A Novel Protocol for Labour Induction

Cairo University (CU)

Status and phase: Completed; Phase 3

Conditions: Failed Induction of Labor

Treatments: Device: foley catheter; Drug: Vaginal IMN; Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT01506388

12012

Details and patient eligibility

About

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

Full description

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

Enrollment: 400 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

folye catheter plus vaginal IMN

Experimental group

Description:

intracervical foley catheter plus vaginal IMN

Treatment:

Device: foley catheter

Drug: Vaginal IMN

Misoprostol vaginally

Active Comparator group

Description:

intravaginal misoprostol

Treatment:

Drug: Misoprostol