metformin has been researched along with Birth Injuries in 2 studies
Metformin: A biguanide hypoglycemic agent used in the treatment of non-insulin-dependent diabetes mellitus not responding to dietary modification. Metformin improves glycemic control by improving insulin sensitivity and decreasing intestinal absorption of glucose. (From Martindale, The Extra Pharmacopoeia, 30th ed, p289)
metformin : A member of the class of guanidines that is biguanide the carrying two methyl substituents at position 1.
Birth Injuries: Mechanical or anoxic trauma incurred by the infant during labor or delivery.
| Excerpt | Relevance | Reference |
|---|---|---|
| "This is a randomized double-blind multi-center clinical trial of insulin plus metformin versus insulin plus placebo for the treatment of type 2 diabetes complicating pregnancy." | 5.27 | Rationale, design, and methods for the Medical Optimization and Management of Pregnancies with Overt Type 2 Diabetes (MOMPOD) study. ( Berry, DC; Boggess, K; de Los Angeles Abreu, M; Dorman, KF; Ivins, AR; Thomas, SD; Young, L, 2018) |
| "In a south Indian population with gestational diabetes, metformin was associated with better neonatal outcomes than glibenclamide." | 2.80 | Comparison of neonatal outcomes in women with gestational diabetes with moderate hyperglycaemia on metformin or glibenclamide--a randomised controlled trial. ( Abraham, A; Antonisamy, B; Beck, M; Benjamin, SJ; George, A; Jana, AK; Mathews, JE; Sam, D; Thomas, N, 2015) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 0 (0.00) | 29.6817 |
| 2010's | 2 (100.00) | 24.3611 |
| 2020's | 0 (0.00) | 2.80 |
| Authors | Studies |
|---|---|
| Berry, DC | 1 |
| Thomas, SD | 1 |
| Dorman, KF | 1 |
| Ivins, AR | 1 |
| de Los Angeles Abreu, M | 1 |
| Young, L | 1 |
| Boggess, K | 1 |
| George, A | 1 |
| Mathews, JE | 1 |
| Sam, D | 1 |
| Beck, M | 1 |
| Benjamin, SJ | 1 |
| Abraham, A | 1 |
| Antonisamy, B | 1 |
| Jana, AK | 1 |
| Thomas, N | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy[NCT02932475] | Phase 3 | 831 participants (Actual) | Interventional | 2017-05-25 | Terminated (stopped due to Recommendation by the DSMB that the study be stopped for futility) | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
Neonatal fat mass measured by skin-fold thickness (anthropometrics).The circumference of the upper limb is the circumference of the upper arm, and the circumference of the lower limb equals the mean of the circumferences measured at the midthigh and calf. The volume of the subcutaneous layer of fat covering each cylinder is estimated by multiplying the length times the circumference times the layer of fat estimated by the skinfold measures. The triceps skinfold measure is used as an estimate of the fat thickness of the limbs, and the subscapular skinfold measure approximates the fat thickness of the trunk. Total body fat is estimated by summing the volumes of fat covering each of the cylinders and multiplying by 0.9 (the density of fat). (NCT02932475)
Timeframe: Within 72 hrs of birth
| Intervention | kg (Mean) |
|---|---|
| Maternal Metformin | 0.46 |
| Maternal Placebo | 0.5 |
"Participants with one or more of the following:~capillary blood glucose level of < 30 mg/dL or capillary blood glucose requiring medical treatment, or~Birth trauma (umbilical cord artery pH < 7.0 or shoulder dystocia with brachial plexus injury), or~Hyperbilirubinemia requiring phototherapy, or~Deliver < 37 weeks' gestation, or~Miscarry, are stillborn, experience a neonatal demise, or~Large for gestational age infant (birth weight > 90th percentile for gestational age), or~Small for gestational age infant (birth weight < 10th percentile for gestational age) or low birth weight (< 2500 gm)" (NCT02932475)
Timeframe: An average of 48 hours for term infants and 30 days for preterm infants
| Intervention | Participants (Count of Participants) |
|---|---|
| Metformin | 269 |
| Placebo | 277 |
Adverse maternal outcomes. (NCT02932475)
Timeframe: An average of 48 hours following delivery
| Intervention | Participants (Count of Participants) | ||||
|---|---|---|---|---|---|
| Any adverse event leading to early study agent discontinuation | Any adverse event associated with maternal death | Any adverse event associated with fetal death | Any maternal serious adverse event | Any maternal non-serious adverse event | |
| Metformin | 13 | 2 | 10 | 113 | 149 |
| Placebo | 20 | 1 | 10 | 111 | 157 |
Adverse neonatal outcomes (NCT02932475)
Timeframe: up to 28 days of life
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Any neonatal serious adverse event | Any neonatal non-serious adverse event | |
| Maternal Metformin | 81 | 157 |
| Maternal Placebo | 105 | 162 |
"Secondary outcome of maternal side effects were defined as:~clinically relevant hypoglycemia defined as capillary blood glucose < 60 or < 80 with symptoms~GI side effects defined as nausea, vomiting, diarrhea" (NCT02932475)
Timeframe: Throughout study until delivery at 40 weeks gestation
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Clinically relevant hypoglycemia | Gastrointestinal side effects | |
| Metformin | 87 | 182 |
| Placebo | 85 | 171 |
2 trials available for metformin and Birth Injuries
| Article | Year |
|---|---|
Rationale, design, and methods for the Medical Optimization and Management of Pregnancies with Overt Type 2 Diabetes (MOMPOD) study.
Topics: Adolescent; Adult; Birth Injuries; Diabetes Mellitus, Type 2; Disease Management; Double-Blind Metho | 2018 |
Comparison of neonatal outcomes in women with gestational diabetes with moderate hyperglycaemia on metformin or glibenclamide--a randomised controlled trial.
Topics: Adult; Birth Injuries; Birth Weight; Diabetes, Gestational; Female; Fetal Macrosomia; Glyburide; Hum | 2015 |