Preterm BirthNCT04409678
Physical Activity and Preterm Birth With Cervical Dynamics
A study testing activity in people with Preterm Birth, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
this RCT is designed to investigate the influence of physical activity on the risk f preterm birth for women with cervical dynamics. Read more about this study
- Who is it for?
- Ages 18 to 54 years, women only
- Conditions the study is for
- Preterm Birth
- What is being tested?
- activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 26 May 2020to 26 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 54 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- refusal to participate medical advise to minimize activity (symphysiolysis) maternal morbidity fetal compromise vaginal bleeding rapture of membranes severe preeclampsia twins pregnancy
- -
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
edith wolfsom MC
Holon, 5822012
yakira izaik, doctor, 972545533462, yakyuk@gmail.com
About this study
Official title: Influence of Physical Activity on Preterm Birth for Women With Cervical Dynamics
this RCT is designed to investigate the influence of physical activity on the risk f preterm birth for women with cervical dynamics.
- Conditions
- Preterm Birth
- Being tested
- activity
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
activityBehavioural
physical activity
| Study group | Role | What they receive |
|---|---|---|
| activity | Experimental | Not described Receives: Behavioral: activity |
| bed rest | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
preterm birth
birth prior to 37 weeks of gestation
Measured: assessed from recruitment to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start26 May 2020
- Primary completion26 May 2021 (estimated)
- Study completion26 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yakira, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409678
- Sponsor's protocol ID
- 0112-19-womc
- Status last verified
- May 2020
- First submitted
- 26 May 2020
- Last updated
- 1 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Physical Activity on Preterm Birth for Women With Cervical Dynamics
- ClinicalTrials.gov ID
- NCT04409678
- Acronym / sponsor ID
- 0112-19-womc
- Conditions
- Preterm Birth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- 26 May 2020 (actual)
- Primary completion
- 26 May 2021 (estimated)
- Study completion
- 26 May 2021 (estimated)
- First posted
- 1 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
this RCT is designed to investigate the influence of physical activity on the risk f preterm birth for women with cervical dynamics.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| activity | Experimental | Behavioral: activity |
| bed rest | No intervention | – |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- refusal to participate medical advise to minimize activity (symphysiolysis) maternal morbidity fetal compromise vaginal bleeding rapture of membranes severe preeclampsia twins pregnancy
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| activityphysical activity | Behavioural | activity |
Primary outcome
preterm birth
Time frame: assessed from recruitment to delivery
birth prior to 37 weeks of gestation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing activity in people with Preterm Birth, run by Wolfson Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yakira Izaik, Doctor (972545533462, yakyuk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
preterm birth (time frame: assessed from recruitment to delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2020; AzTrials last refreshed its copy on 3 Nov 2026.