Cervical Gland Area as a Predictor of Success of Labour Induction

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 7, 2022

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.

Interventions

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

Clinical Trial Outcome Measures

Primary Measures

  • Onset of active labour
    • Time Frame: Up to delivery
    • Percent of patients that reached the active stage of labour (defined as measurement of cervical dilation of greater than 6 cm)

Secondary Measures

  • Time from Induction to second stage
    • Time Frame: Up to delivery
    • Duration of time from initiation of labpur induction to cervical dilation of 10cm
  • Time from Induction to delivery
    • Time Frame: Up to delivery
    • Duration of time from initiation of labpur induction to delivery
  • Rate of vaginal delivery
    • Time Frame: Up to delivery
    • The rate of patient that deliver vaginally including instrumental deliverires
  • Neonatal outcome – PH
    • Time Frame: Up to 10 minutes from delivery
    • The fetal arterial pH measuerment following the delivery
  • Neonatal outcome – APGAR (Apearance, Pulse, Grimace, Activity, Respiration score)
    • Time Frame: Up to 5 minutes from delivery
    • The fetal APGAR score as recieved by pediatrician
  • Neonatal outcome – NICU (Neonatal Intensive Care Unit) admission
    • Time Frame: Up to 48 hours from delivery
    • Percent of neonated that requiered NICU admission

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Rambam Health Care Campus
  • Provider of Information About this Clinical Study
    • Principal Investigator: SAAR AHARONI MD, Dr. Saar Aharoni – Rambam Health Care Campus
  • Overall Contact(s)
    • Saar Aharoni, M.D, + 523395351, s_aharoni@rambam.health.gov.il

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