Gestational Diabetes MellitusSPANNCT05515744
Study of Pregnancy And Neonatal Health (SPAN)
A study testing Childbirth in people with Gestational Diabetes Mellitus, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- Childbirth
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 8 sitesUnited States
- Study dates
- 20 Jan 2023to 16 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35233
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599
Duke University Perinatal Research Center
Durham, North Carolina, 27705
INOVA Fairfax Hospital
Falls Church, Virginia, 22042
Intermountain Healthcare
Murray, Utah, 84107
Ochsner Baptist
New Orleans, Louisiana, 70115
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Utah
Salt Lake City, Utah, 84132
About this study
Official title: Study of Pregnancy And Neonatal Health (SPAN): TIMing of dElivery (TIME) Trial
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.
Read the 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.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- Childbirth
- Keywords
- Gestational Diabetes Mellitus, Delivery Timing
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChildbirthProcedure or surgery
Induction or planned cesarean
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm 1 | Experimental | Intervention Arm 1 Experimental Initiation of Delivery by induction or planned cesarean at 37 weeks 0-2 days. Receives: Procedure: Childbirth |
| Intervention Arm 2 | Experimental | Intervention Arm 2 Experimental Initiation of Delivery by induction or planned cesarean at 37 weeks 3-5 days. Receives: Procedure: Childbirth |
| Intervention Arm 3 | Experimental | Initiation of Delivery by induction or planned cesarean at 37 weeks 6 days to 38 weeks and 1 day. Receives: Procedure: Childbirth |
| Intervention Arm 4 | Experimental | Intervention Arm 4 Experimental Initiation of Delivery by induction or planned cesarean at 38 weeks 2-4 days. Receives: Procedure: Childbirth |
| Intervention Arm 5 | Experimental | Initiation of Delivery by induction or planned cesarean at 38 weeks 5 days to 39 weeks and 0 days. Receives: Procedure: Childbirth |
| Intervention Arm 6 | Experimental | Intervention Arm 6 Experimental Initiation of Delivery by induction or planned cesarean at 39 weeks 1-3 days. Receives: Procedure: Childbirth |
| Intervention Arm 7 | Experimental | Intervention Arm 7 Experimental Initiation of Delivery by induction or planned cesarean at 39 weeks 4-6 days. Receives: Procedure: Childbirth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Neonatal Morbidity and Perinatal Mortality
Measured: Hospital discharge
Occurrence of Antepartum, intrapartum or neonatal death (Component of primary outcome)
Measured: Antepartum pregnancy period through Newborn Discharge
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)
Measured: Delivery through Newborn Discharge
Occurrence of Pneumonia (Component of primary outcome)
Confirmed by X-ray or positive blood culture
Measured: Delivery through Newborn Discharge
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
Measured: Delivery through Newborn Discharge
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.
Measured: Delivery through Newborn Discharge
Occurrence of Neonatal encephalopathy (Component of primary outcome)
Defined by Shankaran et al. 2005
Measured: Delivery through Newborn Discharge
Occurrence of Intracranial hemorrhage (Component of primary outcome)
Intraventricular hemorrhage grades III and IV, subgaleal hematoma, subdural hematoma, or subarachnoid hematoma
Measured: Delivery through Newborn Discharge
Occurrence of Seizures (Component of primary outcome)
Measured: Delivery through Newborn Discharge
Occurrence of Birth trauma (Component of primary outcome)
Bone fractures, brachial plexus palsy, other neurologic injury, retinal hemorrhage, or facial nerve palsy
Measured: Delivery through Newborn Discharge
Occurrence of Hypotension requiring pressor support (Component of primary outcome)
Measured: Delivery through Newborn Discharge
Occurrence of hypertrophic cardiomyopathy (Component of primary outcome)
Measured: Delivery through Newborn Discharge
Incidence of neonatal intensive care unit (NICU) > 1 day (24 hours) stay
NICU stay > 1 day (24 hours)
Measured: Delivery through Newborn Discharge
Secondary outcomes (43)
Incidence of respiratory support less than moderate
Hood oxygen and Nasal cannula <2 LPM (liters per minute); Other than room air (No support)
Measured: Delivery through Newborn Discharge
Duration of any respiratory support
Measured: Delivery through Newborn Discharge
Duration of moderate respiratory support
Measured: Delivery through Newborn Discharge
Occurrence of Transient tachypnea of the newborn
Measured: Delivery through Newborn Discharge
Occurrence of Respiratory distress syndrome in Neonates
Both a clinical diagnosis and whether required surfactant
Measured: Delivery through Newborn Discharge
Occurrence of Hypoglycemia in neonates
