Euglycemia After Antenatal Late Preterm Steroids, the E-ALPS Study

University of North Carolina (UNC)

Status: Completed

Conditions: Neonatal Hypoglycemia; Pregnancy Preterm; Hyperglycemia Drug Induced

Treatments: Other: Maternal glycemic control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03076775

1R03HD096188-01 (U.S. NIH Grant/Contract)

18-1970

Details and patient eligibility

About

Annually in the U.S 300,000 neonates are born late preterm, defined as 34 weeks 0 days - 36 weeks 6 days. The Antenatal Late Preterm Steroids (ALPS) Trial demonstrated that maternal treatment with betamethasone in the late preterm period significantly reduces neonatal respiratory complications, but also increases neonatal hypoglycemia, compared to placebo.

This research study will attempt to answer the following primary question: Does a management protocol aimed at maintaining maternal euglycemia after ALPS decrease fetal hyperinsulinemia, compared to usual antepartum care?

Full description

Euglycemia after Antenatal Late Preterm Steroids, the E-ALPS Study:

There is a fundamental gap in understanding the adverse metabolic effects of antenatal late preterm steroids (ALPS). In 2016, an important randomized clinical trial of 2827 late preterm pregnancies showed that antenatal betamethasone (BMZ) significantly reduced neonatal respiratory complications compared with placebo. However, those neonates exposed to BMZ were also more likely to have hypoglycemia at birth. This unexpected adverse outcome raised concern among both obstetricians and neonatologists and remains an important knowledge gap to be filled. The rationale for the proposed research is that steroid-induced maternal hyperglycemia leads to transient fetal hyperinsulinemia, which causes hypoglycemia in neonates that are delivered during this time-period. Thus, the fetal metabolic consequences and subsequent neonatal hypoglycemia observed after exposure to BMZ in utero can be prevented by achieving maternal euglycemia prior to delivery.

This protocol describes a randomized clinical trial to evaluate whether screening for and treatment of steroid-induced hyperglycemia in non-diabetic women treated with BMZ in the late preterm period can decrease the rate of fetal hyperinsulinemia, thus reducing neonatal hypoglycemia and improving short-term neonatal outcomes.

This study was formerly approved as Institutional Review Board #16-3200.

Enrollment: 86 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Singleton gestation with no known major fetal anomalies
• Gestational age at randomization between 34 weeks 0 days and 36 weeks 5 days
• Receiving antenatal betamethasone due to high probability of delivery in late preterm period

Exclusion criteria

• Pre-gestational or gestational diabetes mellitus
• Maternal contraindication to insulin
• Planned outpatient treatment with antenatal betamethasone
• Participation in clinical trial that could affect primary outcome or participation in this trial in a previous pregnancy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 2 patient groups

Intervention

Experimental group

Description:

Women will undergo regular maternal blood glucose screening and treatment of hyperglycemia following BMZ administration to achieve maternal glycemic control until delivery or hospital discharge, for a maximum of 5 days.

Treatment:

Other: Maternal glycemic control

Usual Care

No Intervention group

Description:

Routine antenatal care will be performed without any maternal blood glucose screening nor treatment as is usual care at each of the study sites.