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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
University of Naples Federico II
Naples, Italy
Spontaneous preterm birth (SPTB)
Time frame: Less than 34 weeks gestation
Spontaneous preterm birth (SPTB)
Time frame: Less than 37,35,32,28 and 24 weeks gestation
Gestational age at delivery
mean gestational age at delivery
Time frame: Delivery (at birth)
Latency
mean latency in days (from randomization to delivery)
Time frame: Delivery (at birth)
Birth weight
mean birth weight in grams
Time frame: Delivery (at birth)
Admission to neonatal intensive care unit
Time frame: Delivery (at birth)
respiratory distress syndrome
Time frame: Delivery (at birth)
low birth weight
birth weight \<2500 grams
Time frame: Delivery (at birth)
intraventricular hemorrhage
grade 3 or 4
Time frame: Between birth and 28 days of age
neonatal mortality
death of a live-born baby within the first 28 days of life
Time frame: Between birth and 28 days of age
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