Obstetrical Gel Use to Shorten Labor and Prevent Lower Genital Tract Trauma

A

American University of Beirut Medical Center

Status and phase

Completed
Phase 4

Conditions

Labor Stage, Second

Treatments

Drug: Natalis

Study type

Interventional

Funder types

Other

Identifiers

NCT03518684
OGY.EH.03

Details and patient eligibility

About

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. 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. Neonatal and maternal morbidities will be also assessed. The study design will be a randomized controlled trial of 2 groups, where the patients presenting for vaginal delivery will be randomly assigned to either: * Group 1 who will receive the standard care during labor and delivery * Group 2 who will receive the standard care during labor and delivery with the vaginal application of the obstetrical gel The goal of this randomized controlled study is to compare the length of the first and 2nd stage of labor and the lower genital tract integrity in the 2 groups of patients.

Enrollment

160 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Age between 18 and 40 years
  • Intended vaginal delivery
  • Singleton baby in vertex presentation
  • Low risk pregnancy at term (37-42 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...)
  • Advanced cervical dilation (≥ 5 cm)
  • Suspected amniotic infection (fever, foul smelling discharge, fetal tachycardia, abdominal pain)
  • 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

None (Open label)

160 participants in 2 patient groups

Group 1
No Intervention group
Description:
Group 1 in which they will receive the standard care during labor and delivery without the use of the obstetrical gel
Group 2
Experimental group
Description:
Group 2 in which they will have the standard care during labor and delivery with the vaginal application of the obstetrical gel according to the study protocol. Those 2 groups will be further divided into 4 subgroups where the parity will be accounted for (nulliparous [never delivered beyond 20 weeks of gestation in a previous pregnancy] or primiparous or more)
Treatment:
Drug: Natalis

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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