Prostaglandine E2 and intra-cervical catheter are categories of cervical ripening before induction of labor. The aim of this study is to compare the effect of the intra-cervical Foley catheter and Prostaglandine E2 vaginal tablet in preinduction cervical ripening. In this study, 89 women with inclusion criteria (term and first pregnancy with Bishop Score less than 5 that had indication for vaginal delivery ,...) and exclusion criteria (PROM, ...) entered the study. Patients were randomized into two groups and they matched by maternal age. In first group: A 3mg Prostaglandin E2 vaginal tablet was put in posterior Culdusac; then primary and new bishop score noted after 12 hours and induction with Oxytocin started after 12 hours (if needed). In second group: An intra-cervical Foley catheter (size of 16) was put intra-cervix with sterile condition and it fixed by 15 mlit liquid; then primary and new bishop score noted after 12 hours and induction with Oxytocin started (if it needed). Solution of Oxytocin was 10 IU in 1 lit serum (Ringer) that at first started with 6MIU per min and every 20 min added to eight drops of up to 64 drops can be increased. Changes of Bishop Score, type of delivery, use of Oxytocin, infant status and possible complication recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012071760N10
Registration date:2011-02-02, 1389/11/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-02-02, 1389/11/13
Registrant information
Name
Nargess Gholizadeh Pasha
Name of organization / entity
Fatemehzahra Infertility Reproductive Health Research Center, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 2282
Email address
zahra@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and technology, Babol University of Medical Sciences
Expected recruitment start date
2007-05-22, 1386/03/01
Expected recruitment end date
2008-05-21, 1387/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Prostaglandine E2 and intra-cervical Foley balloon in labor induction
Public title
Efficacy of Prostaglandine E2 and intra-cervical Foley balloon in labor induction
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Term pregnant women (37-42 weeks), first pregnancy that had indication of labor and Bishop Score less than 5. Exclusion criteria: Rupture of membrane, Twin pregnancy, Preterm labor and closed cervix.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
89
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical sciences
Street address
Gangafroz Avenue
City
Babol
Postal code
Approval date
2007-04-28, 1386/02/08
Ethics committee reference number
6725
Health conditions studied
1
Description of health condition studied
induction of labor
ICD-10 code
O80
ICD-10 code description
Single spontaneous delivery
Primary outcomes
1
Description
preinduction cervical ripening
Timepoint
12 to 48 hours after intervention
Method of measurement
Clinical examinations
Secondary outcomes
1
Description
Use of induction
Timepoint
12 to 48 hours after entries
Method of measurement
Clinical examinations
2
Description
Type of delivery
Timepoint
12 to 48 hours after entries
Method of measurement
Clinical examinations
3
Description
Infant status
Timepoint
12 to 48 hours after entries
Method of measurement
Clinical examinations
4
Description
Possible complication
Timepoint
12 to 48 hours after entries
Method of measurement
Clinical examinations
Intervention groups
1
Description
Group 1: A suppository of Prostaglandin E2 (3mg,), Oxytocine (High Dose, with 6MIU starts and every 20 minutes if needed to be added to eight drops of up to 64 drops can be increased).
Category
Treatment - Drugs
2
Description
Group 2: A Foley catheter of No. 16, Oxytocine (High Dose, with 6MIU starts and every 20 minutes if needed to be added to eight drops of up to 64 drops can be increased).
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Yahyanejad Educational Center
Full name of responsible person
Dr. Shahla Yazdani
Street address
Yahyanejad Educational Center
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Bijani
Street address
Vice Chancellor for Research and Technology, Babol University of Medical Sciences, Gangafroz Avenue
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Fatemehzahra Fertility & reproductive Health Research Center
Full name of responsible person
Nargess Gholizadeh Pasha
Position
M.A/Responsible for Public Affairs Research Center
Other areas of specialty/work
Street address
Noshirvani street
City
Babol
Postal code
4719173716
Phone
+98 11 1227 4881
Fax
+98 11 1227 4880
Email
ngh_pa@yahoo.com , zahra@mubabol.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Obstetrics and Gynecology, Ayatollah Rouhani Educational Center
Full name of responsible person
Dr. Shahla Yazdani
Position
Gynecologist
Other areas of specialty/work
Street address
Department of Obstetrics and Gynecology, Ayatollah Rouhani Educational Center
City
Babol
Postal code
Phone
+98 11 1223 8301
Fax
Email
Shahla_yazdani_1348@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Fatemehzahra Fertility & reproductive Health Research Center
Full name of responsible person
Nargess Gholizadeh Pasha
Position
M.A/Responsible for Public Affairs Research Center
Other areas of specialty/work
Street address
Fatemehzahra Fertility & reproductive Health Research Center - noshirvani street
City
Babol
Postal code
4719173716
Phone
+98 11 1227 4881
Fax
+98 11 1227 4880
Email
ngh_pa@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)