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

NCT03751553 — Phase 4, Completed, 200 participants, Cairo University

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

Registry	NCT03751553
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: triple, prevention
Enrollment	200 (Actual)
Sponsor	Cairo University (Other)
Conditions	Duration of Labor
Interventions	obsteric gel(k-Y jelly) (Drug)
Dates	start 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 in Egypt

-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).

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+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.

+Arms and interventions

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

obsteric gel(k-Y jelly) (Drug): 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.

+Outcome measures

Primary outcomes

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.

+Eligibility

Sex: Female, ages: 18 Years to 40 Years, 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

+Locations (1)

Facility	City	Country	Status
Ahmed Ashour	Giza	Egypt

+Investigators

AHMED SAMY, MD, Principal investigator, Cairo University

My Notes

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