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The effect of supportive interventions on birth experience: Randomized Controlled Trial

Protocol summary

Study aim
Effect of supportive interventions on birth experience
Design
Randomized controlled trial with two parallel arms
Settings and conduct
This study will be conducted at Taleghani Hospital in Tabriz city. So, the researcher will select eligible women in the hospital. Participants will be assigned to two groups of intervention and control. The intervention and control groups will receive supportive care and a routine maternity care during the labor phase, respectively.The birth experience of women will be measured four weeks postpartum.
Participants/Inclusion and exclusion criteria
Inclusion criteria includes age older than 18 years and gestational age of 37-42 weeks. Exclusion criteria includes having complications during pregnancy or childbirth such as preeclampsia, diabetes, placenta abruption; having a cesarean section indication such as history of cesarean section and having mental-psychological problems, according to mother's report.
Intervention groups
The intervention group will be received interventions during labor, delivery, and postpartum including the provision of latent and active labor definitions, management of labor, presence of doula, the possibility of telephone conversation with her family, not doing unnecessary interventions, woman's participation in decision-making, getting different positions such as upright position during labor, doing exercise during labour, encouraging the woman to follow their own urge to push, choosing the delivery position according to the woman choice, delayed umbilical cord clamping, controlled cord traction, skin to skin contact during the first hour after birth, and follow up and responding to postpartum maternity problems by telephone and, if necessary, attending in person will be provided. The control group will be received routine hospital care.
Main outcome variables
Birth experience

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120718010324N50
Registration date: 2019-06-28, 1398/04/07
Registration timing: prospective

Last update: 2019-06-28, 1398/04/07
Update count: 0
Registration date
2019-06-28, 1398/04/07
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-02, 1398/05/11
Expected recruitment end date
2019-09-16, 1398/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of supportive interventions on birth experience: Randomized Controlled Trial
Public title
The effect of supportive interventions on birth experience
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age older than 18 years Gestational age of 37 to 42 weeks
Exclusion criteria:
Having complications during pregnancy or childbirth such as preeclampsia, diabetes, placenta abruption Having a cesarean section indication such as history of cesarean section and ... Having mental-psychological problems, according to mother's report
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be conducted using the website www.random.org and through blocking with block sizes of four and six and an allocation ratio of 1: 1 to the two groups of intervention and control.
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 Tabriz University of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, East Azerbaijan
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2017-12-03, 1396/09/12
Ethics committee reference number
IR.TBZMED.REC.1396.786

Health conditions studied

1

Description of health condition studied
Birth experience
ICD-10 code
Z39.0
ICD-10 code description
Encounter for care and examination of mother immediately after delivery

Primary outcomes

1

Description
Birth experience
Timepoint
Four weeks postpartum
Method of measurement
Childbirth Experience Questionnaire version 2.0

Secondary outcomes

1

Description
Duration of childbirth stages
Timepoint
During the labor and childbirth stages
Method of measurement
Partograph

2

Description
Frequency of oxytocin use
Timepoint
After childbirth
Method of measurement
Postpartum checklist

3

Description
Frequency of Cesarean childbirth
Timepoint
After childbirth
Method of measurement
Postpartum checklist

4

Description
Apgar score
Timepoint
5 minutes and 10 minutes after baby's birth
Method of measurement
Postpartum checklist

Intervention groups

1

Description
Intervention group: The intervention group will receive interventions during labor, delivery, and postpartum. Interventions during labor and delivery include the provision of latent and active labor definitions, duration of labor, answering questions from women, respectful care, caring with empathy, management of labor pain (use of pharmacological pain relief methods such as remifentanil or pethidine or non-pharmacological such as teaching visualization techniques, breathing techniques, progressive muscle relaxation, massage or use a warm bag according to the woman's preference), providing a hygienic room, private, presence of doula, the possibility of telephone conversation with her family, woman's participation in decision-making, not doing unnecessary interventions such as connecting the bladder catheter, frequent vaginal examinations, pushing during delivery, women's inactivity, lack of nutrition, continuous heartbeat auscultation and recording cardiotocography, use of early onset of oxytocin, perineal/pubic shaving, privacy and confidentiality (using a separate room, no vaginal examination in the presence of women or other providers, the absence of a male student, access to a suitable cover for keeping hijab during transfer to other parts of the hospital), getting different positions such as upright position during labor, doing exercise during labour, encouraging the woman to follow their own urge to push, no routine use of episiotomy, choosing the delivery position according to the woman choice, delayed umbilical cord clamping, controlled cord traction, no nasal or oral suction baby in case of clear amniotic fluid, and during postpartum included use of uterotonics for the prevention of postpartum haemorrhage, sufficient analgesia during episiotomy repair, skin to skin contact during the first hour after birth, breastfeeding during the first hour after birth, uterine tonus assessment, regular assessment of vaginal bleeding, uterine contraction, fundal height, temperature and heart rate during the first 24 hours starting from the first hour after birth, no antibiotics prophylaxis for uncomplicated vaginal birth and follow up and responding to postpartum maternity problems by telephone and, if necessary, attending in person will be provided.
Category
Behavior

2

Description
The control group will receive routine maternity care.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Solmaz Ghanbari Homayi
Street address
Nursing & Midwifery Faculty, South Shariati Stree
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
homayisolmaz@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3335 7310
Email
iro@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Solmaz Ghanbari Homayi
Position
PhD in Midwifery
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati street
City
Tabriz
Province
East Azarbaijan
Postal code
5155884818
Phone
+98 41365706391
Email
homayisolmaz@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mojgan Mirghafourvand
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
mirg1385@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mojgan Mirghafourvand
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nursing & midwifery faculty, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
Mirghafourvandm@tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Participants' data is confidential.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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