Preventing Preterm Birth With a Pessary

Medstar Health Research Institute

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Conditions

Preterm Birth

Interventions

Cup pessary (Bioteque America, Inc)DEVICE

Placement of cup pessary in the vagina after randomization

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

Georgetown University Hospital

Washington D.C., District of Columbia, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

Franklin Square Hospital

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

delivery prior to 37 weeks of gestation

Gestational age at birth will be recorded

Time frame: within the first 30 days after delivery of the neonate

Secondary Outcomes

Rate of birth less than seven days from randomization

Gestational age at birth will be recorded

Time frame: within the first 30 days after delivery of the neonate

Previable birth (<24 weeks)

Gestational age at birth will be recorded

Time frame: within the first 30 days after delivery of the neonate

Perinatal death

defined as either a stillbirth or postnatal death prior to hospital discharge

Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Low birth weight

Birthweight at delivery will be recorded

Time frame: within the first 30 days after delivery of the neonate

Major adverse neonatal outcomes

intraventricular hemorrhage, respiratory distress syndrome of the newborn, retinopathy of prematurity, or necrotizing enterocolitis

Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Need for neonatal special care

ventilation, phototherapy, treatment for sepsis, blood transfusion

Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.