Back to resultsStudy of Pregnancy And Neonatal Health (SPAN) (SPAN)
Primary Purpose
Gestational Diabetes Mellitus
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Childbirth
Sponsored by
About this trial
This is an interventional treatment trial for Gestational Diabetes Mellitus focused on measuring Gestational Diabetes Mellitus, Delivery Timing
Eligibility Criteria
INCLUSION CRITERIA:
Aim 3 (GDM randomized trial, TIME) inclusion criteria:
Women inclusion criteria:
- Age ≥ 18 Years
Verified diagnosis of Gestational Diabetes Mellitus (GDM) with abnormal glucose levels*** or meeting other criteria for poor control, specifically any one of the following: Estimated fetal weight ≥90th percentile (LGA), Polyhydramnios, and or Demonstrate noncompliance or nonadherence as defined clinically, including missing visits, not keeping accurate log, etc.
***One or more elevated fasting blood glucoses OR three or more elevated post-prandial blood glucoses after receiving education about appropriate diet and lifestyle modification (e.g. physical activity)
- Accurate gestational age as verified by ultrasound
- Singleton gestation
- English or Spanish speaker
- Plans to deliver at the study site hospital
- Ability to provide informed consent to be randomized to initiation of delivery
EXCLUSION CRITERIA:
Aim 3 (GDM randomized trial, TIME) exclusion criteria:
Pre-gestational diabetes*
*will be defined as diabetes diagnosis before pregnancy OR before 13 weeks of gestation with a documented fasting plasma glucose ≥ 126 mg/dL, random plasma glucose ≥ 200 mg/dL, 2 hour post glucose ≥ 200 mg/dL during an oral glucose tolerance test (75 g glucose load), or hemoglobin A1c ≥ 6.5%.110.
- Previous stillbirth defined as fetal demise ≥ 20 weeks of gestation
- Self-reported history of alcohol dependency disorder and/or other drug/substance dependency in the past year
- Teratogen exposure (e.g. cyclophosphamide, valproic acid, warfarin)
- Known infectious diseases associated with neonatal morbidity (e.g. malaria, cytomegalovirus, rubella, toxoplasmosis, syphilis or Zika virus)
- Genetic disorders, aneuploidy and known major fetal anomalies
- Fetal demise
- Pregnancies with concurrent conditions and other indications for earlier delivery will also be excluded.
- Participation in another interventional study that influences management of labor and delivery or perinatal morbidity or mortality
Sites / Locations
- University of Alabama at BirminghamRecruiting
- Ochsner BaptistRecruiting
- University of North Carolina - Chapel HillRecruiting
- Duke University Perinatal Research CenterRecruiting
- University of PennsylvaniaRecruiting
- Intermountain HealthcareRecruiting
- University of UtahRecruiting
- INOVA Fairfax HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Intervention Arm 1
Intervention Arm 2
Intervention Arm 3
Intervention Arm 4
Intervention Arm 5
Intervention Arm 6
Intervention Arm 7
Arm Description
Intervention Arm 1 Experimental Initiation of Delivery by induction or planned cesarean at 37 weeks 0-2 days.
Intervention Arm 2 Experimental Initiation of Delivery by induction or planned cesarean at 37 weeks 3-5 days.
Initiation of Delivery by induction or planned cesarean at 37 weeks 6 days to 38 weeks and 1 day.
Intervention Arm 4 Experimental Initiation of Delivery by induction or planned cesarean at 38 weeks 2-4 days.
Initiation of Delivery by induction or planned cesarean at 38 weeks 5 days to 39 weeks and 0 days.
Intervention Arm 6 Experimental Initiation of Delivery by induction or planned cesarean at 39 weeks 1-3 days.
Intervention Arm 7 Experimental Initiation of Delivery by induction or planned cesarean at 39 weeks 4-6 days.
