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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05345457
Recruitment Status : Not yet recruiting
First Posted : April 26, 2022
Last Update Posted : June 8, 2022
Sponsor:
Collaborators:
MetroHealth Medical Center
The Cleveland Clinic
Information provided by (Responsible Party):
David Hackney MD, MS, University Hospitals Cleveland Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pregnancy Preterm Pregnancy Prom PROM, Preterm (Pregnancy) PROM (Pregnancy) Premat Rupture Membranes Preterm Unspec to Length of Time Between Rupture/Labor Premature Birth Drug: Azithromycin Pill Drug: Amoxicillin Pill Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outpatient Antibiotics Following Previable Rupture of Membranes (pPPROM) Between 18 0/7 and 22 6/7 Weeks Gestational Age
Estimated Study Start Date : July 2022
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Tears

Arm Intervention/treatment
Experimental: Antibiotics
Patients randomized into the treatment (i.e., antibiotics) arm of the study will be treated with a seven-day course of oral azithromycin and amoxicillin. Azithromycin will be dosed as single 500 mg dose (2-250mg oral tablets) administered immediately following randomization, yet prior to discharge to home, followed with 1-250mg oral tablet daily for 4 additional days (for a total of 5 days). Amoxicillin will be dosed as a single-500mg oral tablet three times daily for 7 days with first dose also being given prior to discharge home.
Drug: Azithromycin Pill
Azithromycin will be dosed as single 500 mg dose (2-250mg oral tablets) administered immediately following randomization, yet prior to discharge to home, followed with 1-250mg oral tablet daily for 4 additional days (for a total of 5 days).

Drug: Amoxicillin Pill
Amoxicillin will be dosed as a single-500mg oral tablet three times daily for 7 days with first dose also being given prior to discharge home.

No Intervention: No antibiotics
Patients randomized into the control (i.e., no antibiotics arm) will be managed according to standard of care practices for previable PPROM desiring of expectant management.



Primary Outcome Measures :
  1. Delivery within 28 days [ Time Frame: 28 days from date of rupture ]
    The proportion of patients that undergo a spontaneous or medically-indicated delivery within 28 days from diagnosis of previable prelabor rupture of membranes (pPPROM)


Secondary Outcome Measures :
  1. Severe maternal morbidity composite [ Time Frame: From diagnosis of membrane rupture to 6 weeks following delivery ]
    The proportion of patient's "positive" for severe maternal morbidity composite. A patient will be termed "positive" for severe maternal morbidity composite if any one of the following is diagnosed: maternal sepsis, postpartum hemorrhage, maternal ICU admission, maternal death.

  2. Severe neonatal morbidity composite [ Time Frame: From date of delivery to date of hospital discharge (up to 6 months) ]
    The proportion of patient's "positive" for severe neonatal morbidity composite. A neonate will be termed "positive" for severe neonatal morbidity composite if any one of the following is diagnosis: bronchopulmonary dysplasia (BPD), pulmonary hypoplasia, intraventricular hemorrhage (IVH) grade III/IV, necrotizing enterocolitis (NEC) Bell's Stage II or greater, neonatal sepsis with positive blood cultures, neonatal pneumonia with positive blood cultures, neonatal death.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05345457


Contacts
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Contact: Felicia LeMoine, MD (216) 983-6606 felicia.lemoine@uhhospitals.org
Contact: David Hackney, MD (216) 844-3787 david.hackney@uhhospitals.org

Sponsors and Collaborators
University Hospitals Cleveland Medical Center
MetroHealth Medical Center
The Cleveland Clinic
Investigators
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Principal Investigator: David Hackney, MD University Hospitals Cleveland Medical Center
Principal Investigator: Justin Lappen, MD The Cleveland Clinic
Principal Investigator: Brian Mercer, MD MetroHealth Hospitals
Publications:

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Responsible Party: David Hackney MD, MS, Division Director, Maternal-Fetal Medicine, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT05345457    
Other Study ID Numbers: OAPROM Trial
First Posted: April 26, 2022    Key Record Dates
Last Update Posted: June 8, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Once data collection and primary analysis has been completed. A de-identified data set will be provided.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data will become available upon publication of study results and remain available for 2 years upon study completion.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Premature Birth
Fetal Membranes, Premature Rupture
Rupture
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries
Amoxicillin
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents