NCT04409678

Brief Summary

this RCT is designed to investigate the influence of physical activity on the risk f preterm birth for women with cervical dynamics.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

May 26, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2021

Completed
Last Updated

June 1, 2020

Status Verified

May 1, 2020

Enrollment Period

1 year

First QC Date

May 26, 2020

Last Update Submit

May 26, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • preterm birth

    birth prior to 37 weeks of gestation

    assessed from recruitment to delivery

Study Arms (2)

activity

EXPERIMENTAL
Behavioral: activity

bed rest

NO INTERVENTION

Interventions

activityBEHAVIORAL

physical activity

activity

Eligibility Criteria

Age18 Years - 54 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • pregnant women between 24-34 weeks of gestation singleton cervical length\<25 mm willing to download an application which traces physical activity on medical indication for reducing activity

You may not qualify if:

  • refusal to participate medical advise to minimize activity (symphysiolysis) maternal morbidity fetal compromise vaginal bleeding rapture of membranes severe preeclampsia twins pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

edith wolfsom MC

Holon, 5822012, Israel

RECRUITING

MeSH Terms

Conditions

Premature Birth

Interventions

Exercise

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Yakira Izaik, Doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Izaik Yakira

Study Record Dates

First Submitted

May 26, 2020

First Posted

June 1, 2020

Study Start

May 26, 2020

Primary Completion

May 26, 2021

Study Completion

May 26, 2021

Last Updated

June 1, 2020

Record last verified: 2020-05

Locations