Gestational Diabetes
Conditions
Keywords
Gestational Diabetes, Diabetes, Pregnancy
Brief summary
The overall objective of the EMERGE trial is to determine whether metformin + usual care, compared to placebo + usual care (introduced at the time of initial diagnosis of GDM), reduces a) the need for insulin use, or hyperglycemia (primary outcome measure); b) excessive maternal weight gain; c) maternal and neonatal morbidities and, d) cost of treatment for women with Gestational Diabetes Mellitus.
Interventions
DRUGMetformin Hydrochloride
Women randomised to the metformin group will receive metformin 500mg once daily, with the dose titrated upwards every 2 days over 10 days increasing to a maximum of 2500mg Metformin daily (5 tablets) or maximum tolerated dose, in addition to usual care (exercise and MNT), and taken until delivery.
OTHERPlacebo
Women randomised to the placebo group will receive 1 placebo tablet once daily, with the dose titrated upwards every 2 days over 10 days increasing to a maximum of five placebo tablets daily, in addition to usual care (exercise and MNT), and taken until delivery.
Sponsors
Health Research Board, Ireland
HRB Clinical Research Facility Galway
University College Hospital Galway
Portiuncula University Hospital
University Hospital of Limerick
University Maternity Hospital Limerick
Clinical Research Support Unit, University of Limerick
National University of Ireland, Galway, Ireland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Willing and able to provide written informed consent 2. Participants aged 18-50 3. Pregnancy gestation up to 28 weeks (+ 6 days) confirmed by positive pregnancy test 4. Singleton pregnancy as determined by scan 5. Positive diagnosis of Gestational Diabetes Mellitus on a Oral Glucose Tolerance Test (OGTT) according to the International Association of the Diabetes and Pregnancy Study Groups (IADPSG) criteria if any one of the following are achieved: i) Fasting glucose \>/= 5.1mmol/l and \<7mmol/l, or ii) 1 hour post glucose load of \>/=10mmol/l, or iii) 2 hour post glucose load of \>/=8.5 mmol/l and \<11.1mmo/l 6. Resident in the locality and intending to deliver within the trial site
Exclusion criteria
1. Participants who have an established diagnosis of diabetes (Type 1, Type 2, Monogenic or secondary) 2. Participants with a fasting glucose \> 7mmol/l or a 2h value \> 11.1 mmol/l 3. Multiple pregnancies (twins, triplets etc.) as determined by scan 4. Known intolerance to metformin 5. Known contraindication to the use of metformin which include: i) renal insufficiency (defined as serum creatinine of greater than 130 µmol/L or creatinine clearance \<60 ml/min), ii) moderate to severe liver dysfunction (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) greater than 3 times the upper limit of normal, iii) shock or sepsis, and iv) previous hypersensitivity to metformin 6. Major congenital malformations or an abnormally deemed unsuitable for metformin by the site PI or attending consultant 7. Known small for gestational age (Small for gestational age (SGA) refers to foetal growth less than the 10th percentile (RCOG, 2014), or if foetal growth is deemed unsatisfactory by the treating obstetrician) 8. Known gestational hypertension or pre-eclampsia or ruptured membranes 9. Participants who have a history of drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements 10. Participants with significant gastrointestinal problems such as severe vomiting, Crohn's disease or colitis which will inadvertently affect absorption of the study drug 11. Participants with congestive heart failure or history of congestive heart failure 12. Participants with serious mental illness which would affect adherence to study medication or compliance with study protocol in the opinion of the investigator 13. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Composite Outcome | Enrolment through delivery, an average of 16 weeks. | The primary efficacy outcome was achieved if any participant experienced: * Insulin initiation * Fasting glucose value \>5.1 mmol/l at 32weeks or 38 weeks gestation. |
