This study will be conducted to compare the effect of oxytocin with and without propranolol in labor augmentation subjects. All pregnant women over 37 weeks gestational age, single fetus in cephalic and heart rate 120-160/ min and about 2500-3500 g fetal weight who are in active phase of labor and are suffering from failure to progress, after their informed consent will be recruited . The participants will be randomly divided into two groups. The first group will recieve oxytocin with propranolol and the second group, oxytocin and placebo. 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 complications including uterine atony (failure to follow proper contraction of the uterus in labor), complications during labor including hyper stimulation ,fetal distress, meconium and placental abruption (placenta abruption from their fetus before birth) and neonatal outcomes including Apgar score 1 and 5 minutes of birth, admition in NICU and birth weight in two groups
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902141096N2
Registration date:2011-05-05, 1390/02/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-05-05, 1390/02/15
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
2010-04-21, 1389/02/01
Expected recruitment end date
2010-09-23, 1389/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized clinical trial of the efficacy of oxytocin with propranol and oxytocin with placebo on the labor augmentation.
Public title
Efficacy of oxytocin with placebo and oxytocin with propranol on the labor augmentation.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria included: Primiparous pregnant women with single fetus and cephalic presentation the top 37 weeks of pregnancy (According to reliable LMP or ultrasound the first trimester) with intact membrance And fetal heart rate between 120 to 160 beats per minute and estimated fetal weight by ultrasound examination or visitors between 2500 and 4000 g and in the active phase of labor had no failure to progress. Exclusion criteria: Multi-parity, History of surgery on the uterus, malpresentation (non-cephalic), Mismatch over maternal fetal pelvis , Fetal distress, including late deceleration (Gradually reducing the minimum and maximum heart rate after completing the contract with the minimum loss rate of 15 and may take over 15 seconds) or prolong deceleration (longs over two minutes and less than 10 minutes) , Suspected macrosomia (Estimated weight over 4000 g) ,polyhydroamnius , IUGR (Estimated fetal weight using ultrasound is lower than the tenth percentile) , Women whit systolic blood pressure 90 mmHg or less And with heart rate <60 beats per minute and Women with a history of these diseases are also excluded: HTN ,Cardiac disease (Cardiac block,CHF , Right ventricular failure secondary to pulmonary hyper tension , Sinus bradycardia, Cardiogenic shock ,Significant aortic or mitral valve disease. And lung disease (Bronchial asthma or bronchospasm, severe chronic obstructive pulmonary disease, allergic rhinitis) Patients with kidney or liver dysfunction, diabetes, patients prone to hypoglycemia, myasthenia Gravis and Wolf - Parkinson – White.
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
118
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 Science
Street address
Mellat St., Namjoo Ave
City
Rasht
Postal code
Approval date
2010-03-15, 1388/12/24
Ethics committee reference number
802
Health conditions studied
1
Description of health condition studied
Single spontaneous delivery
ICD-10 code
O80.0
ICD-10 code description
Spontaneous vertex delivery
Primary outcomes
1
Description
The effect of oxytocin with propranolol on augmentation
Timepoint
Every hour
Method of measurement
After entering an active phase of labor the patient is examined vaginally.
2
Description
The effect of oxytocin without propranolol on augmentation
Timepoint
Every hour
Method of measurement
After entering an active phase of labor the patient is examined vaginally.
3
Description
The effect of propranolol with and without oxytocin on augmentation
Timepoint
Every hour
Method of measurement
After entering an active phase of labor the patient is examined vaginally.
Secondary outcomes
1
Description
The frequency of cesarean section in pregnant women suffering from failure to progress in study groups
Timepoint
Active Phase of labor and then each hour
Method of measurement
vaginal examination for delitation and effacement
2
Description
The frequency of Apgar scores below 7 in study groups
Timepoint
First and fifth minutes of birth
Method of measurement
Sum of all five Apgar score: heart rate, respiratory effort, muscle tone, irritability, and color
3
Description
The average duration of first stage of laborinduced with oxytocin and placebo group
Timepoint
Active Phase of labor and then each hour to full dilatation
Method of measurement
Vaginal examination
4
Description
The average duration of first stage of labor in study groups
Timepoint
Active Phase of labor and then each hour to full dilatation
Method of measurement
Vaginal examination
5
Description
The average duration of second stage of labor in study groups
Timepoint
Every 15 minutes from full dilatation to delivery
Method of measurement
Vaginal examination
6
Description
The uterine inertia in study groups
Timepoint
after delivery every 15 minutes in the first hour, every hour in 4 hours and every 4 hours in 24 hours of labor
Method of measurement
Physical examination for uterus contractions and vagina bleeding
7
Description
The prevalence of meconium in study groups
Timepoint
Active phase of labor after amniotomy and then hourly
Method of measurement
Amniotomy and vaginal examination
8
Description
Prevalence of placental abruption in the study group
Timepoint
Active phase of labor and then hourly
Method of measurement
checking bleeding and contractions
9
Description
The prevalence of fetal distress in study groups
Timepoint
Every 15 minutes
Method of measurement
Listening to the fetal heart rate by Sonic aid
10
Description
The dosage of oxytocin in study groups
Timepoint
In the active phase of labor and then every hour until reaching 3 45-60 sec contractions in 10 min
Method of measurement
Checking contractions with tochometric device
Intervention groups
1
Description
In Primiparous pregnant women suffering from failure to progress in the active phase of labor, 10 units of Oxytocin in one liter of Ringer lactate with 2 mg of propranolol is injected intravenously
Category
Treatment - Drugs
2
Description
In Primiparous pregnant women suffering from failure to progress in the active phase of labor, 10 units of Oxytocin in one liter of Ringer lactate with 2 mg of distilled water as a placebo is injected intravenously
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra hospital,Rasht
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
Mellat St., Namjoo Ave
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
Associate professor of Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Reproduction Health research center-Alzahra hospital-Namjo street
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
sharami@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr. Seyede Hajar Sharami
Position
Associate professor of Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Reproduction Health research center-Alzahra hospital-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-Namjoo street
City
Rasht
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)