Preventing Preterm Birth With a Pessary (PrePPy)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Medstar Research Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Washington Hospital Center
Information provided by:
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT01380158
First received: June 15, 2011
Last updated: July 7, 2011
Last verified: June 2011
  Purpose

The primary objective of this study, is to determine the effect of a Cup pessary, a device that is currently readily available in the USA and similar in design to the Arabin pessary, on the incidence of delivery prior to 37 weeks in women with a history of prior spontaneous birth (before 37 weeks) and incidentally found to have a cervix less than 25 mm in length prior to 23 weeks.


Condition Intervention
Preterm Birth
Device: Cup pessary (Bioteque America, Inc)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Preventing Preterm Birth With a Pessary

Further study details as provided by Medstar Research Institute:

Primary Outcome Measures:
  • delivery prior to 37 weeks of gestation [ Time Frame: within the first 30 days after delivery of the neonate ] [ Designated as safety issue: Yes ]
    Gestational age at birth will be recorded


Secondary Outcome Measures:
  • Rate of birth less than seven days from randomization [ Time Frame: within the first 30 days after delivery of the neonate ] [ Designated as safety issue: Yes ]
    Gestational age at birth will be recorded

  • Previable birth (<24 weeks) [ Time Frame: within the first 30 days after delivery of the neonate ] [ Designated as safety issue: Yes ]
    Gestational age at birth will be recorded

  • Perinatal death [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: Yes ]
    defined as either a stillbirth or postnatal death prior to hospital discharge

  • Low birth weight [ Time Frame: within the first 30 days after delivery of the neonate ] [ Designated as safety issue: No ]
    Birthweight at delivery will be recorded

  • Major adverse neonatal outcomes [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
    intraventricular hemorrhage, respiratory distress syndrome of the newborn, retinopathy of prematurity, or necrotizing enterocolitis

  • Need for neonatal special care [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
    ventilation, phototherapy, treatment for sepsis, blood transfusion

  • Incidence of complications due to pessary [ Time Frame: Every 4 weeks while pregnant with pessary in situ ] [ Designated as safety issue: Yes ]
    Incidence of bacterial vaginosis, urinary tract infections, vaginal erosions will be recorded at monthly visits.


Estimated Enrollment: 238
Study Start Date: January 2011
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pessary use during pregnancy
Device: Cup pessary
Device: Cup pessary (Bioteque America, Inc)
Placement of cup pessary in the vagina after randomization
No Intervention: Expectant management
Expectant Management + weekly intramuscular progesterone injections

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Singleton pregnancies in patients with a history of spontaneous preterm birth (previous delivery between 17 0/7 weeks and 36 6/7 weeks).
  • Women ages 18 to 45 years of age

Exclusion Criteria:

  • Major fetal abnormalities (defined as those that are lethal or require prenatal or postnatal surgery), fetal death, or fetal growth restriction diagnosed before randomization.
  • Presence of prophylactic cervical cerclage
  • Significant maternal-fetal complications (treated chronic hypertension, insulin dependant diabetes mellitus, red cell isoimmunization)
  • Painful regular uterine contractions, or ruptured membranes
  • Visual cervical dilation of 2cm or greater and visible membranes.
  • Patients with a pregnancy dated by an ultrasound after 20 weeks gestation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01380158

Contacts
Contact: Jasbir Singh, MD 202-877-3067 jasbir.singh@medstar.net
Contact: Rita W. Driggers, MD 202-877-7127 rita.w.driggers@medstar.net

Locations
United States, District of Columbia
Georgetown University Hospital Recruiting
Wasghington, District of Columbia, United States, 20007
Contact: Helain Landy, MD    202-444-8757    helain.j.landy@m3dstar.net   
Principal Investigator: Helain J Landy, MD         
Washington Hospital Center Recruiting
Wasghinton, District of Columbia, United States, 20010
Contact: Jasbir Singh, MD    202-877-3067    jasbir.singh@medstar.net   
Sub-Investigator: Jasbir Singh, MD         
Principal Investigator: Rita W Driggers, MD         
United States, Maryland
Franklin Square Hospital Recruiting
Baltimore, Maryland, United States, 21237
Contact: Samuel Smith, MD    443-777-8045    samuel.smith@medstar.net   
Principal Investigator: Samuel Smith, MD         
Sponsors and Collaborators
Medstar Research Institute
Washington Hospital Center
Investigators
Principal Investigator: Rita W Driggers, MD Washington Hospital Center
  More Information

Publications:

Responsible Party: Jasbir Singh, MD, Washington Hospital Center
ClinicalTrials.gov Identifier: NCT01380158     History of Changes
Other Study ID Numbers: 2010-225
Study First Received: June 15, 2011
Last Updated: July 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Medstar Research Institute:
pessary
preterm birth
short cervix
cervical incompetence

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on April 17, 2014