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NCT02133573 · ClinicalTrials.gov registry record · Phase 2

Randomized Trial of Maternal Progesterone Therapy

A Phase 2 study, sponsored by Children's Hospital of Philadelphia.

Completed
Registry status
Phase 2
Development phase
102
Enrollment target

NCT02133573 is a Phase 2 study that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 102 participants.

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The verdict

NCT02133573, a Phase 2 study, has completed, sponsored by Children's Hospital of Philadelphia.

COMPLETED
Registry status
Phase 2
Development phase
102 participants
Enrollment target

Study Summary

Neurodevelopmental disability is now recognized as the most common long-term complication after cardiac surgery in neonates. Research studies have shown that progesterone is critical to the development of the brain and in a variety of clinical situations including brain injury can protect the brain. The purpose of this research study is to determine whether progesterone administered during the 3rd trimester of pregnancy (24-39 weeks) to pregnant women protects the brain of unborn babies with CHD and improves their neurodevelopmental outcomes after heart surgery.

Interventions

  • DRUG Progesterone
  • DRUG Vaginal lubricant

Trial Details

FieldValue
Enrollment Target 102 participants
Start Date 2014-07
Est. Completion 2021-11
Phase Phase 2

Sponsor

Children's Hospital of Philadelphia

431 total trials

What the Registry Record Tells You About NCT02133573

The ClinicalTrials.gov registry entry for NCT02133573 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital of Philadelphia, which has 431 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Progesterone is the first listed.

NCT02133573 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02133573 about?

NCT02133573 is a clinical study titled "Randomized Trial of Maternal Progesterone Therapy". Neurodevelopmental disability is now recognized as the most common long-term complication after cardiac surgery in neonates. Research studies have shown that progesterone is critical to the development of the brain and in a variety of clinical situations including brain injury can protect the brain....

What is the current status of trial NCT02133573?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2014-07. Estimated completion is 2021-11.

What interventions are being tested in trial NCT02133573?

The interventions under investigation include: Progesterone (DRUG), Vaginal lubricant (DRUG).

Who is sponsoring clinical trial NCT02133573?

This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.