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

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ClinicalTrials.gov Identifier: NCT02913495
Recruitment Status : Recruiting
First Posted : September 23, 2016
Last Update Posted : September 14, 2018
Sponsor:
Collaborators:
Baystate Medical Center
George Washington University
Vriginia Commonwealth University
Ohio State University
Information provided by (Responsible Party):
Thomas Jefferson University

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.

Condition or disease Intervention/treatment Phase
Premature Birth Drug: Vaginal Progesterone Drug: Intramuscular Progesterone Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth
Actual Study Start Date : September 2016
Estimated Primary Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: Vaginal Progesterone
Other Name: micronized 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.
Drug: Intramuscular Progesterone
Other Name: Makena




Primary Outcome Measures :
  1. Preterm birth <37 weeks [ Time Frame: up to 9 months (delivery) ]
    Incidence of gestational age of delivery less than 37 weeks


Secondary Outcome Measures :
  1. Gestational age of delivery [ Time Frame: up to 9 months (delivery) ]
  2. Preterm birth <34 weeks and <28 weeks [ Time Frame: up to 9 months (delivery) ]
  3. Second trimester cervical length <25mm [ Time Frame: 2 months ]
  4. Mode of delivery [ Time Frame: up to 9 months (delivery) ]
    Delivery mode- vaginal, cesarean, operative vaginal

  5. Maternal mortality [ Time Frame: up to 9 months (delivery) ]
  6. 5 minute Apgar score [ Time Frame: up to 9 months (delivery) ]
  7. Neonatal intensive care unit admission [ Time Frame: up to 9 months (delivery) ]
  8. 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)

  9. Birthweight [ Time Frame: up to 9 months (delivery) ]
  10. Perinatal mortality up to 28 days of life [ Time Frame: up to 10 months (4 weeks after delivery) ]
  11. Medication side effects [ Time Frame: up to 9 months (delivery) ]
  12. Satisfaction with medication (5 point Likert scale) [ Time Frame: up to 9 months (delivery) ]
  13. 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

  14. 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, BMI >=35 versus BMI<35 and for those started on progesterone 16-20 weeks versus 20-24 weeks.



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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:

  • 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

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): NCT02913495


Contacts
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Contact: Rupsa C Boelig, MD rupsa.boelig@jefferson.edu

Locations
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United States, District of Columbia
George Washington University Recruiting
Washington, District of Columbia, United States
Contact: Alexis Gimovsky, MD       agimovsky@mfa.gwu.edu   
United States, Massachusetts
Baystate Medical Center Recruiting
Springfield, Massachusetts, United States, 01199
Contact: Corina Schoen, MD       Corina.SchoenMD@baystatehealth.org   
United States, Pennsylvania
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Rupsa C Boelig, MD       rupsa.boelig@jefferson.edu   
Sponsors and Collaborators
Thomas Jefferson University
Baystate Medical Center
George Washington University
Vriginia Commonwealth University
Ohio State University
Investigators
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Principal Investigator: Rupsa C Boelig, MD Thomas Jefferson University Hospital; Sidney Kimmel Medical College

Publications:
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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT02913495     History of Changes
Other Study ID Numbers: 16D.542
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Results will be available, individual participant data may not be
Keywords provided by Thomas Jefferson University:
Progesterone
Prevention of preterm birth
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs