Cervical Gland Area as a Predictor of Success of Labour Induction

NCT ID: NCT04416022

Last Updated: 2020-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-07

Study Completion Date

2022-06-07

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Induced Vaginal Delivery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Ultrasound examination

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

* Intrauterine fetal demise (IUFD)
* Contraindication to vaginal delivery
* Status post cervical cerclage
* Previous attempt of labor induction
* History of cervical surgery
* Active vaginal bleeding
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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SAAR AHARONI MD

Dr. Saar Aharoni

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Saar Aharoni, M.D

Role: CONTACT

+ 523395351

Other Identifiers

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0711-19-RMB

Identifier Type: -

Identifier Source: org_study_id

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