Preventing Preterm Birth With a Pessary

Not Applicable

Withdrawn

• Conditions: Preterm Birth
• Interventions: Device: Cup pessary (Bioteque America, Inc)

• Registration Number: NCT01380158
• Lead Sponsor: Medstar Health Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Status Verified: 2011-06
• Study First Submitted: 2011-06-15
• Study First Submitted QC: 2011-06-22
• Study First Posted: 2011-06-27
• Primary Completion: 2012-10
• Last Update Submitted: 2021-02-15
• Last Update Posted: 2021-02-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pessary use during pregnancy	Cup pessary (Bioteque America, Inc)	Device: Cup pessary

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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
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
Previable birth (<24 weeks)	within the first 30 days after delivery of the neonate	Gestational age at birth will be recorded
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.

Trial Locations

Locations (3)

Georgetown University Hospital; 🇺🇸 Washington, District of Columbia, United States

Franklin Square Hospital; 🇺🇸 Baltimore, Maryland, United States

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States