Status:
COMPLETED
Obstetrical Gel and Its Impact in Shortening the Duration of Labor in Women Undergoing a Vaginal Birth After Cesarean (VBAC)
Lead Sponsor:
Cairo University
Conditions:
Duration of Labor
Eligibility:
FEMALE
18-40 years
Phase:
PHASE4
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...
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 stag...
Eligibility Criteria
Inclusion
- • 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
- • 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
Key Trial Info
Start Date :
December 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03751553
Start Date
December 30 2018
End Date
October 15 2021
Last Update
January 14 2022
Active Locations (1)
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1
Ahmed Ashour
Giza, Egypt, 12944