Protocol summary

Study aim
1. comparing average pain intensity score of the first and second stages of labor in two groups 2. comparing average duration of first, second, and third stages of labor in two groups 3. comparing average postpartum hemorrhage volume in two groups 4. comparing frequency of perineal rupture in second stage of labor in two groups 5. comparing frequency of postpartum uterine or urinary tract infection in two groups 6-comparing Apgar score of first and fifth minutes of the newborn in two groups 7. comparing frequency of hospitalization of the newborn in NICU in two groups 8- comparing frequency of shoulder dystocia in two groups 9. comparing frequency of snapped cord in two groups
Design
clinical trial with two groups of control (land delivery) and intervention( water delivery) , with parallel groups; single blinded; randomized by sealed, opaque packets by random selection; on 66 multiparous women
Settings and conduct
In maternity wards of Asgariyah Hospital, multiparous women will be taken to bath-tub to undergo their labor and delivery. Participants will not be blinded.
Participants/Inclusion and exclusion criteria
-Iranian nationality with at least elementary literacy - Singleton full-term pregnancy -Cephalic presentation -Cephalo-pelvic proportion - Absence of any abnormal pattern of fetal heart rate at the time of study entry - Estimated newborn weight 4000-2500 grams
Intervention groups
Intervention involved taking mothers into a tub of warm water to undergo labor and delivery in the water.
Main outcome variables
Maternal outcomes : pain intensity during the first and second stages of labor; duration of the first, second, and third stages of labor; volume of postpa and postpartum uterine or urinary tract infection. Fetal/neonatal outcomes: neonatal Apgar; shoulder dystocia; umbilical cord rupture.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20091001002531N8
Registration date: 2026-08-05, 1405/05/14
Registration timing: prospective

Last update: 2026-08-05, 1405/05/14
Update count: 0
Registration date
2026-08-05, 1405/05/14
Registrant information
Name
Tahmineh Dadkhahtehrani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7596
Email address
dadkhah-tehrani@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-08-20, 1405/05/29
Expected recruitment end date
2026-11-06, 1405/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of maternal and fetal/neonatal outcomes of water birth and land birth in mothers hospitalized in labor wards of selected hospitals of Isfahan in 1404
Public title
maternal and fetal/neonatal outcomes of water birth
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
vaginal bleeding Term singleton pregnancy with cephalic presentation Not having obvious cephalopelvic disproportion Not having any fetal heart rate disorders and meconium excretion when entering the study Optimal non-stress test estimated weight of fetus 2500-4000 grams Not having sever IUGR or absence of placenta grading 3 or more Not having asthma, glaucoma, tuberculosis, adrenal insufficiency and hepatitis Not having active genital herpes, HIV and genital herpes having no psychological disorders based on the statements of the mother/companions and medical documents not having fever and history of caesarean section No oxytocin infusion Not having heart diseases, blood pressure, pre-eclampsia, multiple sclerosis, overt or gestational diabetes, rheumatism not having placenta previa , myoma, uterine abnormality, or fetal abnormality intact amniotic sac mothers age 18-40 BMI less than 30 Not taking herbal medicines to induce labor during 24 hours before induction (such as saffron and cumin) Signing the consent form Iranian nationality
Exclusion criteria:
non satisfying pattern of FHR or meconium excertion during study applying vacuum for head pulling the occurrence of cesarean section Mother's unwillingness to continue participating in the study The occurrence of any problem that deviates from the normal course of labor, such as bleeding, maternal fever or hypertension
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 38
Randomization (investigator's opinion)
Randomized
Randomization description
To allocate the participants to two group (land birth and water birth) randomly, the researcher will ask mothers to take a sealed opaque package out of 80 randomly. 40 packages contains questionnaires and checklists coded 1( related to land birth group) and 40 packages contains the same questionnaires and checklists coded 2( related to water birth group). It will be written code 1 or code 2 instead of land birth or water birth on the questionnaires and checklists in order to the data analyzer could be blinded. This process will continue until having at least 34 samples in both groups. In this way, concealment of randomization will be performed.
Blinding (investigator's opinion)
Single blinded
Blinding description
Please describe who is blind in your study and how you have achieved this. The conventional terms of single, double and triple blinds are not informative in some occasions and you need to describe in detail how people who are involved in your study are blinded. A full description of blinding should have statements on the following groups of people involved in the trial: participants, principle investigator particularly in investigator initiated trials, healthcare providers (Physicians, nurses, physiotherapists, etc.) who care for participants during the trial, data collectors, outcome assessors, and with lessor importance Data Safety and Monitoring Board and manuscript writers
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Schools of Nursing, Management, and Rehabilitation, Isfahan University
Street address
Midwifery and Reproductive Health Department, School of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
8174673
Approval date
2026-07-07, 1405/04/16
Ethics committee reference number
IR.MUI.NUREMA.REC.1405.053

