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

Cairo University (CU) logo

Cairo University (CU)

Status and phase

Completed
Phase 4

Conditions

Duration of Labor

Treatments

Drug: obsteric gel(k-Y jelly)

Study type

Interventional

Funder types

Other

Identifiers

NCT03751553
obstetrical gel

Details and patient eligibility

About

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).

Full 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.

Enrollment

200 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

200 participants in 2 patient groups

obstetric gel group
Experimental group
Description:
they will have the standard care during labor and delivery with the vaginal application of the obstetrical gel.
Treatment:
Drug: obsteric gel(k-Y jelly)
no intervention group
No Intervention group
Description:
they will receive the standard care during labor and delivery without the use of the obstetrical gel

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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