Clinical Trial Radar

Number of Neonates That Show Composite Adverse Neonatal Outcome

Composite adverse neonatal outcome include one or more of the following: * Large for Gestational Age(LGA) is described as weight over 90th percentile of the expected value according to gestational age (using the nomogram by Duryea EL et al) * Shoulder Dystocia is defined as the need for any extra maneuvers, other than gentle downward traction of the fetal head to deliver the fetal body after the fetal head has been delivered * Birth injury: skull, clavicular, humerus fracture, or brachial plexus injury * Neonatal hypoglycemia: less than 40 mg/dL in the first 24 hours of life and less than 50 mg/dL after or requiring medical therapy * Respiratory distress is described as the need for at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure, or ventilation at the first 24 hours of life * Fetal or neonatal death (within 28 days of birth)

From birth to about 28 days of life.

Number of Neonates That Show Adverse Neonatal Outcome of Large for Gestational Age(LGA)

LGA is described as weight over 90th percentile of the expected value according to gestational age (using the nomogram by Duryea EL et al)

at time of birth

Number of Neonates That Show Adverse Neonatal Outcome of Shoulder Dystocia

Shoulder dystocia is defined as the need for any extra maneuvers, other than gentle downward traction of the fetal head to deliver the fetal body after the fetal head has been delivered

at time of birth

Number of Neonates That Show Adverse Neonatal Outcome of Birth Injury

Birth injury: skull, clavicular, humerus fracture, or brachial plexus injury

at time of birth

Number of Neonates That Show Adverse Neonatal Outcome of Neonatal Hypoglycemia

Neonatal hypoglycemia: less than 40 mg/dL in the first 24 hours of life and less than 50 mg/dL after or requiring medical therapy

from birth to discharge (about 3-15 days)

Number of Neonates That Show Adverse Neonatal Outcome of Respiratory Distress

Respiratory distress is described as the need for at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure, or ventilation at the first 24 hours of life

from birth to discharge (about 3-15 days)

Number of Fetal or Neonatal Deaths

within 28 days of birth

Feasibility as Assessed by the Number of Participants Who Complete the CGM Diagnostic Testing

From enrollment to 6 weeks post partum, on average 21 weeks

Number of Women That Use Diabetic Medication During Pregnancy

diabetic medication is described as any glycemic control agent

From enrollment to 6 weeks post partum, on average 21 weeks

Number of Women That Show Polyhydramnios During Pregnancy Not Related to Known Fetal Anomaly

From enrollment to delivery

Number of Women That Have Preterm Birth

Pre term birth is described as delivery less than 37 weeks of gestation

at time of birth

Number of Women That Undergo Induced Labor

at time of birth

Number of Women That Experience Pregnancy Induced Hypertension

From enrollment to 6 weeks post partum, on average 21 weeks

Number of Women That Experience Eclampsia: Seizures

From enrollment to 6 weeks post partum, on average 21 weeks

Number of Women Admitted Due to Poor Glucose Control

From enrollment up to delivery

Number of Women With Primary Cesarean Section

at time of birth

Number of Women With Postpartum Hemorrhage: Defined as Greater Then 1000ml

From enrollment to 6 weeks post partum, on average 21 weeks

Number of Women With Endometritis

From enrollment to 6 weeks post partum, on average 21 weeks

Number of Women With Wound Complications

From enrollment to 6 weeks post partum, on average 21 weeks

Number of Women With Diagnosis of Type 2 Diabetes During Postpartum

birth to 6 weeks postpartum

Number of Neonates With Apgar Score Less Than 7

The Apgar score is determined by evaluating the newborn baby on each of five criteria (appearance, pulse, grimace, activity, respiration) on a scale from zero to two, then summing the five values obtained. The total score ranges from zero to 10. A higher score indicates a better outcome.

5 minutes after birth

Number of Neonates That Are Admitted to the Neonatal Intensive Care Unit (NICU)

birth to time of discharge from NICU (about 15 days)

NICU Length of Stay

birth to time of discharge from NICU (about 15 days)

Number of Neonates With Hyperbilirubinemia Requiring Phototherapy

birth to discharge (about 3-15 days)

Number of Neonates With Need for Intravenous or Oral Administration Glucose Therapy

birth to discharge (about 3-15 days)

Number of Neonates That Are Small for Gestational Age

Small for gestational age, defined as a weight below 10th percentile of the expected value according to gestational age (using the nomogram published by Duryea EL et al)

at time of birth

Number of Participants Who Breastfed Their Babies

from birth to 6 weeks postpartum

Number of Participants Who Formula Fed Their Babies

from birth to 6 weeks postpartum

Maximum Bilirubin Level - Neonates

birth to discharge (about 3 -15 days)

Cord Arterial pH

at time of birth

Number of Neonates With Polycythemia

birth to discharge (about 3 -15 days)

Number of Women That Experience Preeclampsia With Severe Features

From enrollment to 6 weeks post partum, on average 21 weeks

Number of Women That Experience Super Imposed Preeclampsia

From enrollment to 6 weeks post partum, on average 21 weeks

Number of Women With Need for Blood Transfusion

From enrollment to 6 weeks post partum, on average 21 weeks

Number of Participants With Ultrasound Diagnosis of Estimated Fetal Weight >90%Ile in the Third Trimester

Third trimester (≥28 weeks gestation through delivery)

Number of Women That Experience HELLP Syndrome

HELLP syndrome: a group of symptoms in pregnant women characterized by hemolysis (H), elevated liver enzymes (EL), and/or low platelet (LP) count, assessed according to ACOG guidelines.

From enrollment to 6 weeks post partum, on average 21 weeks

Cord Venous pH

at time of birth

Total Health System Costs for Mothers and Infants

From enrollment to 6 weeks post partum, on average 21 weeks