Vaginal Estradiol Pretreatment in Labour Induction With Misoprostol

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02485821

Enrollment

200

Registered

2015-06-30

Start date

2015-06-30

Completion date

2016-02-29

Last updated

2016-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Failed Induction of Labor

Keywords

Estradiol, Misoprostol, Induction of labor, Cervical ripening, Bishop score

Brief summary

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

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).

Interventions

DRUGEstradiol

DRUGPlacebo

DRUGMisoprostol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

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.

Design outcomes

Primary

Measure	Time frame
Time to cervical ripening.	24 hours

Secondary

Measure	Time frame
Number of misoprostol doses	24 hours
Induction delivery time	48 hours
Time to active labor	30 hours

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026