Continuous Glucose Monitoring of Late Preterm Birth After Corticosteroids

Prematurity Clinical Trial

Official title:

An Observational Study to Predict Neonatal Hypoglycemia Using Antenatal Continuous Glucose Monitoring Among Late Preterm Parturients Receiving Corticosteroids

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03738293
• Other study ID #: OBX0042
• Status: Withdrawn
• Start date: December 2019
• Est. completion date: December 2020

Study information

• Verified date: August 2020
• Source: Mednax Center for Research, Education, Quality and Safety
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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:

1. Membrane rupture by 2 criteria (pooling, positive nitrazine, or ferning) OR leaking amniotic fluid from the cervix

2. 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

Exclusion Criteria:

• 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

• Delivery expected within 12 hours of randomization, because of insufficient time for corticosteroids to confer benefit, including:

1. Ruptured membranes with cervical dilation = 3cm or with more than 6 contractions per hour unless Pitocin is deferred for at least 12 hours

2. Chorioamnionitis

3. Cervical dilation = 8cm

4. 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.

Related Conditions & MeSH terms

• Hypoglycemia
• Neonatal Hypoglycemia
• Pregnancy Preterm
• Premature Birth
• Prematurity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mednax Center for Research, Education, Quality and Safety

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal Hypoglycemia	Newborn glucose level less than 40mg/dL	48 hours