RECRUITING

Outpatient Antibiotics Following Previable Rupture of Membranes (pPPROM) Between 18 0/7 and 22 6/7 Weeks Gestational Age

Conditions

Pregnancy Preterm Pregnancy Prom PROM, Preterm (Pregnancy)PROM (Pregnancy)Premat Rupture Membranes Preterm Unspec to Length of Time Between Rupture/Labor Premature Birth

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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

A randomized, controlled, non-placebo trial to primarily assess the effect of oral, outpatient antibiotics (i.e., azithromycin and amoxicillin) on latency (i.e., proportion of patients that deliver within 28 days from membrane rupture) following previable, prelabor rupture of membranes between 18 0/7 and 22 6/7 weeks gestational age.

Official Title

Outpatient Antibiotics Following Previable Rupture of Membranes (pPPROM) Between 18 0/7 and 22 6/7 Weeks Gestational Age

Quick Facts

Study Start:2023-01-13

Study Completion:2027-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05345457

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:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* English-speaking * Pregnant * Live, singleton gestation * Patient able to provide informed consent * Gestational age between 18 weeks and 0 days and 22 weeks and 6 days at the time of -membrane rupture * Diagnosis of preterm, prelabor rupture of membranes by clinical exam findings of either 1) visualization of amniotic fluid passing from the cervical canal and/or pooling in the vagina via sterile speculum examination, 2) a basic pH (i.e., positive nitrazine) test of vaginal fluid, 3) arborization (i.e., ferning) of dried vaginal fluid identified via microscopic examination, and/or 4) an amniotic fluid index (AFI) of less than 4cm	* Gestational dating performed or confirmed by ultrasound at ≥ 18 weeks and 0 days gestational age * Patient desires pregnancy interruption or induction of labor * Known major fetal anomaly or aneuploidy * Amniocentesis ≤ 7 days of diagnosis of rupture of membranes * Cervical cerclage placement ≤ 7 days of diagnosis of rupture of membranes * Known drug allergy or significant adverse reactions to macrolide or penicillin antibiotics * Current antibiotic use at the time of membrane rupture diagnosis * Vaginal bleeding at the time of membrane rupture diagnosis or within first 24 hours from diagnosis * Febrile at the time of membrane rupture diagnosis (i.e., temperature ≥ 38 degrees Celsius) and/or within first 24 hours of diagnosis * Active preterm labor at the time of membrane rupture diagnosis (i.e., consistent contraction pattern associated with cervical change) and/or within first 24 hours of diagnosis * Cervical dilation of ≥ 4 cm * Prolapse of fetal parts beyond the level of the internal cervical os * Declination to complete full, 7-day outpatient monitoring prior to hospital re-admission should rupture occur during the 22nd week of gestation

Inclusion Criteria

Exclusion Criteria

* English-speaking
* Pregnant
* Live, singleton gestation
* Patient able to provide informed consent
* Gestational age between 18 weeks and 0 days and 22 weeks and 6 days at the time of -membrane rupture
* Diagnosis of preterm, prelabor rupture of membranes by clinical exam findings of either 1) visualization of amniotic fluid passing from the cervical canal and/or pooling in the vagina via sterile speculum examination, 2) a basic pH (i.e., positive nitrazine) test of vaginal fluid, 3) arborization (i.e., ferning) of dried vaginal fluid identified via microscopic examination, and/or 4) an amniotic fluid index (AFI) of less than 4cm

* Gestational dating performed or confirmed by ultrasound at ≥ 18 weeks and 0 days gestational age
* Patient desires pregnancy interruption or induction of labor
* Known major fetal anomaly or aneuploidy
* Amniocentesis ≤ 7 days of diagnosis of rupture of membranes
* Cervical cerclage placement ≤ 7 days of diagnosis of rupture of membranes
* Known drug allergy or significant adverse reactions to macrolide or penicillin antibiotics
* Current antibiotic use at the time of membrane rupture diagnosis
* Vaginal bleeding at the time of membrane rupture diagnosis or within first 24 hours from diagnosis
* Febrile at the time of membrane rupture diagnosis (i.e., temperature ≥ 38 degrees Celsius) and/or within first 24 hours of diagnosis
* Active preterm labor at the time of membrane rupture diagnosis (i.e., consistent contraction pattern associated with cervical change) and/or within first 24 hours of diagnosis
* Cervical dilation of ≥ 4 cm
* Prolapse of fetal parts beyond the level of the internal cervical os
* Declination to complete full, 7-day outpatient monitoring prior to hospital re-admission should rupture occur during the 22nd week of gestation

Contacts and Locations

Study Contact

Felicia LeMoine, MD

CONTACT

(216) 983-6606

felicia.lemoine@uhhospitals.org

David Hackney, MD

CONTACT

(216) 844-3787

david.hackney@uhhospitals.org

Principal Investigator

David Hackney, MD

PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Justin Lappen, MD

PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Brian Mercer, MD

PRINCIPAL_INVESTIGATOR

MetroHealth Hospitals

Study Locations (Sites)

University Hospitals

Cleveland, Ohio, 44106

United States

MetroHealth

Cleveland, Ohio, 44109

United States

Cleveland Clinic

Cleveland, Ohio, 44111

United States

Collaborators and Investigators

Sponsor: University Hospitals Cleveland Medical Center

David Hackney, MD, PRINCIPAL_INVESTIGATOR, University Hospitals Cleveland Medical Center
Justin Lappen, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic
Brian Mercer, MD, PRINCIPAL_INVESTIGATOR, MetroHealth Hospitals

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 Date2023-01-13

Study Completion Date2027-06

Study Record Updates

Study Start Date2023-01-13

Study Completion Date2027-06

Terms related to this study

Additional Relevant MeSH Terms

Pregnancy Preterm
Pregnancy Prom
PROM, Preterm (Pregnancy)
PROM (Pregnancy)
Premat Rupture Membranes Preterm Unspec to Length of Time Between Rupture/Labor
Premature Birth