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OpenTrials
Completed

NCT Number: NCT01506388

A Novel Protocol for Labour Induction

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

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Key information

Conditions

Failed Induction of Labor

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Cairo University, Cairo, Cairo Governorate, Egypt

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

foley catheter

Device

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

Misoprostol

Drug

misoprostol 50 Ug , vaginally every 4-6 hours

Other names: misoprostol vaginally

Vaginal IMN

Drug

IMN vaginal 40 mg every 4-6 hours

Primary outcomes

  1. caesarean section rate

    Time frame: 1 year

    caesarean section

Secondary outcomes

  1. time from induction to delivery

    Time frame: 1 year

    from the insertion of the foley catheter to delivery

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Jan 10, 2012
Registry last updated
Jan 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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