NCT02485821

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 30, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

February 17, 2016

Status Verified

February 1, 2016

Enrollment Period

8 months

First QC Date

June 19, 2015

Last Update Submit

February 14, 2016

Conditions

Failed Induction of Labor

Keywords

EstradiolMisoprostolInduction of laborCervical ripeningBishop score

Outcome Measures

Primary Outcomes (1)

  • Time to cervical ripening.

    24 hours

Secondary Outcomes (3)

  • Time to active labor

    30 hours

  • Number of misoprostol doses

    24 hours

  • Induction delivery time

    48 hours

Study Arms (2)

Estradiol + Misoprostol

EXPERIMENTAL

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: EstradiolDrug: Misoprostol

Placebo + Misoprostol

PLACEBO COMPARATOR

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

Drug: PlaceboDrug: Misoprostol

Interventions

EstradiolDRUG
Also known as: Ethinyl Estradiol
Estradiol + Misoprostol
PlaceboDRUG
Placebo + Misoprostol
MisoprostolDRUG
Also known as: Vagiprost
Estradiol + MisoprostolPlacebo + Misoprostol

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Maternal age ≥ 18 years old.
  • Gestational age ≥ 37 wks to 41 wks.
  • BMI between 20 kg/m2 and 35kg/m2.
  • Vertex presentation.
  • Singleton pregnancy.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Interventions

EstradiolEthinyl EstradiolMisoprostol

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNorpregnatrienesNorpregnanesNorsteroidsEstrogenic Steroids, AlkylatedProstaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Osama El-Kady, MD

    AinShams University

    PRINCIPAL INVESTIGATOR

  • AbdEl-Latif El-Kholy, MD

    AinShams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mohamed S. Sweed lecturer of Obstetrics & Gynecology AinShams University.

Study Record Dates

First Submitted

June 19, 2015

First Posted

June 30, 2015

Study Start

June 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

February 17, 2016

Record last verified: 2016-02

Locations

EG(1)