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IRCT20220313054270N2 IRCT 2026-06-25 Birjand University of Medical Sciences Comparing the effects of midwife-assisted delivery and spinal anesthesia on labor pain Comparison of the Effects of Physiological Childbirth with Continuous Midwifery Support and Spinal Anesthesia on Labor Pain, Duration, and Mode of Delivery in Primiparous Women: A Quasi-Experimental Study 2026-06-22 anticipated 120 Complete https://irct.ir/trial/89081 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Eligible participants are initially enrolled in the study using convenience sampling. Given that trained midwives providing continuous support are present only on some shifts in the hospital, allocation to the physiological labor group is based on the availability of these trained personnel; therefore, allocation to this group is quasi-experimental. After the physiological labor group sampling is completed, other eligible women are randomly assigned to one of two groups: spinal anesthesia or routine care. A block randomization method with a block size of 6 is used for this purpose. The random sequence is generated by an independent researcher who has no role in the sample recruitment process and outcome assessment, using a random number table. The group allocations are then placed in opaque, sealed, and numbered envelopes sequentially. After reviewing the inclusion criteria and obtaining informed consent, participants are assigned to the study groups based on the sequence of the envelopes. The randomization unit in this study is the individual (participant) and stratified randomization is not used. Allocation concealment is also maintained until the participant enters the study through the use of opaque and sealed envelopes. N/A Uncomplicated vaginal delivery. Intervention 1: Intervention group 1: Physiological delivery with continuous midwife support: Nulliparous women eligible for vaginal delivery receive continuous care and support from a trained midwife from the time they enter the active phase of labor (cervical dilation of 5 to 6 cm) until the end of labor. The intervention includes the constant presence of a midwife with the mother, emotional support and reassurance, training in breathing and relaxation techniques, encouragement to move and change positions, use of a birthing ball to facilitate pelvic movements, and lumbar and sacral massage. All measures are performed according to the hospital's physiological delivery protocol. Intervention 2: Intervention Group 2: Spinal Anesthesia Nulliparous women eligible for vaginal delivery in the active phase of labor receive spinal anesthesia by an anesthesiologist. The medication used consists of fentanyl or sufentanil plus 1 to 2 mg of bupivacaine. After anesthesia, the condition of the mother and fetus and vital signs are monitored according to the hospital protocol. (Manufacturer: Caspian Tamin Pharmaceutical Company). Intervention 3: Control group: Routine obstetric care Participants in this group receive standard obstetric care, including admission and documentation, monitoring of maternal vital signs, fetal heart rate monitoring, recording of labor on a partograph, periodic prenatal examinations, routine prenatal education, and other common obstetric care. In this group, continuous obstetric support, use of physiological delivery techniques, and spinal anesthesia are not provided. Yes - There is a plan to make this available What will be shared: De-identified datasets including demographic information, primary and secondary outcomes, along with study protocol, informed consent, and questionnaires, are available for sharing. All direct identifiers have been removed prior to sharing. Access to data is available upon reasonable request from the corresponding author and signing of a sharing agreement. When: Access period starts 6 months after results are published. To whom: Access to study data and documentation is available to qualified researchers. Conditions: A written request, along with a proposal and ethics approval, should be sent to the corresponding author and a data sharing agreement signed. Use is permitted solely for non-commercial research and in accordance with the approved proposal, with the commitment to non-reidentification, citation of the original article, and non-sharing with third parties. Where to obtain: Dear applicants, please send your application in the following order of priority: 1. Email (first priority): maryam.katebi8244@yahoo.com Maryam Katebi Response within 10 working days 2. Phone (second priority): Qaen Faculty of Medical Sciences (05632531762) Call during office hours (8am-2pm) All applications will be subject to signing a data sharing agreement after initial review by the corresponding author and approval by the university ethics committee. How to obtain: The applicant sends a written request with a proposal and ethics approval to the corresponding author's email. An initial response will be provided within 10 business days and, if approved, a data sharing agreement will be sent. After the signed agreement is returned, the administrative and ethics process takes 5-7 days. De-identified data will be prepared and sent within 3-5 business days; the entire process takes about 3-4 weeks. Comments:
public Maryam Katbi
17th of Shahrivar Square- Qaen
Qaen Iran (Islamic Republic of) 9761988978 +98 56 3253 1762 maryam.katebi8244@yahoo.com Birjand University of Medical Sciences scientific Maryam Katbi
17th of Shahrivar Square -Qaen
Qaen Iran (Islamic Republic of) 9761988978 +98 56 3253 1762 maryam.katebi8244@yahoo.com Birjand University of Medical Sciences Iran (Islamic Republic of) Primiparous women aged 18 to 35 years singleton pregnancies between 38 and 42 weeks gestation no history of infertility or previous cesarean section and no underlying conditions such as gestational diabetes or hypertension. Participants must be willing to have a vaginal birth and attend childbirth preparation classes. 18 years 35 years Female Maternal coagulation disorders Maternal obesity Maternal spinal deformity Premature rupture of the membranes Fetal macrosomia Diagnosed psychiatric illness in the mother Other N/A N/A Intervention group 1: Physiological delivery with continuous midwife support: Nulliparous women eligible for vaginal delivery receive continuous care and support from a trained midwife from the time they enter the active phase of labor (cervical dilation of 5 to 6 cm) until the end of labor. The intervention includes the constant presence of a midwife with the mother, emotional support and reassurance, training in breathing and relaxation techniques, encouragement to move and change positions, use of a birthing ball to facilitate pelvic movements, and lumbar and sacral massage. All measures are performed according to the hospital's physiological delivery protocol. Intervention Group 2: Spinal Anesthesia Nulliparous women eligible for vaginal delivery in the active phase of labor receive spinal anesthesia by an anesthesiologist. The medication used consists of fentanyl or sufentanil plus 1 to 2 mg of bupivacaine. After anesthesia, the condition of the mother and fetus and vital signs are monitored according to the hospital protocol. (Manufacturer: Caspian Tamin Pharmaceutical Company). Control group: Routine obstetric care Participants in this group receive standard obstetric care, including admission and documentation, monitoring of maternal vital signs, fetal heart rate monitoring, recording of labor on a partograph, periodic prenatal examinations, routine prenatal education, and other common obstetric care. In this group, continuous obstetric support, use of physiological delivery techniques, and spinal anesthesia are not provided. Pain intensity. Timepoint: Every 30 minutes, from the time of entering the active phase (5–6 cm dilation) to full dilation (10 cm) and the second stage of labor. The average of the recorded scores is calculated and reported for each individual. Method of measurement: Visual Pain Scale. Duration of the first stage of labor (in hours). Timepoint: Once after the start of the active phase until complete dilation. Method of measurement: Based on partograph and Friedman curve recording. Type of delivery (vaginal, vacuum, cesarean section). Timepoint: After the embryo is expelled. Method of measurement: Patient file. Duration of the second stage of labor. Timepoint: From full dilation to expulsion of the fetus (in minutes). Method of measurement: Once immediately after the baby is born. The need for oxytocin administration (the need for oxytocin administration to induce or enhance uterine contractions during labor is recorded and assessed.). Timepoint: During the labor process until the baby is born. Method of measurement: Yes / No. First-minute Apgar score (The clinical status of the newborn is assessed based on the Apgar score in the first minute after birth.). Timepoint: One minute after birth. Method of measurement: Score 0 to 10 (based on the Apgar scale). Fifth-minute Apgar score (The clinical status of the newborn is assessed based on the Apgar score at the fifth minute after birth.). Timepoint: Five minutes after birth. Method of measurement: Score 0 to 10 (based on the Apgar scale). Maternal complications (incidence of maternal complications including perineal laceration, postpartum hemorrhage, retained placenta, fever, infection, and other complications related to childbirth are recorded.). Timepoint: From the start of the intervention until the mother's discharge. Method of measurement: Yes / No. Neonatal complications (the occurrence of neonatal complications including the need for resuscitation, respiratory distress, NICU admission, and other neonatal complications is recorded.). Timepoint: From birth to discharge. Method of measurement: Yes / No. Birjand University of Medical Sciences Approved 2019-04-29 Ethics committee of Birjand University of Medical Sciences Shafa Street Qaen South Khorasan Iran (Islamic Republic of)