| Insulation of Insulin | Enrolment through delivery, an average of 16 weeks. | Initiation of insulin treatment at any time up to delivery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting Hyperglycemia | Measured at 32 and 38 weeks' gestation. | Number of women with fasting hyperglycemia at 32wks or at 38wks gestation. |
| Insulin Dose Required | Enrolment through delivery, an average of 16 weeks. | Insulin dose required in any participant requiring insulin. |
| Gestational Weight Gain | Enrolment through delivery, an average of 16 weeks. | Change in weight (kg) from randomization until last visit before delivery |
| Postpartum Impaired Fasting Glucose | 12 weeks post-partum | Impaired fasting glucose at 12 weeks postpartum |
| Postpartum Impaired Glucose Tolerance | 12 weeks postpartum | — |
| Postpartum Metabolic Syndrome | 12 weeks postpartum | — |
| Gestational Age at Delivery | At delivery, an average of 16 weeks after enrolment | — |
| Mode of Delivery - Cesarian Delivery | At delivery, an average of 16 weeks after enrolment | Delivered by Cesarian section. |
| Mode of Delivery - Emergency Cesarian Section | At delivery, an average of 16 weeks after randomization. | Among those having cesarian section, count of emergency procedures. |
| Mode of Delivery - Induced | At time of labor, an average of 16 weeks after enrolment. | Labor induced. |
| Maternal Morbidity - Pregnancy-induced Hypertension | From enrolment through 6 weeks postpartum, an average of 22 weeks. | — |
| Maternal Morbidity - Pre-eclampsia | Enrolment through 6 weeks postpartum, an average of 22 weeks. | Pre-eclampsia diagnosed during study participation |
| Maternal Morbidity - Antepartum Hemorrhage | From enrolment through delivery, an average of 16 weeks. | Any vaginal bleeding prior to delivery |
| Maternal Morbidity - Postpartum Hemorrhage | From delivery through 6 weeks postpartum. | — |
| Birthweight | At birth | — |
| Insulin Initiated | Enrolment through delivery, an average of 16 weeks. | Whether or not insulin was initiated at any time during the study. |
| Neonatal Height | At birth | Height in cm (crown-heel length) |
| Neonatal Abdominal Circumference | At birth | — |
| Neonatal Ponderal Index | At birth | Ponderal index is calculated as 100 x weight(grams)/(crown-heel length). |
| Birth Weight >4000g | At birth | — |
| Birth Weight >90th Percentile | At birth | — |
| Birth Weight <2500g | At birth | — |
| Birth Weight <10th Percentile | At birth | — |
| Neonatal Morbidity - Need for NICU Care | From birth until 6 weeks of life. | — |
| Neonatal Morbidity - Preterm Birth | At birth | Delivery at gestational age \<37 weeks. |
| Neonatal Morbidity - Respiratory Distress Syndrome Requiring Respiratory Support | From birth until 6 weeks of life. | — |
| Neonatal Morbidity - Jaundice Requiring Phototherapy | From birth until 6 weeks of life. | — |
| Neonatal Morbidity - Major Congenital Anomalies | From birth until 6 weeks of life. | — |
| Neonatal Morbidity - Apgar Score <7 at 5 Minutes | At 5 minutes after birth | The Apgar score comprises five components: 1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2. (for example see: https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2015/10/the-apgar-score#:\ :text=The%20Apgar%20score%20comprises%20five,0%2C%201%2C%20or%202) |
| Neonatal Morbidity - Neonatal Hypoglycemia | First hour of life. | serum glucose \<2.6mmol/l on at least one occasion \<60 minutes after delivery |
| Neonatal Head Circumference | At birth | — |
| Time to Insulin Initiation | Time to Insulin Initiation, from date of randomization until the date of delivery, an average of 16 weeks.. | Time to Insulin Initiation, from date of randomization until the date of delivery. |
Countries
Ireland
Participant flow
Recruitment details
Participants were enrolled between June 2017 and September 2022. A total of 535 participants were randomised into the study, 502 at Galway University Hospital GUH and 33 at Portiuncula University Hospital PUH (the second site, PUH, did not start recruiting participants until February 2019).
