Objective: A comparison between misoprostol plus propranolol and misoprostol alone in labour induction ( in post term pregnancies. )
Design: Randomized, ( clinical trial ) , Double blind, placebo-controlled, Academic maternity hospitals
Participants: Pregnant women with post term pregnancy
Inclusion criteria: nulliparous women with Gestational age more than 41 weeks
؛ Single pregnancy؛ Cephalic presentation؛ Bishop score<5؛ indication for the induction of delivery؛ admitted in academic hospitals
Exclusion criteria: Pregnant women with uterus contraction؛ fetal distress؛ Suspected macrosomia؛ Polyhydroamnius؛ Systolic blood pressure less than 100mmHg؛ Pulse rate less than 60 and more than 120؛ Any history of cardiopulmonary disease ؛alcohol abuse.
sample size: 80
Intervention: prescription of propranolol in pregnant women with indication for the induction of delivery
Intervention Time: At the beginning of labour induction
The outcome of the study: The time lapse from the beginning of induction to effective contractions
Other outcomes: the time lapse from the beginning of induction to 4cm dilatation, the time lapse from the beginning of induction to delivery, the neonatal outcomes such as Apgar score and NICU admission, cesarean rate
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016110530709N1
Registration date:2016-12-18, 1395/09/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-12-18, 1395/09/28
Registrant information
Name
Atiyeh Mohamadzade Vatanchi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3801 2477
Email address
vatanchia@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between misoprostol plus propranolol and misoprostol alone in labour induction ( in post term pregnancies. )
Public title
propranolol effect on pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: nulliparous women with Gestational age more than 41 weeks
؛ Single pregnancy؛ Cephalic presentation؛ Bishop score<5؛ indication for the induction of delivery؛ admitted in academic hospitals
Exclusion criteria: Pregnant women with uterus contraction؛ fetal distress؛ Suspected macrosomia؛ Polyhydroamnius؛ Systolic blood pressure less than 100mmHg؛ Pulse rate less than 60 and more than 120؛ Any history of cardiopulmonary disease ؛alcohol abuse.
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Mashhad University of Medical Sciences
Street address
Building Qureshi, Daneshgah street, Taghi Abad
City
Mashhad
Postal code
Approval date
2016-08-17, 1395/05/27
Ethics committee reference number
IR.MUMS.fm.REC.1394.89
Health conditions studied
1
Description of health condition studied
Labour induction
ICD-10 code
o61
ICD-10 code description
Failed induction of labour
Primary outcomes
1
Description
The time of begining of effective contractions
Timepoint
Before Intervention and after effective contractions
Method of measurement
minute
Secondary outcomes
1
Description
The time lapse from the beginning of induction to 4cm dilatation
Timepoint
before intervention and at the time of 4cm dilatation
Method of measurement
minute
2
Description
The time lapse from the beginning of induction to delivery
Timepoint
before intervention and at the time of delivery
Method of measurement
minute
3
Description
Neonatal Apgar score
Timepoint
At the first and the fifth minutes after birth
Method of measurement
Apgar scale
4
Description
Neonatal NICU admission
Timepoint
The first day after the birth
Method of measurement
Questionnaire
5
Description
Cesarean rate
Timepoint
Birth time
Method of measurement
Questionnaire
Intervention groups
1
Description
The Intervention group recieve 20mg Propranolol tablet concurrent with sublingual Misoprostol at the begining of induction. If there is no effective contraction, the dose will be repeated after 3 hours.
Category
Treatment - Drugs
2
Description
The Control group recieve oral Placebo tablets that their shape, color and weight are similar to 20mg propranolol tablets, in the same way of the intervention group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Qaem Hospital
Full name of responsible person
Atiyeh Mohamadzade Vatanchi
Street address
City
Mashhad
2
Recruitment center
Name of recruitment center
Ommol-banin Hospital
Full name of responsible person
Leila Pourali
Street address
City
Mashhad
3
Recruitment center
Name of recruitment center
Imam Reza (a.s.) Hospital
Full name of responsible person
Sedighe Ayati
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Council of Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Mashhad School of Medicine, Pardis University, Azadi Square, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Atiyeh Mohamadzade Vatanchi
Position
assistant professor
Other areas of specialty/work
Street address
Ghaem hosptal
City
mashhad
Postal code
Phone
+98 51 3801 2477
Fax
Email
vaatnchia@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Atiyeh Mohamadzade Vatanchi
Position
assistant professor
Other areas of specialty/work
Street address
Ghaem hospital
City
mashhad
Postal code
Phone
+98 51 3801 2477
Fax
Email
vatanchiha@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Atiyeh Mohamadzade Vatanchi
Position
assistant professor
Other areas of specialty/work
Street address
Ghaem hospital
City
mashhad
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)