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NCT Number: NCT06884761

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

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.

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Key information

Conditions

Cervical Shortening Behavior Female Urogenital Diseases and Pregnancy Complications Motor Activity Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Maximal Rest

Behavioral

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.

Primary outcomes

  1. gestational age at delivery

    Time frame: two years

    to assess the effect of physical activity on the gestational age at delivery.

Secondary outcomes

  1. Rates of preterm labor.

    Time frame: two years

  2. Incidence of premature rupture of membranes (PPROM).

    Time frame: two years

  3. Mod of delivery (cesarean, instrumental, or spontaneous).

    Time frame: two years

Sponsors and collaborators

Lead sponsor

Wolfson Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 19, 2025
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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