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NCT02546193 · ClinicalTrials.gov registry record · NA

Outpatient Foley Catheter Compared to Usual Inpatient Care for Labor Induction

A NA study, sponsored by Mayo Clinic.

Terminated
Registry status
NA
Development phase
39
Enrollment target

NCT02546193: Clinical Trial NA study, sponsored by Mayo Clinic.

NCT02546193 is a NA study that was terminated before completion, run by Mayo Clinic. The registered enrollment target is 39 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02546193, a NA study, was terminated before completion, sponsored by Mayo Clinic.

TERMINATED
Registry status
NA
Development phase
39 participants
Enrollment target

Study Summary

Induction of labor, or causing labor to start before it otherwise starts spontaneously, is sometimes necessary as pregnancy progresses to ensure the safety of both mother and infant. Labor induction often begins with cervical ripening, in which various methods are used to prepare the cervix for contractions and labor. Cervical ripening is beneficial and decreases the need for cesarean section; however, it can be a lengthy process. By tradition, pregnant women are admitted to the hospital at the start of this process and remain inpatient until after the baby is born. There is increasing interest in allowing the mother to return to her own home during the very first part of this process. She may be more satisfied in a more comfortable environment with her family. Growing scientific evidence supports use of the Foley catheter as an approach to outpatient cervical ripening. The Foley catheter is a safe, effective method that is already used often in the inpatient setting. It does not cause increased health risks for either mother or baby. Previous research studies have shown that it is just as safe and effective when women return to their own homes with a Foley catheter and that women spend less time in the hospital before delivery. More information is needed before this becomes a standard of care. This research study will allow pregnant women to return home for the first night of their labor induction with a Foley catheter in place. In the morning they will return to the hospital and stay until after delivery. They will be compared to a group of women who remain in the hospital for their entire labor induction. The benefits to going home during labor induction may include increasing maternal satisfaction and optimizing the use of resources in the hospital.

Interventions

  • DRUG Misoprostol
  • DEVICE Foley catheter

Trial Details

FieldValue
Enrollment Target 39 participants
Start Date 2015-09
Est. Completion 2017-06-08
Phase NA

Sponsor

Mayo Clinic

2,844 total trials

What the Registry Record Tells You About NCT02546193

The ClinicalTrials.gov registry entry for NCT02546193 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.

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

NCT02546193 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02546193 about?

NCT02546193 is a clinical study titled "Outpatient Foley Catheter Compared to Usual Inpatient Care for Labor Induction". Induction of labor, or causing labor to start before it otherwise starts spontaneously, is sometimes necessary as pregnancy progresses to ensure the safety of both mother and infant. Labor induction often begins with cervical ripening, in which various methods are used to prepare the cervix for cont...

What is the current status of trial NCT02546193?

This trial is currently terminated. It is a NA study. The enrollment target is 39 participants. The study started on 2015-09. Estimated completion is 2017-06-08.

What interventions are being tested in trial NCT02546193?

The interventions under investigation include: Misoprostol (DRUG), Foley catheter (DEVICE).

Who is sponsoring clinical trial NCT02546193?

This trial is sponsored by Mayo Clinic, which has 2,844 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, the data changelog, or report a data error.