Premature rupture of membranes due to chorioamnionitis and oxytocin is used for induction of labor after 34 weeks of gestation.Chorioamnionitis with serious maternal and fetal complications and Sepsis can lead to death of mother and fetus. This study will be conducted to evaluate the effect of propranolol on duration of labor. All pregnant women with ruptured of membranes that have inclusion criteria after their informed consent will be recruited . The participants will be randomly divided into two groups. Before induction of labor with oxytocin ,the first group will recieve 2 mg propranolol intravenously and the second group will recieve placebo as the same route. Study outcomes are: the time interval between the start of augmentation and delivery, the average dosage of oxytocin, the length of first and second stages of labor, cesarean section rates and its indications (failure to progress or fetal distress), maternal and fetal complications and neonatal outcomes in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201211108151N4
Registration date:2013-05-20, 1392/02/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-05-20, 1392/02/30
Registrant information
Name
Ladan Ajori
Name of organization / entity
Shahid beheshti university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 1694
Email address
ajori@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Science
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of propranolol on duration of labor in women with rupture of membranes
Public title
Effects of propranolol on labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: GA>34 w; singleton pregnancy; cephalic presentation; no contraindication of vaginal delivery;cervical dilatation < 3 cm; absence of active phase; no contraindication of propranolol; no history of maternal hearth disease , diabetes mellitus and lupus; maternal pulse rate > 60 per minutes; no history of uterine scar; patient inform consent. Exclusion criteria: lack of consent at every stage of research.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
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
Shahid Beheshti University of Medical Science
Street address
Yaman street, Chamran highway
City
Tehran
Postal code
Approval date
2013-04-21, 1392/02/01
Ethics committee reference number
89-01-136-7307
Health conditions studied
1
Description of health condition studied
duration of labor
ICD-10 code
O63
ICD-10 code description
long labour
Primary outcomes
1
Description
duration of labor
Timepoint
from induction of labor to delivery
Method of measurement
minutes
Secondary outcomes
1
Description
cesarean rate
Timepoint
at the last of study
Method of measurement
hospital documents
2
Description
neonatal Apgar
Timepoint
first and fifth minutes
Method of measurement
Apgar score
3
Description
fetal complications
Timepoint
at the last of study
Method of measurement
physical exam
4
Description
maternal complications
Timepoint
at the last of study
Method of measurement
history - physical exam
5
Description
oxytocin dosage
Timepoint
at the last of study
Method of measurement
hospital documents
Intervention groups
1
Description
2 mg propranolol before oxytocin ( intervention group )
Category
Treatment - Drugs
2
Description
normal saline as placebo before oxytocin ( control group )
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tajrish Hospital
Full name of responsible person
Leila Nazari
Street address
Tajrish square, Valiasr street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Science
Full name of responsible person
Seyyed Jalaledin Khoshnevis
Street address
Yaman Street, Chamran Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Science
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
Shahid Beheshti University of Medical Science
Full name of responsible person
Leila Nazari
Position
Gynecologist
Other areas of specialty/work
Street address
Yaman Street, Chamran Highway
City
Tehran
Postal code
Phone
+98 21 2218 1693
Fax
Email
leynaz@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Science
Full name of responsible person
Ladan Ajori
Position
Associated Professor- Gynecologist
Other areas of specialty/work
Street address
Yaman Street, Chamran Highway
City
Tehran
Postal code
Phone
+98 21 2271 8005
Fax
Email
ajori@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Scienece
Full name of responsible person
Leila Nazari
Position
Gynecologist
Other areas of specialty/work
Street address
Yaman Street, Chamran Highway
City
Tehran
Postal code
Phone
+98 21 2218 1693
Fax
Email
nazari@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)