Outcomes
Primary Outcome Measures
Composite of Neonatal Morbidity and Perinatal Mortality
Occurrence of Antepartum, intrapartum or neonatal death (Component of primary outcome)
Incidence of moderate or higher neonatal respiratory support within 72 hours after birth (Component of primary outcome)
Including any of the following: Nasal cannula >/= 2 LPM (liters per minute), Nasal continuous positive airway pressure (NCPAP), NIPPV; (non-invasive intermittent positive pressure ventilation; Note that NIPPV is more general than Bilevel positive airway pressure (BiPAP) i.e. BiPAP is a form of NIPPV, as is non-invasive NAVA, synchronized NIPPV, non-synchronized NIPPV, some ventilators can do nasal IMV in certain situations, etc.), Mechanical ventilation, High frequency ventilation, and ECMO/ECLS (extracorporeal mechanical support/extracorporeal life support)
Occurrence of Pneumonia (Component of primary outcome)
Confirmed by X-ray or positive blood culture
Occurrence of Meconium aspiration syndrome (Component of primary outcome)
Respiratory distress in an infant born through meconium-stained amniotic fluid with X-ray findings consistent with meconium aspiration syndrome, and whose symptoms could not be otherwise explained
Occurrence of Sepsis (Component of primary outcome)
The diagnosis of sepsis will require the presence of a clinically ill infant in whom systemic infection is suspected with a positive blood, CSF, or catheterized/suprapubic urine culture; or, in the absence of positive cultures, clinical evidence of cardiovascular collapse or an unequivocal X-ray confirming infection.
Occurrence of Neonatal encephalopathy (Component of primary outcome)
Defined by Shankaran et al. 2005
Occurrence of Intracranial hemorrhage (Component of primary outcome)
Intraventricular hemorrhage grades III and IV, subgaleal hematoma, subdural hematoma, or subarachnoid hematoma
Occurrence of Seizures (Component of primary outcome)
Occurrence of Birth trauma (Component of primary outcome)
Bone fractures, brachial plexus palsy, other neurologic injury, retinal hemorrhage, or facial nerve palsy
Occurrence of Hypotension requiring pressor support (Component of primary outcome)
Occurrence of hypertrophic cardiomyopathy (Component of primary outcome)
Incidence of neonatal intensive care unit (NICU) > 1 day (24 hours) stay
NICU stay > 1 day (24 hours)
Secondary Outcome Measures
Incidence of respiratory support less than moderate
Hood oxygen and Nasal cannula <2 LPM (liters per minute); Other than room air (No support)
Duration of any respiratory support
Duration of moderate respiratory support
Occurrence of Transient tachypnea of the newborn
Occurrence of Respiratory distress syndrome in Neonates
Both a clinical diagnosis and whether required surfactant
Occurrence of Hypoglycemia in neonates
Glucose < 35 mg/dl) and whether required IV therapy
Occurrence of Hyperbilirubinemia in Neonates
Requiring phototherapy or exchange transfusion in Neonates
Occurrence of Polycythemia in Neonates
Both a clinical diagnosis and whether required partial exchange transfusion
Incidence of Therapeutic hypothermia
Head or body cooling
Incidence of Transfusion of blood products or blood in neonates
Occurrence of neonatal intensive care unit (NICU) or intermediate care unit admission
Duration of Neonatal hospital stay
Measured in days
Birthweight
Incidence of small for gestational age
Defined as < 10th percentile using the Duryea reference
Incidence of large for gestational age and macrosomia
LGA defined as > 90th percentile using the Duryea reference and macrosomia defined as birthweight > 4500 g
Composite of Maternal Morbidity and Mortality
Maternal death, HELLP syndrome, Eclampsia, Pulmonary edema, placental abruption, blood transfusion
Occurrence of maternal death
Occurrence of HELLP syndrome
As defined by American College of Obstetricians and Gynecologists (ACOG)
Occurrence of Eclampsia
As defined by American College of Obstetricians and Gynecologists (ACOG)
Occurrence of Maternal Pulmonary edema
Chest x-ray confirmed
Occurrence of Placental abruption
Incidence of Maternal Blood transfusion
Incidence of spontaneous labor
Incidence of induced labor
Incidence of planned cesarean
Indication for delivery including cesarean for suspected macrosomia
Defined as estimated fetal weight > 4500 grams
Occurrence of Spontaneous vaginal delivery
Occurrence of Operative vaginal delivery
Vacuum or forceps
Occurrence of Cesarean delivery
Indications for operative vaginal delivery
Indication for cesarean
Incidence of Shoulder dystocia
Occurrence of Maternal lacerations
1st, 2nd, 3rd or 4th degree perineal; sulcus, vaginal wall; labial, periurethral, clitoral, abrasion, other
Occurrence of Postpartum hemorrhage
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
Incidence of Maternal venous thromboembolism
Deep venous thrombosis or pulmonary embolism
Incidence of Chorioamnionitis
Defined as a clinical diagnosis before delivery
Maternal postpartum infection
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
Mild and Severe (systolic and diastolic) defined by ACOG
Incidence of Preeclampsia, with or without severe features
Defined by ACOG
Use of antihypertensive drugs
Includes oral antihypertensive, intravenous antihypertensive, or intravenous anticonvulsant
Number of hours in labor and delivery unit
Duration of maternal hospital stay
Measured in Days.
