A Novel Protocol for Labour Induction

Cairo University400 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

400

Conditions

Failed Induction of Labor

Interventions

foley catheterDEVICE

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

MisoprostolDRUG

misoprostol 50 Ug , vaginally every 4-6 hours

Vaginal IMNDRUG

IMN vaginal 40 mg every 4-6 hours

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Cairo University

Cairo, Cairo Governorate, Egypt

Waleed El-khayat

Cairo, Cairo Governorate, Egypt

Outcomes

Primary Outcomes

caesarean section rate

caesarean section

Time frame: 1 year

Secondary Outcomes

time from induction to delivery

from the insertion of the foley catheter to delivery

Time frame: 1 year

Data from ClinicalTrials.gov

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