Protocol summary

Study aim
The impact of breathing exercises and pelvic floor muscle training in the third trimester of pregnancy on the duration of the second stage of labor and pregnancy complications
Design
In this controlled trial, an epidemiologist from the research center will use computer software for randomization, which will ultimately determine the sequence of group allocations. Sixty first-time pregnant women will be equally divided into four parallel groups (breathing exercises group, pelvic floor exercises group, combined breathing and pelvic floor exercises group, and control group). Based on the randomization, exercise training will be provided to the participants. The person conducting the respiratory test and the midwife are not aware of the specific exercise training but will only know the patient's code.
Settings and conduct
Eligible pregnant women in the third trimester who visit health care centers, hospitals, and various health centers in Shiraz (Iran), will be randomly assigned to one of the four study groups after an interview and expressing interest in participating in the research and filling out the consent form, and meeting the entry criteria for the project, and will be followed up until after delivery.
Participants/Inclusion and exclusion criteria
First-time pregnant women in the third trimester of pregnancy, aged 18 to 35 years with a body mass index of 19.8-30, who have no history of miscarriage and are volunteers for natural childbirth. Women who are at risk of premature labor or cesarean and are prohibited from physical activity
Intervention groups
Group one: breathing exercises; group two: pelvic floor exercises; group three: both breathing and pelvic floor exercises; group four: control and will not receive any exercises.
Main outcome variables
Duration of the second stage of labor and pregnancy complications; measurement of patients' lung volumes and capacities; quality of life.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160130026260N4
Registration date: 2024-06-01, 1403/03/12
Registration timing: prospective

Last update: 2024-06-01, 1403/03/12
Update count: 0
Registration date
2024-06-01, 1403/03/12
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3233 2365
Email address
shaghayeghmoradi84@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-04, 1403/03/15
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of breathing exercises and pelvic floor muscles in the third trimester of pregnancy on the duration of the second stage of labor and pregnancy complications
Public title
The effect of breathing exercises and pelvic floor muscles on the labor and pregnancy complications
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
First-time pregnant women in the third trimester of pregnancy, with no history of childbirth or miscarriage The age range is 18 to 35 years old. The Body Mass Index (BMI) should be less than 30 kg/m², within the range of 19.8 to 30 Informed consent for participation in research A healthy fetus in cephalic position, expecting spontaneous vaginal delivery (candidate for natural childbirth), without any pregnancy complications Confirmation of fetal health based on ultrasound findings or the triple test of pregnancy, no addiction to drugs, and no cognitive or psychological problems No apparent risk factors according to the findings of prenatal examinations and ultrasound for the mother and fetus Medical clearance for physical exercise during pregnancy The participant should not have psychiatric disorders or a history of any mental illness such as anxiety or depression, or neurological diseases The participant should not have severe cardiovascular disease The participant should not have high blood pressure due to pregnancy The participant should not have gestational diabetes The participant should not have a history of two or more miscarriages The participant should not have uncontrolled thyroid disease The participant should not have pulmonary-respiratory diseases The participant should not have a history of abdominal/uterine and pelvic surgery The participant should not have any underlying chronic diseases such as chronic constipation, asthma, chronic cough, or dystocia No history of tobacco use or alcohol addiction The ability to correctly perform pelvic floor muscle contractions Healthy sensory and motor function in the lower limbs and no musculoskeletal abnormalities No presence of prolapse, neuropathy (damage or lesions to peripheral nerves for any reason), or collagen tissue disease No prior engagement in pelvic floor muscle exercises similar to the exercise protocol before pregnancy and no history of professional sports
Exclusion criteria:
Women who have a high probability of cesarean delivery or who undergo cesarean delivery Women who are at risk of preterm labor Any contraindication to physical activity according to the American College of Obstetricians and Gynecologists (ACOG) Women who withdraw from the study before its completion for various reasons, including lack of time, changing hospitals, or migrating to other provinces Failure to attend two consecutive training sessions and three non-consecutive sessions, irregular performance of pelvic floor and breathing exercises according to the schedule (depending on the group they are placed in) Pain during pelvic floor muscle contractions Patients with paradoxical contraction of the pelvic floor muscles (defined as the descent of the pelvic floor muscle, where instead of pressing and actively lifting the pelvic floor muscles upwards, the pelvic floor is pushed downwards) The presence of persistent urinary tract infection during pregnancy Preeclampsia (pregnancy poisoning is one of the dangerous diseases of pregnancy that occurs in mothers with high blood pressure after the twentieth week of pregnancy) or other diseases that can affect participation Cephalopelvic disproportion, polyhydramnios or oligohydramnios or deep vein thrombosis. And pregnancy complications such as placenta previa, placenta accreta, known fetal anomaly and intrauterine fetal demise, abnormal placental conditions and vasa previa (a very dangerous condition in which the placenta and vessels within the membranes are positioned over the internal cervical os), antepartum hemorrhage, fetal distress or the administration of pain relief drugs other than IMP Premature rupture of membranes, emergency cesarean delivery, breech presentation, vulvovaginitis during hospitalization for delivery In the final days of pregnancy, if the baby's weight is more than 4000 grams or less than 2500 grams
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data and Safety Monitoring Board
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly assigned by block randomization to four blocks of four and an allocation ratio (1:1) to four groups receiving exercise A, B, C, and D. The blocks will be arranged with different internal combinations using a table of random numbers generated by the Software Allocation Random. Ultimately, a sequence from the total randomization of the groups will be determined, and based on that, the exercise training will be given to the participants.
Blinding (investigator's opinion)
Single blinded
Blinding description
The individual receiving the respiratory test and the midwife performing the delivery are not aware of the variety of exercise training but only know the patient's code
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Cmmittee of Shiraz University of Medical Sciences
Street address
Headquarters Of Shiraz University of Medical Sciences, Zand St., Shiraz
City
Shiraz
Province
Fars
Postal code
7194643786
Approval date
2024-05-12, 1403/02/23
Ethics committee reference number
IR.SUMS.REC.1403.073

