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Vaginal Indomethacin for Preterm Labor (TOCOMED)

Primary Purpose

Obstetric Labor, Premature

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Indomethacin
Nifedipine
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstetric Labor, Premature focused on measuring preterm labor, tocolysis, prematurity

Eligibility Criteria

16 Years - 60 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Singe fetus
  • Gestational age between 24+0/7 and 31+6/7
  • At least one uterine contraction in ten minutes for at least 20 minutes upon tocography admission
  • Cervical parameters: 1 cm dilation or more or 80% cervical effacement or cervical length 20mm or less

Exclusion Criteria:

  • Rupture of membranes
  • Vaginal bleeding
  • Cervical dilation ≥5cm
  • Known fetal malformations
  • Fetal heart rate abnormalities
  • Suspected placental abruption of adherent placental syndrome
  • Known sensitivity to one of the drugs used in the study (Indometacin and nifedipine)
  • Maternal hypotension and known aortic or mitral stenosis
  • Presence of cervical cerclage
  • Previous administration of tocolytic drugs in current pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Indomethacin group

    Nifedipine group

    Arm Description

    Group of patients receiving Indomethacin for preterm labor treatment.

    Group of patients receiving Nifedipine for preterm labor treatment.

    Outcomes

    Primary Outcome Measures

    Time to delivery
    The time from administration of intervention do delivery
    Gestational age
    Days from last menstrual period

    Secondary Outcome Measures

    Rate of preterm deliveries
    Rate of deliveries under 37+0/7 weeks of gestation
    Rate of remote from term deliveries
    Rate of deliveries under 34+0/7 weeks of gestation
    Rate of extreme preterm deliveries
    Rate of deliveries under 28+0/7 weeks of gestation
    neonatal immediate outcomes
    Neonatal Apgar scores
    Neonatal immediate outcome
    Neonatal umbilical cord pH levels
    Neonatal birth weight
    birth wight as recorded in chart in grams
    Neonatal outcomes
    neonatal intensive care unit administration rate

    Full Information

    First Posted
    May 7, 2020
    Last Updated
    August 10, 2020
    Sponsor
    Hadassah Medical Organization
    Collaborators
    Sheba Medical Center, Soroka University Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04404686
    Brief Title
    Vaginal Indomethacin for Preterm Labor
    Acronym
    TOCOMED
    Official Title
    Vaginal Indomethacin Versus Oral Nifedipine for Preterm Labor; a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2020 (Anticipated)
    Primary Completion Date
    April 2024 (Anticipated)
    Study Completion Date
    April 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hadassah Medical Organization
    Collaborators
    Sheba Medical Center, Soroka University Medical Center

    4. Oversight

    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.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Indometacin is a cyclooxygenase agent from the NSAID family that has been used to treat preterm contractions since the 70's by preventing the synthesis of prostaglandins. It has been shown to be significantly more effective than placebo and postpone labor for 7-10 days, prolong pregnancies above 37 weeks of gestation and reduce numbers of small for gestational age neonates. Nifedipine is a calcium channel blocker agent that has been shown to reduce rates of labor within 48 hours from treatment. Previous studies comparing rectal Indometacin to oral nifedipine were inconclusive. Prostaglandins are synthesized in the uterus and the uterine cervix and therefore local administration of Indometacin may be more effective than other forms of administration, as been shown in a previous study. In this study we aim to compare vaginal Indometacin administration to a commonly used tocolytic agent, nifedipine.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obstetric Labor, Premature
    Keywords
    preterm labor, tocolysis, prematurity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Masking Description
    Caregivers will receive a closed envelope with the drug to be used. since the routes of administration are different, from that point on the caregiver and patient will be aware of chosen drug
    Allocation
    Randomized
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Indomethacin group
    Arm Type
    Experimental
    Arm Description
    Group of patients receiving Indomethacin for preterm labor treatment.
    Arm Title
    Nifedipine group
    Arm Type
    Active Comparator
    Arm Description
    Group of patients receiving Nifedipine for preterm labor treatment.
    Intervention Type
    Drug
    Intervention Name(s)
    Indomethacin
    Other Intervention Name(s)
    Indomed
    Intervention Description
    Per vagina administration of 100 mg followed by a second 100 mg dosage the following day
    Intervention Type
    Drug
    Intervention Name(s)
    Nifedipine
    Other Intervention Name(s)
    Pressolat
    Intervention Description
    Per os administration according to current protocol of 20mg each 20 minutes for 1 hour followed by 20 mg q8 for 48 hours.
    Primary Outcome Measure Information:
    Title
    Time to delivery
    Description
    The time from administration of intervention do delivery
    Time Frame
    through study completion, approximately 1 year
    Title
    Gestational age
    Description
    Days from last menstrual period
    Time Frame
    through study completion, approximately 1 year
    Secondary Outcome Measure Information:
    Title
    Rate of preterm deliveries
    Description
    Rate of deliveries under 37+0/7 weeks of gestation
    Time Frame
    through study completion, approximately 1 year
    Title
    Rate of remote from term deliveries
    Description
    Rate of deliveries under 34+0/7 weeks of gestation
    Time Frame
    through study completion, approximately 1 year
    Title
    Rate of extreme preterm deliveries
    Description
    Rate of deliveries under 28+0/7 weeks of gestation
    Time Frame
    through study completion, approximately 1 year
    Title
    neonatal immediate outcomes
    Description
    Neonatal Apgar scores
    Time Frame
    through study completion, approximately 1 year
    Title
    Neonatal immediate outcome
    Description
    Neonatal umbilical cord pH levels
    Time Frame
    through study completion, approximately 1 year
    Title
    Neonatal birth weight
    Description
    birth wight as recorded in chart in grams
    Time Frame
    through study completion, approximately 1 year
    Title
    Neonatal outcomes
    Description
    neonatal intensive care unit administration rate
    Time Frame
    through study completion, approximately 1 year

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Pregnant women
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Singe fetus Gestational age between 24+0/7 and 31+6/7 At least one uterine contraction in ten minutes for at least 20 minutes upon tocography admission Cervical parameters: 1 cm dilation or more or 80% cervical effacement or cervical length 20mm or less Exclusion Criteria: Rupture of membranes Vaginal bleeding Cervical dilation ≥5cm Known fetal malformations Fetal heart rate abnormalities Suspected placental abruption of adherent placental syndrome Known sensitivity to one of the drugs used in the study (Indometacin and nifedipine) Maternal hypotension and known aortic or mitral stenosis Presence of cervical cerclage Previous administration of tocolytic drugs in current pregnancy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hila Hochler, MD
    Phone
    00 972 52 300 3722
    Email
    hilahochler@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hadas Lemberg, PhD
    Phone
    00 972 2 6777572
    Email
    lhadas@hadassah.org.il
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hila Hochler, MD
    Organizational Affiliation
    Hadassah Medical Organization
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
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    7369252
    Citation
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    Zuckerman H, Shalev E, Gilad G, Katzuni E. Further study of the inhibition of premature labor by indomethacin. Part II double-blind study. J Perinat Med. 1984;12(1):25-9. doi: 10.1515/jpme.1984.12.1.25.
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    PubMed Identifier
    2014850
    Citation
    Besinger RE, Niebyl JR, Keyes WG, Johnson TR. Randomized comparative trial of indomethacin and ritodrine for the long-term treatment of preterm labor. Am J Obstet Gynecol. 1991 Apr;164(4):981-6; discussion 986-8. doi: 10.1016/0002-9378(91)90569-d.
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    Vaginal Indomethacin for Preterm Labor

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