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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03744364
Other study ID # JMC-PGE-2014-01
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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