Glucose < 35 mg/dl) and whether required IV therapy
Measured: Delivery through Newborn Discharge
Occurrence of Hyperbilirubinemia in Neonates
Requiring phototherapy or exchange transfusion in Neonates
Measured: Delivery through Newborn Discharge
Occurrence of Polycythemia in Neonates
Both a clinical diagnosis and whether required partial exchange transfusion
Measured: Delivery through Newborn Discharge
Incidence of Therapeutic hypothermia
Head or body cooling
Measured: Delivery through Newborn Discharge
Incidence of Transfusion of blood products or blood in neonates
Measured: Delivery through Newborn Discharge
Occurrence of neonatal intensive care unit (NICU) or intermediate care unit admission
Measured: Delivery through Newborn Discharge
Duration of Neonatal hospital stay
Measured in days
Measured: Delivery through Newborn Discharge
Birthweight
Measured: Delivery through Newborn Discharge
Incidence of small for gestational age
Defined as < 10th percentile using the Duryea reference
Measured: Delivery through Newborn Discharge
Incidence of large for gestational age and macrosomia
LGA defined as > 90th percentile using the Duryea reference and macrosomia defined as birthweight > 4500 g
Measured: Delivery through Newborn Discharge
Composite of Maternal Morbidity and Mortality
Maternal death, HELLP syndrome, Eclampsia, Pulmonary edema, placental abruption, blood transfusion
Measured: Pregnancy through Discharge
Occurrence of maternal death
Measured: Pregnancy through Discharge
Occurrence of HELLP syndrome
As defined by American College of Obstetricians and Gynecologists (ACOG)
Measured: Pregnancy through Discharge
Occurrence of Eclampsia
As defined by American College of Obstetricians and Gynecologists (ACOG)
Measured: Pregnancy through Discharge
Occurrence of Maternal Pulmonary edema
Chest x-ray confirmed
Measured: Pregnancy through Discharge
Occurrence of Placental abruption
Measured: Pregnancy through Delivery
Incidence of Maternal Blood transfusion
Measured: Pregnancy through Discharge
Incidence of spontaneous labor
Measured: Pregnancy through Delivery
Incidence of induced labor
Measured: Pregnancy through Delivery
Incidence of planned cesarean
Measured: Pregnancy through Delivery
Indication for delivery including cesarean for suspected macrosomia
Defined as estimated fetal weight > 4500 grams
Measured: Pregnancy through Delivery
Occurrence of Spontaneous vaginal delivery
Measured: Pregnancy through Delivery
Occurrence of Operative vaginal delivery
Vacuum or forceps
Measured: Pregnancy through Delivery
Occurrence of Cesarean delivery
Measured: Pregnancy through Delivery
Indications for operative vaginal delivery
Measured: Pregnancy through Delivery
Indication for cesarean
Measured: Pregnancy through Delivery
Incidence of Shoulder dystocia
Measured: Delivery through Newborn Discharge
Occurrence of Maternal lacerations
1st, 2nd, 3rd or 4th degree perineal; sulcus, vaginal wall; labial, periurethral, clitoral, abrasion, other
Measured: Delivery through Discharge
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
Measured: Delivery through Discharge
Occurrence of Maternal ICU Admission
Measured: Delivery through Discharge
Incidence of Maternal venous thromboembolism
Deep venous thrombosis or pulmonary embolism
Measured: Delivery through Discharge
Incidence of Chorioamnionitis
Defined as a clinical diagnosis before delivery
Measured: Delivery through Discharge
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
Measured: Delivery through Discharge
Maternal hypertension
Mild and Severe (systolic and diastolic) defined by ACOG
Measured: Delivery through Discharge
Incidence of Preeclampsia, with or without severe features
Defined by ACOG
Measured: Delivery through Discharge
Use of antihypertensive drugs
Includes oral antihypertensive, intravenous antihypertensive, or intravenous anticonvulsant
Measured: Delivery through Discharge
Number of hours in labor and delivery unit
Measured: Delivery through Discharge
Duration of maternal hospital stay
Measured in Days.
Measured: Pregnancy through Newborn Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start20 Jan 2023
- Primary completion16 Dec 2024
- Study completion16 Dec 2024
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- 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.
- Responsible party
- Sponsor
- Investigators
- Katherine L Grantz, MD, MS, Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515744
- Sponsor's protocol ID
- 10000737
- Other IDs
- 000737-CH
- Acronym
- SPAN
- Status last verified
- Mar 2025
- First submitted
- 24 Aug 2022
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Pregnancy And Neonatal Health (SPAN): TIMing of dElivery (TIME) Trial
- ClinicalTrials.gov ID
- NCT05515744
- Acronym / sponsor ID
- SPAN / 10000737
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- Gestational Diabetes Mellitus, Delivery Timing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- 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.
