Health TrialsbyHealthPanel

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

ConditionCervical Shortening
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorWolfson Medical Center

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Singleton pregnancies between 24+0 and 34+6 weeks.

Short cervical length (<25 mm) confirmed via transvaginal ultrasound.

No medical contraindications to physical activity.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Maximal RestExperimental treatment 1 intervention
Group B: Routine ActivityNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

gestational age at delivery

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

Time frame
two years

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wolfson Medical Center

Lead sponsor

Source ClinicalTrials.gov
Apply now