Study of Pregnancy And Neonatal Health (SPAN)

Study of Pregnancy And Neonatal Health (SPAN)

Incidence of respiratory support less than moderate [ Time Frame: Delivery through Newborn Discharge ]
Hood oxygen and Nasal cannula <2 LPM (liters per minute); Other than room air (No support)

Duration of any respiratory support [ Time Frame: Delivery through Newborn Discharge ]
Duration of moderate respiratory support [ Time Frame: Delivery through Newborn Discharge ]
Occurrence of Transient tachypnea of the newborn [ Time Frame: Delivery through Newborn Discharge ]
Occurrence of Respiratory distress syndrome in Neonates [ Time Frame: Delivery through Newborn Discharge ]
Both a clinical diagnosis and whether required surfactant

Occurrence of Hypoglycemia in neonates [ Time Frame: Delivery through Newborn Discharge ]
Glucose < 35 mg/dl) and whether required IV therapy

Occurrence of Hyperbilirubinemia in Neonates [ Time Frame: Delivery through Newborn Discharge ]
Requiring phototherapy or exchange transfusion in Neonates

Occurrence of Polycythemia in Neonates [ Time Frame: Delivery through Newborn Discharge ]
Both a clinical diagnosis and whether required partial exchange transfusion

Incidence of Therapeutic hypothermia [ Time Frame: Delivery through Newborn Discharge ]
Head or body cooling

Incidence of Transfusion of blood products or blood in neonates [ Time Frame: Delivery through Newborn Discharge ]
Occurrence of neonatal intensive care unit (NICU) or intermediate care unit admission [ Time Frame: Delivery through Newborn Discharge ]
Duration of Neonatal hospital stay [ Time Frame: Delivery through Newborn Discharge ]
Measured in days

Birthweight [ Time Frame: Delivery through Newborn Discharge ]
Incidence of small for gestational age [ Time Frame: Delivery through Newborn Discharge ]
Defined as < 10th percentile using the Duryea reference

Incidence of large for gestational age and macrosomia [ Time Frame: Delivery through Newborn Discharge ]
LGA defined as > 90th percentile using the Duryea reference and macrosomia defined as birthweight > 4500 g

Composite of Maternal Morbidity and Mortality [ Time Frame: Pregnancy through Discharge ]
Maternal death, HELLP syndrome, Eclampsia, Pulmonary edema, placental abruption, blood transfusion

Occurrence of maternal death [ Time Frame: Pregnancy through Discharge ]
Occurrence of HELLP syndrome [ Time Frame: Pregnancy through Discharge ]
As defined by American College of Obstetricians and Gynecologists (ACOG)

Occurrence of Eclampsia [ Time Frame: Pregnancy through Discharge ]
As defined by American College of Obstetricians and Gynecologists (ACOG)

Occurrence of Maternal Pulmonary edema [ Time Frame: Pregnancy through Discharge ]
Chest x-ray confirmed

Occurrence of Placental abruption [ Time Frame: Pregnancy through Delivery ]
Incidence of Maternal Blood transfusion [ Time Frame: Pregnancy through Discharge ]
Incidence of spontaneous labor [ Time Frame: Pregnancy through Delivery ]
Incidence of induced labor [ Time Frame: Pregnancy through Delivery ]
Incidence of planned cesarean [ Time Frame: Pregnancy through Delivery ]
Indication for delivery including cesarean for suspected macrosomia [ Time Frame: Pregnancy through Delivery ]
Defined as estimated fetal weight > 4500 grams

Occurrence of Spontaneous vaginal delivery [ Time Frame: Pregnancy through Delivery ]
Occurrence of Operative vaginal delivery [ Time Frame: Pregnancy through Delivery ]
Vacuum or forceps

Occurrence of Cesarean delivery [ Time Frame: Pregnancy through Delivery ]
Indications for operative vaginal delivery [ Time Frame: Pregnancy through Delivery ]
Indication for cesarean [ Time Frame: Pregnancy through Delivery ]
Incidence of Shoulder dystocia [ Time Frame: Delivery through Newborn Discharge ]
Occurrence of Maternal lacerations [ Time Frame: Delivery through Discharge ]
1st, 2nd, 3rd or 4th degree perineal; sulcus, vaginal wall; labial, periurethral, clitoral, abrasion, other

Occurrence of Postpartum hemorrhage [ Time Frame: Delivery through Discharge ]
Defined as any of the following: Transfusion, Non-elective hysterectomy, Use of two or more uterotonics other than oxytocin, Other surgical interventions such as uterine compression sutures, uterine artery ligation, embolization, hypogastric ligation, or balloon tamponade, and Curettage

Occurrence of Maternal ICU Admission [ Time Frame: Delivery through Discharge ]
Incidence of Maternal venous thromboembolism [ Time Frame: Delivery through Discharge ]
Deep venous thrombosis or pulmonary embolism

Incidence of Chorioamnionitis [ Time Frame: Delivery through Discharge ]
Defined as a clinical diagnosis before delivery

Maternal postpartum infection [ Time Frame: Delivery through Discharge ]
Defined as, Clinical diagnosis of endometritis, Wound reopened for hematoma, seroma, infection or other reasons, Cellulitis requiring antibiotics, Pneumonia, Pyelonephritis, Bacteremia unknown source, and Septic pelvic thrombosis

Maternal hypertension [ Time Frame: Delivery through Discharge ]
Mild and Severe (systolic and diastolic) defined by ACOG

Incidence of Preeclampsia, with or without severe features [ Time Frame: Delivery through Discharge ]
Defined by ACOG

Use of antihypertensive drugs [ Time Frame: Delivery through Discharge ]
Includes oral antihypertensive, intravenous antihypertensive, or intravenous anticonvulsant

Number of hours in labor and delivery unit [ Time Frame: Delivery through Discharge ]
Duration of maternal hospital stay [ Time Frame: Pregnancy through Newborn Discharge ]
Measured in Days.

Source: View full study details on ClinicalTrials.gov

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December 16, 2022Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
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