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

Preterm Birth Clinical Trial

— PECEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00706264
• Other study ID #: PECEP-TRIAL
• Status: Completed
• Phase: N/A
• Start date: June 2007
• Est. completion date: July 2014

Study information

• Verified date: March 2021
• Source: Maternal-Infantil Vall d´Hebron Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 385
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Device:
• Silicon ring (Arabin Pessary)
Placement of a silicon pessary in the vagina, around the cervix.

Locations

Country	Name	City	State
Spain	Hospital Vall d´Hebron	Barcelona
Spain	Institut Universitary Dexeus	Barcelona
Spain	Hospital Materno-Infantil de Canarias	Las Palmas de Gran Canaria	Gran Canaria
Spain	Hospital de Fuenlabrada	Madrid
Spain	Hospital Son Llàtzer	Palma de Mallorca	Mallorca
Spain	Hospital de Reus	Reus	Tarragona

Sponsors (4)

Lead Sponsor	Collaborator
Maternal-Infantil Vall d´Hebron Hospital	Hospital Son Llatzer, Hospital Universitario de Canarias, Institut Universitari Dexeus

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spontaneous Delivery Before 34 Completed Weeks	Number of spontaneous preterm births before 34 weeks occurred in each group.	Between 24 and 34 weeks
Secondary	Birthweight Less Than 1500 g	Number of newborns whose birthweight is less than 1500 grams	Time of delivery
Secondary	Birthweight Less Than 2500 g	Number of newborns whose birthweight is less than 2500 grams	Time of delivery
Secondary	Intrauterine Fetal Demise	The number of fetal deaths in the pessary group was compared to those in the no pessary group	Pregnancy
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Spontaneous Delivery Before 28 Completed Weeks	Number of preterm births before 28 weeks occurred in each group.	Between 24 and 28 weeks
Secondary	Any Delivery Before 34 Completed Weeks	Number of all preterm births before 34 weeks occurred in each group.	Between 24 and 34 weeks
Secondary	Spontaneous Delivery Before 37 Completed Weeks	Number of preterm births before 37 weeks occurred in each group.	Between 24 and 37 weeks
Secondary	Gestational Age at Delivery	Number of weeks of gestation completed by time of delivery	At time of birth
Secondary	Use of Tocolysis	Number of participants required use of tocolytic medication	participants will be followed for the duration of pregnancy, up to nine months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Cesarean Delivery	Number of participants that underwent cesarean delivery	At time of delivery
Secondary	Vaginal Discharge	Number of participants who experienced an increased vaginal discharge.	participants will be followed for the duration of pregnancy, up to nine months
Secondary	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
Secondary	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