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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06884761
Enrollment
100
Registered
2025-03-19
Start date
2025-01-15
Completion date
2027-12-29
Last updated
2025-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Shortening

Keywords

Preterm delivery, Physical activity, cervical shortening, Bed rest, Cervical length, High-risk pregnancy, Randomized controlled trial

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.

Interventions

BEHAVIORALMaximal 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.

Sponsors

Wolfson Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
gestational age at deliverytwo yearsto assess the effect of physical activity on the gestational age at delivery.

Secondary

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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026