Activity Restriction for Women With Arrested Preterm Labor

Preterm Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03501030
• Other study ID #: 29/18
• Status: Recruiting
• Phase: N/A
• Start date: November 25, 2019
• Est. completion date: October 1, 2021

Study information

• Verified date: August 2021
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Preterm Birth

Intervention

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.

Locations

Country	Name	City	State
Italy	Giuseppe De Placido	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preterm birth	Preterm delivery at less than 37 weeks of gestation	37 weeks of gestation
Secondary	Mean gestational age at delivery in weeks	Mean gestational age at delivery in weeks	At the time of delivery
Secondary	Mean latency	from randomization to delivery	from randomization to delivery
Secondary	admission to nicu	number of babies admitted to neonatal intensive care unit	at the time of delivery until 28 days of life
Secondary	neonatal death	death of a live-born baby	at the time of delivery until 28 days of life
Secondary	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
Secondary	chorioamnionitis	diagnosis of choriamnionitis at histological examination of the placenta.	at the time of delivery