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

Pregnancy Clinical Trial

— MADUTER  

Official title:

Low-dose Vaginal Misoprostol Versus Vaginal Dinoprostone Insert for Induction of Labor Beyond 41st Week: a Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03744364
• Other study ID #: JMC-PGE-2014-01
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2014
• Est. completion date: November 1, 2017

Study information

• Verified date: November 2018
• Source: Hospital Miguel Servet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: November 1, 2017
• Est. primary completion date: October 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Ripening
• Induced Labor
• Obstetric Labor
• Pregnancy

Intervention

Drug:
• Misoprostol 25 mcg
To determine efficacy and safety of vaginal 'Misoprostol 25 mcg' every 4 hours with a maximum of 6 doses for induction of labor.
• Dinoprostone 10mg
To determine efficacy and safety of 'Dinoprostone 10mg' vaginal insert for induction of labor.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Miguel Servet

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful vaginal delivery within 24 hours	Percentage of women that achieve a vaginal delivery within 24 hours since induction process started	24 hours since induction was started
Secondary	Successful cervical ripening within 24 hours	Percentage of women that achieve Bishop score > 6 within 24 hours since induction process started	24 hours since induction was started
Secondary	Interval time from induction to delivery	Time passed since induction of labor started until delivery	Hours passed between induction of labor until delivery within 72 hours
Secondary	Need for a second induction	Percentage of women that require to use a second method for induction of labor after 24 hours of having started induction of labor	Assessed 24 hours since induction of labor was started
Secondary	Vaginal delivery rate	Percentage of women that achieve vaginal delivery	Since labor induction had started until delivery had ocurred within 72 hours