Evaluation of the birth plan implementation on experiences childbirth and duration of the active phase of labor: a randomized controlled clinical trial
To determine the effect of birth plan implementation on childbirth experience and duration of active phase of labor
Design
Clinical trial, with control group, parallel groups, single blind, randomized
Settings and conduct
This randomized controlled clinical trial will be conducted on pregnant women with gestational age of 32-36 weeks in Taleghani hospital of Tabriz. Participants will be divided into two groups by randomized blocking method and an assignment ratio of 1:1. The participants in intervention group will complete the birth plan checklist and their labor and delivery will be managed according to completed checklist by researcher and the control group will receive routine care. The participants will be followed up until 4-6 weeks after childbirth and the childbirth experience questionnaire, post-traumatic stress scale and Edinburgh’s postpartum depression scale will be completed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with at least 18 years old and with first and second delivery; Residence in Tabriz city; Having a desire to have a vaginal delivery; Gestational age 36-32 weeks; Having Depression score less than 13; Singleton pregnancy and having read and write literacy.
ٍExclusion criteria: Non-cephalic presentation of the fetus; Indication of cesarean section; Obstetrics problems and high-risk pregnancies
Intervention groups
Intervention group (Birth plan requested by the mother and approved by a gynecologist).
Control group (routine care during labor and delivery)
Main outcome variables
Childbirth experience score؛ Duration of active phase of labor
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120718010324N58
Registration date:2020-07-07, 1399/04/17
Registration timing:prospective
Last update:2020-07-07, 1399/04/17
Update count:0
Registration date
2020-07-07, 1399/04/17
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
2020-07-19, 1399/04/29
Expected recruitment end date
2020-12-19, 1399/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the birth plan implementation on experiences childbirth and duration of the active phase of labor: a randomized controlled clinical trial
Public title
Assessing the effect of the birth plan implementation on experiences childbirth and duration of the active phase of labor
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
At least 18 years old
Residence in Tabriz city
Having a desire to have a vaginal delivery
Gestational age 32-36 weeks
Having Depression score less than 13
Singleton pregnancy
Having read and write literacy
Planning for childbirth in Taleghani Hospital
Women with first and second delivery
Exclusion criteria:
Non-cephalic presentation of the fetus
An indication of the cesarean section including abnormal presentation, placental previa, etc.
Obstetrics problems such as placental previa, vaginal delivery after cesarean section, placental abruption, preeclampsia
High-risk pregnancies such as diabetes, heart disease, etc., and a dead or abnormal fetus
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
106
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be assigned into three groups by block randomization method with block sizes of 4 and 6 and allocation ratio of 1:1 including intervention 1 (Having birth plan), and control (Routine care). The allocation sequence will be determined by the person who is'n involved in the sampling and data collection. For allocation concealment, the type of intervention will be written on piece of paper and placed inside the serial numbered envelopes. After obtaining informed consent, the relevant envelope will be opened and the intervention type will be determined.
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 Univercity 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
00984113357311
Approval date
2020-05-21, 1399/03/01
Ethics committee reference number
IR.TBZMED.REC.1399.278
Health conditions studied
1
Description of health condition studied
Delivery
ICD-10 code
080.0
ICD-10 code description
Spontaneous vertex delivery
Primary outcomes
1
Description
Childbirth Experience score
Timepoint
4 to 6 weeks after delivery
Method of measurement
Childbirth Experience Questionnaire
2
Description
Duration of active phase of delivery
Timepoint
From dilatation 4 cm until full dilatation of cervix
Method of measurement
Partograph chart (minute)
Secondary outcomes
1
Description
Duration of second stage of delivery
Timepoint
From full dilatation of cervix until birth of newborn
Method of measurement
Partograph chart (minute)
2
Description
Duration of Third stage of delivery
Timepoint
From birth of newborn until complete expulsion of placenta
Method of measurement
Partograph chart (minute)
3
Description
Fear of Childbirth Score
Timepoint
During labor
Method of measurement
Fear of Childbirth Scale
4
Description
Frequency of vaginal delivery
Timepoint
After childbirth
Method of measurement
Childbirth checklist
5
Description
Post-traumatic stress score
Timepoint
4 to 6 weeks after delivery
Method of measurement
Post Traumatic Stress Questionnaire
6
Description
The frequency of infant hospitalization in the NICU
Timepoint
Postpartum
Method of measurement
Neonatal checklist
7
Description
Postpartum depression score
Timepoint
4 to 6 weeks after delivery
Method of measurement
Edinburgh’s Postpartum Depression Scale
8
Description
Apgar score at one and five minutes
Timepoint
After childbirth
Method of measurement
Childbirth checklist
Intervention groups
1
Description
Intervention group: The participants in intervention group will receive interventions according to completed birth plan checklist by mother herself including the mother's wishes and preferences regarding labour and childbirth (such as delivery position, mother's movements in labour, pain relief, labour acceleration, fetal monitoring, etc) that are approved by the obstetrician.
Category
Treatment - Other
2
Description
The control group will receive hospital routine care.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Educational and Treatment Center of Tabriz
Full name of responsible person
Parivash Ahmadpour
Street address
Rah Ahan square, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5197615413
Phone
+98 41 3442 4425
Email
mjm.mid1373@gmail.com
Web page address
https://www.drsaina.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Samiei
Street address
Research department, third floor, central construction number 2, Tabriz medical science university, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
Samiei.moh@gmail.com
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
Dr. Mojgan Mirghafourvand
Position
Associate professor
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
5138947977
Phone
+98 41 3479 6770
Email
mirghafourvandm@tbzmed.ac.ir
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
Reproductive Health
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
mirghafourvandm@tbzmed.ac.ir
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
Reproductive Health
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
Email
mirghafourvandm@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The results of the clinical study will be published as articles.
When the data will become available and for how long
Immediately after publishing the results
To whom data/document is available
All researchers
Under which criteria data/document could be used
Scientific using with citation to the article
From where data/document is obtainable
mirghafourvandm@tbzmed.ac.ir
What processes are involved for a request to access data/document