Activity Restriction for Women With Arrested Preterm Labor

NCT03501030 | Unknown

• 1 other identifier: 29/18
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (1)

• Preterm birth

  Preterm delivery at less than 37 weeks of gestation

  37 weeks of gestation

Secondary Outcomes (6)

• Mean gestational age at delivery in weeks

  At the time of delivery

• Mean latency

  from randomization to delivery

• admission to nicu

  at the time of delivery until 28 days of life

• neonatal death

  at the time of delivery until 28 days of life

• a composite of adverse perinatal outcome

  at the time of delivery until 28 days of life

Study Arms (2)

Activity restriction

EXPERIMENTAL

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

No activity restriction

NO INTERVENTION

Women in the control group will not receive any reccomandation regarding activity restriction. Bed rest and abstain from sexual intercourse will also not recommended.

Interventions

Activity restriction 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.

Activity restriction

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: only pregnant women (limit to Female)
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• singleton gestations;
• arrested PTL;
• TVU CL \< 25 mm;
• years to 50 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Giuseppe De Placido

Napoli, 80129, Italy

RECRUITING

Related Publications (1)

• Saccone G, Della Corte L, Cuomo L, Reppuccia S, Murolo C, Napoli FD, Locci M, Bifulco G. Activity restriction for women with arrested preterm labor: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 Aug;5(8):100954. doi: 10.1016/j.ajogmf.2023.100954. Epub 2023 Apr 18.

  PMID: 37080296 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

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

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: April 18, 2018
• Study Start: November 25, 2019
• Primary Completion: September 1, 2021
• Study Completion: October 1, 2021
• Last Updated: August 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)