Preterm Birth
Conditions
Brief summary
to test the hypothesis that activity restriction in women with singleton gestations and with arrested PTL would reduce the rate of PTB.
Detailed description
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.
Interventions
BEHAVIORALActivity restriction
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.
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Single center, parallel group non-blinded, prospective, interventional non-pharmacologic, no profit, randomized and controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* singleton gestations; * arrested PTL; * TVU CL \< 25 mm; * 18 years to 50 years.
Exclusion criteria
* multiple gestations; * symptoms of PTL (not arrested PTL); * TVU CL ≥ 25mm; * premature rupture of amnion and chorion membranes (PROM) at the time of randomization; * cerclage in situ at the time of randomization; * pessary in situ at the time of randomization; * vaginal bleeding at the time of randomization; * women who are unconscious, severly ill, mentally handicapped; * women under the age of 18 years or over the age of 50 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preterm birth | 37 weeks of gestation | Preterm delivery at less than 37 weeks of gestation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean latency | from randomization to delivery | from randomization to delivery |
| admission to nicu | at the time of delivery until 28 days of life | number of babies admitted to neonatal intensive care unit |
| Mean gestational age at delivery in weeks | At the time of delivery | Mean gestational age at delivery in weeks |
| a composite of adverse perinatal outcome | at the time of delivery until 28 days of life | 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; |
| chorioamnionitis | at the time of delivery | diagnosis of choriamnionitis at histological examination of the placenta. |
| neonatal death | at the time of delivery until 28 days of life | death of a live-born baby |
Countries
Italy
Outcome results
None listed