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Prevention of Pre-eclampsia Using Metformin: a Randomized Control Trial (PREMET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04855513
Recruitment Status : Not yet recruiting
First Posted : April 22, 2021
Last Update Posted : March 29, 2022
Sponsor:
Collaborator:
Sidra Medical and Research Center
Information provided by (Responsible Party):
Hamad Medical Corporation

Brief Summary:
This is an open label, randomized control trial (RCT) in which high risk for pre-eclampsia pregnant subjects will be randomly assigned to either an intervention group (metformin 1 gm twice daily plus aspirin 100 mg per day and standard of care) versus control group (aspirin 100 mg per day and standard of care) that will be administered between 11 to 13 weeks of gestation until delivery . Only women at high risk of pre-eclampsia as defined by the ACOG practice bulletin will be included (see inclusion criteria). Patient assignment will not be blinded as control group will not be given a placebo; the data will be analyzed on an intention to treat basis. Enrolled subjects will be followed throughout pregnancy and up to 30 days post-delivery (as per hospital practice).

Condition or disease Intervention/treatment Phase
Preeclampsia Preeclampsia Severe High Risk Pregnancy Eclampsia Drug: Metformin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 414 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized control trial into two groups using block randomization based on predefined criteria
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Pre-eclampsia Using Metformin: a Randomized Control Trial
Estimated Study Start Date : March 24, 2022
Estimated Primary Completion Date : April 24, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: standard care
The control group will receive standard care treatment including aspirin according to ACOG guidelines. The control group estimated number of enrollment is 207 patients.
Experimental: Metformin
The intervention group will be give metformin 500 mg orally three times daily in addition to standard of care. The estimated number to be enrolled are 207 patients.
Drug: Metformin
Metformin is a medication used for treatment of diabetes. In this study it will be used to explore is potential role in prevention of preeclampsia. The drug will start before 12 week of pregnancy and continue till delivery
Other Name: Glucophage




Primary Outcome Measures :
  1. Incidence of PET [ Time Frame: Through study completion period (3 years) ]
    To compare the incidence of PET between the metformin group (intervention group) versus control group

  2. Evaluating PIGF/sFlt-1 as a prognostic marker in PET in Qatar [ Time Frame: Through study completion period (3 years) ]
    Comparing PIGF/sFlt-1 ratio in both groups before and after developing PET


Secondary Outcome Measures :
  1. PIGF/sFlt-1 as a prognostic marker in PET patients [ Time Frame: Through study completion period (3 years) ]
    Comparing PIGF/sFlt-1 ratio in PET patients who received metformin versus PET patient in the standard care group

  2. Maternal outcomes [ Time Frame: Through study completion period (3 years) ]
    Comparing gestational age at PET onset, gestation age at delivery and PET severity between study groups



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Because the study will be on pregnant women
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed pregnancy
  • Gestational age < 12+0 weeks
  • Live fetus at time of booking ultrasound scan (between 11+0 and 13+6 weeks of gestation)
  • To be considered as high risk of preeclampsia

Exclusion Criteria:

  • Age under 18 years
  • Hyperemesis gravidarum
  • Unable to sign the consent form
  • Type 1 or 2 diabetes mellitus
  • Early gestational diabetes
  • Auto-immune disease
  • Fetal abnormality identified at time of scanning (between 11+0 and 13+6 weeks of gestation)
  • Bleeding disorder
  • Peptic ulcer
  • Hypersensitivity to aspirin or metformin
  • Long use of NSAIDS before initiation of intervention
  • Contraindication to metformin or aspirin and participation in another concurrent trial.

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): NCT04855513


Contacts
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Contact: Jyothi Lakshmi, MSc +97431152937 jyothilakshmij84@gmail.com
Contact: Mariam Maducolil, MD MMaducolil@hamad.qa

Locations
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Qatar
Women Wellness and Research Center
Doha, Qatar, 3050
Contact: Jyothi Lakshmi, MSc    +97431152937    jyothilakshmij84@gmail.com   
Contact: Mariam Maducolil, MD    +97433938513    MMaducolil@hamad.qa   
Sponsors and Collaborators
Hamad Medical Corporation
Sidra Medical and Research Center
Investigators
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Principal Investigator: Mahmoud Mohamed, MSc Hamad Medical Corporation
Study Chair: Justin Konje, MD, PhD Hamad Medical Corporation
Study Director: Mohamed Bashir, MD Hamad Medical Corporation
Study Director: Damien Chausabel, PhD Sidra Medicine
Study Director: Bara Al Jarrah, BSE Hamad Medical Corporation
  Study Documents (Full-Text)

Documents provided by Hamad Medical Corporation:
Study Protocol and Informed Consent Form  [PDF] September 7, 2020
Statistical Analysis Plan  [PDF] September 7, 2020

Additional Information:
Publications:

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Responsible Party: Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT04855513    
Other Study ID Numbers: IRGC-04-JI-17-164
First Posted: April 22, 2021    Key Record Dates
Last Update Posted: March 29, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Hamad Medical Corporation:
Metformin
Additional relevant MeSH terms:
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Pre-Eclampsia
Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs