Preterm Birth
Conditions
Brief summary
Preterm birth (PTB), defined as birth between 20 and 36 6/7 weeks, is responsible for the majority of the neonatal morbidity and mortality in the United States, and 35% of all U.S. healthcare spending on infants. Globally, about 28% of the 4 million annual neonatal deaths are directly attributable to PTB. Preterm labor (PTL) is the final pathway for about 50% of all PTB. Tocolytic agents are drugs that can slow or stop labor contractions in the attempt to delay births preceded by PTL. Primary tocolysis is defined as tocolysis given on initial presentation of women with PTL. In most of these women, PTL stops, but as their risk of PTB remains high, some have advocated use of maintenance tocolysis, i.e. tocolysis after arrested PTL. So far, no maintenance tocolytic agent has been shown to be beneficial in preventing PTB. The aim of this study is to evaluate the efficacy of maintenance tocolysis with Arabin pessary compared to standard care in singleton gestations with arrested PTL and with short transvaginal ultrasound (TVU) cervical length (CL) \<25mm
Interventions
DEVICEArabin cervical pessary
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 18-50 ages * Singleton pregnancy * 24(0) - 34(6) weeks of gestation * Arrested preterm labor after primary tocolysis * Transvaginal ultrasound cervical length less than 25mm at admission * Agreement to regular follow-up and provision of written informed consent
Exclusion criteria
* pessary and no cerclage in situ * vaginal bleeding * placeta previa/accreta * multiple gestations * \<24(0) or \>24(6) weeks of gestation * Cervical dilatation greater than 3 cm * Chorioamnionitis * Major fetal abnormalities * Abruptio placentae * PPROM * Polyhydramnios or oligohydramnios * IUGR/FGR with or without Doppler abnormalities * Preeclampsia or pregnancy-related hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Spontaneous preterm birth (SPTB) | Less than 34 weeks gestation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Admission to neonatal intensive care unit | Delivery (at birth) | — |
| respiratory distress syndrome | Delivery (at birth) | — |
| low birth weight | Delivery (at birth) | birth weight \<2500 grams |
| intraventricular hemorrhage | Between birth and 28 days of age | grade 3 or 4 |
| Birth weight | Delivery (at birth) | mean birth weight in grams |
| Gestational age at delivery | Delivery (at birth) | mean gestational age at delivery |
| Latency | Delivery (at birth) | mean latency in days (from randomization to delivery) |
| neonatal mortality | Between birth and 28 days of age | death of a live-born baby within the first 28 days of life |
| Spontaneous preterm birth (SPTB) | Less than 37,35,32,28 and 24 weeks gestation | — |
Countries
Italy
Outcome results
None listed