Pregnancy PretermNCT03738293
Continuous Glucose Monitoring of Late Preterm Birth After Corticosteroids
An observational study of Pregnancy Preterm and Neonatal Hypoglycemia, run by Pediatrix.
Trial summary
Women undergoing late preterm birth are at high risk of delivering a newborn with neonatal hypoglycemia. The investigators plan to monitor interstitial glucose levels prior to delivery in these women in order to develop a better understanding of the relationship between maternal hyperglycemia and neonatal hypoglycemia. 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
- Pregnancy Preterm, Neonatal Hypoglycemia, Prematurity
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2019to Dec 2020
- Phase
- Observational
- 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
Study population: Pregnant women admitted in the late preterm period who are at high risk for late preterm birth and receiving betamethasone in accordance to current American College of Obstetrician and Gynecologist guidelines are screened.
Who may be able to join
- Pregnancy admitted to labor and delivery between 34w0d and 36w5d
- English speaking women
- High probability of delivery in late preterm period defined by any of the following:
- Membrane rupture by 2 criteria (pooling, positive nitrazine, or ferning) OR leaking amniotic fluid from the cervix
- Preterm labor with intact membrane, defined as at least 6 uterine contractions in 60 minutes and at least: cervical dilation greater than or equal to 3cm dilated OR 80% effaced OR planned delivery by induction of labor or cesarean in no less than 24 hrs and no more than 7 days, for any indication as deemed necessary by the provider
- Received at least one dose of corticosteroid within twelve hours of enrollment
Who cannot join
- Any prior antenatal corticosteroid course in current pregnancy
- Systemic corticosteroid administration during current pregnancy
- Fetal demise or known major fetal anomaly, including cardiac anomaly or hydrops
- Maternal contraindication to betamethasone: hypersensitivity reaction to any component of the medication, idiopathic thrombocytopenic, purpura, systemic fungal infection, or current use of amphotericin B
- Diabetes, pregestational or gestational
- Preexisting plan for intrapartum monitoring of maternal glucose levels for any reason
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- Delivery expected within 12 hours of randomization, because of insufficient time for corticosteroids to confer benefit, including:
- Ruptured membranes with cervical dilation ≥ 3cm or with more than 6 contractions per hour unless Pitocin is deferred for at least 12 hours
- Chorioamnionitis
- Cervical dilation ≥ 8cm
- Evidence of non-reassuring fetal status requiring immediate delivery
- To ensure that there is an adequate proportion of women presenting at 34 to 35 weeks gestation, enrollment will be restricted so that no more than 50% of the women in the trial present at 36 weeks.
About this study
Official title: An Observational Study to Predict Neonatal Hypoglycemia Using Antenatal Continuous Glucose Monitoring Among Late Preterm Parturients Receiving Corticosteroids
Women undergoing late preterm birth are at high risk of delivering a newborn with neonatal hypoglycemia. The investigators plan to monitor interstitial glucose levels prior to delivery in these women in order to develop a better understanding of the relationship between maternal hyperglycemia and neonatal hypoglycemia.
- Conditions
- Pregnancy Preterm, Neonatal Hypoglycemia, Prematurity
- Keywords
- Steroid, Corticosteroid, Betamethasone, Preterm Birth
- Medical subject headings
- Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Hypoglycemia
Newborn glucose level less than 40mg/dL
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study startDec 2019 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: Study was not started at site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy PretermStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pediatrix
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738293
- Sponsor's protocol ID
- OBX0042
- Status last verified
- Aug 2020
- First submitted
- 14 Aug 2018
- Last updated
- 10 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Predict Neonatal Hypoglycemia Using Antenatal Continuous Glucose Monitoring Among Late Preterm Parturients Receiving Corticosteroids
- ClinicalTrials.gov ID
- NCT03738293
- Acronym / sponsor ID
- OBX0042
- Conditions
- Pregnancy Preterm, Neonatal Hypoglycemia, Prematurity
- Keywords
- Steroid, Corticosteroid, Betamethasone, Preterm Birth
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study was not started at site.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PediatrixUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 13 Nov 2018 (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.
Women undergoing late preterm birth are at high risk of delivering a newborn with neonatal hypoglycemia. The investigators plan to monitor interstitial glucose levels prior to delivery in these women in order to develop a better understanding of the relationship between maternal hyperglycemia and neonatal hypoglycemia.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women admitted in the late preterm period who are at high risk for late preterm birth and receiving betamethasone in accordance to current American College of Obstetrician and Gynecologist guidelines are screened.
Key inclusion criteria (6 listed)
- Pregnancy admitted to labor and delivery between 34w0d and 36w5d
- English speaking women
- High probability of delivery in late preterm period defined by any of the following:
- Received at least one dose of corticosteroid within twelve hours of enrollment
Key exclusion criteria (12 listed)
- Any prior antenatal corticosteroid course in current pregnancy
- Systemic corticosteroid administration during current pregnancy
- Fetal demise or known major fetal anomaly, including cardiac anomaly or hydrops
- Maternal contraindication to betamethasone: hypersensitivity reaction to any component of the medication, idiopathic thrombocytopenic, purpura, systemic fungal infection, or current use of amphotericin B
- Diabetes, pregestational or gestational
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neonatal Hypoglycemia
Time frame: 48 hours
Newborn glucose level less than 40mg/dL
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Preterm and Neonatal Hypoglycemia, run by Pediatrix.
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 6 inclusion and 12 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: withdrawn, as of the sponsor's last update on 10 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Neonatal Hypoglycemia (time frame: 48 hours). 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 10 Aug 2020.