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Completed

NCT Number: NCT02485821

Vaginal Estradiol Pretreatment in Labour Induction With Misoprostol

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

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ain Shams University

Cairo, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Estradiol

Drug

Other names: Ethinyl Estradiol

Placebo

Drug

Misoprostol

Drug

Other names: Vagiprost

Primary outcomes

  1. Time to cervical ripening.

    Time frame: 24 hours

Secondary outcomes

  1. Time to active labor

    Time frame: 30 hours

  2. Number of misoprostol doses

    Time frame: 24 hours

  3. Induction delivery time

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 30, 2015
Registry last updated
Feb 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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