Continuous Glucose Monitoring of Late Preterm Birth After Corticosteroids

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.

Study Overview

• Status: Withdrawn
• Conditions: Prematurity; Pregnancy Preterm; Neonatal Hypoglycemia

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal Hypoglycemia	Newborn glucose level less than 40mg/dL	48 hours

Collaborators and Investigators

• Sponsor: Mednax Center for Research, Education, Quality and Safety

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2019
• Primary Completion (Anticipated): April 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: August 14, 2018
• First Submitted That Met QC Criteria: November 9, 2018
• First Posted (Actual): November 13, 2018

Study Record Updates

• Last Update Posted (Actual): August 10, 2020
• Last Update Submitted That Met QC Criteria: August 6, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Corticosteroid; Steroid; Preterm Birth; Betamethasone
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Hypoglycemia; Premature Birth
• Other Study ID Numbers: OBX0042

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No