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

NCT04855513 | Unknown DMC

• 1 other identifier: IRGC-04-JI-17-164
• Study Type: interventional
• Target: 414
• Locations: 1 country
• Sites: 1

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).

Conditions

Preeclampsia; Preeclampsia Severe; High Risk Pregnancy; Eclampsia

Keywords

Metformin

Outcome Measures

Primary Outcomes (2)

• Incidence of PET

  To compare the incidence of PET between the metformin group (intervention group) versus control group

  Through study completion period (3 years)

• Evaluating PIGF/sFlt-1 as a prognostic marker in PET in Qatar

  Comparing PIGF/sFlt-1 ratio in both groups before and after developing PET

  Through study completion period (3 years)

Secondary Outcomes (2)

• PIGF/sFlt-1 as a prognostic marker in PET patients

  Through study completion period (3 years)

• Maternal outcomes

  Through study completion period (3 years)

Study Arms (2)

standard care

NO INTERVENTION

The control group will receive standard care treatment including aspirin according to ACOG guidelines. The control group estimated number of enrollment is 207 patients.

Metformin

EXPERIMENTAL

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

Interventions

Metformin DRUG

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

Also known as: Glucophage

Metformin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Because the study will be on pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamad Medical Corporation: lead
• Sidra Medicine: collaborator

Study Sites (1)

Women Wellness and Research Center

Doha, 3050, Qatar

Location

Related Publications (63)

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Related Links

• Maternal, Newborn and Infant Clinical Outcome Review Programme

MeSH Terms

Conditions

Pre-Eclampsia; Eclampsia

Interventions

Metformin

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Mahmoud Mohamed, MSc

  Hamad Medical Corporation

  PRINCIPAL INVESTIGATOR

• Justin Konje, MD, PhD

  Hamad Medical Corporation

  STUDY CHAIR

• Mohamed Bashir, MD

  Hamad Medical Corporation

  STUDY DIRECTOR

• Damien Chausabel, PhD

  Sidra Medicine

  STUDY DIRECTOR

• Bara Al Jarrah, BSE

  Hamad Medical Corporation

  STUDY DIRECTOR

Central Study Contacts

Jyothi Lakshmi, MSc

CONTACT

+97431152937; jyothilakshmij84@gmail.com

Mariam Maducolil, MD

CONTACT

MMaducolil@hamad.qa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A randomized control trial into two groups using block randomization based on predefined criteria

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 22, 2021
• Study Start: March 24, 2022
• Primary Completion: April 24, 2023
• Study Completion: December 30, 2023
• Last Updated: March 29, 2022

Record last verified: 2022-03

Locations

QA (1)