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

Not Applicable

Recruiting

• Conditions: Cervical Shortening

• Registration Number: NCT06884761
• Lead Sponsor: Wolfson Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-15
• Study First Submitted: 2025-03-12
• Study First Submitted QC: 2025-03-12
• Study First Posted: 2025-03-19
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Primary Completion: 2027-12-29
• Study Completion: 2027-12-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
gestational age at delivery	two years	to assess the effect of physical activity on the gestational age at delivery.

Secondary Outcome Measures

Name	Time	Method
Rates of preterm labor.	two years
Incidence of premature rupture of membranes (PPROM).	two years
Mod of delivery (cesarean, instrumental, or spontaneous).	two years

Trial Locations

Locations (1)

The Edith Wolfson Medical Center; 🇮🇱 Holon, Israel