The aim of this trial is to compare sublingual Misoprostol with vaginal Misoprostol for cervical ripening in primiparous pregnant women who have been candidats for labour induction. Those Primiparous pregnant women will be entered in this study who have been candidates for pregnancy termination between 36 to 42 weeks of pregnancy with inappropriate bishop score (less than 4). After written and informed consent to participate in the study the women will be divided into two groups randomly, one group will be given 25 microgram of sublingual Misoprostol plus vaginal placebo while another group will receive 50 microgram of vaginal Misoprostol plus sublingual placebo. All researchers who are involved in this study, have no information about type of intervention in the two groups. Drug Doses will be repeated every 4 hours up to four times if necessary. Fetal heart rate and uterus contractions will be checked before every dose prescription for about 10 minutes. Vaginal examination will be done for every person before induction. In case of acquiring three contractions during ten minutes or reaching the active phase (at least 4cm dilatation) we won't give the next dose. Finally we will compare the following factors by means of statistical methods: Time interval from labour induction till the active phase, delivery type, vaginal delivery rate during first 12 hours and also during first 12 to 24 hours, tachysystole and hyper stimulation, caesarean section rate, Apgar score, meconium discharge, and bishop score 4 hours after induction, consumed dose of Misoprostol and Oxytocine in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903121096N3
Registration date:2010-06-02, 1389/03/12
Registration timing:prospective
Last update:
Update count:0
Registration date
2010-06-02, 1389/03/12
Registrant information
Name
Seyede Hajar Sharami
Name of organization / entity
Guilan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 5624
Email address
sharami@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research – Guilan university of medical sciences
Expected recruitment start date
2010-07-23, 1389/05/01
Expected recruitment end date
2011-09-23, 1390/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Sublingual and vaginal Misoprostol for labor induction in primiparous women
Public title
Effect of sublingual Misoprostol versus vaginal Misoprostol in labor induction success.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: a) single pregnancy (between 36 to 42 weeks), b) vertex presentation, c) intact fetal membrane, d) bishop score equal or less than four e) absence of uterus spontaneous contractions f) fetal weight less than 4000gr j) normal fetal heart rate h) cephalopelvic proportion Exclusion criteria: a) sensitivity to PGs b) previous history of cesarean c) uterus wall scar d) preeclampsia or blood pressure more than 140/90 mmhg e) PROM f) vaginal bleeding
Age
From 15 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor for research , Guilan university of medical sciences
Street address
Namjoo street, Vice Chancellor for research , Guilan university of medical sciences
City
Rasht
Postal code
Approval date
empty
Ethics committee reference number
1694
Health conditions studied
1
Description of health condition studied
labour induction
ICD-10 code
O62.3
ICD-10 code description
Precipitate labour
Primary outcomes
1
Description
Time interval from labour induction to delivery
Timepoint
After delivery
Method of measurement
Time recording of induction beginning and delivery in Questionnaire
2
Description
Delivery type frequency
Timepoint
After delivery
Method of measurement
patient medical document
3
Description
Dose amount
Timepoint
Four hours after last prescription of Misoprostol up to delivery time
Method of measurement
Patient medical document
Secondary outcomes
1
Description
Vaginal delivery frequency during first 12 hours
Timepoint
During 12 hours from induction beginning
Method of measurement
Patient medical document
2
Description
Vaginal delivery frequency during first 12 to 24 hours
Timepoint
During 12 to 24 hours from induction beginning
Method of measurement
Patient medical document
3
Description
Tachysystole incidence rate
Timepoint
Every 4 hours until entering in active phase
Method of measurement
Fetal heart monitoring device and recording of uterus contractions
4
Description
Hyper stimulation incidence rate
Timepoint
Every 4 hours until entering in active phase
Method of measurement
Fetal heart monitoring device and recording of uterus contractions
5
Description
Cesarean rate due to FHR disorder
Timepoint
After cesarean
Method of measurement
patient medical document
6
Description
Cesarean section rate due to delivery failure
Timepoint
After cesarean section
Method of measurement
Patient medical document
7
Description
Apgar score below 7 rate
Timepoint
After delivery
Method of measurement
Patient medical document
8
Description
Meconium discharge rate
Timepoint
By presenting 3cm or more dilatation after rupture of membrance
Method of measurement
Clinical examination or patient medical document
9
Description
NICU admission rate
Timepoint
After delivery
Method of measurement
Patient medical document
10
Description
Bishop score alteration average after 4 hours
Timepoint
After 4 hours from beginning of induction
Method of measurement
Vaginal examination
Intervention groups
1
Description
Prescription of 25 microgram of sublingual Misoprostol plus vaginal placebo every four hours up to four times.
Category
Treatment - Drugs
2
Description
Prescription of 50 microgram of vaginal Misoprostol plus sublingual placebo every four hours up to four times.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Guilan university of medical sciences.Alzahra Hospital
Full name of responsible person
Street address
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research -Guilan university of medical sciences
Full name of responsible person
Dr.Abdolrasol Sobhani
Street address
Namjo street, Vice chancellor for research , Guilan University of Medical Sciences
City
Rasht
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 -Guilan 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
Guilan university of medical sciences
Full name of responsible person
Dr.Seyede Hajar Sharami
Position
Accosiated professor of Obstetric and Gynecology, Guilan university of Medical Sciences
Other areas of specialty/work
Street address
Reproductive Health Research center , Department of Ob &Gyn, Alzahra Hospital, Guilan university of Medical Sciences , Namjo street
City
Rasht
Postal code
Phone
+98 911 131 3242
Fax
Email
Sharami@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Scienes
Full name of responsible person
Dr.seyede Hajar Sharami
Position
Accosiated professor of Obstetric and Gynecology, Guilan university of Medical Sciences
Other areas of specialty/work
Street address
Reproductive Health Research center , Department of Ob &Gyn, Alzahra Hospital, Guilan university of Medical Sciences , Namjo street
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
sharami@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Reproductive Health Research Center
Full name of responsible person
Seyede Fatemeh Dalil Heirati
Position
Bs in Midwifery
Other areas of specialty/work
Street address
Reproduction Health research center, Alzahra hospital, Namjo street
City
Rasht
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)