Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix

Study Overview
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Brief Summary
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Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in pregnant women with short cervical length at 18-22 weeks scan.

Detailed Description
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This trial includes pregnant women undergoing routine ultrasound examination at 18.0 to 22.6 weeks of gestation.

Official Title
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Randomized Controlled Trial: Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix (PECEP)

Conditions
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Preterm Birth

Intervention / Treatment
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* Device: Silicon ring (Arabin Pessary)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Singleton pregnancy Minimal age of 18 years Exclusion Criteria: Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap) SROM at the time of randomization Cervical cerclage in situ Active vaginal bleeding Previous cone biopsy or cerclage Major uterine structural anomalies Placenta previa

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Expectant management | |
| Experimental: 2<br>Placement of arabin pessary since 23 weeks until 37 weeks | Device: Silicon ring (Arabin Pessary)<br>* Placement of a silicon pessary in the vagina, around the cervix.<br>* Other names: Vaginal pessaries CE 0482 MED / CERT ISO 9003 /EN 46003;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous Delivery Before 34 Completed Weeks | Number of spontaneous preterm births before 34 weeks occurred in each group. | Between 24 and 34 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Birthweight Less Than 1500 g | Number of newborns whose birthweight is less than 1500 grams | Time of delivery | 
| Birthweight Less Than 2500 g | Number of newborns whose birthweight is less than 2500 grams | Time of delivery | 
| Intrauterine Fetal Demise | The number of fetal deaths in the pessary group was compared to those in the no pessary group | Pregnancy | 
| Neonatal Death | The number of neonatal deaths in the pessary group was compared to those in the no pessary group | Between birth and 28 days of age | 
| Intraventricular Haemorrhage | The number of neonatal intraventricular haemorrhage in the pessary group was compared to those in the no pessary group | Between birth and 28 days of age | 
| Respiratory Distress Syndrome | The number of neonatal Respiratory distress syndrome in the pessary group was compared to those in the no pessary group | Between birth and 28 days of age | 
| Retinopathy of Prematurity | The number of neonatal retinopathy in the pessary group was compared to those in the no pessary group | Between birth and 28 days of age | 
| Necrotising Enterocolitis | The number of neonatal necrotising enterocolitis in the pessary group was compared to those in the no pessary group | Between birth and 28 days of age | 
| Treatment for Sepsis | The number of neonatal cases of treatment needed for sepsis in the pessary group was compared to those in the no pessary group | Between birth and 28 days of age | 
| Composite Adverse Outcomes | The number of neonatal cases with composite adverse outcomes in the pessary group was compared to those in the no pessary group | Between birth and 28 days of age | 
| Spontaneous Delivery Before 28 Completed Weeks | Number of preterm births before 28 weeks occurred in each group. | Between 24 and 28 weeks | 
| Any Delivery Before 34 Completed Weeks | Number of all preterm births before 34 weeks occurred in each group. | Between 24 and 34 weeks | 
| Spontaneous Delivery Before 37 Completed Weeks | Number of preterm births before 37 weeks occurred in each group. | Between 24 and 37 weeks | 
| Gestational Age at Delivery | Number of weeks of gestation completed by time of delivery | At time of birth | 
| 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 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 | 
| Vaginal Discharge | Number of participants who experienced an increased vaginal discharge. | participants will be followed for the duration of pregnancy, up to nine months | 
| Pessary Repositioning Without Removal | Number of participants who required pessary repositioning without removal. This outcome measure only applied to the Experimental (Pessary Arm) and no data were collected from participants in the No Intervention _(No Pessary Arm). | participants will be followed for the duration of pregnancy, up to nine months | 
| Pessary Withdrawal | Number of participants who experience pessary withdrawal. This outcome measure only applied to the Experimental (Pessary Arm) and no data were collected from participants in the No Intervention _(No Pessary Arm). | participants will be followed for the duration of pregnancy, up to nine months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Short cervix, preterm birth, arabin pessary