Comparison the effect of oral propranolol and oxytocin with oxytocin alone on duration of labor and type of delivery in nulliparous women with prolonged pregnancy.
Introduction: prolonged pregnancy increases the maternal morbidity and fetal morbidity and mortality. In order to avoid these complications and to manage prolonged pregnancies, different methods are used. The purpose of this study was comparison the effect of oral propranolol and oxytocin with oxytocin alone on duration of labor and type of delivery in nulliparous women with prolonged pregnancy.
Material and Methods: A double blind randomized controlled trial was performed on 146 nulliparous; 18-35 years; gestational age 40-42 weeks; without CPD; bishop score less than 5; optimal care during pregnancy; blood pressure less than 140/90 mmHg; pulse 60-110; body mass index normal; intact of membran; estimated fetal weight less than 4000 grams; Excluding criteria: Polyhydramnios; abnormal presentation; preeclampsia; known medical conditions before and during pregnancy such as asthma; cardiovascular and metabolicat disease at the admission time. After accurate determination of pregnancy age the patients were classified into two groups of a combination of oral propranolol and oxytocin versus oxytocin only. In the first group (oxytocin group=73), oxytocin alone was used for induction of labor. In the second group (propranolol group=73 cases), oral propranolol 20 mg was prescripted then the induction was began. Induction was similar in both groups using low dose method. The mean duration for obtaining good contractions, first and second stages, type of delivery and apgar scour was determine and statistical analysis was performed using spss software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105316575N3
Registration date:2011-07-23, 1390/05/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-07-23, 1390/05/01
Registrant information
Name
Ashraf Direkvand-Moghadam
Name of organization / entity
Ilam University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 84 3222 7134
Email address
direkvand-a@medilam.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ilam University of Medical Sciences
Expected recruitment start date
2008-09-22, 1387/07/01
Expected recruitment end date
2009-09-23, 1388/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of oral propranolol and oxytocin with oxytocin alone on duration of labor and type of delivery in nulliparous women with prolonged pregnancy.
Public title
Comparison the effect of oral propranolol and oxytocin with oxytocin alone on duration of labor and type of delivery in nulliparous women with prolonged pregnancy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:35-18 years of age; primiparous; singleton pregnancy; gestational age40-42; without CPD; Bishop score less than 5; optimal care during pregnancy; blood pressure less than 140/90 mmHg; pulse 60-110; body mass index 19/8-26(kg/m) before pregnancy; intact of membran; estimated fetal weight less than 4000 grams; Excluding criteria: Polyhydramnios; abnormal presentation; preeclampsia; known medical conditions before and during pregnancy such as asthma; cardiovascular and metabolicat disease at the admission time
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
146
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Secondary trial Id
Registration date
2017-11-21, 1396/08/30
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Ilam University of Medical Sciences
Street address
Ilam University of Medical Sciences
City
Ilam
Postal code
Approval date
2008-05-24, 1387/03/04
Ethics committee reference number
2039/40/22
Health conditions studied
1
Description of health condition studied
The effect of oral propranolol on the duration of labor and type of delivery in nulliparous women with prolonged pregnancy.
ICD-10 code
o48
ICD-10 code description
Prolonged pregnancy
Primary outcomes
1
Description
Duration of labor in nulliparus women with prolonged pregnancy
Timepoint
Start of admission in hospital to 24h after delivery
Method of measurement
Duration of labor according to minute
Secondary outcomes
1
Description
Type of delivery
Timepoint
Start of admission in hospital to 24h after delivery
Method of measurement
Type of delivery vaginal or cesarean
Intervention groups
1
Description
The first group: induction was performed with low dose method
Category
Treatment - Drugs
2
Description
The second group: 20 mg propranolol was administered orally then induction was performed based low dose method. Orally propranolol(20 mg) was administered every 8 hours during the induction
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mustafa Khomeini hospital, Ilam University of Medical Sciences
Full name of responsible person
BA of Midwifery
Street address
Mustafa Khomeini hospital, Ilam, Iran
City
Ilam
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ilam University of Medical Sciences
Full name of responsible person
Dr Afra Khosravi research manager of research, Ilam University of Medical Sciences
Street address
Vice chancellor for research Ilam University of Medical Sciences, Pajuhesh Avenue, Bangnjab, Ilam
City
Ilam
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, Ilam 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
Department of Midwifery, Ilam University of Medical Sciences
Full name of responsible person
Ashraf Direkvand-Moghadam
Position
MSc of Midwifery
Other areas of specialty/work
Street address
Department of Midwifery, Ilam University of Medical Sciences
City
Ilam
Postal code
Phone
+98 918 342 0061
Fax
Email
direkvand-a@medilam.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Midwifery, Ilam University of Medical Sciences
Full name of responsible person
Ashraf Direkvand-Moghadam
Position
MSc of Midwifery
Other areas of specialty/work
Street address
Department of nursing and Midwifery, Ilam University of Medical Sciences
City
Ilam
Postal code
Phone
+98 918 342 0061
Fax
Email
direkvand-a@medilam.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Midwifery, Ilam University of Medical Sciences
Full name of responsible person
Ashraf Direkvand-Moghadam
Position
MSc of Midwifery
Other areas of specialty/work
Street address
Vice chancellor for research Ilam University of Medical Sciences, Pajuhesh Avenue, Bangnjab, Ilam
City
Ilam
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)