Pregnancy Outcomes: Effects of Metformin Study (POEM Study) (POEM)
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|ClinicalTrials.gov Identifier: NCT02947503|
Recruitment Status : Not yet recruiting
First Posted : October 28, 2016
Last Update Posted : November 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Gestational Diabetes Insulin Resistance||Drug: Metformin HCL 850 CF||Phase 3|
The POEM study was designed to investigate the effects of metformin on top of diet and lifestyle (with insulin rescue if needed) in GDM on eight clinically relevant pregnancy outcomes at delivery, summarized by means of an integrated, newly developed score, the GDM Outcome Score (GOS), and on other relevant outcomes on the longer term in mother and child. The investigators hypothesize that metformin given to women with GDM from the start of the diagnosis reduces risks resulting in relevant health benefits for mother and child during pregnancy, at delivery, and many years thereafter.
The POEM study is a randomized controlled intervention study, consisting of three phases:
- Phase A - from inclusion until two weeks after delivery; intervention study with and without exposure of metformin in mother and (unborn) child: two arms after randomization with 1:1 allocation to Diet + Lifestyle + Metformin (DLM) or Diet + Lifestyle (DL);
- Phase B - from two weeks until 1 year after delivery; intervention study with exposure of DLM vs DL in mother;
- Phase C - from 1 until 20 years after delivery; observational extension study of mother and child without study medication.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pregnancy Outcomes: Effects of Metformin Study (POEM Study), a Long Term Randomized Controlled Study in Gestational Diabetes|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||December 2040|
Active Comparator: Metformin on top of usual care
Metformin HCL 850 CF (1-3 times daily) added to usual care from start of the diagnosis GDM.
Usual care has been defined as intensive counselling for diet and lifestyle plus insulin therapy if needed.
Intervention: metformin HCF 850 CF (1-3 times daily) on top of usual care.
Drug: Metformin HCL 850 CF
At inclusion, patients (N=500) will be randomized 1:1 to metformin vs usual care (850 mg tablets, 3 times daily or, if tolerance is suboptimal, a lower maximally tolerated dose, 1-2 times daily), on top of diet and lifestyle, with an insulin rescue in both arms if needed.
Other Name: Metformin
No Intervention: Usual care
Usual care from start of the diagnosis GDM. Control group without metformin. Usual care has been defined as intensive counselling for diet and lifestyle plus insulin therapy if needed.
Intervention: usual care.
- GDM Outcome Score (GOS) in Phase A [ Time Frame: 30 months ]
An aggregate score of eight clinically relevant endpoints, as previously defined:
- pregnancy related hypertension, including (pre-) eclampsia, according validated guidelines,
- large for gestational age baby (LGA) at delivery according validated guidelines,
- premature delivery with a gestational age < 37 weeks,
- instrumental delivery,
- caesarean delivery,
- birth trauma, like fractures of clavicle and humerus, subdural / intracerebral haemorrhage,
- neonatal hypoglycaemia, defined as blood glucose < 2.6 mmol/l,
- admission for neonatal intensive care.
GOS will be assessed in each patient according protocol by the investigator, monitored in detail by an independent Clinical Trial Service, and verified by an independent committee.
- T2D and obesity at the end of Phase B [ Time Frame: 42 months ]Diagnosis of T2D and/or obesity at the end of Phase B
- Development of T2D and obesity during Phase C [ Time Frame: 282 months ]Development of T2D and/or obesity on the long term during Phase C - long term observational in mother and child
- Components of GOS in Phase A [ Time Frame: 30 months ]1. Maternal weight / weight gain, 2. change in body composition, 3. glycemic control, 4. proteinuria, 5. insulin treatment, 6. Maternal urinary tract infection , 7. Pre-eclampsia, / eclampsia / HELLP syndrome, 8 gestational hypertension 9. Maternal mortality, 10. Postpartum haemorrhage, 11 Thrombosis (in pregnancy and/or childbed).
- Components of GOS in Phase B [ Time Frame: 42 months ]1. Diabetes & prediabetes development; 2. Weight development 3. Hypertension development; 4. Thrombotic and CV incidents,
- Components of GOS in Phase C [ Time Frame: 282 months ]Development of any chronic disease
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02947503
|Contact: Adriaan Kooy, Drfirstname.lastname@example.org|
|Contact: Anita Faber, MScemail@example.com|
|Principal Investigator:||Adriaan Kooy, Dr.||BDRC|