Duration of Labor
Conditions
Brief 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.
Interventions
DRUGobsteric 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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| length of the second stage of labor | 1 hour | the length of the second stage of labor starting from full cervical dilatation till delivery of the fetus will be recorded. |
Countries
Egypt
Outcome results
None listed