Trial · NCT02947503
Pregnancy Outcomes: Effects of Metformin Study (POEM Study)
NCT02947503, Phase 3, Recruiting, Bethesda Diabetes Research Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pregnancy Outcomes: Effects of Metformin Study (POEM Study). Trials, record NCT02947503. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02947503
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pregnancy Outcomes: Effects of Metformin Study (POEM Study)
- NCT number
- NCT02947503
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 500 participants, estimated
- Lead sponsor
- Bethesda Diabetes Research Center
- Conditions
- Gestational Diabetes, Insulin Resistance
- Interventions
- Metformin TEVA 850 mg
- First posted
- 2016-10-28
- Last updated
- 2022-02-10
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | GDM Outcome Score (GOS) in Phase A | 30 months | An aggregate score of eight clinically relevant endpoints, as previously defined: 1. pregnancy related hypertension, including (pre-) eclampsia, according validated guidelines, 2. large for gestational age baby (LGA) at delivery according validated guidelines, 3. premature delivery with a gestational age \< 37 weeks, 4. instrumental delivery, 5. caesarean delivery, 6. birth trauma, like fractures of clavicle and humerus, subdural / intracerebral haemorrhage, 7. neonatal hypoglycaemia, defined as blood glucose \< 2.6 mmol/l, 8. admission for neonatal intensive care. |
| Primary | T2D and obesity at the end of Phase B | 42 months | Incidence of maternal T2DM Weight (kg) and BMI (category) development mother Weight (kg) and BMI (percentile) development child |
| Primary | Development of T2D and obesity during Phase C | 282 months | Incidence of maternal T2DM Weight (kg) and BMI (category) development mother Weight (kg) and BMI (percentile) development child |
| Secondary | Secondary Outcome measures phase A mother | 30 months | Maternal outcome score (MOS) 1. Caesarean delivery (yes=1, no=0) 2. (Pre-)eclampsia, HELPP and PIH (if at least one is diagnosed=yes=1,no=0) 3. Maternal mortality (yes=1, no=0) 4. Postpartum haemorrhage (blood loss \> 1000 ml)(yes=1, no=0) 5. Thrombosis (yes=1, no=0) For each individual component applies: if occured=1 point. If not occured =0 points. A total score per individual will be calculated (0-5 for MOS). Each component on its own is also a secondary outcome measure. |
| Secondary | Secondary Outcome measures phase A child | 30 months | Neonatal outcome score (NOS)\*\* 1. IRDS requiring oxygen therapy (CPAP, optiflow, mechanical ventilation or surfactant) (yes=1, no=0) 2. Stillbirth or neonatal death (yes=1, no=0) 3. Preterm birth \<37 weeks (yes=1, no=0) 4. Shoulder dystocia (yes=1, no=0) 5. Instrumental delivery (yes=1, no=0) 6. Caesarean delivery (yes=1, no=0) 7. Neonatal hypoglycaemia \< 2.6 mml/l (yes=1, no=0) 8. Neonatal jaundice needing phototherapy (yes=1, no=0) 9. NICU admission (yes=1, no=0) 10. Apgar score \< 7 at 5 minutes (yes=1, no=0) 11. Congenital anomaly (to a list, if one anomaly = yes = 1, no=0) For each individual component applies: if occured=1. If not occured=0. A total score per individual will be calculated (0-11 for NOS). Each component on its own is also a secondary outcome measure. Apgar score as a variable (1-10) at 1, 5, 10 min Foetal weight at delivery in grams |
| Secondary | Secondary outcome measures phase B | 42 months | Hypertension development (yes/no) Thrombotic and CVD events (yes/no) Development of chronic disease (according to list - yes/no) Gonadal and gender development (to be determined: question(naires) + potentially additional measurements from research blood panel) Puberty and maturation (to be determined: question(naires) + potentially additional measurements from research blood panel) Educational and intellectual development (levels of education completed) Development of chronic disease (according to list - yes/no) |
| Secondary | Secondary outcome measures phase C | 282 months | Hypertension development (yes/no) Thrombotic and CVD events (yes/no) Development of chronic disease (according to list - yes/no) Gonadal and gender development (to be determined: question(naires) + potentially additional measurements from research blood panel) Puberty and maturation (to be determined: question(naires) + potentially additional measurements from research blood panel) Educational and intellectual development (levels of education completed) Development of chronic disease (according to list - yes/no) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35354633 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02947503
GET https://conductscience.org/api/trials/v1/NCT02947503/registered