterone in Expectantly Managed Early-onset Preeclampsia
Primary Purpose
Preeclampsia
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
17 Hydroxyprogesterone Capronate
Sponsored by
About this trial
This is an interventional treatment trial for Preeclampsia
Eligibility 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.
Sites / Locations
- Ahmed Abbas
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
study group
control group
Arm Description
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
No intervention will be given apart from the usual conservative measures of early-onset PE
Outcomes
Primary Outcome Measures
The mean difference between blood pressure measurements in both groups
blood pressure measured by mercury sphygmomanometer
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04077853
Brief Title
Progesterone in Expectantly Managed Early-onset Preeclampsia
Official Title
Efficacy of 17-Hydroxyprogesterone Caproate in Expectantly Managed Early-onset Preeclampsia: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 15, 2019 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
January 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
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
Arm Title
control group
Arm Type
No Intervention
Arm Description
No intervention will be given apart from the usual conservative measures of early-onset PE
Intervention Type
Drug
Intervention Name(s)
17 Hydroxyprogesterone Capronate
Intervention Description
Intramuscular injection 250 mg
Primary Outcome Measure Information:
Title
The mean difference between blood pressure measurements in both groups
Description
blood pressure measured by mercury sphygmomanometer
Time Frame
one month
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Ahmed Abbas
City
Assiut
State/Province
Cairo
ZIP/Postal Code
002
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Progesterone in Expectantly Managed Early-onset Preeclampsia
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