Protocol summary

Summary
The aim of this study is to compare the effects of oxytocin alone and oxytocin in combination with intravenous and oral propranolol on labor progression. This study will be done as a randomized clinical trial study in Sanandaj Besat Hospital. Total of 123 pregnant women who had inclusion criteria divided into three groups using triplex random blocks. The sample size in each group is 41 cases. Inclusion criteria included: 38 to 41 weeks gestational age, nuliparity, singleton, cephalic presentation, fetal heart rate 120 to 160 beats per minute, approximate weight of 2,500 to 4,000 gr (confirmed by examination or ultrasound), the maternal heart rate between 60 to 130 beats per minute, intact membranes and bishop score equal to or less than 5 . Exclusion criteria included: CPD, any history of previous surgery on the uterus, fetal distress, the risk of macrosomia or polyhydramnius, SBP≤100, PR≤60, PR≥130 min, any history of cardiopulmonary disease, metabolic disease of mother or taking medicine for any illness by mother. In the oxytocin alone 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 and 30 mlU. 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 oxytocin with intravenous propranolol group, concurrent with the induction 2 mg propranolol will infuse intravenously and slowly and two hours after administration, patient will be examined vaginally. If after two hours cervical dilation did not change propranolol dose repeated just for another time and induction continues. Patient will be controlled and decision will be made to continue induction to delivery or termination of pregnancy with cesarean section. Patient`s blood pressure every hour and fetal heart rate every 15 minutes will be controlled. In the oxytocin with oral propranolol group, from beginning of induction 20 mg propranolol administered orally, If after four hours cervical dilation did not change propranolol dose repeated just for another time and induction continues. Patient will be controlled and decision will be made to continue induction to delivery or termination of pregnancy with cesarean section.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016103012789N13
Registration date: 2016-12-04, 1395/09/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-12-04, 1395/09/14
Registrant information
Name
Masoud Rasolabady
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3366 4654
Email address
rasolabady@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Kurdistan University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-06-20, 1395/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of oxytocin alone versus oxytocin plus intravenous and oral propranolol on labor progression
Public title
Comparing the effect of oxytocin alone versus oxytocin plus intravenous and oral propranolol on labor progression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Nulliparity, singleton, cephalic presentation, fetal heart rate between 120 to 160 beats per minute, approximate weight of 2,500 to 4,000 (by examination or ultrasound), the maternal heart rate between 60 to 130 beats per minutes. Exclusion Criteria: CPD, any history of previous surgery on the uterus, fetal distress, the risk of macrosomia or polyhydramnius, SBP≤100, PR≤60, PR≥130 min, any history of cardiopulmonary disease, metabolic disease of mother or taking medicine for any illness by mother.
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 123
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not 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 og Kurdistan University of Medical Sciences
Street address
Pasdaran St.,Kurdistan University of Medical Sciences, Sanandaj, Iran
City
Sanandaj
Postal code
Approval date
2016-02-20, 1394/12/01
Ethics committee reference number
IR.MUK.REC.1394.403

Health conditions studied

1

Description of health condition studied
Induction and Promotion of labor
ICD-10 code
O80.0
ICD-10 code description
Spontaneous vertex deliveryr

Primary outcomes

1

Description
The duration of phases of labor
Timepoint
From the intervention to delivery
Method of measurement
vaginal exam

Secondary outcomes

1

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 alone with dose 2 mIU/min which increase every 15 min
Category
Treatment - Drugs

2

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

3

Description
Intervention group oxytocin plus oral propranolol, oxytocin with dose 2 mIU/min which increase every 15 min and propranolol 20 mg oraly
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Dr. Narjes Marjani
Street address
Besat Hospital, Keshavarz St., Mardokh Cross Road, Sanandaj, Iran
City
Sanandaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Kurdistan University of Medical Sciences
Full name of responsible person
Dr. Ebrahim Ghaderi
Street address
Kurdistan University of Medical Sciences, Pasdaran St., Sanandaj, Iran
City
Sanandaj
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 of Kurdistan 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
Kurdistan University of Medical Sciences
Full name of responsible person
Dr. Narjes Marjani
Position
Resident of Gynecology
Other areas of specialty/work
Street address
Besat Hospital, Keshavarz St., Mardokh Cross Road, Sanandaj, Iran
City
Sanandaj
Postal code
Phone
+98 87 3328 8119
Fax
Email
melica313@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Dr. Fariba Farhadifar
Position
Full professor
Other areas of specialty/work
Street address
Besat Hospital, Keshavarz St., Mardokh Cross Road, Sanandaj, Iran
City
Sanandaj
Postal code
Phone
+98 87 3328 8119
Fax
Email
sima_homa@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Dr. Narjes Marjani
Position
Resident of Gynecology
Other areas of specialty/work
Street address
Besat Hospital, Keshavarz St., Mardokh Cross Road, Sanandaj, Iran
City
Sanandaj
Postal code
Phone
+98 87 3328 8119
Fax
Email
melica313@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
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