Vaginal Estradiol Pretreatment in Labour Induction With Misoprostol

Ain Shams University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Failed Induction of Labor

Treatments: Drug: Misoprostol; Drug: Placebo; Drug: Estradiol

Study type: Interventional

Funder types: Other

Identifiers

NCT02485821

MS39825273

Details and patient eligibility

About

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

Full 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).

Enrollment: 200 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups, including a placebo group

Estradiol + Misoprostol

Experimental group

Description:

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.

Treatment:

Drug: Estradiol

Drug: Misoprostol

Placebo + Misoprostol

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: Misoprostol