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Comparing Two Prophylactic Antibiotic Protocols in Women With Term Prolonged Pre-labor Rupture of Membrane and Preterm Labor

Primary Purpose

Preterm Labor With Preterm Delivery, Premature Rupture of Membranes Prolonged

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ampicillin Only Product
ampicillin plus gentamicin
Sponsored by
Western Galilee Hospital-Nahariya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Labor With Preterm Delivery focused on measuring prolonged term PROM, pre-term labor, prophylactic antibiotic, peripartum infection, bacterial distribution

Eligibility Criteria

18 Years - 48 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: maternal age > 18 years singleton pregnancy vertex presentation prolonged >18 h prom or preterm delivery

-

Exclusion Criteria:

  • GBS carrier
  • preterm premature rupture of membrane for conservative treatment
  • intra-uterine fetal death fetal major anomaly
  • drug allergy for the antibiotic in use in this study
  • women receiving antibiotic treatment for other infection such as urinary tract infection

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    women with term prolonged>18h rupture of membrane

    women with preterm labor

    Arm Description

    women with term prolonged >18 h prom or in preterm delivery will be treated with IV ampicillin 2 gr every 6 hours until delivery

    women with term prolonged >18 h prom or in preterm delivery will be treated with IV ampicillin 2 gr every 6 hours until delivery plus IV gentamicin 5 mg/kg every 24 hours

    Outcomes

    Primary Outcome Measures

    endometritis rate
    chorioamnionitis rate

    Secondary Outcome Measures

    cord blood pH
    maternal intrapartum fever
    body temperature,
    NICU (neonatal intensive care unit) hospitalization length,
    days
    rate of neonatal early onset sepsis
    positive blood culture
    neonatal APGAR score
    Rate of participants treated with antibiotics during the postpartum period
    maternal postpartum hospitalization length
    Number of neonate with ventilation support
    Number of neonate treated with antibiotics

    Full Information

    First Posted
    July 9, 2022
    Last Updated
    July 19, 2022
    Sponsor
    Western Galilee Hospital-Nahariya
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05469984
    Brief Title
    Comparing Two Prophylactic Antibiotic Protocols in Women With Term Prolonged Pre-labor Rupture of Membrane and Preterm Labor
    Official Title
    Comparing Obstetrical Outcomes and Infectious Morbidity Between Two Prophylactic Antibiotic Protocols in Women With Term Prolonged Pre-labor Rupture of Membrane and Preterm Labor
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2022 (Anticipated)
    Primary Completion Date
    September 2024 (Anticipated)
    Study Completion Date
    September 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Western Galilee Hospital-Nahariya

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This randomized prospective trial aimed to compare 2 prophylactic antibiotic regiment (ampicillin alone versus ampicillin plus gentamycin) in term prolonged pre-labor rupture of membrane and in preterm deliveries and examine related obstetrical outcome and infectious morbidity
    Detailed Description
    Maternal peripartum fever is a common complication of pregnancy and postpartum period associated with potentially serious obstetrical outcomes and infectious morbidity. Peripartum infections includes intrapartum intraamniotic infection (IAI) and postpartum endometritis. Both are caused by polymicrobial bacterial infection. Increased latency period from rupture of membranes (ROM) until delivery is a common risk factor. Another risk factor is pre-term delivery. This randomized prospective trial aimed to compare 2 prophylactic antibiotic regiment (ampicillin alone versus ampicillin plus gentamycin) in term prolonged pre-labor rupture of membrane and in preterm deliveries and examine related obstetrical outcome and infectious morbidity. Primary outcome-peripartum infections- chorioamnionitis, endometritis and surgical site infection secondary outcome- obstetrical outcome- mode of delivery, Apgar score, cord blood pH, peripartum fever, maternal length of admission, postpartum maternal antibiotic treatment, Surface swab cultures were obtained from the placenta, amnion and umbilical cord (birth cultures) and uterine swab cultures, maternal blood culture, placental histologic evaluation neonatal outcomes-NICU admission, length of admission, neonatal morbidity-ventilation support, early neonatal sepsis

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Preterm Labor With Preterm Delivery, Premature Rupture of Membranes Prolonged
    Keywords
    prolonged term PROM, pre-term labor, prophylactic antibiotic, peripartum infection, bacterial distribution

