Continuous Glucose Monitoring of Late Preterm Birth After Corticosteroids

Withdrawn

• Conditions: Pregnancy Preterm; Neonatal Hypoglycemia; Prematurity

• Registration Number: NCT03738293
• Lead Sponsor: Pediatrix

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-14
• Study First Submitted QC: 2018-11-09
• Study First Posted: 2018-11-13
• Study Start: 2019-12
• Primary Completion: 2020-04
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-06
• Last Update Posted: 2020-08-10
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neonatal Hypoglycemia	48 hours	Newborn glucose level less than 40mg/dL