Study of Pregnancy And Neonatal Health (SPAN) (SPAN)

December 11, 2025 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
304

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Ochsner Baptist
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina - Chapel Hill
      • Durham, North Carolina, United States, 27705
        • Duke University Perinatal Research Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Healthcare
      • Salt Lake City, Utah, United States, 84132
        • University of Utah
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

INCLUSION CRITERIA:

Aim 3 (GDM randomized trial, TIME) inclusion criteria:

Women inclusion criteria:

  1. Age ≥ 18 Years

  2. 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)

  3. Accurate gestational age as verified by ultrasound
  4. Singleton gestation
  5. English or Spanish speaker
  6. Plans to deliver at the study site hospital
  7. Ability to provide informed consent to be randomized to initiation of delivery

EXCLUSION CRITERIA:

Aim 3 (GDM randomized trial, TIME) exclusion criteria:

  1. 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.

  2. Previous stillbirth defined as fetal demise ≥ 20 weeks of gestation
  3. Self-reported history of alcohol dependency disorder and/or other drug/substance dependency in the past year
  4. Teratogen exposure (e.g. cyclophosphamide, valproic acid, warfarin)
  5. Known infectious diseases associated with neonatal morbidity (e.g. malaria, cytomegalovirus, rubella, toxoplasmosis, syphilis or Zika virus)
  6. Genetic disorders, aneuploidy and known major fetal anomalies
  7. Fetal demise
  8. Pregnancies with concurrent conditions and other indications for earlier delivery will also be excluded.
  9. Participation in another interventional study that influences management of labor and delivery or perinatal morbidity or mortality

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Arm 1
Intervention Arm 1 Experimental Initiation of Delivery by induction or planned cesarean at 37 weeks 0-2 days.
Procedure: Childbirth
Induction or planned cesarean
Experimental: Intervention Arm 2
Intervention Arm 2 Experimental Initiation of Delivery by induction or planned cesarean at 37 weeks 3-5 days.
Procedure: Childbirth
Induction or planned cesarean
Experimental: Intervention Arm 3
Initiation of Delivery by induction or planned cesarean at 37 weeks 6 days to 38 weeks and 1 day.
Procedure: Childbirth
Induction or planned cesarean
Experimental: Intervention Arm 4
Intervention Arm 4 Experimental Initiation of Delivery by induction or planned cesarean at 38 weeks 2-4 days.
Procedure: Childbirth
Induction or planned cesarean
Experimental: Intervention Arm 5
Initiation of Delivery by induction or planned cesarean at 38 weeks 5 days to 39 weeks and 0 days.
Procedure: Childbirth
Induction or planned cesarean
Experimental: Intervention Arm 6
Intervention Arm 6 Experimental Initiation of Delivery by induction or planned cesarean at 39 weeks 1-3 days.
Procedure: Childbirth
Induction or planned cesarean
Experimental: Intervention Arm 7
Intervention Arm 7 Experimental Initiation of Delivery by induction or planned cesarean at 39 weeks 4-6 days.
Procedure: Childbirth
Induction or planned cesarean

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Composite of Neonatal Morbidity and Perinatal Mortality
Time Frame: Hospital discharge
Hospital discharge
Occurrence of Antepartum, intrapartum or neonatal death (Component of primary outcome)
Time Frame: Antepartum pregnancy period through Newborn Discharge
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)
Delivery through Newborn Discharge
Occurrence of Pneumonia (Component of primary outcome)
Time Frame: Delivery through Newborn Discharge
Confirmed by X-ray or positive blood culture
Delivery through Newborn Discharge
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
Delivery through Newborn Discharge
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.
Delivery through Newborn Discharge
Occurrence of Neonatal encephalopathy (Component of primary outcome)
Time Frame: Delivery through Newborn Discharge
Defined by Shankaran et al. 2005
Delivery through Newborn Discharge
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
Delivery through Newborn Discharge
Occurrence of Seizures (Component of primary outcome)
Time Frame: Delivery through Newborn Discharge
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
Delivery through Newborn Discharge
Occurrence of Hypotension requiring pressor support (Component of primary outcome)
Time Frame: Delivery through Newborn Discharge
Delivery through Newborn Discharge
Occurrence of hypertrophic cardiomyopathy (Component of primary outcome)
Time Frame: Delivery through Newborn Discharge
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)
Delivery through Newborn Discharge

