Routine Activity and Preterm Delivery Risk in Women With a Short Cervix

April 14, 2025 updated by: Wolfson Medical Center

The Effect of Routine Activity on the Risk for Preterm Delivery in Women With a Short Cervix. A Randomized Control Trial

The goal of this clinical trial is to evaluate the effect of routine activity versus rest on the risk of preterm delivery in pregnant women with a short cervix diagnosed between 24 and 34 weeks of gestation. The main questions it aims to answer are:

Does routine activity influence the gestational age at delivery? How does routine activity affect secondary outcomes such as preterm labor, premature rupture of membranes, delivery mode, maternal anxiety, and satisfaction?

Researchers will compare women instructed to maintain routine activity (control group) to women advised to practice maximal rest (intervention group) to see if physical activity impacts preterm birth outcomes.

Participants will:

Wear a smart band to monitor step counts over a two-week period. Be randomized into two groups: one encouraged to maintain routine activity and the other advised to follow strict rest protocols.

Undergo regular follow-ups at a high-risk pregnancy clinic and have their data collected through hospital records and smart band tracking.

This randomized controlled trial will assess gestational age at delivery as the primary outcome, along with secondary maternal and neonatal outcomes, providing insight into the role of physical activity in managing pregnancies complicated by a short cervix.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Holon, Israel, 5822012
        • Recruiting
        • The Edith Wolfson Medical Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Singleton pregnancies between 24+0 and 34+6 weeks.
  • Short cervical length (<25 mm) confirmed via transvaginal ultrasound.
  • No medical contraindications to physical activity.

Exclusion Criteria:

  • Twin pregnancies or higher-order multiples.
  • Medical indications for reduced mobility (e.g., symphysiolysis, fall risk).
  • Maternal comorbidities, fetal distress, vaginal bleeding, PPROM, or need for immediate delivery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Maximal Rest
Participants in this group are instructed to follow maximal rest protocols. They are advised to avoid strenuous activities, including prolonged standing, lifting heavy objects, or engaging in physically demanding tasks. This group represents the traditional bed rest approach to managing pregnancies with a short cervix.
Behavioral: Maximal Rest
Participants in this group are instructed to follow maximal rest protocols. They are advised to avoid strenuous activities, including prolonged standing, lifting heavy objects, or engaging in physically demanding tasks. This group represents the traditional bed rest approach to managing pregnancies with a short cervix.
No Intervention: Routine Activity
Participants in this group are encouraged to maintain routine, non-strenuous physical activity. They are not instructed to follow bed rest but are asked to avoid overtly strenuous activities. This group reflects the standard approach of allowing typical daily activity without additional restrictions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gestational age at delivery
Time Frame: two years
to assess the effect of physical activity on the gestational age at delivery.
two years

Secondary Outcome Measures

Outcome Measure
Time Frame
Rates of preterm labor.
Time Frame: two years
two years
Incidence of premature rupture of membranes (PPROM).
Time Frame: two years
two years
Mod of delivery (cesarean, instrumental, or spontaneous).
Time Frame: two years
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wolfson Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2025

Primary Completion (Estimated)

December 29, 2027

Study Completion (Estimated)

December 29, 2027

Study Registration Dates

First Submitted

March 12, 2025

First Submitted That Met QC Criteria

March 12, 2025

First Posted (Actual)

March 19, 2025

Study Record Updates

Last Update Posted (Actual)

April 17, 2025

Last Update Submitted That Met QC Criteria

April 14, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 124-24-WOMC

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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