Protocol summary

Study aim
To determine the effect of a structured Second Stage of Labor Management Program on pelvic floor muscle health and related postpartum outcomes.
Design
A two-arm randomized controlled clinical trial. Eligible pregnant women will be consecutively recruited and assigned to the intervention or control group according to the group allocation of their attending midwife. Outcomes will be assessed at 8–12 weeks postpartum by trained assessors.
Settings and conduct
This study will be conducted at Mother Government Hospital in Ramhormoz, Khuzestan Province, Iran. Midwives allocated to the intervention group will implement the Second Stage of Labor Management Program, while those in the control group will provide routine intrapartum care. Outcome assessments will be performed at 8–12 weeks postpartum.
Participants/Inclusion and exclusion criteria
Inclusion criteria included Willingness to participate in the study, Maternal age between 18 and 45 years, Singleton live fetus , Cephalic fetal presentation Low-risk pregnancy, Gestational age between 37 and 41 weeks of pregnancy. Exclusion criteria included Attendance at more than four childbirth preparation classes, Performing perineal massage during pregnancy, Presence of a birth companion (professional labor support midwife/doula or a family member), high-risk pregnancy, contraindications to vaginal birth , maternal medical conditions documented in the medical record .
Intervention groups
Participants in the intervention group will receive a structured Second Stage of Labor Management Program aimed at preserving pelvic floor muscle health. Participants in the control group will receive routine intrapartum care.
Main outcome variables
The primary outcome is pelvic floor muscle strength at 8–12 weeks postpartum. Secondary outcomes include urinary incontinence, bowel dysfunction, pelvic organ prolapse symptoms and sexual dysfunction.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260805070545N1
Registration date: 2026-08-27, 1405/06/05
Registration timing: prospective

Last update: 2026-08-27, 1405/06/05
Update count: 0
Registration date
2026-08-27, 1405/06/05
Registrant information
Name
Hadis Bahmaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3311 2397
Email address
bahmani.h@ajums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-09-06, 1405/06/15
Expected recruitment end date
2027-03-20, 1405/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design, Implementation, and Evaluation of the Impact of a Second-Stage Labor Management Program on Pelvic Floor Muscle Health: A Mixed-Methods Evaluation Design
Public title
Effect of second stage of labor management program on pelvic floor muscle
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study Maternal age between 18 and 45 years Singleton live fetus Cephalic fetal presentation Low-risk pregnancy Gestational age between 37 and 41 weeks of pregnancy
Exclusion criteria:
Attendance at more than four childbirth preparation classes Performing perineal massage during pregnancy Presence of a birth companion (professional labor support midwife/doula or a family member) high-risk pregnancy Presence of contraindications to vaginal birth Presence of maternal medical conditions documented in the medical record
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 420
Randomization (investigator's opinion)
Randomized
Randomization description
Midwives are divided into two intervention and control groups with a 1:1 allocation ratio using stratified randomization based on the variable of work experience (less than 5 years and 5 years or more). The randomization sequence is generated by an independent person from the research team using a random number table. The final allocation is kept in opaque, sealed, and numbered envelopes and is known only to the independent person until the results are announced.
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
Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences
Street address
Ground Floor, Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences, University Campus, Ahvaz, Khuzestan, Iran
City
رامهرمز
Province
Khouzestan
Postal code
61357-15794
Approval date
2026-08-15, 1405/05/24
Ethics committee reference number
IR.AJUMS.REC.1405.203

Health conditions studied

1

Description of health condition studied
Pelvic floor disorders after vaginal delivery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pelvic floor muscle strength
Timepoint
8–12 weeks postpartum
Method of measurement
Pelvic floor muscle strength will be assessed using the Modified Oxford Scale (MOS) through standardized digital vaginal examination performed by trained assessors. The MOS is a validated 6-point grading system ranging from 0 (no palpable contraction) to 5 (strong contraction).

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Participants in the intervention group will receive a Second Stage of Labor Management Program designed to protect pelvic floor muscle health during childbirth. The program will be implemented by trained midwives and includes evidence-based interventions during the second stage of labor, such as guidance on spontaneous pushing, appropriate maternal birthing positions, controlled breathing techniques, perineal support, controlled delivery of the fetal head, and other standardized practices aimed at reducing pelvic floor muscle strain and birth-related pelvic floor injury.
Category
Treatment - Other

2

Description
Control group: Participants in the control group will receive routine intrapartum care according to the standard clinical protocols of the study setting. Labor and birth management will be conducted by the attending healthcare providers without implementation of the structured Second Stage of Labor Management Program.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Mother Government Hospital, Ramhormoz, Khuzestan, Iran
Full name of responsible person
Mina Iravani
Street address
Iran, Ahvaz, Golestan Highway, Ahvaz Jundishapur University
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۵۷۱۵۷۹۴
Phone
+98 916 322 2899
Email
minairavani2004@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mina Iravani
Street address
Iran, Ahvaz, Golestan Highway, Ahvaz Jundishapur University
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۵۷۱۵۷۹۴
Phone
+98 916 322 2899
Email
minairavani2004@yahoo.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
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
Hadis Bahmaei
Position
Master
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Iran, Ahvaz, Golestan Highway, Ahvaz Jundishapur University
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۵۷۱۵۷۹۴
Phone
+98 61 3314 0000
Email
hadisbahmaei8894@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hadis Bahmaei
Position
Master
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Iran, Ahvaz, Golestan Highway, Ahvaz Jundishapur University
City
رامهرمز
Province
Khouzestan
Postal code
۶۱۳۵۷۱۵۷۹۴
Phone
+98 61 3314 0000
Email
hadisbahmaei8894@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hadis Bahmaei
Position
Master
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Iran, Ahvaz, Golestan Highway, Ahvaz Jundishapur University
City
َAhvaz
Province
Khouzestan
Postal code
۶۱۳۵۷۱۵۷۹۴
Phone
+98 61 3314 0000
Email
hadisbahmaei8894@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
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
Undecided - It is not yet known if there will be 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 documentation will be published as articles on scientific websites.
When the data will become available and for how long
Access period begins 6 months after the publication of results.
To whom data/document is available
Researchers at academic and scientific institutions, students, and midwives working in public and private centers.
Under which criteria data/document could be used
For the purpose of conducting further research or applying the results in clinical settings or scientific documentation.
From where data/document is obtainable
Articles published on domestic and international scientific and research websites will be accessible.
What processes are involved for a request to access data/document
Scientific articles based on research findings are eligible for publication in journals following rigorous peer review.
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