A Novel Protocol for Labour Induction

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01506388

Enrollment

400

Registered

2012-01-10

Start date

2012-02-29

Completion date

2014-01-31

Last updated

2014-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Failed Induction of Labor

Keywords

labour induction, Foley catheter, misoprostol, isosorbide mononitrate

Brief summary

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

Detailed description

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

Interventions

DEVICEfoley catheter

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

DRUGMisoprostol

misoprostol 50 Ug , vaginally every 4-6 hours

DRUGVaginal IMN

IMN vaginal 40 mg every 4-6 hours

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
caesarean section rate	1 year	caesarean section

Secondary

Measure	Time frame	Description
time from induction to delivery	1 year	from the insertion of the foley catheter to delivery

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026