Full Information
NCT ID
NCT05515744
First Posted
August 24, 2022
Last Updated
September 26, 2023
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
Ochsner Health System, University of Pennsylvania, Intermountain Health Care, Inc., Duke University, Inova Fairfax Hospital, University of Utah, University of Alabama at Birmingham, University of North Carolina, Chapel Hill, Technical Resources International, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05515744
Brief Title
Study of Pregnancy And Neonatal Health (SPAN)
Acronym
SPAN
Official Title
Study of Pregnancy And Neonatal Health (SPAN): TIMing of dElivery (TIME) Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2023 (Actual)
Primary Completion Date
December 31, 2027 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
Ochsner Health System, University of Pennsylvania, Intermountain Health Care, Inc., Duke University, Inova Fairfax Hospital, University of Utah, University of Alabama at Birmingham, University of North Carolina, Chapel Hill, Technical Resources International, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will conduct a randomized trial among women with gestational diabetes (GDM). Study of Pregnancy And Neonatal health (SPAN), TIMing of dElivery (TIME) is a randomized trial that will recruit up to 3,450 pregnant women with uncontrolled GDM and randomize the timing of their delivery. Women with GDM who are approached for the trial and are found eligible but do not consent to participating in randomization for delivery will be asked to consent for chart review only (estimated additional n=3,000). The primary objective is to determine the best time to initiate delivery for GDM-complicated deliveries (defined as the time when risk of illness and death for the newborn is the lowest) between 37-39 weeks.
Detailed Description
This is a randomized clinical trial under an adaptive design nested in a larger observational study, among women who are diagnosed with uncontrolled gestational diabetes mellitus (GDM). Women from multiple clinical sites around the United States will be recruited into the study (n=3,450). Women with GDM who are approached for the trial and are found eligible but do not consent to participating to randomization for delivery will be asked to consent for chart review only (estimated additional n=3,000). The primary objective is to determine the optimal time to initiate delivery for GDM complicated deliveries (defined as the time when neonatal morbidity and perinatal mortality risk is the lowest) between 37-39 weeks (n=3,450 women). Newborn developmental and behavior outcomes, and anthropometric measures will also be assessed as secondary outcomes, as well as an exploratory analysis to investigate whether there are clinical, non-clinical or biochemical factors such as glucose measures that will further assist in refining the interval for optimizing time of GDM complicated deliveries relative to neonatal morbidity and perinatal mortality.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus
Keywords
Gestational Diabetes Mellitus, Delivery Timing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6450 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Arm 1
Arm Type
Experimental
Arm Description
Intervention Arm 1 Experimental Initiation of Delivery by induction or planned cesarean at 37 weeks 0-2 days.
Arm Title
Intervention Arm 2
Arm Type
Experimental
Arm Description
Intervention Arm 2 Experimental Initiation of Delivery by induction or planned cesarean at 37 weeks 3-5 days.
Arm Title
Intervention Arm 3
Arm Type
Experimental
Arm Description
Initiation of Delivery by induction or planned cesarean at 37 weeks 6 days to 38 weeks and 1 day.
Arm Title
Intervention Arm 4
Arm Type
Experimental
Arm Description
Intervention Arm 4 Experimental Initiation of Delivery by induction or planned cesarean at 38 weeks 2-4 days.
Arm Title
Intervention Arm 5
Arm Type
Experimental
Arm Description
Initiation of Delivery by induction or planned cesarean at 38 weeks 5 days to 39 weeks and 0 days.
