NCT02485821

Vaginal Estradiol Pretreatment in Labour Induction With Misoprostol

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

To assess the effect of vaginal estradiol pretreatment before vaginal misoprostol on labor induction.

Detailed description

A prospective double blind randomized clinical trial. Conducted at Ain Shams University Maternity Hospital. Patients fulfilling inclusion and exclusion criteria will be divided into two groups. Group (A): 100 patient will receive single dose vaginal estradiol 50mcg tablet (Ethinyl Estradiol manufactured by KAHIRA Pharmaceutical company) and vaginal misoprostol 25mcg tablet (Vagiprost manufactured by ADWIA Pharmaceutical company), misoprostol alone will repeated every 6hours up to five doses. Group (B): 100 patients will receive placebo vaginally and misoprostol 25 mcg which will be repeated every 6 hours up to five doses. Primary Outcome * Measure the time to cervical ripening. Secondary Outcome * Measure the time to active labor. * Number of misoprostol doses. * Induction delivery time. * Time to achieve vaginal delivery. * Fetal outcome (Apgar score).

Conditions

• Failed Induction of Labor

Interventions

Type	Name	Description
DRUG	Estradiol
DRUG	Placebo
DRUG	Misoprostol

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2015-06-30
• Last updated: 2016-02-17

Locations

1 site across 1 country: Egypt