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NCT05773014 · ClinicalTrials.gov registry record · NA

Digital vs. Speculum Exams for PPROM

A NA study of PPROM, sponsored by Washington University School of Medicine.

Recruiting
Registry status
NA
Development phase
86
Enrollment target
1
Study location

NCT05773014 is a NA study of PPROM that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 86 participants. The trial reports 1 study location across 1 state.

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The verdict

NCT05773014, a NA study of PPROM, is actively recruiting participants, sponsored by Washington University School of Medicine.

RECRUITING
Registry status
NA
Development phase
86 participants
Enrollment target
1
Study location

Study Summary

After preterm prelabor rupture of membranes (PPROM)\[breaking of the amniotic sac prior to 37 weeks gestation in pregnancy\], patients are recommended for inpatient admission and close monitoring for complications including preterm labor, intraamniotic infection (infection of the sac around the baby), and placental abruption (separation of the placenta from wall of the uterus). When evaluation of cervical dilation is clinically indicated, obstetricians traditionally perform sterile speculum exams due to concern for decrease in pregnancy latency (length of time between breaking the water and delivery) with sterile digital exams in retrospective studies. These studies are concerning, however, by the indications for the exams and are at risk for confounding by indication. This is a randomized, non-inferiority trial to examine if sterile digital versus speculum exams effect latency of pregnancy in patients with PPROM.

Conditions Studied

Interventions

  • PROCEDURE Speculum Exams
  • PROCEDURE Digital Exams

Study Locations (1)

Missouri

  • Barnes Jewish Hospital - St Louis

Trial Details

FieldValue
Enrollment Target 86 participants
Start Date 2023-03-27
Est. Completion 2027-07-01
Phase NA

What the Registry Record Tells You About NCT05773014

The ClinicalTrials.gov registry entry for NCT05773014 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with PPROM appearing as the primary indexed condition, and to 2 interventions - of which Speculum Exams is the first listed.

NCT05773014 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.

Frequently Asked Questions

What is clinical trial NCT05773014 about?

NCT05773014 is a clinical study titled "Digital vs. Speculum Exams for PPROM". After preterm prelabor rupture of membranes (PPROM)\[breaking of the amniotic sac prior to 37 weeks gestation in pregnancy\], patients are recommended for inpatient admission and close monitoring for complications including preterm labor, intraamniotic infection (infection of the sac around the baby...

What is the current status of trial NCT05773014?

This trial is currently recruiting. It is a NA study. The enrollment target is 86 participants. The study started on 2023-03-27. Estimated completion is 2027-07-01.

What conditions does trial NCT05773014 study?

This clinical trial studies the following conditions: PPROM.

What interventions are being tested in trial NCT05773014?

The interventions under investigation include: Speculum Exams (PROCEDURE), Digital Exams (PROCEDURE).

Who is sponsoring clinical trial NCT05773014?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05773014 being conducted?

This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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