Arm Title
Intervention Arm 6
Arm Type
Experimental
Arm Description
Intervention Arm 6 Experimental Initiation of Delivery by induction or planned cesarean at 39 weeks 1-3 days.
Arm Title
Intervention Arm 7
Arm Type
Experimental
Arm Description
Intervention Arm 7 Experimental Initiation of Delivery by induction or planned cesarean at 39 weeks 4-6 days.
Intervention Type
Procedure
Intervention Name(s)
Childbirth
Intervention Description
Induction or planned cesarean
Primary Outcome Measure Information:
Title
Composite of Neonatal Morbidity and Perinatal Mortality
Time Frame
Hospital discharge
Title
Occurrence of Antepartum, intrapartum or neonatal death (Component of primary outcome)
Time Frame
Antepartum pregnancy period through Newborn Discharge
Title
Incidence of moderate or higher neonatal respiratory support within 72 hours after birth (Component of primary outcome)
Description
Including any of the following: Nasal cannula >/= 2 LPM (liters per minute), Nasal continuous positive airway pressure (NCPAP), NIPPV; (non-invasive intermittent positive pressure ventilation; Note that NIPPV is more general than Bilevel positive airway pressure (BiPAP) i.e. BiPAP is a form of NIPPV, as is non-invasive NAVA, synchronized NIPPV, non-synchronized NIPPV, some ventilators can do nasal IMV in certain situations, etc.), Mechanical ventilation, High frequency ventilation, and ECMO/ECLS (extracorporeal mechanical support/extracorporeal life support)
Time Frame
Delivery through Newborn Discharge
Title
Occurrence of Pneumonia (Component of primary outcome)
Description
Confirmed by X-ray or positive blood culture
Time Frame
Delivery through Newborn Discharge
Title
Occurrence of Meconium aspiration syndrome (Component of primary outcome)
Description
Respiratory distress in an infant born through meconium-stained amniotic fluid with X-ray findings consistent with meconium aspiration syndrome, and whose symptoms could not be otherwise explained
Time Frame
Delivery through Newborn Discharge
Title
Occurrence of Sepsis (Component of primary outcome)
Description
The diagnosis of sepsis will require the presence of a clinically ill infant in whom systemic infection is suspected with a positive blood, CSF, or catheterized/suprapubic urine culture; or, in the absence of positive cultures, clinical evidence of cardiovascular collapse or an unequivocal X-ray confirming infection.
Time Frame
Delivery through Newborn Discharge
Title
Occurrence of Neonatal encephalopathy (Component of primary outcome)
Description
Defined by Shankaran et al. 2005
Time Frame
Delivery through Newborn Discharge
Title
Occurrence of Intracranial hemorrhage (Component of primary outcome)
Description
Intraventricular hemorrhage grades III and IV, subgaleal hematoma, subdural hematoma, or subarachnoid hematoma
Time Frame
Delivery through Newborn Discharge
Title
Occurrence of Seizures (Component of primary outcome)
Time Frame
Delivery through Newborn Discharge
Title
Occurrence of Birth trauma (Component of primary outcome)
Description
Bone fractures, brachial plexus palsy, other neurologic injury, retinal hemorrhage, or facial nerve palsy
Time Frame
Delivery through Newborn Discharge
Title
Occurrence of Hypotension requiring pressor support (Component of primary outcome)
Time Frame
Delivery through Newborn Discharge
Title
Occurrence of hypertrophic cardiomyopathy (Component of primary outcome)
Time Frame
Delivery through Newborn Discharge
Title
Incidence of neonatal intensive care unit (NICU) > 1 day (24 hours) stay
Description
NICU stay > 1 day (24 hours)
Time Frame
Delivery through Newborn Discharge
Secondary Outcome Measure Information:
Title
Incidence of respiratory support less than moderate
Description
Hood oxygen and Nasal cannula <2 LPM (liters per minute); Other than room air (No support)
Time Frame
Delivery through Newborn Discharge
Title
Duration of any respiratory support
Time Frame
Delivery through Newborn Discharge
Title
Duration of moderate respiratory support
Time Frame
Delivery through Newborn Discharge
Title
Occurrence of Transient tachypnea of the newborn
Time Frame
Delivery through Newborn Discharge
Title
Occurrence of Respiratory distress syndrome in Neonates
Description
Both a clinical diagnosis and whether required surfactant
Time Frame
Delivery through Newborn Discharge
Title
Occurrence of Hypoglycemia in neonates
Description
Glucose < 35 mg/dl) and whether required IV therapy
Time Frame
Delivery through Newborn Discharge
Title
