Protocol summary

Study aim
Determining the effects of squatting, sitting and supine (lithotomy) positions on the severity of pain and duration of latent and active phase of the second stage of labor in primipara women
Design
The clinical trial included two intervention groups and one control groups, with parallel groups, randomized, 96 samples, sampling from 30/11/2010 to 22/09/2011
Settings and conduct
This is a clinical trial conducted on the primiparous women referring to Shahid Beheshti hospital affiliated to Isfahan University of Medical Sciences and Ostad Motahari hospitals affiliated to Jahrom University of Medical Sciences in 2010-2011. Based on the inclusion criteria and obtaining a written consent of the samples about how to do the study, information about pain intensity of the latent and active phase of the second stage of labor, the severity of pain in the third stage of labor, the duration of the latent phase and the active phase of the second stage of labor, the duration of the third stage of labor, perineum status, type and degree of rupture, through the examination and interview were collected. The severity of pain was measured by McGill's visual analogue scale pain. From the beginning of the study, the researcher used a delivery chart or partograph to determine how progress of labor, maternal and fetal health, or any problems that have occurred during the study. In dilatation of 8-9 centimeters and after engagement or zero station and until the end of the second stage of delivery, the mother was placed in the sitting, squatting and lithotomy position. The length of the latent and active phase of the second stage of labor was measured by a kronometer. During the full cervical dilatation, the kronometer was switched on and immediately upon first observation of the first strong contraction and straining kronometer off and again immediately on and it was shut again When the baby was completely exited, it was extinguished.Thus, the length of the latent and active phase of the second stage would be calculated. In order to determine the amount of bleeding in the first hour after the birth of the baby in all three groups, immediately after the extraction of the baby, one basin was placed under the mother's hips. In the three groups after the extraction of the placenta and its blood completely, the basin was removed and immediately after, the pad which was weighed were placed in the anus and vulva area and if necessary, the pads were replaced. In the next step, the blood inside the basin was transferred to a graded case and then it was measured and recorded. At the end of the first hour after delivery, the pads and gauzes ( which were weighed before by using a digital scale) were weighed again and deducted from the previous weight, and the amount of blood was measured in grams, and according to the blood weight ( per grams) formula, they were divided by total blood concentration (total blood concentration is 1.06), which resulted in blood volume per cc and it was accumulated with the volume of blood measured in the scaled container and the volume of bleeding in the first hour after delivery was obtained ( by cc).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant women aged between 18-35 years old، primiparous women, gestational age between 37 and 41 weeks, women in dilatation 8-9 cm, singleton pregnancy, fetal presentation (head) in the second stage of labor engagement and at least ischial spines is reached, estimated fetal weight is based on Johnson's law between 2,500-4,000 grams, the tendency and readiness for the physiological delivery; Exclusion criteria: Anatomical and skeletal disorders, lack of labor progress in the first stage of labor, rupture of the water bag over 12 hours, weakness and numbness in the legs (in squat position), short Perinea (vaginal insertion distance to the anal inlet less than 3.5 cm), maternal fatigue at the end of the first stage of labor;
Intervention groups
Supine (lithotomy) group: Position of lithotomy in the present study was in the way that the mother was in supine position with 30 head elevation and bent knees. Squatting group: In squatting position, the mother was sitting on her feet so that her sole was in touch with the floor and knee joints were higher than the hips. Sitting group: In sitting position the mother sat on labor chair in the way that her lumbar spines were completely strait and the hip and knee joints were at the same level.
Main outcome variables
The main consequences include the intensity of the latent and active phase of the second stage of labor, duration of latent phase and active phase of the second stage of labor, duration of third stage of labor, volume of bleeding in the first hour after delivery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180128038535N3
Registration date: 2018-02-26, 1396/12/07
Registration timing: retrospective

