CClinicalTrials.gg
Status unknownNCT04416022Updated Jun 4, 2020

Cervical Gland Area as a Predictor of Success of Labour Induction

An observational study in Induced Vaginal Delivery, sponsored by Rambam Health Care Campus. Status unknown. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-04.

Sponsored by Rambam Health Care Campus · Observational

The sponsor has not verified this record recently (last verified Jun 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 45 Years
Sex
Female
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Study summary

Women who fulfil the inclusion criteria and who are planned for labour induction will be recruited. Bishop score, cervical length, and the presence of cervical glandular area (CGA) will be documented for every patient up to 12 hours prior to the induction process, and patient information and maternal and neonatal outcome will be documented following the delivery.

Read the detailed description

Patient consent to participate in the study will be retrieved following the medical decision of labor induction and the mode of induction and following the patient consent to the induction.

Bishop score, cervical length, and the presence of cervical glandular area (CGA) will be documented for every patient up to 12 hours prior to the induction process.

The method of induction, data regarding patient demographics, the progress of labor, and the maternal and neonatal outcome will be documented following the delivery.

02

Conditions studied

  • Induced Vaginal Delivery

Keywords

  • Labour induction
  • Cervical glandular area
03

In context

Lead sponsor

Rambam Health Care Campus is the lead sponsor of 456 studies on the registry; 33 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
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Pregnant women who are planned form labour induction

Inclusion criteria

  • Singleton and twins' pregnancies
  • Pregnancy 34-41 weeks of gestation
  • Vertex presentation
  • Induction methods (Oxytocin, prostaglandin 1 (PGE1), prostaglandin 2 (PGE2), double balloon catheter, rupture of memebrane (ROM)

Exclusion criteria

Exclusion Criteria:

  • Intrauterine fetal demise (IUFD)
  • Contraindication to vaginal delivery
  • Status post cervical cerclage
  • Previous attempt of labor induction
  • History of cervical surgery
  • Active vaginal bleeding
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testUltrasound examination

    Women that are planned for labour induction, will undergo a routine ultrasound examination prior to the initiation of the induction process.

06

What researchers measure

Primary outcomes

  1. Onset of active labour

    Percent of patients that reached the active stage of labour (defined as measurement of cervical dilation of greater than 6 cm)

    Time frame: Up to delivery

Secondary outcomes

  1. Time from Induction to second stage

    Duration of time from initiation of labpur induction to cervical dilation of 10cm

    Time frame: Up to delivery

  2. Time from Induction to delivery

    Duration of time from initiation of labpur induction to delivery

    Time frame: Up to delivery

  3. Rate of vaginal delivery

    The rate of patient that deliver vaginally including instrumental deliverires

    Time frame: Up to delivery

  4. Neonatal outcome - PH

    The fetal arterial pH measuerment following the delivery

    Time frame: Up to 10 minutes from delivery

  5. Neonatal outcome - APGAR (Apearance, Pulse, Grimace, Activity, Respiration score)

    The fetal APGAR score as recieved by pediatrician

    Time frame: Up to 5 minutes from delivery

  6. Neonatal outcome - NICU (Neonatal Intensive Care Unit) admission

    Percent of neonated that requiered NICU admission

    Time frame: Up to 48 hours from delivery

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04416022
Lead sponsor
Rambam Health Care Campus
Responsible party
SAAR AHARONI MD (Dr. Saar Aharoni, Rambam Health Care Campus) — Principal investigator
First posted
Jun 4, 2020
Start date
Jun 7, 2020 (estimated)
Primary completion
Jun 7, 2022 (estimated)
Completion
Jun 7, 2022 (estimated)
Last update
Jun 4, 2020

Study contacts

Saar Aharoni, M.D
Contact
s_aharoni@rambam.health.gov.il
+ 523395351

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 status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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