Cervical Gland Area as a Predictor of Success of Labour Induction

Induced Vaginal Delivery Clinical Trial

Official title:

Cervical Gland Area as a Predictor of Success of Labour Induction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04416022
• Other study ID #: 0711-19-RMB
• Status: Not yet recruiting
• Start date: June 7, 2020
• Est. completion date: June 7, 2022

Study information

• Verified date: June 2020
• Source: Rambam Health Care Campus
• Contact: Saar Aharoni, M.D
• Phone: + 523395351
• Email: s_aharoni[@]rambam.health.gov.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 7, 2022
• Est. primary completion date: June 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Induced Vaginal Delivery

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Outcome

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