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NCT03076775 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by University of North Carolina, Chapel Hill.

Completed
Registry status
NA
Development phase
86
Enrollment target

NCT03076775: Completed NA study, sponsored by University of North Carolina, Chapel Hill.

NCT03076775 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 86 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03076775, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.

COMPLETED
Registry status
NA
Development phase
86 participants
Enrollment target

Study Summary

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?

Primary Outcome

C-peptide level (ng/mL) as measure of fetal hyperinsulinemia

Interventions

  • OTHER Maternal glycemic control

Trial Details

FieldValue
Enrollment Target 86 participants
Start Date 2017-06-08
Est. Completion 2021-11-19
Phase NA

What the finished NCT03076775 record still lists

NCT03076775 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 1 intervention - of which Maternal glycemic control is the first listed.

NCT03076775 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03076775 about?

NCT03076775 is a clinical study titled "Euglycemia After Antenatal Late Preterm Steroids, the E-ALPS Study". 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 ...

What is the current status of trial NCT03076775?

This trial is currently completed. It is a NA study. The enrollment target is 86 participants. The study started on 2017-06-08. Estimated completion is 2021-11-19.

What interventions are being tested in trial NCT03076775?

The interventions under investigation include: Maternal glycemic control (OTHER).

Who is sponsoring clinical trial NCT03076775?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03076775's enrollment target sits among peer trials

86 976th of 2000 higher than 1,021 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03076775, the US trial registry maintained by the National Library of Medicine. NCT03076775 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.