Activity Restriction for Women With Arrested Preterm Labor

Activity Restriction for Women With Arrested Preterm Labor: a Randomized Controlled Trial

to test the hypothesis that activity restriction in women with singleton gestations and with arrested PTL would reduce the rate of PTB.

Study Overview

• Status: Recruiting
• Conditions: Preterm Birth
• Intervention / Treatment: Behavioral: Activity restriction

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Napoli, Italy, 80129
    • Recruiting
    • Giuseppe De Placido
    • Contact: Giuseppe De Placido; Phone Number: 7462979; Email: gabriele.saccone.1990@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Activity 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.	Behavioral: Activity 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.
NO_INTERVENTION: No activity restriction; Women in the control group will not receive any reccomandation regarding activity restriction. Bed rest and abstain from sexual intercourse will also not recommended.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preterm birth	Preterm delivery at less than 37 weeks of gestation	37 weeks of gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean gestational age at delivery in weeks	Mean gestational age at delivery in weeks	At the time of delivery
Mean latency	from randomization to delivery	from randomization to delivery
admission to nicu	number of babies admitted to neonatal intensive care unit	at the time of delivery until 28 days of life
neonatal death	death of a live-born baby	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;	at the time of delivery until 28 days of life
chorioamnionitis	diagnosis of choriamnionitis at histological examination of the placenta.	at the time of delivery

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 25, 2019
• Primary Completion (ANTICIPATED): September 1, 2021
• Study Completion (ANTICIPATED): October 1, 2021

Study Registration Dates

• First Submitted: April 10, 2018
• First Submitted That Met QC Criteria: April 10, 2018
• First Posted (ACTUAL): April 18, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 24, 2021
• Last Update Submitted That Met QC Criteria: August 21, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Premature Birth; Obstetric Labor, Premature
• Other Study ID Numbers: 29/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No