The aim of this survey is comparison of oral Misoprostol versus intra venous oxytocin for cervical ripening in primiparous pregnant women with premature rupture of membrane. Those Primiparous pregnant women with premature rupture of membrane admitted in hospital between 36 to 42 weeks of pregnancy with inappropriate bishop score (less than 4). After written and informed consent to participate in the survey the women will be divided into two groups randomly, one group will be given 75 microgram of oral Misoprostol plus intra venous saline normal while another group intra venous oxytocin 2mlu/min increased 2 mlu/min any 10 minute plus oral placebo. Any person who involved as Executive agents in this study, have no information about prescribed drugs. Drug Doses will be repeated each 4 hour up to two times when it will be necessary. Fetal heart rate and uterus contractions will be checked before every dose prescription for about 10 minutes. Also vaginal examination will be done for every person before induction. In case of acquiring three contractions during ten minutes or reaching to active phase (at least 4cm dilatation) we won't give next dose. Finally we will compare these factors by using statistical methods: Time interval from labor induction beginning to active phase reaching, delivery type, vaginal delivery rate during first 12 hours, tachysystole and hyper stimulation, Apgar score, and 4 hours after induction bishop score, consumed dose of Misoprostol and maternal complication.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104131946N9
Registration date:2011-08-21, 1390/05/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-08-21, 1390/05/30
Registrant information
Name
Mandana Mansur Ghanaie
Name of organization / entity
Giulan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 5624
Email address
m_m_ghanaie@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Guilan University of Medical Sciences
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2012-09-22, 1391/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of oral misoprostol and Intravenous oxytocin for induction of labor at Premature rupture of membrane in primigravida women
Public title
Comparison of oral misoprostol and Intravenous oxytocin for induction of labor at Premature rupture of membrane in primigravida women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: a) single pregnancy (between 36 to 42 weeks); b)vertex presentation; c)bishop score equal or less than four; d) absence of uterus spontaneous contractions;e)normal fetal heart rate; f) 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) history of heart disease ,asthma, glaucoma; f)IUGR; g)age under18 years
Age
From 18 years old to 45 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
240
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
Ethic committee Guilan University of Medical Sciences
Street address
Vice Chancellor for research, Guilan University of Medical Sciences, Melat st, Namjoo Ave
City
Rasht
Postal code
0098
Approval date
2011-07-20, 1390/04/29
Ethics committee reference number
1900189604
Health conditions studied
1
Description of health condition studied
Pregnancy, childbirth and the puerperium
ICD-10 code
O74.8
ICD-10 code description
Other complications of anaesthesia during labour and delivery
Primary outcomes
1
Description
Comparison of oral misoprostol and Intravenous oxytocin
Timepoint
Every four hours up to two times
Method of measurement
Vaginal examination and record in Questionnaire
Secondary outcomes
1
Description
Determination of time interval from labor induction beginning to active phase reaching
Timepoint
Time recording of induction beginning and delivery
Method of measurement
Time recording of induction beginning and delivery in Questionnaire
2
Description
Delivery type frequency
Timepoint
After delivery
Method of measurement
Patients' medical document
3
Description
Vaginal delivery frequency during first 12 hours
Timepoint
After delivery
Method of measurement
Patients' medical document
4
Description
Tachysystole incidence
Timepoint
Time recording of induction beginning up to active phase
Method of measurement
Patients' medical document
5
Description
Hyper stimulation incidence
Timepoint
Time recording of induction beginning up to active phase
Method of measurement
Patients' medical document
6
Description
Fetal Heart Rate disorder
Timepoint
Time recording of induction beginning and delivery
Method of measurement
Patients' medical document
7
Description
Failure to progress frequency
Timepoint
Entering to active phase up to delivery
Method of measurement
Patients' medical document
8
Description
Determination of Bishop Score alteration average after 4 hours
Timepoint
After 4 hours from induction beginning
Method of measurement
Vaginal examination
9
Description
Determination of NICU admission rate
Timepoint
After delivery
Method of measurement
Patients' medical document
10
Description
APGAR score less than 7
Timepoint
After delivery
Method of measurement
Patients' medical document
11
Description
Frequency of maternal complication
Timepoint
Time recording of induction beginning and delivery
Method of measurement
Patients' medical document
Intervention groups
1
Description
Prescription of 75 microgram of oral Misoprostol plus intra venous normal saline
Category
Treatment - Drugs
2
Description
Prescription of intra venous oxytocin 2mlu/min increased 2 mlu/min any 10 minute.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Guilan University of Medical Sciences. Alzahra Hospital
Full name of responsible person
Dr. Mandana Mansur Ghanaie
Street address
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for researchr, Guilan University of Medical Sciences
Full name of responsible person
Dr. Abdolrasol Sobhani
Street address
Namjo street, Mellat street
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 researchr, 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. Mandana Mansur Ghanaie
Position
Accosiated professor of Obstetrics and Gynecology,
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
m_m_ghanaie@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr. Mandana Mansur Ghanaie
Position
Associated professor of Obstetrics and Gynecology
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
m_m_ghanaie@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Seyedeh Maryam Mousavi Chahardeh
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)