Continuous Glucose Monitoring of Late Preterm Birth After Corticosteroids

NCT ID: NCT03738293

Last Updated: 2020-08-10

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-12-31
• Study Completion Date: 2020-12-31

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Pediatrix

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

OBX0042

Identifier Type: -

Identifier Source: org_study_id