The Effect of Routine Activity on the Risk for Preterm Delivery in Women With a Short Cervix. A Randomized Control Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Wolfson Medical Center
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- gestational age at delivery
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Sex
- Female
- Accepts 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.
Arms & Interventions
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.
Intervention: Maximal Rest (Behavioral)
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.
Outcomes
Primary Outcomes
gestational age at delivery
Time Frame: two years
to assess the effect of physical activity on the gestational age at delivery.
Secondary Outcomes
- Rates of preterm labor.(two years)
- Incidence of premature rupture of membranes (PPROM).(two years)
- Mod of delivery (cesarean, instrumental, or spontaneous).(two years)