Occurrence of Hyperbilirubinemia in Neonates
Description
Requiring phototherapy or exchange transfusion in Neonates
Time Frame
Delivery through Newborn Discharge
Title
Occurrence of Polycythemia in Neonates
Description
Both a clinical diagnosis and whether required partial exchange transfusion
Time Frame
Delivery through Newborn Discharge
Title
Incidence of Therapeutic hypothermia
Description
Head or body cooling
Time Frame
Delivery through Newborn Discharge
Title
Incidence of Transfusion of blood products or blood in neonates
Time Frame
Delivery through Newborn Discharge
Title
Occurrence of neonatal intensive care unit (NICU) or intermediate care unit admission
Time Frame
Delivery through Newborn Discharge
Title
Duration of Neonatal hospital stay
Description
Measured in days
Time Frame
Delivery through Newborn Discharge
Title
Birthweight
Time Frame
Delivery through Newborn Discharge
Title
Incidence of small for gestational age
Description
Defined as < 10th percentile using the Duryea reference
Time Frame
Delivery through Newborn Discharge
Title
Incidence of large for gestational age and macrosomia
Description
LGA defined as > 90th percentile using the Duryea reference and macrosomia defined as birthweight > 4500 g
Time Frame
Delivery through Newborn Discharge
Title
Composite of Maternal Morbidity and Mortality
Description
Maternal death, HELLP syndrome, Eclampsia, Pulmonary edema, placental abruption, blood transfusion
Time Frame
Pregnancy through Discharge
Title
Occurrence of maternal death
Time Frame
Pregnancy through Discharge
Title
Occurrence of HELLP syndrome
Description
As defined by American College of Obstetricians and Gynecologists (ACOG)
Time Frame
Pregnancy through Discharge
Title
Occurrence of Eclampsia
Description
As defined by American College of Obstetricians and Gynecologists (ACOG)
Time Frame
Pregnancy through Discharge
Title
Occurrence of Maternal Pulmonary edema
Description
Chest x-ray confirmed
Time Frame
Pregnancy through Discharge
Title
Occurrence of Placental abruption
Time Frame
Pregnancy through Delivery
Title
Incidence of Maternal Blood transfusion
Time Frame
Pregnancy through Discharge
Title
Incidence of spontaneous labor
Time Frame
Pregnancy through Delivery
Title
Incidence of induced labor
Time Frame
Pregnancy through Delivery
Title
Incidence of planned cesarean
Time Frame
Pregnancy through Delivery
Title
Indication for delivery including cesarean for suspected macrosomia
Description
Defined as estimated fetal weight > 4500 grams
Time Frame
Pregnancy through Delivery
Title
Occurrence of Spontaneous vaginal delivery
Time Frame
Pregnancy through Delivery
Title
Occurrence of Operative vaginal delivery
Description
Vacuum or forceps
Time Frame
Pregnancy through Delivery
Title
Occurrence of Cesarean delivery
Time Frame
Pregnancy through Delivery
Title
Indications for operative vaginal delivery
Time Frame
Pregnancy through Delivery
Title
Indication for cesarean
Time Frame
Pregnancy through Delivery
Title
Incidence of Shoulder dystocia
Time Frame
Delivery through Newborn Discharge
Title
Occurrence of Maternal lacerations
Description
1st, 2nd, 3rd or 4th degree perineal; sulcus, vaginal wall; labial, periurethral, clitoral, abrasion, other
Time Frame
Delivery through Discharge
Title
Occurrence of Postpartum hemorrhage
Description
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
Time Frame
Delivery through Discharge
Title
Occurrence of Maternal ICU Admission
Time Frame
Delivery through Discharge
Title
Incidence of Maternal venous thromboembolism
Description
Deep venous thrombosis or pulmonary embolism
Time Frame
Delivery through Discharge
Title
Incidence of Chorioamnionitis
Description
Defined as a clinical diagnosis before delivery
Time Frame
Delivery through Discharge
Title
Maternal postpartum infection
Description
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
Time Frame
Delivery through Discharge
Title
Maternal hypertension
Description
Mild and Severe (systolic and diastolic) defined by ACOG
Time Frame
Delivery through Discharge
Title
Incidence of Preeclampsia, with or without severe features
Description
Defined by ACOG
Time Frame
Delivery through Discharge
Title
Use of antihypertensive drugs
Description
Includes oral antihypertensive, intravenous antihypertensive, or intravenous anticonvulsant
Time Frame
Delivery through Discharge
Title
Number of hours in labor and delivery unit
Time Frame
Delivery through Discharge
Title
Duration of maternal hospital stay
Description
Measured in Days.
