Effect of Acidic Vaginal pH on the Efficacy of Dinoprostone (PGE2) Vaginal Tablet for Labor Induction in Full Term Pregnant Women: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 230
- Locations
- 2
- Primary Endpoint
- Interval from induction to delivery
Study Overview
Brief Summary
Acidification of vaginal pH has been proposed as a potential factor that could help increase the efficacy of vaginal prostaglandins in labor induction. The aim of the present randomized controlled trial is to evaluate the impact of an acidic vaginal pH on the progress of labor induction with dinoprostone (Prostaglandin E2 - PGE2) vaginal tablet.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Randomization will be computer generated. Allocation concealment will be ensured by opaque sealed envelopes. Blinding of outcomes assessor, principal as well as other investigators will be ensured as randomization will be performed by an external investigator that will not participate in the clinical process of the study or the statistical analysis. The ward midwife will open the randomization envelope after patient enrollment and different types of vaginal washing will be applied as per randomization. Participant as well outcomes assessor (physician that will evaluate the progress of labor as well statistician involved in the analysis) will be blinded to the procedure.
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Singleton pregnancy
- •Full term (>37 weeks)
- •Cephalic presentation
- •Reactive NST (nonstress test)
- •Absence of spontaneous uterine contractions
- •No contraindications to vaginal delivery
Exclusion Criteria
- •Multifetal pregnancy
- •Fetal malpresentation
- •Preterm delivery (<37 weeks)
- •Advanced maternal age (>40 years)
- •Bishop score > 7
- •Fetal macrosomia ( >4500 gr)
- •Non reassuring NST (nonstress test)
- •Suspected chorioamnionitis
- •Previous cesarean delivery or other uterine surgery
Arms & Interventions
Vaginal washing 5% acetic acid
Intervention: Vaginal washing with 5% acetic acid (Other)
Vaginal washing 0.9% N/S
Intervention: Vaginal washing with 0.9% NS (Other)
Outcomes
Primary Outcomes
Interval from induction to delivery
Time Frame: 36 hours
Time interval (minutes)
Secondary Outcomes
- Interval from induction to active labor(36 hours)
- Interval from induction to second stage of labor(36 hours)
- Failure of induction of labor(36 hours)
Investigators
Georgios Daskalakis
Professor of Obstetrics and Gynecology
Alexandra Hospital, Athens, Greece