Participants by arm
| Arm | Count |
|---|---|
| Treatment Participants randomised to the treatment arm received active metformin in addition to standard care. Metformin tablets will be titrated according to a dosing schedule to achieve the pre-specified glucose targets. Tablets will be in 500mg doses and will commence at 1 tablet per day (500mg) increasing to a maximum of 5 tablets per day (2500mg). | 268 |
| Control Participants randomised to the placebo arm received placebo in addition to standard care. Placebo will be titrated according to the dosing schedule to achieve the pre-specified glucose targets. Placebo tablets will commence at 1 tablet per day and will be increased to a maximum of 5 tablets per day over 10 days as with the treatment group. | 267 |
| Total | 535 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 18 | 18 |
| Overall Study | Miscellaneous other | 10 | 4 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 4 |
Baseline characteristics
| Characteristic | Treatment | Total | Control |
|---|---|---|---|
| 1hour Glucose Tolerance Test Result | 9.4 mmol/L STANDARD_DEVIATION 1.9 | 9.5 mmol/L STANDARD_DEVIATION 1.9 | 9.7 mmol/L STANDARD_DEVIATION 1.9 |
| 2hour Glucose Tolerance Test Result | 7.1 mmol/L STANDARD_DEVIATION 1.6 | 7.1 mmol/L STANDARD_DEVIATION 1.6 | 7.1 mmol/L STANDARD_DEVIATION 1.6 |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 268 Participants | 535 Participants | 267 Participants |
| Age, Continuous | 34.3 years STANDARD_DEVIATION 4.9 | 34.3 years STANDARD_DEVIATION 4.8 | 34.3 years STANDARD_DEVIATION 4.7 |
| BMI | 31.2 kg per metre squared STANDARD_DEVIATION 7 | 31.7 kg per metre squared STANDARD_DEVIATION 7.1 | 32.1 kg per metre squared STANDARD_DEVIATION 6.9 |
| BMI <30 | 108 Participants | 211 Participants | 103 Participants |
| BMI Category >=30 | 160 Participants | 324 Participants | 164 Participants |
| Current Smoker | 34 Participants | 51 Participants | 17 Participants |
| Fasting glucose | 5.2 mmol/L STANDARD_DEVIATION 0.45 | 5.2 mmol/L STANDARD_DEVIATION 0.46 | 5.2 mmol/L STANDARD_DEVIATION 0.47 |
| Gestational Age at Randomization | 27 weeks | 27 weeks | 27 weeks |
| History of Hypertension | 12 Participants | 16 Participants | 4 Participants |
| History of Macrosomia | 57 Participants | 101 Participants | 44 Participants |
| Medical Card | 63 Participants | 126 Participants | 63 Participants |
| Nulliparous | 84 Participants | 168 Participants | 84 Participants |
| Previous Ante-partum Haemorrhage | 20 Participants | 35 Participants | 15 Participants |
| Previous Cesarian Section | 70 Participants | 144 Participants | 74 Participants |
| Previous Miscarriage | 106 Participants | 199 Participants | 93 Participants |
| Previous Polyhydramnios | 10 Participants | 17 Participants | 7 Participants |
| Previous Post-partum Hemorrhage | 28 Participants | 48 Participants | 20 Participants |
| Previous Stillbirth | 2 Participants | 4 Participants | 2 Participants |
| Prevous Pre-eclampsia | 24 Participants | 47 Participants | 23 Participants |
| Private Health Insurance | 126 Participants | 242 Participants | 116 Participants |
| Race/Ethnicity, Customized African/Black | 7 Participants | 13 Participants | 6 Participants |
| Race/Ethnicity, Customized Asian | 17 Participants | 46 Participants | 29 Participants |
| Race/Ethnicity, Customized Irish Traveller | 11 Participants | 13 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 14 Participants | 35 Participants | 21 Participants |
| Race/Ethnicity, Customized White | 219 Participants | 428 Participants | 209 Participants |
| Region of Enrollment Ireland | 268 Pregnancies | 535 Pregnancies | 267 Pregnancies |
| Sex: Female, Male Female | 268 Participants | 535 Participants | 267 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Unemployed | 19 Participants | 46 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 264 | 1 / 262 | 1 / 264 | 1 / 262 |
| other Total, other adverse events | 225 / 264 | 247 / 262 | 157 / 264 | 172 / 262 |
| serious Total, serious adverse events | 79 / 264 | 72 / 262 | 107 / 264 | 123 / 262 |
Outcome results
Primary
Insulation of Insulin
Initiation of insulin treatment at any time up to delivery.
