Cervical Pessary to Prevent Preterm Singleton Birth in High Risk Population

Launched by HOSPITAL SANT JOAN DE DEU · Oct 30, 2019

Keywords

ClinConnect Summary

Spontaneous preterm birth (sPB) is still a leading cause of neonatal and infant death and responsible of neonatal morbidity as cerebral palsy. In spite of improvements of neonatal care, rates of preterm birth have not changed in the recent 10 years.

Clinical risk factors for preterm birth include: 1) Demographic characteristics such a low socioeconomic status, poor antenatal care, malnutrition or extremes in maternal age; 2) Behavioral factors including smoking, illicit drug abuse, alcohol consumption or heavy physical work; 3) Obstetric history including uterine malformation, previous pre...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Singleton pregnancy.
• • Age \> 18 years old.
• • Gestational age between 18.0 -23.6 weeks of gestation.
• * Asymptomatic singleton pregnancies, with at least one of the following:
• • Previous spontaneous preterm delivery or PPROM (23 - 34.6 weeks).
• • Previous spontaneous second trimester miscarriage (16.0-22.6 weeks).
• • Previous surgery on uterine cervix.
• • Uterine malformation.
• • Able to sign informed consent form.
• Exclusion Criteria:
• • Congenital, chromosomal abnormalities or stillbirth in current pregnancy before randomization.
• • Women with an obstetrical history of iatrogenic preterm birth indicated for maternal or fetal conditions.
• • Symptomatic high-risk women or preterm prelabor rupture of membranes (PROM) in the current pregnancy.
• • Pregnant women with an indication of prophylactic cervical cerclage due to her own obstetrical history.
• • Pregnant women with an indication to perform a cervical cerclage, prior to study inclusion.
• • Cerclage in situ.
• • Active vaginal bleeding.