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.
This trial includes pregnant women undergoing routine ultrasound examination at 18.0 to 22.6 weeks of gestation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
385
Placement of a silicon pessary in the vagina, around the cervix.
Hospital Materno-Infantil de Canarias
Las Palmas de Gran Canaria, Gran Canaria, Spain
Hospital Son Llàtzer
Palma de Mallorca, Mallorca, Spain
Hospital de Reus
Reus, Tarragona, Spain
Hospital Vall d´Hebron
Barcelona, Spain
Spontaneous Delivery Before 34 Completed Weeks
Number of spontaneous preterm births before 34 weeks occurred in each group.
Time frame: Between 24 and 34 weeks
Birthweight Less Than 1500 g
Number of newborns whose birthweight is less than 1500 grams
Time frame: Time of delivery
Birthweight Less Than 2500 g
Number of newborns whose birthweight is less than 2500 grams
Time frame: Time of delivery
Intrauterine Fetal Demise
The number of fetal deaths in the pessary group was compared to those in the no pessary group
Time frame: Pregnancy
Neonatal Death
The number of neonatal deaths in the pessary group was compared to those in the no pessary group
Time frame: 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
Time frame: 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
Time frame: 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
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Institut Universitary Dexeus
Barcelona, Spain
Hospital de Fuenlabrada
Madrid, Spain
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Between birth and 28 days of age
Spontaneous Delivery Before 28 Completed Weeks
Number of preterm births before 28 weeks occurred in each group.
Time frame: Between 24 and 28 weeks
Any Delivery Before 34 Completed Weeks
Number of all preterm births before 34 weeks occurred in each group.
Time frame: Between 24 and 34 weeks
Spontaneous Delivery Before 37 Completed Weeks
Number of preterm births before 37 weeks occurred in each group.
Time frame: Between 24 and 37 weeks
Gestational Age at Delivery
Number of weeks of gestation completed by time of delivery
Time frame: At time of birth
Use of Tocolysis
Number of participants required use of tocolytic medication
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: participants will be followed for the duration of pregnancy, up to nine months
Cesarean Delivery
Number of participants that underwent cesarean delivery
Time frame: At time of delivery
Vaginal Discharge
Number of participants who experienced an increased vaginal discharge.
Time frame: 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).
Time frame: 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).
Time frame: participants will be followed for the duration of pregnancy, up to nine months