Vaginal Estradiol Pretreatment in Labour Induction With Misoprostol

Study Overview
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Brief Summary
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To assess the effect of vaginal estradiol pretreatment before vaginal misoprostol on labor induction.

Detailed Description
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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).

Official Title
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Vaginal Estradiol Pretreatment in Labour Induction With Misoprostol

Conditions
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Failed Induction of Labor

Intervention / Treatment
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* Drug: Estradiol
* Drug: Placebo
* Drug: Misoprostol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Estradiol + Misoprostol<br>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<br> <br> * Other names: Ethinyl Estradiol;Drug: Misoprostol<br> <br> * Other names: Vagiprost;|
| Placebo Comparator: Placebo + Misoprostol<br>100 patients will receive placebo vaginally and misoprostol 25 mcg which will be repeated every 6 hours up to five doses. | Drug: Placebo<br> <br> Drug: Misoprostol<br> <br> * Other names: Vagiprost;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to cervical ripening. |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to active labor |  | 30 hours | 
| Number of misoprostol doses |  | 24 hours | 
| Induction delivery time |  | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Estradiol, Misoprostol, Induction of labor, Bishop score, Cervical ripening