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

Duration of Labor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03751553
• Other study ID #: obstetrical gel
• Status: Completed
• Phase: Phase 4
• Start date: December 30, 2018
• Est. completion date: October 15, 2021

Study information

• Verified date: December 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 15, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• • Age between 18 and 40 years
• Women who have had only one prior cesarean birth with no previous vaginal delivery, are eligible for VBAC and plan to attempt a VBAC after counseling.
• Singleton baby in vertex presentation
• Low-risk pregnancy at term (37-41 weeks of gestation)
• Estimated birth weight between 2000 g and 4500 g (clinically or by sonography)
• Signed written informed consent

Exclusion Criteria:

• • Contraindications for vaginal delivery (placenta previa, active herpes infection, etc…)
• Suspected amniotic infection (fever, foul-smelling discharge, fetal tachycardia, abdominal pain)
• A non-reassuring fetal heart tracing
• Prolonged rupture of the membranes (24 hours)
• Suspected major fetal malformations
• Suspected cephalopelvic disproportion

Related Conditions & MeSH terms

• Duration of Labor

Intervention

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.

Locations

Country	Name	City	State
Egypt	Ahmed Ashour	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	length of the second stage of labor	the length of the second stage of labor starting from full cervical dilatation till delivery of the fetus will be recorded.	1 hour