RECRUITING

Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To conduct an unblinded pragmatic randomized controlled trial (pRCT) "Improvement of PPROM Management with Prophylactic Antimicrobial Therapy (iPROMPT)" of a seven-day course of ceftriaxone, clarithromycin, and metronidazole versus the current standard of care of a seven-day course of ampicillin/amoxicillin and azithromycin or erythromycin to prolong pregnancy and decrease adverse perinatal outcomes among hospitalized pregnant individuals undergoing expectant management of PPROM \<34 weeks.

Official Title

Improvement of PPROM Management With Prophylactic Antimicrobial Therapy

Quick Facts

Study Start:2024-07-18
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06396078

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Marissa Berry, MD
CONTACT
614-293-4780
Marissa.Berry@osumc.edu

Principal Investigator

Marissa Berry, MD
PRINCIPAL_INVESTIGATOR
Ohio State University
Kartik K Venkatesh, MD, PhD
PRINCIPAL_INVESTIGATOR
Ohio State University

Study Locations (Sites)

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Ohio State University

  • Marissa Berry, MD, PRINCIPAL_INVESTIGATOR, Ohio State University
  • Kartik K Venkatesh, MD, PhD, PRINCIPAL_INVESTIGATOR, Ohio State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-18
Study Completion Date2025-12

Study Record Updates

Study Start Date2024-07-18
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Pregnancy
  • Preterm premature rupture of membranes
  • Latency
  • Chorioamnionitis
  • Antibiotic prophylaxis

Additional Relevant MeSH Terms

  • Preterm Premature Rupture of Membrane
  • Pregnancy, High Risk
  • Preterm Birth