Health conditions studied

1

Description of health condition studied
maternal Complications of labour and delivery such as pain, postpartum hemorrage, ...
ICD-10 code
O60-O75
ICD-10 code description
Complications of labour and delivery

Primary outcomes

1

Description
severity of pain of avtive phase of the first stage of delivery
Timepoint
During the first two hours after delivery, as soon as the mother is ready.
Method of measurement
visual analoge scale

2

Description
severity of pain of avtive phase of the first stage of delivery
Timepoint
During the first two hours after delivery, as soon as the mother is ready.
Method of measurement
visual analoge scale

3

Description
duration of active phase of the first stage od delivery
Timepoint
When cervical dilation reaches 10 centimeters
Method of measurement
kornometere

4

Description
duration of the second stage od delivery
Timepoint
As soon as the baby is born
Method of measurement
kornometere

5

Description
duration of the third stage od delivery
Timepoint
As soon as the placenta comes out
Method of measurement
kornometere

6

Description
volume of bleeding after delivery
Timepoint
during third and fourth stage of delivery ( frome birth of newborn untill one hour afer placental delivery)
Method of measurement
Weighing the sheets before and after changing

7

Description
tear of perinium in second stage of delivery
Timepoint
just after placenta delivery
Method of measurement
observation

8

Description
infections of mother during one week after delivery
Timepoint
one week after delivery
Method of measurement
asking the mother

9

Description
APGAR score neonate
Timepoint
one and 5 minutes after birth
Method of measurement
apgar score scale

10

Description
hospitalization of newborn in neonatal intensive care unit
Timepoint
one week after birth
Method of measurement
hospital record

11

Description
infectious diseases of newborn during 0ne week after birth
Timepoint
one week after birth
Method of measurement
asking the mother

12

Description
shoulder dysticia
Timepoint
During the baby's shoulder protrusion
Method of measurement
observation

13

Description
Umbilical cord snap during childbirth
Timepoint
In the time between the birth of the baby and the expulsion of the placenta
Method of measurement
observation

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: At onset of the active stage of delivery (minimum dilation of cervix 5 cm), the parturient mothers enter a warm tub to undergo labor and give birth in water.
Category
Other

2

Description
Control group: The mothers undergo their labor in bed or out of bed. then they give birth in bed on lithotomy position as usual routin.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Askarieh Hospital
Full name of responsible person
Dr. Mohammad-reza Shah-Naser
Street address
Asgariye street
City
Isfahan
Province
Isfehan
Postal code
8199753966
Phone
+98 31 3225 0041
Fax
+98 31 3225 5891
Email
info@askariehospital.com
Web page address
https://askariehospital.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholam-reza Askari
Street address
Hezar-jerib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Fax
+98 31 3668 7898
Email
askari@mui.ac.ir
Web page address
https://research.mui.ac.ir/fa
Grant name
Grant code / Reference number
2404203
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Tahmineh Dadkhahtehrani
Position
academic member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Hezar-jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7596
Email
tdtahmineh1404@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Tahmineh Dadkhahtehrani
Position
Academic Member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Hezar-Jerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7596
Email
tdtahmineh1404@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Tahmineh Dadkhahtehrani
Position
ACADEMIC MEMBERT. INSTRUCTOR
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Midwifery and Reproductive Health Department, School of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar-jerib Street, Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7596
Email
tdtahmineh1404@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
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