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Effect of the presence of support person and routine intervention for women during childbirth in Isfahan, Iran: A randomized controlled trial

Protocol summary

Summary
In this interventional study, 100 pregnant women will be enrolled. Inclusion criteria are: 1. Singleton normal full-term pregnancy and desire to have natural vaginal delivery, 2. 38-42 weeks of gestation, 3. Spontaneous onset of labor and normal birth with no special procedures or consultation, 4. Family member or a female friend was available to stay in the hospital throughout the birth process. Exclusion criteria are: 1. Chose a caesarean section, 2. Cervical dilatation of more than four centimeters at the time of admission. Eligible patients will be randomly divided into two 50-member groups. Group 1 will be received routine intervention with a support person during labor. Group 2 will be received routine intervention without support person during labor. Patients and support persons will be informed about labor process. The support persons will be guided to support the laboring woman. A support person will be defined as a person, such as mother, sister, or friend, who the patient wants present with her in the delivery room. The role of the support person in labor includes provision of continuous presence, reassurance and praise, comforting touch, massage, warm baths/showers, and overall continuous labor support from their birth partner until the end of the first stage, and continued to receive help throughout the second stages of labor. Data collection include the sociodemographic, length of stage of labor, the cervical laceration, pain before and after labor and satisfaction with labor experience.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013111710297N3
Registration date: 2013-11-25, 1392/09/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-11-25, 1392/09/04
Registrant information
Name
Leili Allahbakhshian
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1668 7079
Email address
allahbakhshian@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2012-05-01, 1391/02/12
Expected recruitment end date
2012-12-30, 1391/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of the presence of support person and routine intervention for women during childbirth in Isfahan, Iran: A randomized controlled trial
Public title
Effect of the presence of support person and routine intervention for women during childbirth in Isfahan, Iran: A randomized controlled trial
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Singleton normal full-term pregnancy and desire to have natural vaginal delivery, 38 to 42 weeks of gestation, spontaneous onset of labor and normal birth with no special procedures or consultation, family or a female friend was available to stay in the hospital throughout the birth process. Exclusion criteria: Chose a caesarean section, cervical dilatation of more than four centimeters at the time of admission.
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: 100
Randomization (investigator's opinion)
Randomized
Randomization description
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
Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Postal code
Approval date
2012-02-15, 1390/11/26
Ethics committee reference number
391023

Health conditions studied

1

Description of health condition studied
labor
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Length of stage of labor
Timepoint
During intervention
Method of measurement
Time of cervical dilation

2

Description
Cervical laceration
Timepoint
After intervention
Method of measurement
Yes / No

3

Description
Pain
Timepoint
Before and after intervention
Method of measurement
The numeric rating scale, between 0 (no pain) and 10 (worst pain)

Secondary outcomes

1

Description
Satisfaction
Timepoint
After intervention
Method of measurement
The numeric rating scale (between 0 and 100)

Intervention groups

1

Description
Intervention group received routine intervention with a support person during labor. Routine intervention will be included monitoring of uterine contractions, bleeding, fetal medicals care and other usual hospitals' medical cares. Also, role of the support person will be included includes provision of continuous presence, reassurance and praise, comforting touch, massage, warm baths/showers, and overall continuous labor support from their birth partner until the end of the first stage, and overall continuous labor support from patient during labor.
Category
Other

2

Description
Control group received routine intervention without a support person during labor. monitoring of uterine contractions, bleeding, fetal medicals care and other usual hospitals' medical cares and other interventions will be done by a member of the health team in care of the patient in labor.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Zahra Shahshahan
Street address
Shahid Beheshti hospital, Ostad Motahari St., Felezi Bridge, Isfahan, Iran
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of medical sciences
Full name of responsible person
Peyman Adibi
Street address
Deputy of research, Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq.
City
Isfahan
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, Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Zahra Shahshahan
Position
Associate professor
Other areas of specialty/work
Street address
Shahid Beheshti hospital, Ostad Motahari St., Felezi Bridge, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 1334 6340
Fax
Email
shahshahan@med.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Zahra Shahshahan
Position
Associate professor
Other areas of specialty/work
Street address
Shahid Beheshti hospital, Ostad Motahari St., Felezi Bridge, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 1334 6340
Fax
Email
shahshahan@med.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Shaghyegh Mashoori
Position
Other areas of specialty/work
Street address
Shahid Behesht hospital, Ostad Motahari St., Felezi Bridge, Isfahan, Iran.
City
Isfahan
Postal code
Phone
+98 31 1334 6340
Fax
Email
smashoori@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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