Time frame: Enrolment through delivery, an average of 16 weeks.
Population: Population of pregnancies followed up until delivery. 268 were randomised to Treatment Group, of whom 264 received Metformin as randomised. Two participants delivered outside the country; delivery and neonatal information was available for the remaining 262 participants. Among those randomised to Treatment Group, 264 Pregnancies were included in the Primary Outcome Analysis. All 262 patients randomised to placebo were followed until delivery and included in Primary Outome Analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Insulation of Insulin | 101 Participants |
| Control | Insulation of Insulin | 134 Participants |
p-value: 0.00495% CI: [-21.2, -4.3]Risk difference
Primary
Primary Composite Outcome
The primary efficacy outcome was achieved if any participant experienced: * Insulin initiation * Fasting glucose value \>5.1 mmol/l at 32weeks or 38 weeks gestation.
Time frame: Enrolment through delivery, an average of 16 weeks.
Population: Population of pregnancies followed up until delivery. 268 were randomised to Treatment Group, of whom 264 received Metformin as randomised. Two participants delivered outside the country; delivery and neonatal information was available for the remaining 262 participants. Among those randomised to Treatment Group, 264 Pregnancies were included in the Primary Outcome Analysis. All 262 patients randomised to placebo were followed until delivery and included in Primary Outome Analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Primary Composite Outcome | 150 Participants |
| Control | Primary Composite Outcome | 167 Participants |
Comparison: The primary analysis, as per sample size calculation, was a two-sample comparison of reduction in the proportion of women needing insulin between treatment and control arms using an exact test for a binomial response.p-value: 0.1395% CI: [-15.1, 1.4]Risk difference
Secondary
Birthweight
Time frame: At birth
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Birthweight | 3393 grams | Standard Deviation 527 |
| Control | Birthweight | 3505 grams | Standard Deviation 510 |
p-value: 0.00595% CI: [-201, -24]Regression, Linear
Secondary
Birth Weight <10th Percentile
Time frame: At birth
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Birth Weight <10th Percentile | 15 Participants |
| Control | Birth Weight <10th Percentile | 7 Participants |
p-value: 0.1395% CI: [-0.4, 6.5]Regression, Logistic
Secondary
Birth Weight <2500g
Time frame: At birth
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Birth Weight <2500g | 16 Participants |
| Control | Birth Weight <2500g | 9 Participants |
p-value: 0.01295% CI: [-1, 6.3]Risk difference
Secondary
Birth Weight >4000g
Time frame: At birth
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Birth Weight >4000g | 20 Participants |
| Control | Birth Weight >4000g | 39 Participants |
p-value: 0.0295% CI: [-12.6, -1.8]Regression, Logistic
Secondary
Birth Weight >90th Percentile
Time frame: At birth
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Birth Weight >90th Percentile | 17 Participants |
| Control | Birth Weight >90th Percentile | 39 Participants |
p-value: 0.00395% CI: [-13.7, -3.2]Risk difference
Secondary
Fasting Hyperglycemia
Number of women with fasting hyperglycemia at 32wks or at 38wks gestation.
Time frame: Measured at 32 and 38 weeks' gestation.
Population: Participants having fasting glucose levels measured at 32 and/or 38 weeks' gestation. Data available for 255 in the Treatment group and 248 in the Control group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Fasting Hyperglycemia | 94 Participants |
| Control | Fasting Hyperglycemia | 106 Participants |
p-value: 0.17895% CI: [0.55, 1.12]Regression, Logistic
p-value: 0.10595% CI: [0.48, 1.07]Regression, Logistic
Secondary
Gestational Age at Delivery
Time frame: At delivery, an average of 16 weeks after enrolment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Gestational Age at Delivery | 39.1 weeks | Standard Deviation 1.5 |
| Control | Gestational Age at Delivery | 39.1 weeks | Standard Deviation 1.6 |
p-value: 0.6695% CI: [-0.3, 0.2]t-test, 2 sided
Secondary
Gestational Weight Gain
Change in weight (kg) from randomization until last visit before delivery
Time frame: Enrolment through delivery, an average of 16 weeks.
