Activity Restriction for Women With Arrested Preterm Labor

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-25

Study Completion Date

2021-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Bed Rest After Preterm Premature Rupture of the Membranes

NCT03814278

Preterm Premature Rupture of Membrane

COMPLETED NA

Cervical Pessary in Women With Arrested Preterm Labor and Short Cervix

NCT02849301

Preterm Birth

WITHDRAWN PHASE3

Aspiration Technique-based Device for Preterm Labor

NCT05355649

Preterm Labor Preterm Birth

UNKNOWN NA

Post Term Pregnancy - Induction of Labor or Monitoring of Pregnancy

NCT00385229

Perinatal Morbidity

COMPLETED NA

Progesterone and Aminophylline for the Prevention of Preterm Labour

NCT03152942

Premature Obstetric Labor

UNKNOWN PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Preterm Birth

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single center, parallel group non-blinded, prospective, interventional non-pharmacologic, no profit, randomized and controlled trial

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Activity restriction

Intervention Type BEHAVIORAL

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 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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No