Combined Method for Induction of Labor

Induced Labor Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02685085
• Other study ID #: FM0702116
• Status: Recruiting
• Phase: Phase 2
• First received: February 9, 2016
• Last updated: February 12, 2016
• Start date: February 2016
• Est. completion date: August 2016

Study information

• Verified date: February 2016
• Source: Woman's Health University Hospital, Egypt
• Contact: Dina MR Dakhly, MD
• Phone: 01003498919
• Email: dinadakhly[@]gmail.com
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• females presenting for induction of labor

Exclusion Criteria:

• previous cesarean section

• previous uterine scars e.g. myomectomy

• refusal to participate in the study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Induced Labor

Intervention

Drug:
• Misoprostol ( Prostaglandin E2)

Device:
• Foley's catheter

Locations

Country	Name	City	State
Egypt	Kasr el aini hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Woman's Health University Hospital, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of induction of labor		24 hours	Yes