NCT03751553

Obstetrical Gel and Its Impact in Shortening the Duration of Labor in Women Undergoing a Vaginal Birth After Cesarean (VBAC)

Obstetrical Gel and Its Impact in Shortening the Duration of Labor in Women Undergoing a Vaginal Birth After Cesarean (VBAC):a Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The objective of our study is to investigate whether the use of obstetric gel shortens the first and second stage of labor and exerts a protective effect on the lower genital tract in women undergoing a Vaginal Birth After Cesarean (VBAC).

Detailed description

Recent literature shows that birth injury is associated with postpartum pelvic floor dysfunction (pelvic organ prolapse and fecal and urinary incontinence). Prolonged labor, namely during the 2nd stage, is one of the main obstetric risk factors responsible for anal sphincter rupture and fecal incontinence. In addition, it is associated with increased maternal and neonatal morbidities including increased risk of lower genital tract lacerations. In an effort to shorten labor and decrease lower genital tract trauma many techniques have been investigated.

Conditions

• Duration of Labor

Interventions

Type	Name	Description
DRUG	obsteric gel(k-Y jelly)	A sterile obstetric gel( K-Y Jelly 82GM; manufactured by Johnson\& Johnson) will be used for this trial. The obstetric gel is a birth gel with no pharmacologic effects that have purely physical activity. Starting with the first vaginal examination the obstetric gel will be used. After each vaginal examination, 3-5 mL of obstetric gel will be introduced into the vaginal birth canal in the area in front of the child manually or using the sterile obstetric gel applicator without any manipulation or massage.

Timeline

• Start date: 2018-12-30
• Primary completion: 2021-09-15
• Completion: 2021-10-15
• First posted: 2018-11-23
• Last updated: 2022-01-14

Locations

1 site across 1 country: Egypt