Objective: We aimed to determine the effect of physiological birth in outcomes of delivery, including duration of first, second and third stages of labour, amount of blood loss in the third and fourth stages of labour, perineal statue, delivery method, decolman, asphyxia, apgar score and satisfaction of birth. Methods: A randomised controlled trial was completed on 200 women who gave birth at Akbar Abadi hospital in Tehran, Iran. 100 were allocated to physiological birth (intervention group) and 100 to routine vaginal birth (control group). Inclusion criteria included the following: gestational age between 37 and 42 weeks; singleton pregnancy; live fetus; cephalic presentation; neonatal birth weight estimation of 2500–4000 g; maternal age 18-45 years; and vaginal dilatation between 3 and 4 centimeter. The data collection instruments included three questionnaires.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138805062248N1
Registration date:2010-08-30, 1389/06/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-08-30, 1389/06/08
Registrant information
Name
Fereshteh Jahdi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00982188773073,00982182471404
Email address
f.jahdi@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences, Vice chancellor for research
Expected recruitment start date
2009-07-29, 1388/05/07
Expected recruitment end date
2010-03-27, 1389/01/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of physiological birth on mother and newborn health
Public title
The effect of physiological bith on mother and newborn health
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria included the following:
1- gestational age between 37 and 42 weeks
2- singleton pregnancy
3- live fetus
4- cephalic presentation; neonatal birth
5- weight estimation of fetus : 2500–4000 g
6- maternal age 18-45 years
7- vaginal birth.
Exclusion criteria included the following:
1- Blood pressure <140/90mmHg
2- Placenta previa
3- A history of caesarean section or any uterine scar
4- Polyhydramnios
5- Prolonged rupture of membranes
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of nursing and midwifery, Iran University of Medical Sciences
Street address
Valiasr Ave. Rashidyasemi Ave.
City
Tehran
Postal code
Approval date
2009-07-20, 1388/04/29
Ethics committee reference number
1323583
Health conditions studied
1
Description of health condition studied
Physiological Birth
ICD-10 code
O00-O99
ICD-10 code description
Pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Duration of the first stage of labor
Timepoint
cervix dilatation from 4 centimeter to 10 centimeter
Method of measurement
Digital chronometer
2
Description
Duration of the second stage of labor
Timepoint
Cervix dilatation from 10 centimeter to fetus expolsion
Method of measurement
Digital chronometer
3
Description
Duration of the third stage of labor
Timepoint
From completed delivery of the fetus to completed delivery of the placenta
Method of measurement
Digital chronometer
4
Description
The amount of blood loss during the third stage of labour
Timepoint
Third stage of labour
Method of measurement
Scaled dish
5
Description
The amount of blood loss during the third stage of labour
Timepoint
Third stage of labour
Method of measurement
Scaled dish
6
Description
The amount of blood loss during the forth stage of labour
Timepoint
Forth stage of labour
Method of measurement
Scaled dish
Secondary outcomes
1
Description
Decolman
Timepoint
First stage of labor
Method of measurement
Obsevation and record in questionnaire
2
Description
Asphyxia
Timepoint
First and second stage of labor
Method of measurement
Obsevation and record in questionnaire
3
Description
Perineal statue
Timepoint
After delivery of placenta
Method of measurement
Obsevation and record in questionnair
4
Description
Method of delivary
Timepoint
After delivery of fetus
Method of measurement
Obsevation and record in questionnair
5
Description
Apgar score
Timepoint
1 and 5 minute
Method of measurement
Obsevation and record in questionnaire
6
Description
Satisfaction of delivery
Timepoint
Before discharging of hospital
Method of measurement
Macky satisfaction questionnaire
Intervention groups
1
Description
Intevention: physiological birth
Category
Prevention
2
Description
Control group: Rutine normal delivery
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar Abaadi hospital
Full name of responsible person
Maryam Shahnazari Avval
Street address
Molavi street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences, vice chancellor for research
Full name of responsible person
Dr. Motevalian
Street address
Hemmat High way
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences, vice chancellor for research
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
Iran University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
Maryam shahnazari Avval
Position
Master in midwifery
Other areas of specialty/work
Street address
Vali asr Ave. Rashid Yasemi Ave.
City
Tehran
Postal code
Phone
+98 26 1445 1433
Fax
+98 912 608 7357
Email
shahnazari.maryam@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
Maryam shahnazari Avval
Position
Master in Midwifery
Other areas of specialty/work
Street address
Valiasr Ave. Rashidyasemi Ave.
City
Tehran
Postal code
Phone
+98 26 1445 1433
Fax
+98 26 1224 6981
Email
shahnazari.maryam@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)