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

Last updated: April 14, 2025
Sponsor: Wolfson Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Maximal Rest

Clinical Study ID

NCT06884761
124-24-WOMC
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

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 forimmediate delivery.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Maximal Rest
Phase:
Study Start date:
January 15, 2025
Estimated Completion Date:
December 29, 2027

Connect with a study center

  • The Edith Wolfson Medical Center

    Holon, 5822012
    Israel

    Active - Recruiting

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