to test the hypothesis that activity restriction in women with singleton gestations and with arrested PTL would reduce the rate of PTB.
Preterm birth (PTB) is a major cause of perinatal morbidity and mortality. Worldwide, about 15 million babies are born too soon every year, causing 1.1 million deaths, as well as short- and long-term disability in countless survivors. 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. Some authors have also advocated the use of activity restriction in women with arrested PTL to reduce the risk of PTB. Activity restriction is defined as the following forms of activity restriction: pelvic rest and prohibition of sexual activity, reduction of work and/or non work activity. So far, the benefit of activity restriction in women with arrested PTL is still subject of debate and no Randomized Controlled Trial (RCT) has been undertaken. Thus, the aim of this trial is to test the hypothesis that activity restriction in women with singleton gestations and with arrested PTL would reduce the rate of PTB.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
120
Women in the intervention group will be recommended activity restriction. Activity restriction is defined as the following forms of activity restriction: pelvic rest and prohibition of sexual activity, reduction of work and/or non work activity. Bed rest will not recommended.
Giuseppe De Placido
Napoli, Italy
RECRUITINGPreterm birth
Preterm delivery at less than 37 weeks of gestation
Time frame: 37 weeks of gestation
Mean gestational age at delivery in weeks
Mean gestational age at delivery in weeks
Time frame: At the time of delivery
Mean latency
from randomization to delivery
Time frame: from randomization to delivery
admission to nicu
number of babies admitted to neonatal intensive care unit
Time frame: at the time of delivery until 28 days of life
neonatal death
death of a live-born baby
Time frame: at the time of delivery until 28 days of life
a composite of adverse perinatal outcome
defined as at least one of the following: * necrotizing enterocolitis (NEC); * intraventricular hemorrhage (IVH) grade 3 or higher; * respiratory distress syndrome (RDS); * bronchopulmonry dysplasia (BPD); * retinopathy of prematurity (ROP) requiring therapy; * blood-culture proven sepsis; * admission to neonatal intensive care unit (NICU); * neonatal death;
Time frame: at the time of delivery until 28 days of life
chorioamnionitis
diagnosis of choriamnionitis at histological examination of the placenta.
Time frame: at the time of delivery
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