- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07563374
Continuous Birth Support by Student Midwives and Labor Pain and Birth Satisfaction (MİDWİFERY)
The Effect of Continuous Birth Support Provided by Student Midwives on Labor Outcomes, Birth Perception, and Birth Satisfaction: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Döşemealti
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Antalya, Döşemealti, Turkey (Türkiye), 07190
- Antalya
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Continuous Birth Support by Student Midwives
Participants received continuous non-pharmacological birth support provided by trained senior student midwifery students under supervision throughout labor.
|
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.
|
|
Other: Routine Intrapartum Care
Participants received routine intrapartum care without continuous one-to-one birth support.
|
Standard intrapartum care practices routinely provided in the study setting.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and during active labor, up to 24 hours
|
|
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.
|
Up to 24 hours postpartum (Day 1)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
During active labor (cervical dilation 4-10 cm, assessed continuously until delivery and at 1 hour postpartum
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Seda Serhatlioglu, Doctorate, Antalya Bilim University
Publications and helpful links
General Publications
- 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
- 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-SS
- 1919B012325051 (Other Grant/Funding Number: TUBITAK 2209-A Undergraduate Research Support Program)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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