NCT02685085

Brief Summary

Induction of labor is performed via the vaginal misorostol 25 ug/ 6 hours and intracervical foley's cather administration and both techniques performed together.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 18, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

February 18, 2016

Status Verified

February 1, 2016

Enrollment Period

6 months

First QC Date

February 9, 2016

Last Update Submit

February 12, 2016

Conditions

Induced Labor

Outcome Measures

Primary Outcomes (1)

  • Duration of induction of labor

    24 hours

Study Arms (3)

Misoprostol

EXPERIMENTAL

in this group misoprostol 25 ug will be administrated for induction of labor every 6 hours

Drug: Misoprostol ( Prostaglandin E2)

Foley's catheter

EXPERIMENTAL

In this group foley's catheter 30 cc will be used for induction of labor

Device: Foley's catheter

Combined

EXPERIMENTAL

Both misoprostol 25 ug and foley's catheter will be used for induction

Drug: Misoprostol ( Prostaglandin E2)Device: Foley's catheter

Interventions

Misoprostol ( Prostaglandin E2)DRUG
Also known as: Cytotec
CombinedMisoprostol
Foley's catheterDEVICE
CombinedFoley's catheter

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • females presenting for induction of labor

You may not qualify if:

  • previous cesarean section
  • previous uterine scars e.g. myomectomy
  • refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr el aini hospital

Cairo, Cairo Governorate, 12211, Egypt

RECRUITING

MeSH Terms

Interventions

MisoprostolDinoprostone

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsProstaglandins E

Study Officials

  • Dina MR Dakhly, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dina MR Dakhly, MD

CONTACT

01003498919dinadakhly@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Obstetrics and Gynecology

Study Record Dates

First Submitted

February 9, 2016

First Posted

February 18, 2016

Study Start

February 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

February 18, 2016

Record last verified: 2016-02

Locations

EG(1)