Preterm Birth
Conditions
Keywords
pessary, preterm birth, short cervix, cervical incompetence
Brief summary
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.
Interventions
DEVICECup pessary (Bioteque America, Inc)
Placement of cup pessary in the vagina after randomization
Sponsors
Medstar Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| delivery prior to 37 weeks of gestation | within the first 30 days after delivery of the neonate | Gestational age at birth will be recorded |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Previable birth (<24 weeks) | within the first 30 days after delivery of the neonate | Gestational age at birth will be recorded |
| Perinatal death | participants will be followed for the duration of hospital stay, an expected average of 4 weeks | defined as either a stillbirth or postnatal death prior to hospital discharge |
| Low birth weight | within the first 30 days after delivery of the neonate | Birthweight at delivery will be recorded |
| Rate of birth less than seven days from randomization | within the first 30 days after delivery of the neonate | Gestational age at birth will be recorded |
| Need for neonatal special care | participants will be followed for the duration of hospital stay, an expected average of 4 weeks | ventilation, phototherapy, treatment for sepsis, blood transfusion |
| Incidence of complications due to pessary | Every 4 weeks while pregnant with pessary in situ | Incidence of bacterial vaginosis, urinary tract infections, vaginal erosions will be recorded at monthly visits. |
| Major adverse neonatal outcomes | participants will be followed for the duration of hospital stay, an expected average of 4 weeks | intraventricular hemorrhage, respiratory distress syndrome of the newborn, retinopathy of prematurity, or necrotizing enterocolitis |
Countries
United States
Outcome results
None listed