Continuous Glucose Monitoring of Late Preterm Birth After Corticosteroids

NCT03738293 | Withdrawn

• 1 other identifier: OBX0042
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pregnancy Preterm; Neonatal Hypoglycemia; Prematurity

Keywords

Steroid; Corticosteroid; Betamethasone; Preterm Birth

Outcome Measures

Primary Outcomes (1)

• Neonatal Hypoglycemia

  Newborn glucose level less than 40mg/dL

  48 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Pediatrix: lead

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: November 13, 2018
• Study Start: December 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 10, 2020

Record last verified: 2020-08