Last update: 2018-02-26, 1396/12/07
Update count: 0
Registration date
2018-02-26, 1396/12/07
Registrant information
Name
Mehri Rezaie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 4223 0789
Email address
me.rezaei@savehums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2010-11-30, 1389/09/09
Expected recruitment end date
2011-09-22, 1390/06/31
Actual recruitment start date
2010-11-30, 1389/09/09
Actual recruitment end date
2011-09-22, 1390/06/31
Trial completion date
empty
Scientific title
Comparative study of the effect of using lithotomy, squatting and sitting positions in the second stage of physiologic delivery on severity of pain and outcome of childbirth in primiparous women
Public title
The effect of childbirth positions on the severity of labor pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women aged between 18-35 years old Primiparous women Gestational age between 37 and 41 weeks Women in dilatation 8-9 cm (active phase of labor phase) Singleton pregnancy Fetal presentation (head) in the second stage of labor engagement and at least ischial spines is reached Estimated fetal weight is based on Johnson's law between 4,000-2500 grams The tendency and readiness for the physiological delivery
Exclusion criteria:
Anatomical and skeletal disorders All that leads to cesarean section Lack of labor progress in the first stage of labor by using paratograph form Rupture of the water bag over 12 hours Weakness and numbness in the legs (in squat position) Short Perinea (vaginal insertion distance to the anal inlet less than 3.5 cm) Maternal fatigue at the end of the first stage of labor
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 96
Actual sample size reached: 96
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomize in three group every day, the first person in the squatting group,the second person in the sitting position and the third person in lithotomy position were placed
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib Ave., Research Deputy of Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2010-11-03, 1389/08/12
Ethics committee reference number
389292

Health conditions studied

1

Description of health condition studied
Study of the effect of three childbirth positions of squatting, sitting and lithotomy on the severity of labor pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Severity of labor pain in the latent phase of the second stage of labor
Timepoint
After the intervention and the end of the latent phase of the second stage of labor
Method of measurement
Visual analogue Scale of McGill Pain

2

Description
Severity of labor pain in the active phase of the second stage of labor
Timepoint
After the intervention and the end of the active phase of the second stage of labor
Method of measurement
Visual analogue Scale of McGill Pain

3

Description
Severity of labor pain in the third stage of labor
Timepoint
After the intervention and the end of the third stage of labor
Method of measurement
Visual analogue Scale of McGill Pain

4

Description
Duration of the latent phase of the second stage of labor
Timepoint
After the intervention
Method of measurement
Kronometer

5

Description
Duration of the active phase of the second stage of labor
Timepoint
After the intervention
Method of measurement
Kronometer

6

Description
Duration of the third stage of labor
Timepoint
After the intervention
Method of measurement
Kronometer

Secondary outcomes

1

Description
Volume of bleeding in the first hour after delivery
Timepoint
After the intervention
Method of measurement
Scales, sanitary pad

2

Description
Type and degree of perineal tear
Timepoint
After the intervention and childbirth
Method of measurement
Observation and examination

3

Description
Apgar score of the infant in the first and fifth minutes of birth
Timepoint
After intervention and delivery
Method of measurement
Neonate Apgar Scale

Intervention groups

1

Description
Intervention group: Squatting position
Category
Treatment - Other

2

Description
Intervention group: Sitting position
Category
Treatment - Other

3

Description
Control group: Supine position(Lithotomy)
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti hospital in Isfahan
Full name of responsible person
Mehri Rezaie
Street address
Hezar Jarib Ave., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174683452
Phone
+98 31 7927 5332
Email
mehrangize_rezai@yahoo.com

2

Recruitment center
Name of recruitment center
Ostad Motahari Hospital in Jahrom
Full name of responsible person
Mehri Rezaie
Street address
Ostad Motahari Blvd
City
Jahrom
Province
Fars
Postal code
5415713597
Phone
+98 71 5433 3002
Email
mehrangize_rezai@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Keianpoor
Street address
Hezar Jarib Ave., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 7927 5333
Email
mehrangize_rezai@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Mehri Rezaie
Position
Non-faculty midwife
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ostad Motahari Blvd
City
Jahrom
Province
Fars
Postal code
5415713597
Phone
+98 71 5433 3002
Email
mehrangize_rezai@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Mehri Rezaie
Position
Non-faculty Midwife
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ostad Motahari Blvd
City
Jahrom
Province
Fars
Postal code
5415713597
Phone
+98 71 5433 3002
Email
mehrangize_rezai@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Mehri Rezaie
Position
Non-faculty midwife
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ostad Motahari Blvd
City
Jahrom
Province
Fars
Postal code
5415713597
Phone
+98 71 5433 3002
Email
mehrangize_rezai@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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