Vaginal Estradiol Pretreatment in Labour Induction With Misoprostol

Failed Induction of Labor Clinical Trial

Official title:

Vaginal Estradiol Pretreatment in Labour Induction With Misoprostol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02485821
• Other study ID #: MS39825273
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 19, 2015
• Last updated: February 14, 2016
• Start date: June 2015
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion criteria:

• Maternal age = 18 years old.

• Gestational age = 37 wks to 41 wks.

• BMI between 20 kg/m2 and 35kg/m2.

• Vertex presentation.

• Singleton pregnancy.

Exclusion criteria:

• Multiple pregnancy.

• Non vertex presentation.

• Absolute or relative contraindication to vaginal delivery e.g. (Placenta previa, fibroid uterus, uterine anomalies, previous uterine surgery).

• PROM.

• IUFD.

• Fetal distress.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Failed Induction of Labor

Intervention

Drug:
• Estradiol

• Placebo

• Misoprostol

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to cervical ripening.		24 hours	Yes
Secondary	Time to active labor		30 hours	Yes
Secondary	Number of misoprostol doses		24 hours	Yes
Secondary	Induction delivery time		48 hours	Yes