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NCT Number: NCT07563374

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Antalya

Antalya, Döşemealti, 07190, Turkey (Türkiye)

About this study

This randomized controlled trial is designed to evaluate the effect of continuous birth support provided by student midwives on labor pain intensity and birth satisfaction among women giving birth vaginally. The study will be conducted in a maternity hospital setting.

Eligible pregnant women who are admitted to the labor ward and meet the inclusion criteria will be informed about the study and asked to provide written informed consent before participation. After enrollment, participants will be randomly assigned to either an experimental group receiving continuous birth support or a control group receiving routine intrapartum care.

Participants in the experimental group will receive continuous birth support provided by trained student midwives in addition to routine intrapartum care. The intervention will consist of structured breathing exercises guided by student midwives, including slow-paced breathing, patterned breathing during contractions, and relaxation-focused breathing between contractions. The support will begin at admission to the labor ward and continue throughout labor until birth, following a standardized intervention protocol.

Participants in the control group will receive routine intrapartum care according to the standard clinical protocols of the maternity hospital, including regular maternal and fetal monitoring and clinical care by midwives and obstetric staff. No structured breathing exercise program will be provided.

The primary outcome of the study is labor pain intensity, assessed using the Visual Analog Scale (VAS). Pain will be measured at two time points: at admission to the labor ward (baseline) and at cervical dilatation of 6-7 cm.

The secondary outcome is birth satisfaction, assessed within 24 hours postpartum using the Birth Satisfaction Scale-Revised (BSS-R). he study aims to determine whether continuous birth support provided by student midwives is associated with reduced labor pain intensity and increased birth satisfaction compared to routine intrapartum care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Routine care

Other

Standard intrapartum care practices routinely provided in the study setting.

Primary outcomes

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

    Time frame: Baseline and during active labor, up to 24 hours

    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.

  2. Birth satisfaction measured by the Birth Satisfaction Scale-Revised

    Time frame: Up to 24 hours postpartum (Day 1)

    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.

Secondary outcomes

  1. Obstetric Interventions

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

    Frequency of obstetric interventions during labor, including episiotomy, amniotomy, and labor augmentation.

Sponsors and collaborators

Lead sponsor

Antalya Bilim University

Other

Registry information

Official study title

The Effect of Continuous Birth Support Provided by Student Midwives on Labor Outcomes, Birth Perception, and Birth Satisfaction: A Randomized Controlled Trial

Acronym: MİDWİFERY

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 4, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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