Vaginal Estradiol Pretreatment in Labour Induction With Misoprostol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-02-29

Brief Summary

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

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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).

Conditions

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Failed Induction of Labor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Estradiol

Intervention Type DRUG

Misoprostol

Intervention Type DRUG

Placebo + Misoprostol

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Misoprostol

Intervention Type DRUG

Interventions

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Estradiol

Intervention Type DRUG

Placebo

Intervention Type DRUG

Misoprostol

Intervention Type DRUG

Other Intervention Names

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Ethinyl Estradiol Vagiprost

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes