Vaginal Estradiol Pretreatment in Labour Induction With Misoprostol

Phase 2

Completed

• Conditions: Failed Induction of Labor
• Interventions: Drug: Placebo; Drug: Estradiol; Drug: Misoprostol

• Registration Number: NCT02485821
• Lead Sponsor: Ain Shams University

Brief 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).

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-19
• Study First Submitted QC: 2015-06-26
• Study First Posted: 2015-06-30
• Status Verified: 2016-02
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Last Update Submitted: 2016-02-14
• Last Update Posted: 2016-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo + Misoprostol	Placebo	100 patients will receive placebo vaginally and misoprostol 25 mcg which will be repeated every 6 hours up to five doses.
Estradiol + Misoprostol	Estradiol	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.
Estradiol + Misoprostol	Misoprostol	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.
Placebo + Misoprostol	Misoprostol	100 patients will receive placebo vaginally and misoprostol 25 mcg which will be repeated every 6 hours up to five doses.

Primary Outcome Measures

Name	Time	Method
Time to cervical ripening.	24 hours

Secondary Outcome Measures

Name	Time	Method
Time to active labor	30 hours
Number of misoprostol doses	24 hours
Induction delivery time	48 hours

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt