Cervical Gland Area as a Predictor of Success of Labour Induction

NCT04416022 | Unknown

• 1 other identifier: 0711-19-RMB
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Induced Vaginal Delivery

Keywords

Labour induction; Cervical glandular area

Outcome Measures

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)

  Up to delivery

Secondary Outcomes (6)

• Time from Induction to second stage

  Up to delivery

• Time from Induction to delivery

  Up to delivery

• Rate of vaginal delivery

  Up to delivery

• Neonatal outcome - PH

  Up to 10 minutes from delivery

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

  Up to 5 minutes from delivery

Interventions

Ultrasound examination DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women who are planned form labour induction

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Central Study Contacts

Saar Aharoni, M.D

CONTACT

+ 523395351; s_aharoni@rambam.health.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Saar Aharoni

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 4, 2020
• Study Start: June 7, 2020
• Primary Completion: June 7, 2022
• Study Completion: June 7, 2022
• Last Updated: June 4, 2020

Record last verified: 2020-06