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm 1 | Experimental | Procedure: ChildbirthIntervention Arm 1 Experimental Initiation of Delivery by induction or planned cesarean at 37 weeks 0-2 days. |
| Intervention Arm 2 | Experimental | Procedure: ChildbirthIntervention Arm 2 Experimental Initiation of Delivery by induction or planned cesarean at 37 weeks 3-5 days. |
| Intervention Arm 3 | Experimental | Procedure: ChildbirthInitiation of Delivery by induction or planned cesarean at 37 weeks 6 days to 38 weeks and 1 day. |
| Intervention Arm 4 | Experimental | Procedure: ChildbirthIntervention Arm 4 Experimental Initiation of Delivery by induction or planned cesarean at 38 weeks 2-4 days. |
| Intervention Arm 5 | Experimental | Procedure: ChildbirthInitiation of Delivery by induction or planned cesarean at 38 weeks 5 days to 39 weeks and 0 days. |
| Intervention Arm 6 | Experimental | Procedure: ChildbirthIntervention Arm 6 Experimental Initiation of Delivery by induction or planned cesarean at 39 weeks 1-3 days. |
| Intervention Arm 7 | Experimental | Procedure: ChildbirthIntervention Arm 7 Experimental Initiation of Delivery by induction or planned cesarean at 39 weeks 4-6 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChildbirthInduction or planned cesarean | Procedure or surgery | Intervention Arm 1, Intervention Arm 2, Intervention Arm 3, Intervention Arm 4, Intervention Arm 5, Intervention Arm 6, Intervention Arm 7 |
Primary outcome
Composite of Neonatal Morbidity and Perinatal Mortality
Time frame: Hospital discharge
Occurrence of Antepartum, intrapartum or neonatal death (Component of primary outcome)
Time frame: Antepartum pregnancy period through Newborn Discharge
Incidence of moderate or higher neonatal respiratory support within 72 hours after birth (Component of primary outcome)
Time frame: Delivery through Newborn Discharge
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)
Time frame: Delivery through Newborn Discharge
Confirmed by X-ray or positive blood culture
Occurrence of Meconium aspiration syndrome (Component of primary outcome)
Time frame: Delivery through Newborn Discharge
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)
Time frame: Delivery through Newborn Discharge
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)
Time frame: Delivery through Newborn Discharge
Defined by Shankaran et al. 2005
Occurrence of Intracranial hemorrhage (Component of primary outcome)
Time frame: Delivery through Newborn Discharge
Intraventricular hemorrhage grades III and IV, subgaleal hematoma, subdural hematoma, or subarachnoid hematoma
Occurrence of Seizures (Component of primary outcome)
Time frame: Delivery through Newborn Discharge
Occurrence of Birth trauma (Component of primary outcome)
Time frame: Delivery through Newborn Discharge
Bone fractures, brachial plexus palsy, other neurologic injury, retinal hemorrhage, or facial nerve palsy
Occurrence of Hypotension requiring pressor support (Component of primary outcome)
Time frame: Delivery through Newborn Discharge
Occurrence of hypertrophic cardiomyopathy (Component of primary outcome)
Time frame: Delivery through Newborn Discharge
Incidence of neonatal intensive care unit (NICU) > 1 day (24 hours) stay
Time frame: Delivery through Newborn Discharge
NICU stay > 1 day (24 hours)
43 secondary outcomes
Incidence of respiratory support less than moderate
Time frame: Delivery through Newborn Discharge
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
Occurrence of Hypoglycemia in neonates
Time frame: Delivery through Newborn Discharge
Occurrence of Hyperbilirubinemia in Neonates
Time frame: Delivery through Newborn Discharge
Occurrence of Polycythemia in Neonates
Time frame: Delivery through Newborn Discharge
Incidence of Therapeutic hypothermia
Time frame: Delivery through Newborn Discharge
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
Birthweight
Time frame: Delivery through Newborn Discharge
Incidence of small for gestational age
Time frame: Delivery through Newborn Discharge
Incidence of large for gestational age and macrosomia
Time frame: Delivery through Newborn Discharge
Composite of Maternal Morbidity and Mortality
Time frame: Pregnancy through Discharge
Occurrence of maternal death
Time frame: Pregnancy through Discharge
Occurrence of HELLP syndrome
Time frame: Pregnancy through Discharge
Occurrence of Eclampsia
Time frame: Pregnancy through Discharge
Occurrence of Maternal Pulmonary edema
Time frame: Pregnancy through Discharge
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
Occurrence of Spontaneous vaginal delivery
Time frame: Pregnancy through Delivery
Occurrence of Operative vaginal delivery
Time frame: Pregnancy through Delivery
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
Occurrence of Postpartum hemorrhage
Time frame: Delivery through Discharge
Occurrence of Maternal ICU Admission
Time frame: Delivery through Discharge
Incidence of Maternal venous thromboembolism
Time frame: Delivery through Discharge
Incidence of Chorioamnionitis
Time frame: Delivery through Discharge
Maternal postpartum infection
Time frame: Delivery through Discharge
Maternal hypertension
Time frame: Delivery through Discharge
Incidence of Preeclampsia, with or without severe features
Time frame: Delivery through Discharge
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine L Grantz, MD, MS principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Childbirth in people with Gestational Diabetes Mellitus, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of Neonatal Morbidity and Perinatal Mortality (time frame: Hospital discharge). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.