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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Complications
Obstetric Labor, Premature
Pregnancy Complications

ClinicalTrials.gov processed this record on October 20, 2014