Health conditions studied

1

Description of health condition studied
Normal Vaginal Delivery
ICD-10 code
O80.0
ICD-10 code description
Single spontaneous delivery

Primary outcomes

1

Description
The duration of the second stage of labor
Timepoint
During vaginal delivery
Method of measurement
Clinical

2

Description
Pregnancy complications
Timepoint
Before the intervention starts and after the intervention ends
Method of measurement
Pregnancy symptom inventory questionnaire

Secondary outcomes

1

Description
Assessment of lung volumes and capacities
Timepoint
Before the intervention starts and after the intervention ends
Method of measurement
Body plethysmography

2

Description
ًQuality of life
Timepoint
Before the intervention starts and after the intervention ends
Method of measurement
SF-36 Quality of Life Questionnaire

Intervention groups

1

Description
Intervention group: Breathing exercises, specifically diaphragmatic breathing, are to be performed at home. They should be done twice a day, consisting of 3 sets with 5 to 10 repetitions each. Between each set, there should be a rest period of 5 to 10 counts. The breathing technique involves inhaling for a count of 3 and exhaling for a count of 3. The exercises will be progressively challenging, gradually increasing the number of repetitions per set. Diaphragmatic breathing exercises should be done in a seated (semi-reclined) position. The participant is instructed to place one hand on the chest and the other on the abdomen. The breathing should be calm, ensuring that during inhalation, the hand on the abdomen rises, and during exhalation, it falls, while the hand on the chest should move as little as possible.
Category
Lifestyle

2

Description
Intervention group: Pelvic floor muscle exercises, Pelvic floor muscle exercises should be performed at home and are to be done 5 days a week, twice a day (morning and afternoon), to achieve a total of 60 repetitions each day. Initially, in all three positions—lying down, sitting, and standing—perform 5 repetitions with 1 to 2 counts of contraction and 1 to 2 counts of rest between each contraction. Then, perform another 5 repetitions with 5 to 10 counts of contraction and 5 to 10 counts of rest. To adhere to the principle of progressive overload, start the first week in each position with 5 repetitions of 1-count contractions and relaxations, followed by 5 repetitions of 5-count contractions and relaxations. There will be a weekly increase in the number of contractions and the rest period.
Category
Lifestyle

3

Description
Intervention group: breathing exercises and the pelvic floor muscle exercises, The group will perform both the breathing exercises and the pelvic floor muscle exercises according to the previous protocol
Category
Lifestyle

4

Description
Control group: control, The control group will not perform any kind of exercise.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Haspial affiliated to Shiraz university of medical sciences
Full name of responsible person
Fateme Firoozi Nezhad
Street address
Building of Shiraz University of Medical Sciences, Zand Ave
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3647 9830
Email
f.firouzi368@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempour
Street address
Building of Shiraz University of Medical Sciences, Zand Ave
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3235 7282
Email
hashempurm@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Shaghayegh Moradi Alamdarloo
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Maternal- Fetal Medicine (Perinatology), Hafez Hospital, Chamran Ave., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
00887136479830
Email
shaghayeghmoradi84@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shaghayegh Moradi Alamdarloo
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Maternal- Fetal Medicine (Perinatology), Hafez Hospital, Chamran Ave., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
00887136479830
Email
shaghayeghmoradi84@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shaghayegh Moradi Alamdarloo
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Maternal- Fetal Medicine (Perinatology), Hafez Hospital, Chamran Ave., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
00887136479830
Email
shaghayeghmoradi84@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
Not applicable
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
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Information and research data Ethic form: Complete the ٍEthic form by the patient
When the data will become available and for how long
IPD: 2024و Ethic form: 2024
To whom data/document is available
IPD: Researcher & Patient Ethic form: Patient
Under which criteria data/document could be used
IPD: Ethic form: Awareness of test results
From where data/document is obtainable
IPD: OB & Gyn ward Shiraz university of medical sciences Ethic form: OB & Gyn ward Shiraz university of medical sciences
What processes are involved for a request to access data/document
IPD: Vice chancellery Ethic form: Vice chancellery
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