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Metformin and Esomeprazole For Preterm Pre-eclampsia

Primary Purpose

Preeclampsia Severe, Preeclampsia Second Trimester, Preterm Birth Complication

Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Esomeprazole 20mg
Sponsored by
Christiana Care Health Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preeclampsia Severe

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Individuals presenting with pre-eclampsia between 24+0 and 31+6 weeks of gestation, with a single viable fetus and no major anomalies

  • Women 18 years or older
  • Women diagnosed with preeclampsia
  • Women with pre-eclampsia superimposed on chronic hypertension
  • Candidates for expectant management and had no clinical indication for immediate delivery

Exclusion Criteria:

  • Delivery within 48hr is highly likely
  • Maternal or fetal compromise that necessitated immediate delivery
  • Diabetes or gestational diabetes currently on metformin therapy
  • Contraindications to metformin, esomeprazole
  • Baseline creatinine >124 μmol/L
  • Hypersensitivity to metformin or esomeprazole
  • Metabolic acidosis
  • Use of drugs that might interact with metformin (glyburide, furosemide, or cationic drugs) Multiple gestations

Sites / Locations

  • Christiana Care Health Systems

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

combination metformin and esomeprazole

expectant management

Arm Description

Combination 2 g of oral extended release metformin, in divided doses and Esomeprazole 20mg daily until delivery.

Outcomes

Primary Outcome Measures

mean plasma difference in sFlt-1 from randomization to day 7

Secondary Outcome Measures

Mean plasma difference in vascular endothelial growth factor (VEGF)
Mean plasma difference in placental growth factor (PlGF) levels
Mean plasma difference in soluble endoglin (sEng)
Maternal death
Mean highest blood pressure during expectant management mmHg
Number of anti-hypertensive medications at delivery
Fetal growth restriction defined as a sonographic estimated fetal weight (EFW) or abdominal circumference (AC) below the 10th percentile for gestational age using Hadlock cutoffs
Gestational age at delivery
Neonatal intensive care unit (nicu) admission

Full Information

First Posted
January 31, 2022
Last Updated
February 9, 2023
Sponsor
Christiana Care Health Services
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1. Study Identification

Unique Protocol Identification Number
NCT05232994
Brief Title
Metformin and Esomeprazole For Preterm Pre-eclampsia
Official Title
Use of Combination Metformin and Esomeprazole in Preterm Pre- Eclampsia: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Christiana Care Health Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A recent randomized controlled trial by Cluver et al included 180 women with preterm pre-eclampsia between 26+0 to 31+6 weeks' gestation undergoing expectant management: 90 were randomised to extended release metformin and 90 to placebo. Investigators found that extended release metformin (3g daily) can prolong gestation in women with preterm pre-eclampsia. Combination metformin and esomeprazole has shown promise in the treatment of preeclampsia as both agents reduce placental and endothelial secretion of soluble fms-like tyrosine kinase 1 (sFlt-1) and soluble endoglin, and reduce endothelial dysfunction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia Severe, Preeclampsia Second Trimester, Preterm Birth Complication

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
combination metformin and esomeprazole
Arm Type
Experimental
Arm Description
Combination 2 g of oral extended release metformin, in divided doses and Esomeprazole 20mg daily until delivery.
Arm Title
expectant management
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Esomeprazole 20mg
Other Intervention Name(s)
Metformin
Intervention Description
Combination 2 g of oral extended release metformin, Esomeprazole 20mg daily until delivery.
Primary Outcome Measure Information:
Title
mean plasma difference in sFlt-1 from randomization to day 7
Time Frame
from randomization to day 7
Secondary Outcome Measure Information:
Title
Mean plasma difference in vascular endothelial growth factor (VEGF)
Time Frame
from randomization to day 7
Title
Mean plasma difference in placental growth factor (PlGF) levels
Time Frame
from randomization to day 7
Title
Mean plasma difference in soluble endoglin (sEng)
Time Frame
from randomization to day 7
Title
Maternal death
Time Frame
At time of delivery
Title
Mean highest blood pressure during expectant management mmHg
Time Frame
At time of delivery
Title
Number of anti-hypertensive medications at delivery
Time Frame
at time of delivery
Title
Fetal growth restriction defined as a sonographic estimated fetal weight (EFW) or abdominal circumference (AC) below the 10th percentile for gestational age using Hadlock cutoffs
Time Frame
at time of delivery
Title
Gestational age at delivery
Time Frame
at time of delivery
Title
Neonatal intensive care unit (nicu) admission
Time Frame
at time of delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals presenting with pre-eclampsia between 24+0 and 31+6 weeks of gestation, with a single viable fetus and no major anomalies Women 18 years or older Women diagnosed with preeclampsia Women with pre-eclampsia superimposed on chronic hypertension Candidates for expectant management and had no clinical indication for immediate delivery Exclusion Criteria: Delivery within 48hr is highly likely Maternal or fetal compromise that necessitated immediate delivery Diabetes or gestational diabetes currently on metformin therapy Contraindications to metformin, esomeprazole Baseline creatinine >124 μmol/L Hypersensitivity to metformin or esomeprazole Metabolic acidosis Use of drugs that might interact with metformin (glyburide, furosemide, or cationic drugs) Multiple gestations
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marwan Ma'ayeh, MD
Phone
302-319-5680
Email
maayehmarwan@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kendall M Bielak, MD
Phone
302-320-4414
Email
kendall.bielak@christianaacare.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Hoffman, MD, MPH
Organizational Affiliation
ChristianaCare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christiana Care Health Systems
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marwan Ma'ayeh, MD
Phone
302-320-5680
Email
maayehmarwan@gmail.com
First Name & Middle Initial & Last Name & Degree
Matthew Hoffman, MD, MPH

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
Data are available for 5 years at a third party website

Learn more about this trial

Metformin and Esomeprazole For Preterm Pre-eclampsia

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