Vaginal Estradiol Pretreatment in Labour Induction With Misoprostol

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT02485821

Collaborator

(none)

200

Enrollment

Location

Arms

Duration (Months)

24.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Failed Induction of Labor	Drug: Estradiol Drug: Placebo Drug: Misoprostol	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Vaginal Estradiol Pretreatment in Labour Induction With Misoprostol

Study Start Date :

Jun 1, 2015

Actual Primary Completion Date :

Feb 1, 2016

Actual Study Completion Date :

Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Estradiol + 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.	Drug: Estradiol Other Names: Ethinyl Estradiol Drug: Misoprostol Other Names: Vagiprost
Placebo Comparator: Placebo + Misoprostol 100 patients will receive placebo vaginally and misoprostol 25 mcg which will be repeated every 6 hours up to five doses.	Drug: Placebo Drug: Misoprostol Other Names: Vagiprost

Arm

Intervention/Treatment

Experimental: Estradiol + Misoprostol

Drug: Estradiol

Other Names:

Ethinyl Estradiol

Drug: Misoprostol

Other Names:

Vagiprost

Placebo Comparator: Placebo + Misoprostol

100 patients will receive placebo vaginally and misoprostol 25 mcg which will be repeated every 6 hours up to five doses.

Drug: Placebo

Drug: Misoprostol

Other Names:

Vagiprost

Outcome Measures

Primary Outcome Measures

Time to cervical ripening. [24 hours]

Secondary Outcome Measures

Time to active labor [30 hours]
Number of misoprostol doses [24 hours]
Induction delivery time [48 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.