Activity Restriction for Women With Arrested Preterm Labor
Primary Purpose
Preterm Birth
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Activity restriction
Sponsored by
About this trial
This is an interventional prevention trial for Preterm Birth
Eligibility Criteria
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.
Sites / Locations
- Giuseppe De PlacidoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Activity restriction
No activity restriction
Arm Description
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.
Women in the control group will not receive any reccomandation regarding activity restriction. Bed rest and abstain from sexual intercourse will also not recommended.
Outcomes
Primary Outcome Measures
Preterm birth
Preterm delivery at less than 37 weeks of gestation
Secondary Outcome Measures
Mean gestational age at delivery in weeks
Mean gestational age at delivery in weeks
Mean latency
from randomization to delivery
admission to nicu
number of babies admitted to neonatal intensive care unit
neonatal death
death of a live-born baby
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;
chorioamnionitis
diagnosis of choriamnionitis at histological examination of the placenta.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03501030
Brief Title
Activity Restriction for Women With Arrested Preterm Labor
Official Title
Activity Restriction for Women With Arrested Preterm Labor: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 25, 2019 (Actual)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
October 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single center, parallel group non-blinded, prospective, interventional non-pharmacologic, no profit, randomized and controlled trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Activity restriction
Arm Type
Experimental
Arm Description
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.
Arm Title
No activity restriction
Arm Type
No Intervention
Arm Description
Women in the control group will not receive any reccomandation regarding activity restriction. Bed rest and abstain from sexual intercourse will also not recommended.
Intervention Type
Behavioral
Intervention Name(s)
Activity restriction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Preterm birth
Description
Preterm delivery at less than 37 weeks of gestation
Time Frame
37 weeks of gestation
Secondary Outcome Measure Information:
Title
Mean gestational age at delivery in weeks
Description
Mean gestational age at delivery in weeks
Time Frame
At the time of delivery
Title
Mean latency
Description
from randomization to delivery
Time Frame
from randomization to delivery
Title
admission to nicu
Description
number of babies admitted to neonatal intensive care unit
Time Frame
at the time of delivery until 28 days of life
Title
neonatal death
Description
death of a live-born baby
Time Frame
at the time of delivery until 28 days of life
Title
a composite of adverse perinatal outcome
Description
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
Title
chorioamnionitis
Description
diagnosis of choriamnionitis at histological examination of the placenta.
Time Frame
at the time of delivery
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
only pregnant women (limit to Female)
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Giuseppe De Placido
City
Napoli
ZIP/Postal Code
80129
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe De Placido
Phone
7462979
Email
gabriele.saccone.1990@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Activity Restriction for Women With Arrested Preterm Labor
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