Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix
- Conditions
- Preterm Birth
- Interventions
- Device: Silicon ring (Arabin Pessary)
- Registration Number
- NCT00706264
- Lead Sponsor
- Maternal-Infantil Vall d´Hebron Hospital
- Brief Summary
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
This trial includes pregnant women undergoing routine ultrasound examination at 18.0 to 22.6 weeks of gestation.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 385
- Singleton pregnancy
- Minimal age of 18 years
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Silicon ring (Arabin Pessary) Placement of arabin pessary since 23 weeks until 37 weeks
- Primary Outcome Measures
Name Time Method Spontaneous Delivery Before 34 Completed Weeks Between 24 and 34 weeks Number of spontaneous preterm births before 34 weeks occurred in each group.
- Secondary Outcome Measures
Name Time Method Retinopathy of Prematurity Between birth and 28 days of age The number of neonatal retinopathy in the pessary group was compared to those in the no pessary group
Birthweight Less Than 1500 g Time of delivery Number of newborns whose birthweight is less than 1500 grams
Birthweight Less Than 2500 g Time of delivery Number of newborns whose birthweight is less than 2500 grams
Intrauterine Fetal Demise Pregnancy The number of fetal deaths in the pessary group was compared to those in the no pessary group
Neonatal Death Between birth and 28 days of age The number of neonatal deaths in the pessary group was compared to those in the no pessary group
Intraventricular Haemorrhage Between birth and 28 days of age The number of neonatal intraventricular haemorrhage in the pessary group was compared to those in the no pessary group
Respiratory Distress Syndrome Between birth and 28 days of age The number of neonatal Respiratory distress syndrome in the pessary group was compared to those in the no pessary group
Treatment for Sepsis Between birth and 28 days of age The number of neonatal cases of treatment needed for sepsis in the pessary group was compared to those in the no pessary group
Composite Adverse Outcomes Between birth and 28 days of age The number of neonatal cases with composite adverse outcomes in the pessary group was compared to those in the no pessary group
Spontaneous Delivery Before 28 Completed Weeks Between 24 and 28 weeks Number of preterm births before 28 weeks occurred in each group.
Any Delivery Before 34 Completed Weeks Between 24 and 34 weeks Number of all preterm births before 34 weeks occurred in each group.
Spontaneous Delivery Before 37 Completed Weeks Between 24 and 37 weeks Number of preterm births before 37 weeks occurred in each group.
Gestational Age at Delivery At time of birth Number of weeks of gestation completed by time of delivery
Use of Tocolysis participants will be followed for the duration of pregnancy, up to nine months Number of participants required use of tocolytic medication
Use of Antenatal Steroids participants will be followed for the duration of pregnancy, up to nine months Number of participants that received betamethasone to reduce morbidity of expected preterm delivery
Chorioamnionitis participants will be followed for the duration of pregnancy, up to nine months Number of participants that showed intrauterine infection diagnosed by maternal tachycardia, fever, uterine tenderness, purulent or abnormal cervical discharge, fetal tachycardia.
Vaginal Bleeding participants will be followed for the duration of pregnancy, up to nine months Number of participants who experienced bleeding from lower genital tract during antepartum period
Preterm Premature Rupture of Membranes participants will be followed for the duration of pregnancy, up to nine months Number of participants who experienced rupture of membranes as diagnosed by speculum exam showing pooling, ferning, positive nitrazine test, positive amnisure test.
Necrotising Enterocolitis Between birth and 28 days of age The number of neonatal necrotising enterocolitis in the pessary group was compared to those in the no pessary group
Cesarean Delivery At time of delivery Number of participants that underwent cesarean delivery
Vaginal Discharge participants will be followed for the duration of pregnancy, up to nine months Number of participants who experienced an increased vaginal discharge.
Pessary Repositioning Without Removal participants will be followed for the duration of pregnancy, up to nine months 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).
Pessary Withdrawal participants will be followed for the duration of pregnancy, up to nine months 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).
Trial Locations
- Locations (6)
Hospital de Reus
🇪🇸Reus, Tarragona, Spain
Hospital Materno-Infantil de Canarias
🇪🇸Las Palmas de Gran Canaria, Gran Canaria, Spain
Hospital Vall d´Hebron
🇪🇸Barcelona, Spain
Institut Universitary Dexeus
🇪🇸Barcelona, Spain
Hospital Son Llàtzer
🇪🇸Palma de Mallorca, Mallorca, Spain
Hospital de Fuenlabrada
🇪🇸Madrid, Spain