Metformin in Obese Non-diabetic Pregnant Women (MOP)
![]() |
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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01273584 |
Recruitment Status :
Completed
First Posted : January 10, 2011
Last Update Posted : January 22, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Obesity is on the rise in all developed countries. Of particular concern is that more young people including children are being recognised as being overweight or obese. We know from a recent large national enquiry into all maternal and child deaths in the UK, known as CEMACH, that obesity is a major risk both for the mother and her child. When all deaths in women during pregnancy are analysed, obesity comes out as the most common risk factor. Babies of obese mothers are more than 3 times as likely to need admission to the Neonatal Intensive Care Unit.
Traditionally, obesity is treated by lifestyle measures encouraging healthy eating and increasing physical activity. Unfortunately these measures are often insufficient to produce significant improvements in weight. If obese women gain little or even no weight during pregnancy, the outcome of the pregnancy is known to be improved. This was shown in a very large study of more than 120, 000 obese women.
The drug metformin has been used for years in the treatment of diabetes and more recently for polycystic ovary syndrome (PCOS). Studies in pregnant PCOS women and women with diabetes in pregnancy have shown it to be safe and effective. Fortunately it is relatively cheap and taken as a tablet with meals.
Metformin has the great advantage of not causing weight gain and often leads to a small amount of weight loss. It works by improving the body's sensitivity to insulin which is important as resistance to insulin is common in obesity.
We have a lot of experience using metformin to treat women with diabetes in pregnancy where it is greatly beneficial. We now wish to examine its potential for obese women who do not have diabetes. We are hoping to show that it will benefit these women by causing less weight gain, less high blood pressure, and less diabetes. We anticipate babies will also have better birth weights, will be easier to deliver naturally, will not need to go to special care baby units and will be healthier.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pregnancy Complications Obesity | Drug: Metformin Drug: Placebo | Phase 2 Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 450 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Prevention |
Official Title: | Does Metformin Improve Pregnancy Outcomes (Incidence of LGA (≥90% Birth Weight Centile) Babies, Onset of Maternal GDM, Hypertension, PET, Macrosomia, Shoulder Dystocia, Admission to SCBU) in Obese Non-diabetic Women? |
Study Start Date : | October 2010 |
Actual Primary Completion Date : | July 2015 |
Actual Study Completion Date : | September 2015 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Metformin
Tablet Metformin 500 mg, starting dose of 1 tablet twice a day with meals, gradually titrated upwards by 1 tablet every week to a maximum dose of 2 tablets three times a day. Tablets started at recruitment and continued till the delivery of the baby |
Drug: Metformin
Maximum dosage 500 mg 2 tablets 3 times a day (with each meal) start with 1 tablet twice a day and gradually titrate upwards to maximum dose
Other Name: Glucophage |
Placebo Comparator: Placebo
Tablet Placebo 500 mg, starting dose of 1 tablet twice a day with meals, gradually titrated upwards by 1 tablet every week to a maximum dose of 2 tablets three times a day. Tablets started at recruitment and continued till the delivery of the baby |
Drug: Placebo
Placebo maximum dosage 2 tablets 3 times a day ( with meals) start with 1 tablet twice a day and gradually titrate upwards to maximum dose
Other Name: Dummy tablet |
- Birth Weight centile (z-score) [ Time Frame: At Birth ]
- Maternal Weight gain [ Time Frame: Weight at recruitment and at end of pregnancy ]
- Development of Gestational Diabetes [ Time Frame: 28 weeks of pregnancy ]A Glucose Tolerance Test would be conducted at 28 wks of pregnancy to diagonose diabetes
- Development of hypertension/Preeclampsia [ Time Frame: Throughout pregnancy ]Blood Pressure and urinary proteins would be monitored at each visit to diagonose hypertension/Preeclampsia
- Caesarian Section [ Time Frame: delivery ]
- Postpartum haemorrhage [ Time Frame: Delivery ]
- Neonatal Hypoglycemia [ Time Frame: within 2 hours after birth and immediate post birth ]
Blood glucose is checked within 2 hours after birth and before each feeding until consecutive glucose values of 2.6 mmol per liter (46.8 mg per deciliter) or greater were achieved.
Neonatal hypoglycemia was defined as 2 capillary plasma glucose levels< 2.6 mmol/l at least 30 minutes apart.
- Prematurity [ Time Frame: Delivery ]Born < 37 weeks gestation
- Hyperbilirubinemia [ Time Frame: at birth and after ]Hyperbilirubinemia requiring phototherapy
- Polycythaemia [ Time Frame: At birth ]Cord blood hematocrit > 0.6
- Respiratory Distress [ Time Frame: At birth and within 24 hours ]4 or more hours of respiratory suppory or oxygen with associated diagnosis
- Macrosomia/Large for Gestational Age [ Time Frame: At birth ]Birth weight>90th centile based on appropriate growth standards
- Birth Trauma [ Time Frame: At birth ]Shoulder dystocia, brachial plexus injury
- Apgar score <6 [ Time Frame: 5 minutes after birth ]
- Admission to level 2 or greater neonatal unit [ Time Frame: at birth and immediately after ]If yes, then length of stay
- Stillbirth/Intrauterine deaths [ Time Frame: Throughout pregnancy ]
- 2nd trimester miscarriages [ Time Frame: in 2nd trimester of pregnancy ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 19 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Obese pregnant women with BMI>35
- Informed written consent
Exclusion Criteria:
- Diabetes at booking
- Presence of contra-indication to metformin(renal, liver, heart failure)
- moving out of study area for pregnancy management
- Participants who suffer with hyperemesis
- Participants who are 18 years and below
- Participants with significantly raised creatinine
- Participants with high alcohol intake

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): NCT01273584
United Kingdom | |
Medway Hospital NHS Trust | |
Gillingham, Kent, United Kingdom, ME7 5NY | |
Epsom and St Helier University Hospitals NHS Trust | |
Carshalton, Surrey, United Kingdom, SM5 1AA | |
Kings College, London | |
London, United Kingdom, SE5 8RX |
Principal Investigator: | Mr Hassan Shehata, MD MRCOG | Epsom and St Helier University Hospitals NHS Trust | |
Study Director: | Dr Steve Hyer, MD, FRCP | Epsom and St Helier University Hospitals NHS Trust | |
Principal Investigator: | Prof Kypros Nicolaides, PhD, MRCOG | King's College London | |
Principal Investigator: | Dr Jyoti Balani, MD | Epsom and St Helier University Hospitals NHS Trust | |
Principal Investigator: | Dr Ranjit Akolekar | Medway Hospital NHS Trust |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Epsom and St Helier University Hospitals NHS Trust |
ClinicalTrials.gov Identifier: | NCT01273584 |
Other Study ID Numbers: |
WCH/2008/001 2008-005892-83 ( EudraCT Number ) |
First Posted: | January 10, 2011 Key Record Dates |
Last Update Posted: | January 22, 2016 |
Last Verified: | January 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Metformin, obese, pregnancy, gestational diabetes |
Pregnancy Complications Metformin Hypoglycemic Agents Physiological Effects of Drugs |