Protocol summary

Study aim
determining the effect of team collaboration based on an evidence-based collaborative model in the management of normal labor and delivery on maternal and neonatal outcomes: a randomized controlled clinical trial.
Design
A controlled, parallel-group, single-blind, randomized clinical trial on 204 mothers.
Settings and conduct
The research environment is the maternity hospital of Imam Hospital.
Participants/Inclusion and exclusion criteria
-Inclusion criteria -Consent to participate in the research - First to third pregnancy - From the time of admission for delivery to dilatation of 6 cm - Mother's age between 15-45 - Singleton pregnancy - Live fetus - Gestational age 37 to 42 weeks - Cephalic presentation - Normal fetal heart rate -Exclusion criteria  History of any incision on the uterus  Indication for caesarean section (fetal distress, prolapse of the umbilical cord, diagnosis of absolute pelvic stenosis by the doctor)  Known medical diseases based on the patient's file (including history or current suffering from any systemic diseases such as diabetes, high blood pressure, heart disease, kidney, nervous, liver, digestive, respiratory, thyroid disease)  Mental-psychological problems of the mother in the last 6 months  abnormal fetus or intrauterine growth restriction  High-risk pregnancy (preeclampsia, placenta previa, Placental abruption, chorioamnionitis, placenta accreta, placenta previa)
Intervention groups
In the intervention group, care delivery will be implemented by the evidence-based collaborative model by the team members.
Main outcome variables
The duration of the stages of labor, the type of labor, postpartum bleeding, ruptures of the genital tract, the Apgar score of newborns in the first and fifth effective minutes, hospitalization of newborns, the mother's satisfaction with the birth process, the mother's experience with the birth process

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181214041963N5
Registration date: 2024-04-21, 1403/02/02
Registration timing: prospective

Last update: 2024-04-21, 1403/02/02
Update count: 0
Registration date
2024-04-21, 1403/02/02
Registrant information
Name
Atefeh Ebrahimian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3420 0651
Email address
ebrahimiyan127@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-27, 1403/02/08
Expected recruitment end date
2024-07-29, 1403/05/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of team collaboration based on an evidence-based collaborative model in the management of normal labor and delivery on maternal and neonatal outcomes: a randomized controlled clinical trial
Public title
Investigating the effect of team cooperation in the administration of normal labor and delivery on maternal and neonatal outcomes
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the research Gravid 1to3 From the time of admission for delivery to 6 cm dilatation Mother's age between 15 and 45 years singleton pregnancy live fetus Gestational age 37 to 42 weeks (based on the first day of the last menstrual period or ultrasound of the first trimester) Cephalic presentation Normal fetal heart rate (110-160)
Exclusion criteria:
History of any incision on the uterus Indication for caesarean section (fetal distress, prolapse of the umbilical cord, diagnosis of absolute pelvic stenosis by the doctor) Known medical diseases based on the patient's file (including history or current suffering from any systemic diseases such as diabetes, high blood pressure, heart, kidney, nervous, liver, digestive, respiratory, thyroid disease) Mother's psychological problems in the last 6 months Having an abnormal fetus or intrauterine growth restriction High-risk pregnancy (pre-eclampsia, placenta previa, Placental abruption, chorioamnionitis, placenta accreta, placenta previa)
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 204
Randomization (investigator's opinion)
Randomized
Randomization description
ampling will be done by the available method. In this way, since the beginning of the study, all mothers who meet the entry criteria and do not meet the exit criteria have been selected as samples, and this work will continue until the final sample size is reached. allocation to random groups: Research units will be assigned to intervention and control groups using random block method (six blocks). In this way, first 6 possible states of blocks (AABB, ABAB, BBAA, BABA, ABBA, BAAB) are listed and a number from one to six will be assigned to each block. Then a number between one and six is randomly selected using the random number table, and then people are selected based on the block corresponding to the number. will be assigned to the intervention (A) and control (B) groups. This work will continue until the sample volume is completed.
Blinding (investigator's opinion)
Single blinded
Blinding description
The statistical analyst is unaware of the type of intervention and control groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
37333-61349
Approval date
2024-02-24, 1402/12/05
Ethics committee reference number
IR.AJUMS.REC.1402.672

Health conditions studied

1

Description of health condition studied
Team collaboration based on an evidence-based collaborative model in the management of normal labor and delivery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The length of labor stages
Timepoint
During the study
Method of measurement
Partograph

2

Description
Type of delivery
Timepoint
After the study
Method of measurement
Questionnaire

3

Description
Postpartum bleeding
Timepoint
During the study
Method of measurement
Check list

4

Description
Genital lacerations
Timepoint
During the study
Method of measurement
Check list

5

Description
Apgar first and fifth minutes
Timepoint
After the intervention
Method of measurement
Check list

6

Description
Hospitalization in the neonatal intensive care unit
Timepoint
After the intervention
Method of measurement
Check list

7

Description
Satisfaction with childbirth
Timepoint
After the study
Method of measurement
Mackey questionnaire

8

Description
Childbirth Experience
Timepoint
After the study
Method of measurement
Childbirth Experience Questionnaire

9

Description
Admission to the neonatal unit
Timepoint
After the study
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Early breastfeeding
Timepoint
During the study
Method of measurement
Check list

Intervention groups

1

Description
Intervention group: In each stage of labor, delivery care is provided based on the decision and cooperation of the team members regarding the conditions of the progress of labor, the condition of the mother and the condition of the baby. Delivery will be done with the cooperation of midwife and female resident. 2 maternity care teams are formed in Imam Hospital. People in two teams can move between the two groups according to their work shifts. After declaring their consent to participate in the research, the team members are informed of the description of their duties and responsibilities by the researcher upon entering the team. They are required to maintain teamwork throughout the care delivery. In making decisions related to each mother, the team members should have a conversation and use the information in making decisions. Team members monitor the mother from the time of admission until 2 hours after delivery
Category
N/A

2

Description
Control group: Mothers receive routine maternity care.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ahvaz Hospital
Full name of responsible person
Atefeh Ebrahimian
Street address
Golestan Boulevard
City
Ahvaz
Province
Khouzestan
Postal code
‬‏ebrahimiyan127@gma
Phone
+98 916 040 5709
Email
Ebrahimiyan127@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakerkish
Street address
Golestan Boulevard
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 916 040 5709
Email
Ebrahimiyan127@gmail.com
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
70
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
Mina Iravani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Ahvaz University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3311 0000
Email
Minairavani2004@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mina Iravani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Ahvaz University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 916 040 5709
Email
Minairavani2004@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Atefeh Ebrahimian
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Golestan Boulevard
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3311 0000
Email
Ebrahimiyan127@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
Not applicable
Title and more details about the data/document
The reviewed data can be shared without mentioning the names of people
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Policymakers, researchers in academic and scientific institutions
Under which criteria data/document could be used
If you have an official letter from the scientific center
From where data/document is obtainable
Request from the printed magazine and indexed sites, request via e-mail of the project manager
What processes are involved for a request to access data/document
6 months after completing the study of the application, the data will be sent to the project manager, if the conditions are met, up to two months.
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