Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06884761

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

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
Wolfson Medical Center · Other Government
Sex
Female
Age
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMaximal RestParticipants 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.

Timeline

Start date
2025-01-15
Primary completion
2027-12-29
Completion
2027-12-29
First posted
2025-03-19
Last updated
2025-04-17

Locations

1 site across 1 country: Israel

Source: ClinicalTrials.gov record NCT06884761. Inclusion in this directory is not an endorsement.