Metformin in obese non-diabetic pregnant women (MOP Trial).

Does metformin improve pregnancy outcomes [ incidence of LGA (=90% birth weight centile) babies onset of maternal Gestational Diabetes, hypertension, PET, shoulder dystocia, admission to SCBU) in obese non-diabetic women? - Metformin in Obese Non-Diabetic Pregnant Women (MOP Trial)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-005892-83-GB

Enrollment

400

Registered

2009-04-28

Start date

2009-01-14

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity in pregnancy. Obesity in pregnancy has been identified by Confidential Enquiry into Maternal And Child Health (CEMACH) (2008-2011) as a major health risk to mother and baby.

Interventions

Trade Name: Metformin 500mg Product Name: Metformin Pharmaceutical Form: Tablet INN or Proposed INN: Metformin CAS Number: N/A

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Obese pregnant women with bmi >35 2. Informed written consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Gestational diabetes at booking, Type I and Type II diabetes. 2. Presence of contra indications to metformin (renal, liver and heart failure). 3. Moving out of study area for pregnancy management. 4. Participants who suffer with hyperemesis. 5. Participants who are 18 years and below. 6. Participants with high alcohol intake.

Design outcomes

Primary

Measure	Time frame
Main Objective: There is substantial evidence that obesity in pregnancy contributes to increased morbidity and mortality for both mother and baby. The purpose of the study is whether management of obese non-diabetic pregnant women with standarised lifestyle intervention (diet and physical activity) and metformin will lead to improve maternal and peri-natal outcomes compared to lifestyle intervention alone. We aim to compare peri-natal outcomes in women randomised to the two home glucose monitoring protocols: Group 1 - Standardised lifestyle intervention and placebo. Group 2 - Standardised lifestyle intervnetion and metformin. ;Secondary Objective: Satisfaction with maternity care will be measured using the national survey for women's experience and maternity care questionnaires.; Primary end point(s): Primary Outcome: Birth weight centile (z-score). ;Timepoint(s) of evaluation of this end point: On the birth of the baby.	—

Measure

Time frame

Main Objective: There is substantial evidence that obesity in pregnancy contributes to increased morbidity and mortality for both mother and baby. The purpose of the study is whether management of obese non-diabetic pregnant women with standarised lifestyle intervention (diet and physical activity) and metformin will lead to improve maternal and peri-natal outcomes compared to lifestyle intervention alone. We aim to compare peri-natal outcomes in women randomised to the two home glucose monitoring protocols: Group 1 - Standardised lifestyle intervention and placebo. Group 2 - Standardised lifestyle intervnetion and metformin. ;Secondary Objective: Satisfaction with maternity care will be measured using the national survey for women's experience and maternity care questionnaires.; Primary end point(s): Primary Outcome: Birth weight centile (z-score). ;Timepoint(s) of evaluation of this end point: On the birth of the baby.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary Outcomes: Maternal: a) Maternal weight gain b) Maternal development of Gestational Diabetes c) Maternal development of hypertension/PET d) Caesarean section e) Postpartum haemorrhage f) Maternal Insulin Resistance and relation to Metformin efficacy g) Changes in circulating levels of cytokines including CRP, adiponectine, leptin and metabolic markers like uric acid and lipid profile h) FTO gene variant and its relation to baby outcome i) Changes in body composition as measured by Bioimpedence - comparison between the two groups Neonatal: a) Neonatal hypoglycemia b) Prematurity 0.6 e) Respiratory distress f) Macrosomia/large for gestational age birth weight =90% centile based on approriate growth standards g) Birth trauma - shoulder dystocia, brachial plexus injury or facture h) Apgar score <6 at 5 minutes i) Admission to level 2 or greater neonatal unit including lenght of stay j) Neonatal body composition including skin fold thickness. ;Timepoint(s) of evaluation of this end point: During pregnacy and after birth of baby.	—

Measure

Time frame

Secondary end point(s): Secondary Outcomes: Maternal: a) Maternal weight gain b) Maternal development of Gestational Diabetes c) Maternal development of hypertension/PET d) Caesarean section e) Postpartum haemorrhage f) Maternal Insulin Resistance and relation to Metformin efficacy g) Changes in circulating levels of cytokines including CRP, adiponectine, leptin and metabolic markers like uric acid and lipid profile h) FTO gene variant and its relation to baby outcome i) Changes in body composition as measured by Bioimpedence - comparison between the two groups Neonatal: a) Neonatal hypoglycemia b) Prematurity 0.6 e) Respiratory distress f) Macrosomia/large for gestational age birth weight =90% centile based on approriate growth standards g) Birth trauma - shoulder dystocia, brachial plexus injury or facture h) Apgar score <6 at 5 minutes i) Admission to level 2 or greater neonatal unit including lenght of stay j) Neonatal body composition including skin fold thickness. ;Timepoint(s) of evaluation of this end point: During pregnacy and after birth of baby.

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Countries

United Kingdom

Contacts

Public ContactJyoti Balani

Epsom and St Helier University Hospitals NHS Trust

jyoti.balani@esth.nhs.uk440208296 2140

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026