Induced; Birth, Labor, Induced
Conditions
Keywords
labor induction, dinoprostone, vaginal pH
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.
Interventions
OTHERVaginal washing with 5% acetic acid
Induction of labor (vaginal tablet dinoprostone and vaginal washing with 5% acetic acid)
OTHERVaginal washing with 0.9% NS
Induction of labor (vaginal tablet dinoprostone and vaginal washing 0.9% NS)
Sponsors
National and Kapodistrian University of Athens
Alexandra Hospital, Athens, Greece
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, 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
Sex/Gender
FEMALE
Age
18 Years to 40 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interval from induction to delivery | 36 hours | Time interval (minutes) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interval from induction to active labor | 36 hours | Time interval (minutes) |
| Interval from induction to second stage of labor | 36 hours | Time interval (minutes) |
| Failure of induction of labor | 36 hours | Rate of participants with failure of induction of labor |
Countries
Greece
Outcome results
None listed