Low-dose Vaginal Misoprostol Versus Vaginal Dinoprostone Insert for Induction of Labor (MADUTER)

University Hospital Miguel Servet

Status and phase: Completed; Phase 4

Conditions: Obstetric Labor; Cervical Ripening; Induced Labor; Pregnancy

Treatments: Drug: Misoprostol 25 mcg; Drug: Dinoprostone 10mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03744364

JMC-PGE-2014-01

Details and patient eligibility

About

Purpose:

To compare the efficacy and safety of low-dose protocol of vaginal misoprostol and vaginal dinoprostone insert for induction of labor in women with post-term pregnancies.

Methods:

The investigators designed a prospective, randomized, open-labeled, blinded for the end-point evaluators trial including women of at least 41 weeks of gestational age with uncomplicated singleton pregnancies and Bishop score lower than 6. Participants were randomized into dinoprostone or misoprostol groups in a 1:1 ratio. Baseline maternal data and perinatal outcomes were recorded for statistical analysis. Successful vaginal delivery within 24 hours was the primary outcome variable.

Enrollment: 198 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Singleton uncomplicated pregnancy
• Nulliparity
• Live fetus
• 286 days of gestational age or above
• Abscence of contraindication for vaginal delivery
• Bishop score lower than 6

Exclusion criteria

• Multiple pregnancy
• Multiparity
• Stillbirth
• Oligohydramnios
• Suspected fetal distress
• Severe asthma
• Intolerance/allergy to prostaglandins
• Contraindication for vaginal birth

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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198 participants in 2 patient groups

Misoprostol

Active Comparator group

Description:

Group of women allocated to misoprostol induction.

Treatment:

Drug: Misoprostol 25 mcg

Dinoprostone

Active Comparator group

Description:

Group of women allocated to dinoprostone induction.

Treatment:

Drug: Dinoprostone 10mg