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NCT04028765 · ClinicalTrials.gov registry record · Phase 4

Pitocin or Oral Misoprostol for PROM IOL

A Phase 4 study, sponsored by University of Pennsylvania.

Completed
Registry status
Phase 4
Development phase
108
Enrollment target

NCT04028765: Completed Phase 4 study, sponsored by University of Pennsylvania.

NCT04028765 is a Phase 4 study that has completed, run by University of Pennsylvania. The registered enrollment target is 108 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04028765, a Phase 4 study, has completed, sponsored by University of Pennsylvania.

COMPLETED
Registry status
Phase 4
Development phase
108 participants
Enrollment target

Study Summary

Premature rupture of membranes (PROM) is a common occurrence of pregnancies at term. A delay from PROM to labor is associated with an increased risk of intrauterine infection and associated maternal and fetal morbidity; therefore, induction of labor (IOL) is recommended. The ideal agent for IOL is not known, particularly among specific subpopulations. The primary aim of this study is to determine if oxytocin (Pitocin) or oral misoprostol results in a shorter interval to delivery after the start of induction among nulliparous women with unfavorable cervical exams with term PROM.

Interventions

  • DRUG Oxytocin
  • DRUG Misoprostol

Trial Details

FieldValue
Enrollment Target 108 participants
Start Date 2019-08-12
Est. Completion 2023-01-08
Phase Phase 4

Sponsor

University of Pennsylvania

1,423 total trials

What the Registry Record Tells You About NCT04028765

The ClinicalTrials.gov registry entry for NCT04028765 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.

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

NCT04028765 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04028765 about?

NCT04028765 is a clinical study titled "Pitocin or Oral Misoprostol for PROM IOL". Premature rupture of membranes (PROM) is a common occurrence of pregnancies at term. A delay from PROM to labor is associated with an increased risk of intrauterine infection and associated maternal and fetal morbidity; therefore, induction of labor (IOL) is recommended. The ideal agent for IOL is n...

What is the current status of trial NCT04028765?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 108 participants. The study started on 2019-08-12. Estimated completion is 2023-01-08.

What interventions are being tested in trial NCT04028765?

The interventions under investigation include: Oxytocin (DRUG), Misoprostol (DRUG).

Who is sponsoring clinical trial NCT04028765?

This trial is sponsored by University of Pennsylvania, which has 1,423 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.