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Vaginal Compared With Intramuscular Progesterone for Prevention of Preterm Birth in High Risk Pregnant Women

Primary Purpose

Premature Birth

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Vaginal progesterone
Intramuscular progesterone
Sponsored by
Ewha Womans University Mokdong Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Premature Birth focused on measuring Premature Birth, progesterone

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • With a history of prior spontaneous preterm birth or short cervix length
  • Spontaneous preterm birth: preterm birth <37 weeks of gestation due to spontaneous preterm labor or preterm premature rupture of membranes (PPROM)
  • Short Cervix length : cervix length <25 mm as measured by transvaginal ultrasound at 16-24 weeks of gestation

Exclusion Criteria:

  • Multiple gestations
  • Major congenital anomalies
  • Elective prophylactic cervical cerclage <16 weeks of gestation during current pregnancy
  • Previous intentional preterm birth due to maternal or fetal indications, such as preeclampsia and fetal growth restriction
  • Diabetes, hypertension, other severe medical diseases

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Vaginal progesterone

    Intramuscular progesterone

    Arm Description

    Vaginal progesterone(Utrogestan)200mg/day, during 14~21 weeks.

    Intramuscular progesterone(Progesterone Depot Jenapharm Injection)250mg/week, during 14~21 weeks.

    Outcomes

    Primary Outcome Measures

    Preterm Birth Rate before 37 weeks of gestation

    Secondary Outcome Measures

    Preterm Birth Rate before 34 weeks of gestation
    Preterm Birth Rate before 28 weeks of gestation
    Result of birth(rate of death, weight, cause of hospitalization to NICU)
    Any complications occurred to newborn and mother

    Full Information

    First Posted
    November 26, 2014
    Last Updated
    November 26, 2014
    Sponsor
    Ewha Womans University Mokdong Hospital
    Collaborators
    Samsung Medical Center, Han Wha Pharma Co., Ltd., Ministry of Health & Welfare, Korea
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02304237
    Brief Title
    Vaginal Compared With Intramuscular Progesterone for Prevention of Preterm Birth in High Risk Pregnant Women
    Official Title
    A Multicenter, Randomized, Open-label, Investigator Initiated Trial of Vaginal Compared With Intramuscular Progesterone for Prevention of Preterm Birth in High Risk Pregnant Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2014 (undefined)
    Primary Completion Date
    November 2016 (Anticipated)
    Study Completion Date
    December 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ewha Womans University Mokdong Hospital
    Collaborators
    Samsung Medical Center, Han Wha Pharma Co., Ltd., Ministry of Health & Welfare, Korea

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study is for compare the efficacy of two different regimens(vaginal vs intramuscular) of progesterone therapy in prevention of preterm birth in high risk pregnant women.
    Detailed Description
    The objectives of this study is 1) To compare the efficacy of two different regimens of progesterone therapy in preventing preterm birth less than 37 weeks of gestation. 2) To compare the cost-benefit, adverse effects and patient preference of two different regimens of progesterone therapy. Design: Multi-center, randomized, open-label trial

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Premature Birth
    Keywords
    Premature Birth, progesterone

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    360 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Vaginal progesterone
    Arm Type
    Experimental
    Arm Description
    Vaginal progesterone(Utrogestan)200mg/day, during 14~21 weeks.
    Arm Title
    Intramuscular progesterone
    Arm Type
    Active Comparator
    Arm Description
    Intramuscular progesterone(Progesterone Depot Jenapharm Injection)250mg/week, during 14~21 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Vaginal progesterone
    Other Intervention Name(s)
    Utrogestan
    Intervention Description
    micronized progesterone 200mg/day till 36 weeks 6 days of gestation or premature rupture of membranes
    Intervention Type
    Drug
    Intervention Name(s)
    Intramuscular progesterone
    Other Intervention Name(s)
    Progesterone Depot Jenapharm Injection
    Intervention Description
    hydroxyprogesterone caproate 250mg/ml/week till 36 weeks 6 days of gestation or premature rupture of membranes
    Primary Outcome Measure Information:
    Title
    Preterm Birth Rate before 37 weeks of gestation
    Time Frame
    from study enrollment to maximum 37 weeks of gestation
    Secondary Outcome Measure Information:
    Title
    Preterm Birth Rate before 34 weeks of gestation
    Time Frame
    from study enrollment to maximum 34 weeks of gestation
    Title
    Preterm Birth Rate before 28 weeks of gestation
    Time Frame
    from study enrollment to maximum 28 weeks of gestation
    Title
    Result of birth(rate of death, weight, cause of hospitalization to NICU)
    Time Frame
    from study enrollment to maximum 37 weeks of gestation
    Title
    Any complications occurred to newborn and mother
    Time Frame
    from study enrollment to maximum 37 weeks of gestation

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: With a history of prior spontaneous preterm birth or short cervix length Spontaneous preterm birth: preterm birth <37 weeks of gestation due to spontaneous preterm labor or preterm premature rupture of membranes (PPROM) Short Cervix length : cervix length <25 mm as measured by transvaginal ultrasound at 16-24 weeks of gestation Exclusion Criteria: Multiple gestations Major congenital anomalies Elective prophylactic cervical cerclage <16 weeks of gestation during current pregnancy Previous intentional preterm birth due to maternal or fetal indications, such as preeclampsia and fetal growth restriction Diabetes, hypertension, other severe medical diseases
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Young Ju Kim
    Phone
    822-2650-5500
    Email
    kkyj@ewha.ac.kr
    First Name & Middle Initial & Last Name or Official Title & Degree
    SUK-JOO CHOI
    Phone
    822-3410-3546
    Email
    drmaxmix.choi@samsung.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Young Ju Kim
    Organizational Affiliation
    Ewha Womans University Mokdong Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32536019
    Citation
    Choi SJ, Kwak DW, Kil K, Kim SC, Kwon JY, Kim YH, Na S, Bae JG, Cha HH, Shim JY, Oh KY, Lee KA, Kim SM, Cho IA, Lee SM, Cho GJ, Jo YS, Choi GY, Choi SK, Hur SE, Hwang HS, Kim YJ; from The Preterm Birth Research Committee of the Korean Society of Maternal Fetal Medicine. Vaginal compared with intramuscular progestogen for preventing preterm birth in high-risk pregnant women (VICTORIA study): a multicentre, open-label randomised trial and meta-analysis. BJOG. 2020 Dec;127(13):1646-1654. doi: 10.1111/1471-0528.16365. Epub 2020 Jul 14.
    Results Reference
    derived

    Learn more about this trial

    Vaginal Compared With Intramuscular Progesterone for Prevention of Preterm Birth in High Risk Pregnant Women

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