Preterm Birth
Conditions
Brief summary
The incidence of multiple gestations has increased over the past years, mostly because of increased use of assisted reproductive technologies. Triplet pregnancies are at increased risk of preterm birth (PTB), which is the primary reason for their increased morbidity and mortality compared to singletons. Multiple gestations, including triplets, account for about 3% of all pregnancies in the US but constitute at least 10% of cases of PTB, over 30% of very low birth weight infants, and nearly 20% of infant mortality. A short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of PTB, including in multiple gestations. In singletons with a prior PTB and a short CL \<25mm before 24weeks, cerclage is associated with significant decreases in PTB and perinatal morbidity and mortality in the meta-analysis of randomized trials (RCTs). On the contrary, the effect of cerclage in multiple gesttations has been insufficiently studied, with meta-analysis data showing a possible harm from cerclage compared to controls. The aim of this RCT is to evaluate the efficacy of cervical pessary in prevention of PTB in unselected triplet gestations. We planned to assess outcomes in subgroup analysis of women with short cervical length (TVU CL \<30 mm)
Interventions
DEVICECervical Pessary
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 18-50 years of age * Triplet pregnancy (limits the participants to female gender) * Gestational age at randomization between 20(0) and 22(6)
Exclusion criteria
* Singleton, twin or higher order than triplets multiple gestation * Twin twin transfusion syndrome * Ruptured membranes * Lethal fetal structural anomaly * Fetal chromosomal abnormality * Cerclage in place (or planned placement) * Vaginal bleeding * Suspicion of chorioamnionitis * Ballooning of membranes outside the cervix into the vagina * Painful regular uterine contractions * Labor * Placenta previa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Preterm delivery | Less than 34 weeks gestation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preterm delivery | Less than 24, 28 and 37 weeks | — |
| Gestational age at delivery | Time of delivery | — |
| Birth weight | Time of delivery | — |
| pontaneous preterm birth rates | Less than 24, 28, 34 and 37 weeks gestation | — |
| Spontaneous rupture of membranes | Less than 34 weeks gestation | — |
| Intolerance to pessary | Prior to delivery | Defined as request for removal secondary to discomfort and/or discharge |
| Neonatal death | Between birth and 28 days of age | — |
| Composite adverse neonatal outcome | Between birth and 28 days of age | Includes necrotizing enterocolitis, intraventricular hemorrhage (grade 3 or higher), respiratory distress syndrome, bronchopulmonary dysplasia (BPD), retinopathy, blood-culture proven sepsis and neonatal death |
| Admission to neonatal intensive care unit | Between birth and 28 days of age | — |
| Chorioamnionitis | Time of delivery | — |
| Significant adverse maternal effects | Time of delivery | Includes heavy bleeding, injury (eg erosion; fistula; etc) to vagina; injury (eg erosion; fistula; etc) to bladder, cervical tear and uterine rupture |
| Type of delivery: rate of cesaran delivery, vaginal delivery and operative vaginal delivery | Time of delivery | — |
Countries
Italy
Outcome results
None listed