A Novel Protocol for Labour Induction

Failed Induction of Labor Clinical Trial

Official title:

Foley Catheter Plus Vaginal Isosorbide Mononitrate Versus Vaginal Misoprostol for Induction of Labour:a Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01506388
• Other study ID #: 12012
• Status: Completed
• Phase: Phase 3
• First received: January 4, 2012
• Last updated: January 19, 2014
• Start date: February 2012
• Est. completion date: January 2014

Study information

• Verified date: January 2014
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The use of foley catheter was tested many times and proved to be effective for induction of labour.

Description:

The investigators compare between vaginal misoprostol versus foley catheter plus vaginal isosorbide mononitrate (IMN) for induction of labour

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Term or post term pregnancies.

• Live,singleton fetus.

• Cephalic presentation.

• Intact membrane.

• Bishop score < 6.

• Not in labour.

• Medically indicated for labour induction.

• Primigravida or parity of 3 or less.

Exclusion Criteria:

• Previous caesarean delivery.

• Malpresentation.

• Placenta previa.

• Sever intrauterine growth restriction.

• Multiple pregnancy.

• Polyhydramnios.

• Oligohydramnios.

• Bishop score 7 or more.

Study Design

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

Related Conditions & MeSH terms

• Failed Induction of Labor

Intervention

Device:
• foley catheter
foley 14 catheter intracervical plus vaginal IMN 40 mg evry 6 hours

Drug:
• Misoprostol
misoprostol 50 Ug , vaginally every 4-6 hours
• Vaginal IMN
IMN vaginal 40 mg every 4-6 hours

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo
Egypt	Waleed El-khayat	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	caesarean section rate	caesarean section	1 year	No
Secondary	time from induction to delivery	from the insertion of the foley catheter to delivery	1 year	No