Labor PainMİDWİFERYNCT07563374
Continuous Birth Support by Student Midwives and Labor Pain and Birth Satisfaction
A study testing Continuous Birth Support and Routine Care in people with Labor Pain and Birth Satisfaction, run by Antalya Bilim University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Labor Pain, Birth Satisfaction
- What is being tested?
- Continuous Birth Support and Routine Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Dec 2024to 4 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Continuous Birth Support Provided by Student Midwives on Labor Outcomes, Birth Perception, and Birth Satisfaction: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Labor Pain, Birth Satisfaction
- Being tested
- Continuous Birth Support, Routine Care
- Keywords
- Birth Satisfaction, Continuous Birth Support, Midwifery Education, Student Midwives
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Birth SupportBehavioural
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 CareOther
Standard intrapartum care practices routinely provided in the study setting.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Continuous Birth Support |
| Routine Intrapartum Care | Other | Participants received routine intrapartum care without continuous one-to-one birth support. Receives: Other: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 24 hours postpartum (Day 1)
Secondary outcomes (1)
Obstetric Interventions
Frequency of obstetric interventions during labor, including episiotomy, amniotomy, and labor augmentation.
Measured: During active labor (cervical dilation 4-10 cm, assessed continuously until delivery and at 1 hour postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start3 Dec 2024
- Primary completion4 Mar 2025
- Study completion4 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Labor PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Bilim University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seda Serhatlioglu, Doctorate, Principal investigator, Antalya Bilim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07563374
- Sponsor's protocol ID
- 2025-SS
- Other IDs
- 1919B012325051
- Acronym
- MİDWİFERY
- Status last verified
- Apr 2026
- First submitted
- 31 Dec 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared.
Publications
Bohren MA, Hofmeyr GJ, Sakala C, Fukuzawa RK, Cuthbert A. Continuous support for women during childbirth. Cochrane Database Syst Rev. 2017 Jul 6;7(7):CD003766. doi: 10.1002/14651858.CD003766.pub6.
PubMed 28681500Hodnett ED, Gates S, Hofmeyr GJ, Sakala C. Continuous support for women during childbirth. Cochrane Database Syst Rev. 2013 Jul 15;7:CD003766. doi: 10.1002/14651858.CD003766.pub5.
PubMed 23857334
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Continuous Birth Support Provided by Student Midwives on Labor Outcomes, Birth Perception, and Birth Satisfaction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07563374
- Acronym / sponsor ID
- MİDWİFERY / 2025-SS
- Conditions
- Labor Pain, Birth Satisfaction
- Keywords
- Birth Satisfaction, Continuous Birth Support, Midwifery Education, Student Midwives
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Antalya Bilim UniversityUniversity, hospital or other
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- 4 Mar 2025 (actual)
- Study completion
- 4 Mar 2025 (actual)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Birth Support by Student Midwives | Experimental | Behavioral: Continuous Birth SupportParticipants received continuous non-pharmacological birth support provided by trained senior student midwifery students under supervision throughout labor. |
| Routine Intrapartum Care | Other | Other: Routine CareParticipants received routine intrapartum care without continuous one-to-one birth support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pregnant women aged 18 years or older
- Singleton pregnancy
- Gestational age ≥ 37 completed weeks
- Low-risk pregnancy
- Planned vaginal birth
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Birth SupportContinuous 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. | Behavioural | Continuous Birth Support by Student Midwives |
| Routine CareStandard intrapartum care practices routinely provided in the study setting. | Other | Routine Intrapartum Care |
Primary outcome
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.
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.
1 secondary outcome
Obstetric Interventions
Time frame: During active labor (cervical dilation 4-10 cm, assessed continuously until delivery and at 1 hour postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Results publication: PubMed 28681500Bohren MA, Hofmeyr GJ, Sakala C, Fukuzawa RK, Cuthbert A. Continuous support for women during childbirth. Cochrane Database Syst Rev. 2017 Jul 6;7(7):CD003766. doi: 10.1002/14651858.CD003766.pub6.
- Results publication: PubMed 23857334Hodnett ED, Gates S, Hofmeyr GJ, Sakala C. Continuous support for women during childbirth. Cochrane Database Syst Rev. 2013 Jul 15;7:CD003766. doi: 10.1002/14651858.CD003766.pub5.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seda Serhatlioglu, Doctorate principal investigator
Antalya Bilim University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Birth Support and Routine Care in people with Labor Pain and Birth Satisfaction, run by Antalya Bilim University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in labor pain intensity from baseline to active labor. (time frame: Baseline and during active labor, up to 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07563374, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.