Time Frame
Pregnancy through Newborn Discharge
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA:
Aim 3 (GDM randomized trial, TIME) inclusion criteria:
Women inclusion criteria:
Age ≥ 18 Years
Verified diagnosis of Gestational Diabetes Mellitus (GDM) with abnormal glucose levels*** or meeting other criteria for poor control, specifically any one of the following: Estimated fetal weight ≥90th percentile (LGA), Polyhydramnios, and or Demonstrate noncompliance or nonadherence as defined clinically, including missing visits, not keeping accurate log, etc.
***One or more elevated fasting blood glucoses OR three or more elevated post-prandial blood glucoses after receiving education about appropriate diet and lifestyle modification (e.g. physical activity)
Accurate gestational age as verified by ultrasound
Singleton gestation
English or Spanish speaker
Plans to deliver at the study site hospital
Ability to provide informed consent to be randomized to initiation of delivery
EXCLUSION CRITERIA:
Aim 3 (GDM randomized trial, TIME) exclusion criteria:
Pre-gestational diabetes*
*will be defined as diabetes diagnosis before pregnancy OR before 13 weeks of gestation with a documented fasting plasma glucose ≥ 126 mg/dL, random plasma glucose ≥ 200 mg/dL, 2 hour post glucose ≥ 200 mg/dL during an oral glucose tolerance test (75 g glucose load), or hemoglobin A1c ≥ 6.5%.110.
Previous stillbirth defined as fetal demise ≥ 20 weeks of gestation
Self-reported history of alcohol dependency disorder and/or other drug/substance dependency in the past year
Teratogen exposure (e.g. cyclophosphamide, valproic acid, warfarin)
Known infectious diseases associated with neonatal morbidity (e.g. malaria, cytomegalovirus, rubella, toxoplasmosis, syphilis or Zika virus)
Genetic disorders, aneuploidy and known major fetal anomalies
Fetal demise
Pregnancies with concurrent conditions and other indications for earlier delivery will also be excluded.
Participation in another interventional study that influences management of labor and delivery or perinatal morbidity or mortality
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine L Grantz, MD, MS
Phone
(301) 435-6935
Email
katherine.grantz@nih.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Edwina Yeung, PhD
Phone
301-435-6921
Email
edwina.yeung@nih.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine L Grantz, MD, MS
Organizational Affiliation
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alan Tita
Facility Name
Ochsner Baptist
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Biggio
Facility Name
University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Thorp
Facility Name
Duke University Perinatal Research Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brenna Hughes
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Celeste Durnwald
Facility Name
Intermountain Healthcare
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sean Esplin
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Silver
Facility Name
INOVA Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
G. Larry Maxwell
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized phenotypic data and the SNP genotype, DNA methylation, and RNA sequence data generated from the study will be deposited into scientific databases that are maintained by the National Institutes of Health.
IPD Sharing Time Frame
Data will be shared before publication or at the time of publication or shortly thereafter.
IPD Sharing Access Criteria
Access to the anonymised information stored in NIH archives like DASH and dbGaP will only be accepted via applications from appropriately qualified researchers who sign a legally-binding Data Access Agreement in which they commit to use the data only for research purposes; protect the data confidentiality; provide appropriate data security; not attempt to identify individual participants from whom data were obtained; and not redistribute the data or any subset or derivative that could be used to identify the research participant.
IPD Sharing URL
https://dash.nichd.nih.gov/
Learn more about this trial
Study of Pregnancy And Neonatal Health (SPAN)
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