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

This study aims to compare the effects of physiological labor with continuous obstetric support and spinal anesthesia on pain intensity, duration of labor, and method of delivery in primiparous women.

This study is a three-group quasi-experimental study with a parallel design on 120 primiparous women. The physiological labor group will be formed non-randomly and based on the availability of trained midwives. Other participants will be allocated to two groups of spinal anesthesia and routine care by block randomization (block of 6) and opaque and coded envelopes. The allocation unit and the study will be conducted in an open manner

The study is being conducted at Qaen Martyrs Hospital on 120 primiparous women. The intervention in the physiological labor group includes continuous midwife support. The group receives spinal anesthesia and the control group has routine care. Due to the nature of the interventions, blinding of participants and midwives is not possible, but the statistical consultant is blinded to the groups. Data collectors are also unaware of the study objectives

Inclusion criteria: primiparous, age 18-35 years, singleton, gestational age 38-42 weeks, no chronic disease, desire for vaginal delivery, participation in childbirth preparation classes. Exclusion criteria: extreme obesity, spinal disorders, macrosomia, ruptured membranes

Intervention group 1: Mothers who receive continuous obstetric support from the active phase of labor until birth. Intervention group 2: Mothers who receive spinal anesthesia during the active phase of labor. Control group: Mothers who receive only standard maternity care.

The intensity of labor pain

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.

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.

Access period starts 6 months after results are published.

Access to study data and documentation is available to qualified researchers.

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.

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.

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.