Cervical Gland Area as a Predictor of Success of Labour Induction

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 Overview

• Status: Unknown
• Conditions: Induced Vaginal Delivery
• Intervention / Treatment: Diagnostic test: Ultrasound examination

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Saar Aharoni, M.D; Phone Number: + 523395351; Email: s_aharoni@rambam.health.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women who are planned form labour induction

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (Anticipated): June 7, 2020
• Primary Completion (Anticipated): June 7, 2022
• Study Completion (Anticipated): June 7, 2022

Study Registration Dates

• First Submitted: June 1, 2020
• First Submitted That Met QC Criteria: June 1, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 1, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Labour induction; Cervical glandular area
• Other Study ID Numbers: 0711-19-RMB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No