Population: Population of pregnancies followed up until delivery. 268 were randomised to Treatment Group, of whom 264 received Metformin as randomised. Two participants delivered outside the country; delivery and neonatal information was available for the remaining 262 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Gestational Weight Gain | 0.88 kg | Standard Deviation 3.31 |
| Control | Gestational Weight Gain | 1.96 kg | Standard Deviation 3.53 |
p-value: 0.00395% CI: [-1.99, -0.42]t-test, 2 sided
Secondary
Insulin Dose Required
Insulin dose required in any participant requiring insulin.
Time frame: Enrolment through delivery, an average of 16 weeks.
Population: Population of pregnancies followed up until delivery. 268 were randomised to Treatment Group, of whom 264 received Metformin as randomised. Two participants delivered outside the country; delivery and neonatal information was available for the remaining 262 participants. Among those randomised to Treatment Group, 264 Pregnancies were included in the Primary Outcome Analysis which includes Insulin Initiation (yes/no).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Insulin Dose Required | 20.4 IU | Standard Deviation 19.8 |
| Control | Insulin Dose Required | 2.2 IU | Standard Deviation 22.8 |
p-value: 0.1795% CI: [-9.3, 1.7]t-test, 2 sided
Secondary
Insulin Initiated
Whether or not insulin was initiated at any time during the study.
Time frame: Enrolment through delivery, an average of 16 weeks.
Population: Population of pregnancies followed up until delivery. 268 were randomised to Treatment Group, of whom 264 received Metformin as randomised. Two participants delivered outside the country; delivery and neonatal information was available for the remaining 262 participants. Among those randomised to Treatment Group, 264 Pregnancies were included in the Primary Outcome Analysis. Data for this outcome available for 263 in Treatment group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Insulin Initiated | 94 Participants |
| Control | Insulin Initiated | 106 Participants |
p-value: 0.00595% CI: [0.43, 0.86]Regression, Logistic
p-value: 0.00395% CI: [0.38, 0.82]Regression, Logistic
Secondary
Maternal Morbidity - Antepartum Hemorrhage
Any vaginal bleeding prior to delivery
Time frame: From enrolment through delivery, an average of 16 weeks.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Maternal Morbidity - Antepartum Hemorrhage | 15 Participants |
| Control | Maternal Morbidity - Antepartum Hemorrhage | 27 Participants |
p-value: 0.05895% CI: [0.27, 1.01]Regression, Logistic
p-value: 0.06195% CI: [0.27, 1.02]Regression, Logistic
Secondary
Maternal Morbidity - Postpartum Hemorrhage
Time frame: From delivery through 6 weeks postpartum.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Maternal Morbidity - Postpartum Hemorrhage | 51 Participants |
| Control | Maternal Morbidity - Postpartum Hemorrhage | 63 Participants |
p-value: 0.2495% CI: [-11.6, 2.5]Risk difference
p-value: 0.2495% CI: [0.59, 1.12]Regression, Logistic
Secondary
Maternal Morbidity - Pre-eclampsia
Pre-eclampsia diagnosed during study participation
Time frame: Enrolment through 6 weeks postpartum, an average of 22 weeks.
Population: Participants followed from randomisation through delivery.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Maternal Morbidity - Pre-eclampsia | 10 Participants |
| Control | Maternal Morbidity - Pre-eclampsia | 5 Participants |
Comparison: Unadjustedp-value: 0.28295% CI: [0.63, 6.04]Regression, Logistic
p-value: 0.19695% CI: [0.7, 7.38]Regression, Logistic
Secondary
Maternal Morbidity - Pregnancy-induced Hypertension
Time frame: From enrolment through 6 weeks postpartum, an average of 22 weeks.
