Protocol summary

Summary
Objectives: The Main objective of this study is to compare the effect of oxytocin versus oxytocin– propranolol on labor progression Study design: This study will be done randomized single – blind clinical in Sayyad Shirazi Hospital, Gorgan Inclusion/exclusion criteria: Inclusion criteria includes 37 to 41 weeks gestational age according to certain LMP and confirmed ultrasound in the first quarter, also nuliparity, singleton, cephalic presentation, intact membranes and bishop score equal to or less than 5 are among the inclusion criteria. Exclusion criteria includes CPD, any history of previous surgery on the uterus, fetal distress, the risk of macrosomia or polyhydramnius, SBP≤100, PR≤60, PR≥120 min, any history of cardiopulmonary disease, metabolic disease of mother or taking medicine for any illness by mother. Interventions: In oxytocin group, use of oxytocin will start at 2mIU/min and every 15 minutes the same amount will added to create a good contraction (3 contractions in 10 minutes) this continues maximally up to 8 hours. In entering the active phase of labor induction continues to delivery, in case of no entry to the active phase (3- 4 cm Dilation) stop induction after 8 hours and continues it the next day. In the absence of response to induction the second day will be cesarean section. In the propranolol group before induction, 2 mg propranolol will infuse intravenously and slowly and then induction starts with oxytocin the same as mentioned above. If the condition continues for the second day, use injection of 2 mg propranolol through vein and continue all induction processes. Control patient s blood pressure and fetal heart rate in every 15 minutes and follow the patient status and note down the information until delivery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016092629983N1
Registration date: 2016-11-15, 1395/08/25
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-11-15, 1395/08/25
Registrant information
Name
Elaheh Amiri
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 3225 1391
Email address
narges.mohammadi@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Gorgan Congenital Malformations Research Center of Golestan University of Medical Sciences, Gorgan, Iran.
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-04-20, 1396/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing effect of oxytocin versus oxytocin-propranolol combination on labor progression
Public title
Comparing effect of oxytocin versus oxytocin-propranolol combination on labor progression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 37 to 41 weeks gestational age based on reliable LMP and ultrasound confirmation in the first quarter, also nuliparity; singleton, cephalic presentation;, intact membranes , bishop score equal to or less than 5. Exclusion criteria: CPD; any history of previous surgery on the uterus; fetal distress; the risk of macrosomia or polyhydramnius; SBP≤100; PR≤60; PR≥120 min; any history of cardiopulmonary disease; known metabolic disease of mother or taking medicine for any illness in the mother.
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 130
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
Ethic committee of Golestan University of Medical Sciences
Street address
Medical Faculty, Golestan University of Medical Sciences, Hirakan avenue, Gorgan, Iran
City
Gorgan
Postal code
4917867439
Approval date
2016-10-02, 1395/07/11
Ethics committee reference number
IR.Goums.REC.1395.144

Health conditions studied

1

Description of health condition studied
]nduction and Promotion of labor
ICD-10 code
O80.0
ICD-10 code description
Spontaneous vertex delivery

Primary outcomes

1

Description
The duration of phases of labor
Timepoint
Since the intervention untile delivery
Method of measurement
vaginal exam

Secondary outcomes

1

Description
Neonate s Apgar
Timepoint
After Delivery
Method of measurement
According to the protocol

2

Description
pregnancy ending in caesarean section
Timepoint
After the second period of injection
Method of measurement
Based on the indications for cesarean section

Intervention groups

1

Description
Intervention group oxytocin with dose 2 mIU/min which increase every 15 min
Category
Treatment - Drugs

2

Description
Intervention group oxytocin- propranolol, oxytocin with dose 2 mIU/min which increase every 15 min and propranolol 2 mg/ml IV
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sayyad Shirazi Hospital
Full name of responsible person
Dr. Sepideh Bakhshandeh Nosrat
Street address
Sayyad Shirazi Hospital, Sayyad Shirazi Blvd
City
Goragn

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gorgan Congenital malformations research center, Golestan University of Medical Sciences,Gorgan, Ira
Full name of responsible person
Dr. Elham Mobasheri
Street address
Gorgan Congenital malformations research center, Sayyad Shirazi hospital, Golestan University of Medical Sciences
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan Congenital malformations research center, Golestan University of Medical Sciences,Gorgan, Ira
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
Golestan University of Medical Sciences
Full name of responsible person
Dr. Elaheh Amiri
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Sayyad Shirazi Hospital, Sayyad Shirazi Blv
City
Gorgan
Postal code
4917867439
Phone
+98 17 3225 1391
Fax
Email
dr_amiri_91@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sayyad Shirazi Hospital, Golestan university of medical sciences
Full name of responsible person
Dr. Sepideh Bakhshandeh Nosrat
Position
Gyneacologist/Associate Professor
Other areas of specialty/work
Street address
Sayyad Shirazi Hospital, Sayyad Shirazi Blv
City
Gorgan
Postal code
4917867439
Phone
+98 17 3225 1391
Fax
Email
bakhshandehs@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Sayyad Shirazi Hospital, Golestan university of medical sciences
Full name of responsible person
Dr. Elaheh Amiri
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Sayyad Shirazi Hospital, Sayyad Shirazi Blv
City
Gorgan
Postal code
4917867439
Phone
+98 17 3225 1391
Fax
Email
dr_amiri_91@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...