Protocol summary

Study aim
The effect of the birth plan and childbirth preparation classes on delivery outcomes and maternal satisfaction
Design
Controlled randomized controlled clinical trial
Settings and conduct
This randomized controlled trial will be conducted at childbirth preparation classes of Tehran University of Medical Sciences and Omid, Ansari, and Baharloo hospitals. The topic of the birth plan will be merged into the scientific content of the childbirth preparation classes and will be taught to pregnant mothers. The subjects will be randomly using www.random.org assigned to a group with a birth plan and without a birth plan. Their delivery will be done according to their birth plan. The allocation sequence will be determined by the person not involved in sampling and data collection. In order to the allocation concealment, the type of intervention will be sequentially numbered sealed packages by a person not involved in sampling and analysis. After obtaining informed consent, the envelope and the type of intervention will be determined.
Participants/Inclusion and exclusion criteria
Singleton pregnancy,Low risk pregnancy without medical or medwifery history such as history of abortion, infertility and preterm labour Gestational age of 32–33 weeks , participation at least 5 session of the childbirth preparation classes,Willingness to undergo vaginal delivery Literacy (reading and writing in Persian), Previous cesarean section with Willingness to undergo vaginal delivery
Intervention groups
Pregnant mothers attending at least 5 sessions of childbirth preparation classes and having a birth plan
Main outcome variables
Delivery type, Perineal lacerations rate, Episiotomy rate, Induction of labor rate , Maternal satisfaction with childbirth, Apgar score at 1 and 5 minutes, Neonatal intensive care unit admission rates, Breastfeeding initiation within the first hour of life, Fulfilling mother's wishes rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190415043283N2
Registration date: 2020-12-07, 1399/09/17
Registration timing: registered_while_recruiting

Last update: 2020-12-07, 1399/09/17
Update count: 0
Registration date
2020-12-07, 1399/09/17
Registrant information
Name
Zaynab Mohaghegh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8331
Email address
mohaghegh.z@ajmus.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-05, 1399/09/15
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of implementation of birth plan and childbirth preparation classes maternal satisfaction and delivery outcomes: a randomized controlled clinical trial
Public title
The implementation of birth plan and childbirth preparation classes plan on maternal satisfaction and delivery outcomes
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Singleton pregnancy Low risk pregnancy without medical or medwifery history such as history of abortion, infertility and preterm labour Gestational age of 32–33 weeks participation in 5 session of the childbirth preparation classes Willingness to undergo vaginal delivery Literacy (reading and writing in Persian) Previous cesarean section with willingness to undergo vaginal delivery
Exclusion criteria:
Reluctance to continue attending the study Change of decision to C-section
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 300
Randomization (investigator's opinion)
Randomized
Randomization description
Pregnant mothers participating in childbirth preparation classes will be randomly assigned into one of with the birth plan or with not birth plan (routine) using www.random.org.
Blinding (investigator's opinion)
Single blinded
Blinding description
The outcome assessor will not know how the intervention and control groups are assigned and will review data on outcome variables without considering groups of individuals.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Research Committee Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Ave
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2020-10-19, 1399/07/28
Ethics committee reference number
1399.586.IR.AJUMS.REC.

Health conditions studied

1

Description of health condition studied
Vaginal delivery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Frequency of vaginal delivery
Timepoint
After delivery
Method of measurement
Maternal and neonatal outcomes checklist

2

Description
Duration of labor stages
Timepoint
At the beginning of the active phase until one hour after postpartum
Method of measurement
Recorded time(minute)

3

Description
Frequency of labor induction
Timepoint
During labor
Method of measurement
Maternal outcomes checklist

4

Description
Maternal satisfaction with childbirth
Timepoint
24 hours after postpartum
Method of measurement
McKay Questionnaire

5

Description
Initiation of breastfeeding within 30 minutes after birth
Timepoint
After postpartum
Method of measurement
Neonatal outcomes checklist

6

Description
Delivery fear scale
Timepoint
During labor
Method of measurement
Delivery fear scale

7

Description
Frequency of fulfilling mother's wishes
Timepoint
After postpartum
Method of measurement
Maternal outcomes checklist

8

Description
Frequency of perineal lacerations
Timepoint
After postpartum
Method of measurement
Maternal outcomes checklist

9

Description
Frequency of episiotomy
Timepoint
After postpartum
Method of measurement
Maternal outcomes checklist

10

Description
Frequency of hospitalization in the neonatal intensive care NICU
Timepoint
After postpartum
Method of measurement
Neonatal outcomes checklist

Secondary outcomes

empty

Intervention groups

1

Description
First, the topic of birth plan is integrated into the educational content of childbirth preparation classes.Then, the subjects participating in session 5 of the childbirth preparation classes write the birth plan and their childbirth will be scheduled base on their's birth plan.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Childbirth preparation Classes at Tehran University of Medical Sciences
Full name of responsible person
MojganJavadnoori
Street address
No 226, Hafez Avenue,Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1134845764
Phone
+98 21 6345 3117
Fax
Email
mojganjavadnoori@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Ahmadi Moghadam
Street address
Golestan Ave
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8383
Email
ahmadi-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mojgan Javadnoori
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Golestan Ave
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8331
Email
mojganjavadnoori@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mojgan Javadnoori
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Golestan Ave
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8331
Email
mojganjavadnoori@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mojgan Javadnoori
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Golestan Ave
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8331
Email
mojganjavadnoori@gmail.com

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
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
Yes - There is 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
Title and more details about the data/document
The data of this study will be accessible upon the request form the corresponding author after publication, or we may deposit our data in the “Figshare” for sharing with other researchers after the publication of the manuscript.
When the data will become available and for how long
The data will be accessible upon the request from the corresponding author or in the Figshare” after publication of the manuscript (we anticipate this time by the end of 2021)
To whom data/document is available
Our data will be accessible upon the request from faculty members who interested to use our data with the research purpose (with acknowledgement of authors in our study).
Under which criteria data/document could be used
Interested researchers can send an e-mail to the corresponding author and request our data. In case of if we deposited our data in the “Figshare” cite, they will be accessible from the cite
From where data/document is obtainable
Mojgan Javadnoori Ahvaz, Golestan Ave, Ahvaz Jundishapur University of Medical Sciences, Nursing & Midwifery School, Midwifery Department
What processes are involved for a request to access data/document
The requested information will be sent at the most up to one week after receiving the email.
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