Population: Participants followed from randomisation through to 12 weeks postpartum. 268 participants were randomised to Treatment Group; 264 received Metformin as randomised. Two of those participants delivered outside the country; delivery and neonatal information was available for the remaining 262 participants. 267 were randomised to Placebo, of which 262 received Placebo as randomised and were followed through to delivery.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Maternal Morbidity - Pregnancy-induced Hypertension | 31 Participants |
| Control | Maternal Morbidity - Pregnancy-induced Hypertension | 28 Participants |
p-value: 0.73995% CI: [0.45, 1.76]Regression, Logistic
p-value: 0.81295% CI: [0.46, 1.84]Regression, Logistic
Secondary
Mode of Delivery - Cesarian Delivery
Delivered by Cesarian section.
Time frame: At delivery, an average of 16 weeks after enrolment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Mode of Delivery - Cesarian Delivery | 114 Participants |
| Control | Mode of Delivery - Cesarian Delivery | 100 Participants |
p-value: 0.36795% CI: [0.8, 1.85]Regression, Logistic
p-value: 0.35995% CI: [0.8, 1.87]Regression, Logistic
Secondary
Mode of Delivery - Emergency Cesarian Section
Among those having cesarian section, count of emergency procedures.
Time frame: At delivery, an average of 16 weeks after randomization.
Population: Among those having cesarian section, count of emergency procedures.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Mode of Delivery - Emergency Cesarian Section | 53 Participants |
| Control | Mode of Delivery - Emergency Cesarian Section | 53 Participants |
p-value: 195% CI: [-13.9, 12.9]Risk difference
Secondary
Mode of Delivery - Induced
Labor induced.
Time frame: At time of labor, an average of 16 weeks after enrolment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Mode of Delivery - Induced | 73 Participants |
| Control | Mode of Delivery - Induced | 87 Participants |
p-value: 0.60395% CI: [0.56, 1.39]Regression, Logistic
p-value: 0.62195% CI: [0.57, 1.4]Regression, Logistic
Secondary
Neonatal Abdominal Circumference
Time frame: At birth
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Neonatal Abdominal Circumference | 33.4 cm | Standard Deviation 2.4 |
| Control | Neonatal Abdominal Circumference | 33.3 cm | Standard Deviation 2.8 |
p-value: 0.7295% CI: [-0.5, 0.7]t-test, 2 sided
Secondary
Neonatal Head Circumference
Time frame: At birth
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Neonatal Head Circumference | 34.7 cm | Standard Deviation 1.6 |
| Control | Neonatal Head Circumference | 34.7 cm | Standard Deviation 1.8 |
p-value: 0.8295% CI: [-0.3, 0.3]t-test, 2 sided
Secondary
Neonatal Height
Height in cm (crown-heel length)
Time frame: At birth
Population: Pregnancies followed until delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Neonatal Height | 51 cm | Standard Deviation 3.2 |
| Control | Neonatal Height | 51.7 cm | Standard Deviation 3.2 |
p-value: 0.0295% CI: [-1.3, -0.2]t-test, 2 sided
Secondary
Neonatal Morbidity - Apgar Score <7 at 5 Minutes
The Apgar score comprises five components: 1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2. (for example see: https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2015/10/the-apgar-score#:\ :text=The%20Apgar%20score%20comprises%20five,0%2C%201%2C%20or%202)
Time frame: At 5 minutes after birth
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Neonatal Morbidity - Apgar Score <7 at 5 Minutes | 1 Participants |
| Control | Neonatal Morbidity - Apgar Score <7 at 5 Minutes | 1 Participants |
p-value: >0.9995% CI: [-1, 1]Risk difference
Secondary
Neonatal Morbidity - Jaundice Requiring Phototherapy
Time frame: From birth until 6 weeks of life.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Neonatal Morbidity - Jaundice Requiring Phototherapy | 1 Participants |
| Control | Neonatal Morbidity - Jaundice Requiring Phototherapy | 0 Participants |
