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A Novel Protocol for Labour Induction

Phase 3
Completed
Conditions
Failed Induction of Labor
Interventions
Device: foley catheter
Drug: Vaginal IMN
Registration Number
NCT01506388
Lead Sponsor
Cairo University
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

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
400
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
folye catheter plus vaginal IMNfoley catheterintracervical foley catheter plus vaginal IMN
folye catheter plus vaginal IMNVaginal IMNintracervical foley catheter plus vaginal IMN
Misoprostol vaginallyMisoprostolintravaginal misoprostol
Primary Outcome Measures
NameTimeMethod
caesarean section rate1 year

caesarean section

Secondary Outcome Measures
NameTimeMethod
time from induction to delivery1 year

from the insertion of the foley catheter to delivery

Trial Locations

Locations (2)

Waleed El-khayat

🇪🇬

Cairo, Egypt

Cairo University

🇪🇬

Cairo, Egypt

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