Cervical Pessary to Prevent Preterm Birth in Singleton Pregnancies With a Sonographically Measured Short Cervix

Study Overview
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Brief Summary
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The purpose of this study is to learn if the Arabin pessary can reduce preterm birth less than 37 weeks 0 days in singleton pregnancies that have a short cervix.

Detailed Description
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This is an open label randomized controlled study. The pessary will be offered to those patients who have a transvaginal cervical length less than 25 mm before 23 weeks 0 days. The control group will receive the current standard of care which includes surveillance of cervical length, vaginal progesterone, and emergency cerclage. The primary outcome of the study is preterm delivery less than 37 weeks 0 days.

Official Title
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Cervical Pessary to Prevent Preterm Birth in Singleton Pregnancies With a Sonographically Measured Short Cervix: an Open-label Randomized Controlled Trial

Conditions
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Premature Birth

Intervention / Treatment
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* Device: Arabin Pessary


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: singleton cervical length < 25 mm measured by transvaginal ultrasound prior to 23 weeks 0 days agrees to refrain from sexual intercourse Exclusion Criteria: major fetal anomalies painful regular uterine contractions active vaginal bleeding ruptured membranes evidence of chorioamnionitis or other maternal/fetal infectious morbidity placenta previa cervical cerclage in situ visual cervical dilation of 2 cm or greater with visible amnion/chorion significant maternal-fetal complications (chronic hypertension, insulin dependent diabetes mellitus, systemic lupus erythematosus with nephritis, chronic hypertension, red cell alloimmunization, drug abuse)

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device: Arabin Pessary<br>Participants randomized to this group will receive the pessary. | Device: Arabin Pessary<br>* Arabin pessary is a ring manufactured from medical grade silicone. It comes in 13 different sizes. Participants will be fitted to the appropriate size by the study team.<br>|
| No Intervention: Standard of Care<br>Patients randomized to the control group will receive standard of care for their condition. This includes surveillance of cervical length, vaginal progesterone, and emergency cerclage. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm Birth Before 37 Weeks | Preterm birth refers to pregnancies that deliver before 37 weeks. Count of participants that deliver before they reach 37 weeks. | Up to 37 weeks 0 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm Birth Before 34 Weeks | Number of deliveries before 34 weeks 0 days of gestation | up to 34 weeks 0 days | 
| Neonatal Composite Morbidity | Count of Fetal or Neonatal death up to 28 days after birth, respiratory distress syndrome, chronic lung disease, periventricular lucency, periventricular leukomalacia, intraventricular hemorrhage grade 3 or 4, necrotizing enterocolitis, early-onset-culture-proven sepsis | antepartum and up to 28 days after postnatal gestational age of 36 weeks | 
| Neonatal Length of Stay | Total number of days in hospital after birth | participants will be followed for the duration of hospital stay, up to 17 weeks after delivery | 
| Admission to Neonatal Intensive Care Unit | Number of babies admitted to neonatal intensive care unit after birth during the same hospital stay. | participants will be followed for the duration of hospital stay, up to 17 weeks after delivery | 
| Total Days in the Neonatal Intensive Care Unit | Number of days a baby spends in the neonatal intensive care unit | participants will be followed for the duration of hospital stay, up to 17 weeks after delivery | 
| Duration of Ventilator Support | Number of days a baby requires use of mechanical ventilation | participants will be followed for the duration of hospital stay, up to 17 weeks after delivery | 
| Retinopathy of Prematurity Requiring Treatment | Number of newborn with Retinopathy of Prematurity that requires intervention. | participants will be followed for the duration of hospital stay, up to 17 weeks after delivery | 
| Birthweight < 1500 Grams | Number of newborns whose birthweight is less than 1500 grams | at time of birth, expected to be within 4 weeks of due date | 
| Birthweight < 2500 Grams | Number of newborns whose birthweight is less than 2500 grams | at time of birth, expected to be within 4 weeks of due date | 
| Gestational Age at Delivery | Number of weeks of gestation completed by time of delivery | at time of birth, expected to be within 4 weeks of due date | 
| Use of Tocolysis | Number of participants required use of tocolytic medication | participants will be followed for the duration of pregnancy, up to nine months | 
| Use of Antenatal Steroids | Number of participants that received betamethasone or dexamethasone to reduce morbidity of expected preterm delivery | participants will be followed for the duration of pregnancy, up to nine months | 
| Chorioamnionitis | Number of participants that showed intrauterine infection diagnosed by maternal tachycardia, fever, uterine tenderness, purulent or abnormal cervical discharge, fetal tachycardia. | participants will be followed for the duration of pregnancy, up to nine months | 
| Vaginal Bleeding | Number of participants who experienced bleeding from lower genital tract during antepartum period | participants will be followed for the duration of pregnancy, up to nine months | 
| Preterm Premature Rupture of Membranes | Number of participants who experienced rupture of membranes as diagnosed by speculum exam showing pooling, ferning, positive nitrazine test, positive amnisure test. | participants will be followed for the duration of pregnancy, up to nine months | 
| Cesarean Delivery | Number of participants that underwent cesarean delivery | at time of delivery, expected to be within 4 weeks of due date | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arabin pessary, short cervix