Induction of Labor Affected Fetus / NewbornNCT06187779
Induction ATAD Catheter and Lower Segment Thickness
A study testing Lower segment measurment in people with Induction of Labor Affected Fetus / Newborn, run by Meir Medical Center at 1 site in Israel.
Trial summary
A prospective cohort study of pregnant women undergoing induction of labor at term .inculding- Women with a singleton pregnancy at ≥ 37 weeks' gestation, with a live fetus in cephalic presentation. all women will undergo transvaginal ultrasound assessment before induction of labor admission. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induction of Labor Affected Fetus / Newborn
- What is being tested?
- Lower segment measurment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteIsrael
- Study dates
- 6 Dec 2023to 6 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Gestational age above 24 weeks
- Singleton
- Vertex position
- Labor induction based on obstetrics guidelines
Who cannot join
- C/I for Induction of labor
- C/I for vaginal birth
- Multiple gestation
- Known fetal anatomical or genetic anomalies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Lower Segment Thickness on Induction of Labor With Balloon Insertion (ATAD)
A prospective cohort study of pregnant women undergoing induction of labor at term .inculding- Women with a singleton pregnancy at ≥ 37 weeks' gestation, with a live fetus in cephalic presentation. all women will undergo transvaginal ultrasound assessment before induction of labor admission. Maternal and obstetric characteristics and Bishop score will be recorded. The main outcome is the overall rate of Cesarean delivery after induction of labor.
- Being tested
- Lower segment measurment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower segment measurmentOther
Lower segment measurement will be taken prior to induction with a balloon catheter (ATAD).
| Study group | Role | What they receive |
|---|---|---|
| Segmental thickness measurement | Experimental | This population's lower segment will be measured. Receives: Other: Lower segment measurment |
| Segmental thickness no measurement | No intervention | No measurements of lower segment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cesarean section prevalence
Number of patients who delivered with CS
Measured: during labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start6 Dec 2023
- Primary completion6 Dec 2025 (estimated)
- Study completion6 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induction of Labor Affected Fetus / NewbornStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187779
- Sponsor's protocol ID
- MEIRATAD
- Status last verified
- Dec 2023
- First submitted
- 17 Dec 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Lower Segment Thickness on Induction of Labor With Balloon Insertion (ATAD)
- ClinicalTrials.gov ID
- NCT06187779
- Acronym / sponsor ID
- MEIRATAD
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 6 Dec 2023 (actual)
- Primary completion
- 6 Dec 2025 (estimated)
- Study completion
- 6 Dec 2026 (estimated)
- First posted
- 3 Jan 2024 (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.
A prospective cohort study of pregnant women undergoing induction of labor at term .inculding- Women with a singleton pregnancy at ≥ 37 weeks' gestation, with a live fetus in cephalic presentation. all women will undergo transvaginal ultrasound assessment before induction of labor admission. Maternal and obstetric characteristics and Bishop score will be recorded. The main outcome is the overall rate of Cesarean delivery after induction of labor.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Segmental thickness measurement | Experimental | Other: Lower segment measurmentThis population's lower segment will be measured. |
| Segmental thickness no measurement | No intervention | –No measurements of lower segment. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Gestational age above 24 weeks
- Singleton
- Vertex position
- Labor induction based on obstetrics guidelines
Key exclusion criteria (4 listed)
- C/I for Induction of labor
- C/I for vaginal birth
- Multiple gestation
- Known fetal anatomical or genetic anomalies.
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 |
|---|---|---|
| Lower segment measurmentLower segment measurement will be taken prior to induction with a balloon catheter (ATAD). | Other | Segmental thickness measurement |
Primary outcome
Cesarean section prevalence
Time frame: during labor
Number of patients who delivered with CS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lower segment measurment in people with Induction of Labor Affected Fetus / Newborn, run by Meir 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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 3 Jan 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cesarean section prevalence (time frame: during labor). 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 3 Jan 2024; AzTrials last refreshed its copy on 27 Oct 2026.