Preventing Preterm Birth With a Pessary

Study Overview
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Brief Summary
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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.

Official Title
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Preventing Preterm Birth With a Pessary

Conditions
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Preterm Birth

Intervention / Treatment
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* Device: Cup pessary (Bioteque America, Inc)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pessary use during pregnancy<br>Device: Cup pessary | Device: Cup pessary (Bioteque America, Inc)<br>* Placement of cup pessary in the vagina after randomization<br>|
| No Intervention: Expectant management<br>Expectant Management + weekly intramuscular progesterone injections | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| delivery prior to 37 weeks of gestation | Gestational age at birth will be recorded | within the first 30 days after delivery of the neonate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of birth less than seven days from randomization | Gestational age at birth will be recorded | within the first 30 days after delivery of the neonate | 
| Previable birth (<24 weeks) | Gestational age at birth will be recorded | within the first 30 days after delivery of the neonate | 
| Perinatal death | defined as either a stillbirth or postnatal death prior to hospital discharge | 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 | 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 | 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 | participants will be followed for the duration of hospital stay, an expected average of 4 weeks | 
| Incidence of complications due to pessary | Incidence of bacterial vaginosis, urinary tract infections, vaginal erosions will be recorded at monthly visits. | Every 4 weeks while pregnant with pessary in situ | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pessary, preterm birth, short cervix, cervical incompetence