Effect of Acidic Vaginal pH on the Efficacy of Dinoprostone for Labor Induction

Alexandra Hospital, Athens, Greece

Status: Completed

Conditions: Induced; Birth; Labor, Induced

Treatments: Other: Vaginal washing with 0.9% NS; Other: Vaginal washing with 5% acetic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT05100264

68/7/22-9-21

Details and patient eligibility

About

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.

Enrollment: 230 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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230 participants in 2 patient groups, including a placebo group

Vaginal washing 5% acetic acid

Experimental group

Treatment:

Other: Vaginal washing with 5% acetic acid

Vaginal washing 0.9% N/S

Placebo Comparator group

Treatment:

Other: Vaginal washing with 0.9% NS