Insertion of Foley catheter to uterine cervix versus oral misoprostol for preparation of uterine cervix for induction of labour in post dated pregnancies

• Register: SLCTR
• Last refreshed on: 27 April 2013
• Main ID: SLCTR/2011/002
• Date of registration: 17/01/2011
• Primary sponsor: University of Ruhuna
• Public title: Insertion of Foley catheter to uterine cervix versus oral misoprostol for preparation of uterine cervix for induction of labour in post dated pregnancies
• Scientific title: Intra cervical Foley catheter versus oral misoprostol for pre induction cervical ripening of post dated pregnancies. A randomized controlled trial
• Date of first enrolment: 1/2/2011
• Target sample size: 150
• Recruitment status: Recruiting
• URL: http://www.slctr.lk/trial_details.asp?reg_id={E75D5570-2359-454D-A82B-12E355047904}
• Study type: Interventional
• Study design: Randomized controlled trial

Countries of recruitment

Sri Lanka

Contacts

• Name: Prof. Malik Goonewardene
• Affiliation: Senior Professor and Head of the Dept. of Obstetrics and Gynaecology

• Name: Prof. Malik Goonewardene
• Affiliation: Senior Professor and Head of the Dept. of Obstetrics and Gynaecology

Key inclusion & exclusion criteria

Inclusion criteria: Consecutive women with uncomplicated singleton pregnancies having a cephalic presentation at period of gestation of 40 weeks and 6 days
Exclusion criteria: Complicated pregnancies – both maternal or fetal complications.
Pregnancies with uncertain dates not confirmed by early scan, even though clinically considered as 41 weeks.
Multiple pregnancies.
Pregnancies with contraindication for normal vaginal delivery.
Pregnancies with previous caesarean section.
Women who have had insertion of intra cervical Foley catheter or vaginal PGE2 before 40 + 6 days.
Contraindication for the use of misoprostol.


Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Effects of Foley catheter versus oral misoprostol for pre-induction cervical ripening

Intervention(s)

Women will be randomly allocated to two groups by using stratified (primi/multi) block randomization at 40 weeks and 6 days. One group will have the Foley catheter inserted and the other group will have two doses of oral misoprostol 25 micro grams 4 hours apart.

Primary Outcome(s)

1. Proportions establishing labour by day two after the intervention

2. Proportions of women suitable for induction of labour with modified Bishop score (mBS) 6 or more by day two after the intervention

3. Induction to delivery interval

Secondary Outcome(s)

1. Induction to delivery interval

2. Mode of delivery

3. Side effects of misoprostol therapy

Secondary ID(s)

Nil known

Source(s) of Monetary Support

None