p-value: >0.9995% CI: [-0.4, 1.1]Risk difference
Secondary
Neonatal Morbidity - Major Congenital Anomalies
Time frame: From birth until 6 weeks of life.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Neonatal Morbidity - Major Congenital Anomalies | 10 Participants |
| Control | Neonatal Morbidity - Major Congenital Anomalies | 7 Participants |
p-value: 0.6295% CI: [-1.9, 4.2]Risk difference
Secondary
Neonatal Morbidity - Need for NICU Care
Time frame: From birth until 6 weeks of life.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Neonatal Morbidity - Need for NICU Care | 41 Participants |
| Control | Neonatal Morbidity - Need for NICU Care | 33 Participants |
p-value: 0.3895% CI: [-2.9, 9]Risk difference
Secondary
Neonatal Morbidity - Neonatal Hypoglycemia
serum glucose \<2.6mmol/l on at least one occasion \<60 minutes after delivery
Time frame: First hour of life.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Neonatal Morbidity - Neonatal Hypoglycemia | 36 Participants |
| Control | Neonatal Morbidity - Neonatal Hypoglycemia | 34 Participants |
p-value: 0.995% CI: [-5.1, 6.6]Risk difference
Secondary
Neonatal Morbidity - Preterm Birth
Delivery at gestational age \<37 weeks.
Time frame: At birth
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Neonatal Morbidity - Preterm Birth | 24 Participants |
| Control | Neonatal Morbidity - Preterm Birth | 17 Participants |
p-value: 0.3395% CI: [-2, 7.3]Risk difference
Secondary
Neonatal Morbidity - Respiratory Distress Syndrome Requiring Respiratory Support
Time frame: From birth until 6 weeks of life.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Neonatal Morbidity - Respiratory Distress Syndrome Requiring Respiratory Support | 24 Participants |
| Control | Neonatal Morbidity - Respiratory Distress Syndrome Requiring Respiratory Support | 18 Participants |
p-value: 0.4295% CI: [-2.4, 6.9]Risk difference
Secondary
Neonatal Ponderal Index
Ponderal index is calculated as 100 x weight(grams)/(crown-heel length).
Time frame: At birth
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Neonatal Ponderal Index | 2.6 grams/cm | Standard Deviation 0.4 |
| Control | Neonatal Ponderal Index | 2.6 grams/cm | Standard Deviation 0.5 |
p-value: 0.6895% CI: [-0.1, 0.1]t-test, 2 sided
Secondary
Postpartum Impaired Fasting Glucose
Impaired fasting glucose at 12 weeks postpartum
Time frame: 12 weeks post-partum
Population: Participants followed until 12 weeks postpartum who contributed samples for analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Postpartum Impaired Fasting Glucose | 51 Participants |
| Control | Postpartum Impaired Fasting Glucose | 52 Participants |
p-value: 0.9995% CI: [0.65, 1.55]Regression, Logistic
Secondary
Postpartum Impaired Glucose Tolerance
Time frame: 12 weeks postpartum
Population: Participants followed until 12 weeks postpartum who contributed samples.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Postpartum Impaired Glucose Tolerance | 15 Participants |
| Control | Postpartum Impaired Glucose Tolerance | 16 Participants |
p-value: 0.91195% CI: [0.46, 2]Regression, Logistic
Secondary
Postpartum Metabolic Syndrome
Time frame: 12 weeks postpartum
Population: Participants followed until 12 weeks postpartum who contributed samples
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Postpartum Metabolic Syndrome | 20 Participants |
| Control | Postpartum Metabolic Syndrome | 25 Participants |
p-value: 0.51995% CI: [0.44, 1.51]Regression, Logistic
Secondary
Time to Insulin Initiation
Time to Insulin Initiation, from date of randomization until the date of delivery.
Time frame: Time to Insulin Initiation, from date of randomization until the date of delivery, an average of 16 weeks..
Population: Pregnancies followed up until delivery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Time to Insulin Initiation | 68 days | Standard Deviation 38.1 |
| Control | Time to Insulin Initiation | 58.7 days | Standard Deviation 37 |
p-value: 0.001Log Rank