Cervical Pessary to Prevent Preterm Singleton Birth in High Risk Population
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Hospital Sant Joan de Deu
- Enrollment
- 214
- Locations
- 1
- Primary Endpoint
- Spontaneous preterm birth before 37 weeks of gestation
Study Overview
Brief Summary
DESIGN: Observational prospective study. INCLUSION CRITERIA: All women are 18 years old of age or older with high risk for preterm birth, based on clinical history, and between 18.0 weeks and 23.6 weeks of pregnancy. SAMPLE SIZE: 214 asymptomatic high risk pregnant women.
METHODOLOGY: Patient selection, obtaining of informed consent, randomization for cervical placement of pessary. Current follow-up until delivery. Pessary is removed at 37 week or before in some specific situations.
MAIN OUTCOME: sPTB <370 weeks of gestation. SECONDARY OUTCOMES: Pregnancy outcomes and a neonatal composite morbidity. EXPECTED RESULTS: Cervical pessary reduces sPB below 37 weeks in high risk of preterm birth population.
Detailed Description
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 preterm labor or preterm rupture of membranes (PROM), previous cervical surgery, late miscarriage >16-17 weeks; 4) Aspects of the current pregnancy as multiple pregnancy, genital tract bleeding or infection, Preterm Rupture of Membranes (PROM), short cervix and others.
In nulliparous women with no previous pregnancies or fetal losses >16 weeks, screening based on clinical history (maternal racial origin, age, height, smoking status and method of conception) could detect about 20% of sPB. In women with previous pregnancies at or beyond 16 weeks the detection rate is doubled by incorporating obstetric history.
The risks for women with a previous spontaneous preterm birth with a normal cervix in pregnancy are not negligible. It has been suggested that there is a continuum risk dependent on absolute cervical length while other authors showed that absolute length of cervix above 25mm had little impact on the risk of preterm birth before 35 weeks. A posterior study has not identified any clinical or obstetric risk factors in high-risk women with cervical length greater than 25mm that could help to identify those who will subsequently have a spontaneous preterm birth.
The risk of preterm birth is inversely related to cervical length (CL) as measured by ultrasound. Current options for the management of short cervix in singleton pregnancies are: vaginal progesterone, with proved benefit; cervical cerclage in high risk and short cervix, and cervical pessary.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Pessary Group
A pessary certified is inserted through the vagina with the woman in recumbent position and is placed around the cervix.
Correct placement of the pessary is assessed by ultrasound. Patients on the pessary group are specially awarded about adverse symptoms and the need of immediate report in case of pain, bleeding and symptomatic contractions.
The pessary is not removed when symptoms of infection occur after pessary insertion, but appropriate treatment is given.
The pessary is removed at 37 weeks of pregnancy. Indications for pessary removal before 37 weeks are: active vaginal bleeding, premature labor not responding to tocolysis or severe patient discomfort.
Intervention: Cervical pessary (Device)
Control group
Current management for the follow-up of these women in the PBPC.
Outcomes
Primary Outcomes
Spontaneous preterm birth before 37 weeks of gestation
Time Frame: 3 years
Delivery \< 37.0 weeks of gestation (Yes/No)
Secondary Outcomes
- Neonatal outcomes. Death(5 months)
- Pessary tolerance(5 months)
- Neonatal outcomes NEC(5 months)
- Neonatal outcomes. Sepsis(5 months)
- Threatened preterm labor(5 months)
- Infection(5 months)
- Neonatal outcomes SDR(5 months)
- Neonatal outcomes IVH(5 months)
- Preterm birth 34 weeks(5 months)
- Preterm birth 28 weeks(5 months)
- PPROM before 34 weeks(5 months)
- Cervical trauma(5 months)
- Progesterone co-treatment(5 months)
- Maternal mortality or morbidity(5 months)
- Neonatal birthweight(5 months)
- Neonatal outcomes APGAR(5 months)
- Neonatal outcomes for respiratory support(5 months)
- Choriomanionitis(5 months)
- Neonatal outcomes umbilical artery pH(5 months)
- Neonatal outcomes NICU(5 months)