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CompletedNCT03944187Updated Apr 20, 2022

Sonographic Assessment for Prediction of Labor Induction Success

An observational study in Induction of Labor Affected Fetus / Newborn, sponsored by Rambam Health Care Campus. Completed at 1 site in Israel. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-04-20.

Sponsored by Rambam Health Care Campus · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

The study is conducted to assess several sonographic parameters for prediction of labor induction success. These parameters include cervical length, fetal head circumference, and fetal head to cervix angle.

Read the detailed description

Pregnant women at term over 37 weeks' gestation visiting the obstetric emergency room for various obstetric indications will be assessed. Women with obstetric or medical indication for induction will receive an explanation regarding the study protocol and will sign an informed consent.

After recruitment and during the evaluation in the obstetric emergency room, patients will undergo transvaginal sonography during which, cervical length, fetal head circumference and fetal head to cervix angle will be measured.

Relevant demographic and obstetric information will be collected from a computerized database.

02

Conditions studied

  • Induction of Labor Affected Fetus / Newborn
03

In context

Lead sponsor

Rambam Health Care Campus is the lead sponsor of 466 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

Pregnant women with singleton pregnancy over 37 weeks' gestation

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Singleton pregnancy.
  • Term pregnancy.

Exclusion criteria

Exclusion Criteria:

  • Multiple gestation.
  • Fetal anomalies and malformations.
  • Preterm pregnancy.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testTransvaginal sonography

    Transvaginal sonography for measurement of cervical length, fetal head circumference and fetal head to cervix angle .

06

What researchers measure

Primary outcomes

  1. Success in induction of labor

    Vaginal delivery rate after labor induction

    Time frame: From admission to the obstetric emergency room up to 24 hours postpartum

07

Study locations

1 site
  • Rambam health care campus
    Haifa, Israel
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2019 to primary completion in Dec 2021, 30 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 8, 2019
First posted
May 9, 2019
StartActual
Jun 1, 2019
Primary completionActual
Dec 31, 2021
CompletionActual
Apr 1, 2022
Last update
Apr 20, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03944187
Responsible party
ROY LAUTERBACH MD (Principal Investigator, Rambam Health Care Campus) — Principal investigator
First posted
May 9, 2019
Start date
Jun 1, 2019
Primary completion
Dec 31, 2021
Completion
Apr 1, 2022
Last update
Apr 20, 2022

Study contacts

Roy Lauterbach, MD
principal investigator · Rambam healthcare campus

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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