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

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

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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