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IRCT20091001002531N8 IRCT 2026-08-05 Esfahan University of Medical Sciences maternal and fetal/neonatal outcomes of water birth 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 2026-08-20 anticipated 38 Complete https://irct.ir/trial/79638 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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 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. 3 maternal Complications of labour and delivery such as pain, postpartum hemorrage, .... Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Tahmineh Dadkhahtehrani
Hezar-jerib Street
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7596 tdtahmineh1404@gmail.com Esfahan University of Medical Sciences scientific Tahmineh Dadkhahtehrani
Hezar-Jerib
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7596 tdtahmineh1404@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) 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 no limit no limit Female 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 O60-O75 Complications of labour and delivery Other Other 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. 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. 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. 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. Duration of active phase of the first stage od delivery. Timepoint: When cervical dilation reaches 10 centimeters. Method of measurement: kornometere. Duration of the second stage od delivery. Timepoint: As soon as the baby is born. Method of measurement: kornometere. Duration of the third stage od delivery. Timepoint: As soon as the placenta comes out. Method of measurement: kornometere. 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. Tear of perinium in second stage of delivery. Timepoint: just after placenta delivery. Method of measurement: observation. Infections of mother during one week after delivery. Timepoint: one week after delivery. Method of measurement: asking the mother. APGAR score neonate. Timepoint: one and 5 minutes after birth. Method of measurement: apgar score scale. Hospitalization of newborn in neonatal intensive care unit. Timepoint: one week after birth. Method of measurement: hospital record. Infectious diseases of newborn during 0ne week after birth. Timepoint: one week after birth. Method of measurement: asking the mother. Shoulder dysticia. Timepoint: During the baby's shoulder protrusion. Method of measurement: observation. 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. Esfahan University of Medical Sciences Approved 2026-07-07 Research Ethics Committee of Schools of Nursing, Management, and Rehabilitation, Isfahan University Midwifery and Reproductive Health Department, School of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran. Isfahan Isfehan Iran (Islamic Republic of)