Continuous Birth Support by Student Midwives and Labor Pain and Birth Satisfaction

NCT07563374 | Completed DMC

• 2 other identifiers: 2025-SS1919B012325051
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled study aimed to evaluate the effect of continuous birth support provided by senior student midwives on labor outcomes, birth perception, and birth satisfaction. Pregnant women admitted for spontaneous vaginal birth were randomly assigned to either a continuous birth support group or a routine care control group. The intervention consisted of continuous non-pharmacological support provided by trained student midwives under supervision throughout labor. Primary outcomes included perceived birth pain and birth satisfaction, while secondary outcomes included birth perception and obstetric interventions.

Conditions

Labor Pain; Birth Satisfaction

Keywords

Birth Satisfaction; Continuous Birth Support; Midwifery Education; Student Midwives

Outcome Measures

Primary Outcomes (2)

• Change in labor pain intensity from baseline to active labor.

  Labor pain intensity will be assessed using the Visual Analog Scale, a 10-centimeter horizontal line anchored with "no pain" and "worst pain imaginable." Scores range from 0 to 10. Higher scores indicate greater pain intensity. The outcome will be the change in participant-reported VAS score from baseline to active labor.

  Baseline and during active labor, up to 24 hours

• Birth satisfaction measured by the Birth Satisfaction Scale-Revised

  Birth satisfaction will be assessed using the Birth Satisfaction Scale-Revised, a validated self-report questionnaire measuring women's satisfaction with the childbirth experience. The total score ranges from 0 to 40. Higher scores indicate greater birth satisfaction. The total scale score will be used as the outcome measure.

  Up to 24 hours postpartum (Day 1)

Secondary Outcomes (1)

• Obstetric Interventions

  During active labor (cervical dilation 4-10 cm, assessed continuously until delivery and at 1 hour postpartum

Study Arms (2)

Continuous Birth Support by Student Midwives

EXPERIMENTAL

Participants received continuous non-pharmacological birth support provided by trained senior student midwifery students under supervision throughout labor.

Behavioral: Continuous Birth Support

Routine Intrapartum Care

OTHER

Participants received routine intrapartum care without continuous one-to-one birth support.

Other: Routine Care

Interventions

Continuous Birth Support BEHAVIORAL

Continuous emotional, physical, informational, and advocacy support provided by senior student midwifery students under supervision during labor, including positioning, breathing techniques, massage, relaxation techniques, and psychological support.

Continuous Birth Support by Student Midwives

Routine Care OTHER

Standard intrapartum care practices routinely provided in the study setting.

Routine Intrapartum Care

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women aged 18 years or older
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women aged 18 years or older
• Singleton pregnancy
• Gestational age ≥ 37 completed weeks
• Low-risk pregnancy
• Planned vaginal birth
• Admitted to the labor ward in the latent or early active phase of labor
• No pharmacological analgesia before the first pain assessment
• Ability to communicate and provide written informed consent

You may not qualify if:

• High-risk pregnancy requiring continuous medical or obstetric intervention
• Planned cesarean section
• Multiple pregnancy
• Known fetal anomaly
• Use of pharmacological analgesia (e.g., epidural anesthesia, systemic opioids) before baseline pain assessment
• Obstetric complications requiring emergency intervention at admission (e.g., fetal distress, placental abruption, cord prolapse)
• Inability to cooperate with breathing exercises

Sponsors & Collaborators

• Antalya Bilim University: lead

Study Sites (1)

Antalya

Antalya, Döşemealti, 07190, Turkey (Türkiye)

Location

Related Publications (2)

• Bohren MA, Hofmeyr GJ, Sakala C, Fukuzawa RK, Cuthbert A. Continuous support for women during childbirth. Cochrane Database of Systematic Reviews. 2017;7:CD003766. doi:10.1002/14651858.CD003766.pub6

  RESULT

• Hodnett ED, Gates S, Hofmeyr GJ, Sakala C. Continuous support for women during childbirth. Cochrane Database of Systematic Reviews. 2013;7:CD003766. doi:10.1002/14651858.CD003766.pub5

  RESULT

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Seda Serhatlioglu, Doctorate

  Antalya Bilim University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were blinded to group allocation; care providers and investigators were not blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2025
• First Posted: May 4, 2026
• Study Start: December 3, 2024
• Primary Completion: March 4, 2025
• Study Completion: March 4, 2025
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)