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Delivery through Newborn Discharge
Duration of any respiratory support
Time Frame: Delivery through Newborn Discharge
Delivery through Newborn Discharge
Duration of moderate respiratory support
Time Frame: Delivery through Newborn Discharge
Delivery through Newborn Discharge
Occurrence of Transient tachypnea of the newborn
Time Frame: Delivery through Newborn Discharge
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
Delivery through Newborn Discharge
Occurrence of Hypoglycemia in neonates
Time Frame: Delivery through Newborn Discharge
Glucose < 35 mg/dl) and whether required IV therapy
Delivery through Newborn Discharge
Occurrence of Hyperbilirubinemia in Neonates
Time Frame: Delivery through Newborn Discharge
Requiring phototherapy or exchange transfusion in Neonates
Delivery through Newborn Discharge
Occurrence of Polycythemia in Neonates
Time Frame: Delivery through Newborn Discharge
Both a clinical diagnosis and whether required partial exchange transfusion
Delivery through Newborn Discharge
Incidence of Therapeutic hypothermia
Time Frame: Delivery through Newborn Discharge
Head or body cooling
Delivery through Newborn Discharge
Incidence of Transfusion of blood products or blood in neonates
Time Frame: Delivery through Newborn Discharge
Delivery through Newborn Discharge
Occurrence of neonatal intensive care unit (NICU) or intermediate care unit admission
Time Frame: Delivery through Newborn Discharge
Delivery through Newborn Discharge
Duration of Neonatal hospital stay
Time Frame: Delivery through Newborn Discharge
Measured in days
Delivery through Newborn Discharge
Birthweight
Time Frame: Delivery through Newborn Discharge
Delivery through Newborn Discharge
Incidence of small for gestational age
Time Frame: Delivery through Newborn Discharge
Defined as < 10th percentile using the Duryea reference
Delivery through Newborn Discharge
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
Delivery through Newborn Discharge
Composite of Maternal Morbidity and Mortality
Time Frame: Pregnancy through Discharge
Maternal death, HELLP syndrome, Eclampsia, Pulmonary edema, placental abruption, blood transfusion
Pregnancy through Discharge
Occurrence of maternal death
Time Frame: Pregnancy through Discharge
Pregnancy through Discharge
Occurrence of HELLP syndrome
Time Frame: Pregnancy through Discharge
As defined by American College of Obstetricians and Gynecologists (ACOG)
Pregnancy through Discharge
Occurrence of Eclampsia
Time Frame: Pregnancy through Discharge
As defined by American College of Obstetricians and Gynecologists (ACOG)
Pregnancy through Discharge
Occurrence of Maternal Pulmonary edema
Time Frame: Pregnancy through Discharge
Chest x-ray confirmed
Pregnancy through Discharge
Occurrence of Placental abruption
Time Frame: Pregnancy through Delivery
Pregnancy through Delivery
Incidence of Maternal Blood transfusion
Time Frame: Pregnancy through Discharge
Pregnancy through Discharge
Incidence of spontaneous labor
Time Frame: Pregnancy through Delivery
Pregnancy through Delivery
Incidence of induced labor
Time Frame: Pregnancy through Delivery
Pregnancy through Delivery
Incidence of planned cesarean
Time Frame: Pregnancy through Delivery
Pregnancy through Delivery
Indication for delivery including cesarean for suspected macrosomia
Time Frame: Pregnancy through Delivery
Defined as estimated fetal weight > 4500 grams
Pregnancy through Delivery
Occurrence of Spontaneous vaginal delivery
Time Frame: Pregnancy through Delivery
Pregnancy through Delivery
Occurrence of Operative vaginal delivery
Time Frame: Pregnancy through Delivery
Vacuum or forceps
Pregnancy through Delivery
Occurrence of Cesarean delivery
Time Frame: Pregnancy through Delivery
Pregnancy through Delivery
Indications for operative vaginal delivery
Time Frame: Pregnancy through Delivery
Pregnancy through Delivery
Indication for cesarean
Time Frame: Pregnancy through Delivery
Pregnancy through Delivery
Incidence of Shoulder dystocia
Time Frame: Delivery through Newborn Discharge
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
Delivery through Discharge
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
Delivery through Discharge
Occurrence of Maternal ICU Admission
Time Frame: Delivery through Discharge
Delivery through Discharge
Incidence of Maternal venous thromboembolism
Time Frame: Delivery through Discharge
Deep venous thrombosis or pulmonary embolism
Delivery through Discharge
Incidence of Chorioamnionitis
Time Frame: Delivery through Discharge
Defined as a clinical diagnosis before delivery
Delivery through Discharge
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
Delivery through Discharge
Maternal hypertension
Time Frame: Delivery through Discharge
Mild and Severe (systolic and diastolic) defined by ACOG
Delivery through Discharge
Incidence of Preeclampsia, with or without severe features
Time Frame: Delivery through Discharge
Defined by ACOG
Delivery through Discharge
Use of antihypertensive drugs
Time Frame: Delivery through Discharge
Includes oral antihypertensive, intravenous antihypertensive, or intravenous anticonvulsant
Delivery through Discharge
Number of hours in labor and delivery unit
Time Frame: Delivery through Discharge
Delivery through Discharge
Duration of maternal hospital stay
Time Frame: Pregnancy through Newborn Discharge
Measured in Days.
Pregnancy through Newborn Discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Pennsylvania
University of Alabama at Birmingham
Duke University
University of North Carolina, Chapel Hill
University of Utah
Intermountain Health Care, Inc.
Ochsner Health System
Inova Fairfax Hospital
Technical Resources International, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katherine L Grantz, MD, MS, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 16, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 16, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10000737
  • 000737-CH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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