A Randomized Placebo Controlled Trial of the Effectiveness of Metformin in Addition to Usual Care in the Reduction of Gestational Diabetes Mellitus Effects (EMERGE)

  • STATUS
    Recruiting
  • days left to enroll
    88
  • participants needed
    550
  • sponsor
    National University of Ireland, Galway, Ireland
Updated on 26 May 2022
diabetes
insulin
fasting
tolerance test
oral glucose tolerance test
hyperglycemia
metformin
glucose tolerance test
pregnancy tests

Summary

The overall objective of the EMERGE trial is to determine whether metformin + usual care, compared to placebo + usual care (introduced at the time of initial diagnosis of GDM), reduces a) the need for insulin use, or hyperglycemia (primary outcome measure); b) excessive maternal weight gain; c) maternal and neonatal morbidities and, d) cost of treatment for women with Gestational Diabetes Mellitus.

Details
Condition Gestational Diabetes
Treatment Placebo, Metformin Hydrochloride
Clinical Study IdentifierNCT02980276
SponsorNational University of Ireland, Galway, Ireland
Last Modified on26 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Willing and able to provide written informed consent
Participants aged 18-50
Pregnancy gestation up to 28 weeks (+ 6 days) confirmed by positive pregnancy test
Singleton pregnancy as determined by scan
Positive diagnosis of Gestational Diabetes Mellitus on a Oral Glucose Tolerance Test (OGTT) according to the International Association of the Diabetes and Pregnancy Study Groups (IADPSG) criteria if any one of the following are achieved: i) Fasting glucose >/= 5.1mmol/l and <7mmol/l, or ii) 1 hour post glucose load of >/=10mmol/l, or iii) 2 hour post glucose load of >/=8.5 mmol/l and <11.1mmo/l
Resident in the locality and intending to deliver within the trial site

Exclusion Criteria

Participants who have an established diagnosis of diabetes (Type 1, Type 2, Monogenic or secondary)
Participants with a fasting glucose > 7mmol/l or a 2h value > 11.1 mmol/l
Multiple pregnancies (twins, triplets etc.) as determined by scan
Known intolerance to metformin
Known contraindication to the use of metformin which include: i) renal insufficiency (defined as serum creatinine of greater than 130 µmol/L or creatinine clearance <60 ml/min), ii) moderate to severe liver dysfunction (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) greater than 3 times the upper limit of normal, iii) shock or sepsis, and iv) previous hypersensitivity to metformin
Major congenital malformations or an abnormally deemed unsuitable for metformin by the site PI or attending consultant
Known small for gestational age (Small for gestational age (SGA) refers to foetal growth less than the 10th percentile (RCOG, 2014), or if foetal growth is deemed unsatisfactory by the treating obstetrician)
Known gestational hypertension or pre-eclampsia or ruptured membranes
Participants who have a history of drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements
Participants with significant gastrointestinal problems such as severe vomiting, Crohn's disease or colitis which will inadvertently affect absorption of the study drug
Participants with congestive heart failure or history of congestive heart failure
Participants with serious mental illness which would affect adherence to study medication or compliance with study protocol in the opinion of the investigator
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
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