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    women with prolonged premature rupture of membrane>18 h or women in preterm delivery will be randomized to receive one of two prophylactic antibiotic treatment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    women with term prolonged>18h rupture of membrane
    Arm Type
    Active Comparator
    Arm Description
    women with term prolonged >18 h prom or in preterm delivery will be treated with IV ampicillin 2 gr every 6 hours until delivery
    Arm Title
    women with preterm labor
    Arm Type
    Active Comparator
    Arm Description
    women with term prolonged >18 h prom or in preterm delivery will be treated with IV ampicillin 2 gr every 6 hours until delivery plus IV gentamicin 5 mg/kg every 24 hours
    Intervention Type
    Drug
    Intervention Name(s)
    Ampicillin Only Product
    Intervention Description
    women will be randomize to receive Ampicillin Only Product or ampicillin plus gentamicin
    Intervention Type
    Drug
    Intervention Name(s)
    ampicillin plus gentamicin
    Intervention Description
    women will be randomize to receive Ampicillin Only Product or ampicillin plus gentamicin
    Primary Outcome Measure Information:
    Title
    endometritis rate
    Time Frame
    up to 6 weeks postpartum
    Title
    chorioamnionitis rate
    Time Frame
    during labor (up to delivery of the newborn)
    Secondary Outcome Measure Information:
    Title
    cord blood pH
    Time Frame
    immediately after delivery of the placenta
    Title
    maternal intrapartum fever
    Description
    body temperature,
    Time Frame
    during labor (up to delivery of the newborn)
    Title
    NICU (neonatal intensive care unit) hospitalization length,
    Description
    days
    Time Frame
    up to 3 month from delivery
    Title
    rate of neonatal early onset sepsis
    Description
    positive blood culture
    Time Frame
    up to one week from delivery
    Title
    neonatal APGAR score
    Time Frame
    at 1 and 5 minute post-delivery
    Title
    Rate of participants treated with antibiotics during the postpartum period
    Time Frame
    6 week postpartum
    Title
    maternal postpartum hospitalization length
    Time Frame
    up to 6 weeks post partum
    Title
    Number of neonate with ventilation support
    Time Frame
    one week from delivery
    Title
    Number of neonate treated with antibiotics
    Time Frame
    one week from delivery

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    women 18 years or older with singleton pregnancy
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    48 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: maternal age > 18 years singleton pregnancy vertex presentation prolonged >18 h prom or preterm delivery - Exclusion Criteria: GBS carrier preterm premature rupture of membrane for conservative treatment intra-uterine fetal death fetal major anomaly drug allergy for the antibiotic in use in this study women receiving antibiotic treatment for other infection such as urinary tract infection
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maya Wolf, MD
    Phone
    972-50-7887800
    Email
    mayaw@gmc.gov.il

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    17365450
    Citation
    Apantaku O, Mulik V. Maternal intra-partum fever. J Obstet Gynaecol. 2007 Jan;27(1):12-5. doi: 10.1080/01443610601016644.
    Results Reference
    background
    PubMed Identifier
    28742677
    Citation
    Committee Opinion No. 712: Intrapartum Management of Intraamniotic Infection. Obstet Gynecol. 2017 Aug;130(2):e95-e101. doi: 10.1097/AOG.0000000000002236.
    Results Reference
    background
    PubMed Identifier
    31783982
    Citation
    Kachikis A, Eckert LO, Walker C, Bardaji A, Varricchio F, Lipkind HS, Diouf K, Huang WT, Mataya R, Bittaye M, Cutland C, Boghossian NS, Mallett Moore T, McCall R, King J, Mundle S, Munoz FM, Rouse C, Gravett M, Katikaneni L, Ault K, Klein NP, Roberts DJ, Kochhar S, Chescheir N; Brighton Collaboration Chorioamnionitis Working Group. Chorioamnionitis: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data. Vaccine. 2019 Dec 10;37(52):7610-7622. doi: 10.1016/j.vaccine.2019.05.030. No abstract available.
    Results Reference
    background
    PubMed Identifier
    11717646
    Citation
    Yoon BH, Romero R, Moon JB, Shim SS, Kim M, Kim G, Jun JK. Clinical significance of intra-amniotic inflammation in patients with preterm labor and intact membranes. Am J Obstet Gynecol. 2001 Nov;185(5):1130-6. doi: 10.1067/mob.2001.117680.
    Results Reference
    background
    PubMed Identifier
    8765246
    Citation
    Soper DE, Mayhall CG, Froggatt JW. Characterization and control of intraamniotic infection in an urban teaching hospital. Am J Obstet Gynecol. 1996 Aug;175(2):304-9; discussion 309-10. doi: 10.1016/s0002-9378(96)70139-4.
    Results Reference
    background

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    Comparing Two Prophylactic Antibiotic Protocols in Women With Term Prolonged Pre-labor Rupture of Membrane and Preterm Labor

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