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Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth (VIP)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02913495
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : October 13, 2021
Sponsor:
Collaborators:
Baystate Medical Center
George Washington University
Vriginia Commonwealth University
Ohio State University
Information provided by (Responsible Party):
Thomas Jefferson University

Tracking Information
First Submitted Date  ICMJE September 22, 2016
First Posted Date  ICMJE September 23, 2016
Last Update Posted Date October 13, 2021
Actual Study Start Date  ICMJE September 2016
Actual Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2016)
Preterm birth <37 weeks [ Time Frame: up to 9 months (delivery) ]
Incidence of gestational age of delivery less than 37 weeks
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2021)
  • Gestational age of delivery [ Time Frame: up to 9 months (delivery) ]
  • Preterm birth <34 weeks and <28 weeks [ Time Frame: up to 9 months (delivery) ]
  • Second trimester cervical length <25mm [ Time Frame: 2 months ]
  • Mode of delivery [ Time Frame: up to 9 months (delivery) ]
    Delivery mode- vaginal, cesarean, operative vaginal
  • Maternal mortality [ Time Frame: up to 9 months (delivery) ]
  • 5 minute Apgar score [ Time Frame: up to 9 months (delivery) ]
  • Neonatal intensive care unit admission [ Time Frame: up to 9 months (delivery) ]
  • Composite neonatal morbidity [ Time Frame: up to 9 months (delivery) ]
    (respiratory distress syndrome, grade III or IV intraventricular hemorrhage, culture proven sepsis, neonatal enterocolitis, and perinatal mortality up to 28 days of life)
  • Birthweight [ Time Frame: up to 9 months (delivery) ]
  • Perinatal mortality up to 28 days of life [ Time Frame: up to 10 months (4 weeks after delivery) ]
  • Medication side effects [ Time Frame: up to 9 months (delivery) ]
  • Satisfaction with medication (5 point Likert scale) [ Time Frame: up to 9 months (delivery) ]
  • Medication adherence [ Time Frame: up to 9 months (delivery) ]
    Vaginal progesterone:
    • Overall adherence: #days used/#days of treatment x 100
    • Non-adherent: ≥4 days between doses
    Intramuscular progesterone:
    • Overall adherence: #weeks used/#weeks of treatment x 100
    • Non-adherent: ≥10 days between doses
  • Planned subgroup analysis for the outcome preterm birth <37 weeks, <34 weeks, <28 weeks [ Time Frame: up to 9 months (delivery) ]
    Planned subgroup analysis for the primary outcome as well as the secondary outcomes of preterm birth <34 weeks and <28 weeks of patients with a cervical length <25mm versus ≥25mm, history-indicated cerclage versus not, and for those started on progesterone 16-20 weeks versus 20-24 weeks.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2016)
  • Gestational age of delivery [ Time Frame: up to 9 months (delivery) ]
  • Preterm birth <34 weeks and <28 weeks [ Time Frame: up to 9 months (delivery) ]
  • Second trimester cervical length <25mm [ Time Frame: 2 months ]
  • Mode of delivery [ Time Frame: up to 9 months (delivery) ]
    Delivery mode- vaginal, cesarean, operative vaginal
  • Maternal mortality [ Time Frame: up to 9 months (delivery) ]
  • 5 minute Apgar score [ Time Frame: up to 9 months (delivery) ]
  • Neonatal intensive care unit admission [ Time Frame: up to 9 months (delivery) ]
  • Composite neonatal morbidity [ Time Frame: up to 9 months (delivery) ]
    (respiratory distress syndrome, grade III or IV intraventricular hemorrhage, culture proven sepsis, neonatal enterocolitis, and perinatal mortality up to 28 days of life)
  • Birthweight [ Time Frame: up to 9 months (delivery) ]
  • Perinatal mortality up to 28 days of life [ Time Frame: up to 10 months (4 weeks after delivery) ]
  • Medication side effects [ Time Frame: up to 9 months (delivery) ]
  • Satisfaction with medication (5 point Likert scale) [ Time Frame: up to 9 months (delivery) ]
  • Medication adherence [ Time Frame: up to 9 months (delivery) ]
    Vaginal progesterone:
    • Overall adherence: #days used/#days of treatment x 100
    • Non-adherent: ≥4 days between doses
    Intramuscular progesterone:
    • Overall adherence: #weeks used/#weeks of treatment x 100
    • Non-adherent: ≥10 days between doses
  • Planned subgroup analysis for the outcome preterm birth <37 weeks, <34 weeks, <28 weeks [ Time Frame: up to 9 months (delivery) ]
    Planned subgroup analysis for the primary outcome as well as the secondary outcomes of preterm birth <34 weeks and <28 weeks of patients with a cervical length <25mm versus ≥25mm and for those started on progesterone 16-20 weeks versus 20-24 weeks.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth
Official Title  ICMJE Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth
Brief Summary The purpose of this study is to evaluate the two suggested therapies for prevention of recurrent preterm birth (PTB) in women with a prior spontaneous preterm birth, vaginal and intramuscular progesterone to determine whether vaginal progesterone is superior to intramuscular progesterone in the prevention of recurrent preterm birth.
Detailed Description Preterm birth is one of the leading causes of neonatal morbidity and mortality. One of the greatest predictors of preterm birth is a history of prior spontaneous preterm birth. Presently 17 hydroxyprogesterone caproate (intramuscular) is the only FDA approved product for the prevention of recurrent preterm birth, however recent studies suggest that vaginal progesterone may be used for this purpose, and may even be superior. The American College of Obstetrics and Gynecology does not specify the optimal route of progesterone administration for the prevention of recurrent preterm birth. It is our intention to compare vaginal and intramuscular progesterone to see if one is superior.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Premature Birth
Intervention  ICMJE
  • Drug: Vaginal Progesterone
    Other Name: micronized progesterone
  • Drug: Intramuscular Progesterone (17 alpha hydroxprogesterone caproate)
    Other Name: Makena
Study Arms  ICMJE
  • Experimental: Vaginal Progesterone
    200mg micronized progesterone vaginally, to be taken daily starting at 16 0/7 - 23 6/7 weeks, and continued daily until 36 6/7 weeks' gestation or delivery
    Intervention: Drug: Vaginal Progesterone
  • Active Comparator: Intramuscular Progesterone
    250mg intramuscular progesterone to be administered weekly starting at 16 0/7 - 23 6/7 weeks, and continued weekly until 36 6/7 weeks' or delivery.
    Intervention: Drug: Intramuscular Progesterone (17 alpha hydroxprogesterone caproate)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 5, 2021)
205
Original Estimated Enrollment  ICMJE
 (submitted: September 22, 2016)
224
Actual Study Completion Date  ICMJE September 2021
Actual Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pregnant women with singleton pregnancies
  • ≥18 years old
  • Estimated gestational age less than 24 0/7 weeks
  • Prior spontaneous preterm birth of a singleton pregnancy between 16 0/7-36 6/7 weeks.
  • Patients are also required provide consent, demonstrate an understanding of the purpose of the study, and agree to the study protocol.

Exclusion Criteria:

  • History of an adverse reaction to progesterone;
  • A contraindication to progesterone treatment;
  • Placenta previa or accreta;
  • Major fetal anomaly diagnosed on ultrasound or known chromosomal disorder;
  • Multifetal gestation;
  • Preterm labor, premature rupture of membranes, or clinical chorioamnionitis, at the time of enrollment
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02913495
Other Study ID Numbers  ICMJE 16D.542
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Results will be available, individual participant data may not be
Current Responsible Party Thomas Jefferson University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Thomas Jefferson University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Baystate Medical Center
  • George Washington University
  • Vriginia Commonwealth University
  • Ohio State University
Investigators  ICMJE
Principal Investigator: Rupsa C Boelig, MD Thomas Jefferson University Hospital; Sidney Kimmel Medical College
PRS Account Thomas Jefferson University
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP