Feasibility and safety of a new device (Odon device) for assisted vaginal deliveries

Not Applicable

• Conditions: Prolonged second stage of labour; Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy

• Registration Number: ACTRN12613000141741
• Lead Sponsor: World Health Organization

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: Female
• Target Recruitment: 130

Inclusion Criteria

Age more or equal to 18 years, and less or equal 35 years
- Singleton pregnancy
- Gestational age equal to or more than 37 weeks
- Live fetus
- Fully dilated cervix
- Membranes ruptured (spontaneous or artificial).
- Any anterior occiput presentation.
- Station level equivalent to 2 cm or more below the spines
- Fetal Heart Rate Pattern recorded by continuous fetal electronic monitoring meeting the following criteria: (i) stable baseline rate between 110 and 160 beats/min, (ii) normal short and long term variability, (iii) absence of late decelerations.

Exclusion Criteria

- Suspected or confirmed maternal infection
- Prolonged rupture of membranes (>24 hours)
- Meconium stained
- History of coagulation disorder
- Previous uterine surgery
- Intrapartum hemorrhage
- Absolute cephalopelvic disproportion
- Known recto-vaginal Streptoccocus B Haemolyticcus positive culture
- Known HIV positive women

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome 1: Time from application of device to delivery of the cephalic pole.[During labour and delivery];Primary outcome 2: Failure rate of device application (only one attempt will be made)[During labour and delivery];Primary outcome 3: Incidence of: (i) Operative delivery with forceps or vacuum; (ii) caesarean section<br>[During labour and delivery]