Birth OutcomesNCT06681675
The Effect of the Intrapartum Care Model Given in Line With WHO Recommendations on the Birth Process and Care
A study testing The group that applied the Intrapartum Care Model in people with Birth Outcomes and Labor Pain and to Reduce Pain, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the effects of the intrapartum care model provided in line with the World Health Organization (WHO) recommendations on labor pain, fear, comfort, duration, oxytocin use and perception of midwifery care. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Birth Outcomes, Labor Pain and to Reduce Pain, Fear of Birth
- What is being tested?
- The group that applied the Intrapartum Care Model
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 1 Jan 2024
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being 18 years of age or older,
- History of term pregnancy (38-42 weeks),
- Having a primiparous,
- Single, healthy, vertex positioned fetus,
- Having no complications that may cause dystocia in labor (such as contraction anomalies, birth object,
- Birth canal dystocia, dystocia related to the mother's psychology),
Show all 9Show fewer
- Having a partner/husband,
- History of cervical dilatation of 5 cm or more,
- Being able to speak and understand Turkish
Who cannot join
- Those with maternal and fetal complications (oligohydramnios and polyhydramnios, placenta previa, preeclampsia, premature membrane rupture, presentation anomalies, intrauterine growth retardation, fetal anomalies, intrauterine death, macrosomic baby, etc.),
- Those with any complications that prevent vaginal delivery,
- Elective caesarean section, those who became pregnant with assisted reproductive techniques,
- Those who are multiparous,
- Those who have chronic diseases (such as hypertension, diabetes, heart disease).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Intrapartum Care Model Given in Line With WHO Recommendations on Labor Pain, Fear, Comfort, Duration, Oxytocin Use and Midwifery Care Perception: A Randomized Controlled Trial
This study aimed to evaluate the effects of the intrapartum care model provided in line with the World Health Organization (WHO) recommendations on labor pain, fear, comfort, duration, oxytocin use and perception of midwifery care.
Read the detailed description
The research is a randomized controlled trial. The research was conducted with 124 primiparous pregnant women (intervention group n=62, control group n=62) who were hospitalized in the delivery unit of Aksaray Training and Research Hospital between September 2023 and January 2024. The pregnant women in the intervention group were given the intrapartum care model in line with WHO recommendations after cervical dilation reached 5 cm. The control group received only the standard intrapartum care in the hospital. Data were collected using the personal information form, labor and postpartum follow-up form, Visual Analog Scale (VAS), Labor Comfort Scale (DKS), Intrapartum Fear of Labor Scale, and Women's Perception of Supportive Care Given During Childbirth Scale. VAS, DKS, and Fear of Childbirth scale were applied to women in both groups when cervical dilation was 5 cm and 9 cm. After birth, the Women's Perception of Supportive Care Given During Childbirth scale was applied.
- Conditions
- Birth Outcomes, Labor Pain and to Reduce Pain, Fear of Birth, Birth Comfort, Perception of Midwifery Care, Birth Period
- Being tested
- The group that applied the Intrapartum Care Model
- Keywords
- WHO intrapartum care recommendations, Labor pain and to reduce pain, fear of birth, birth comfort, perception of midwifery care, Birth period, Oxytocin Deficiency
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The group that applied the Intrapartum Care ModelProcedure or surgery
In pregnant women with cervical dilatation of 5 cm, the Personal Information Form was completed at the initial clinic admission.
•The Intrapartum Care Model was implemented for all primiparous pregnant women assigned to the intervention group during labor and after delivery by the researcher midwife, in accordance with the World Health Organization's positive birth recommendations.
Data were collected using the Personal Information Form, Labor and Postpartum Follow-up Form, Visual Analog Scale (VAS), Labor Comfort Scale (CSC), Intrapartum Fear of Labor Scale, and Women's Perception of Supportive Care Given During Labor Scale. VAS, CSC, and Fear of Labor Scale were applied to women when cervical dilation was 5 cm and 9 cm. After delivery, the Women's Perception of Supportive Care Given During Labor Scale was applied.
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | No intervention | No intervention was made to the primiparous pregnant women in the control group other than routine intrapartum care applied in the hospital. After being admitted to the hospital for delivery, the pregnant women in the control group were informed about the study. Written consent was obtained. A personal information form was applied at the first clinic admission. When the cervical dilatation was 5 cm, VAS, Fear of Childbirth and Childbirth Comfort scales were applied. When the cervical dilatation was 9 cm, the labor monitoring form, VAS, Fear of Childbirth and Childbirth Comfort scales were applied. The routine practices and care of the maternity ward affiliated to the hospital were performed (anamnesis was taken, file was filled, intravenous access was established, routine blood tests were taken, vital signs were taken, enema was performed, vaginal examination every two hours and cervical changes were recorded on the partograph, continuous EFM (Electronic Fetal Monitoring) was applied |
| The group that applied the Intrapartum Care Model | Experimental | In pregnant women with cervical dilatation of 5 cm, the Personal Information Form was completed at the initial clinic admission. •The Intrapartum Care Model was implemented for all primiparous pregnant women assigned to the intervention group during labor and after delivery by the researcher midwife, in accordance with the World Health Organization's positive birth recommendations. Data were collected using the Personal Information Form, Labor and Postpartum Follow-up Form, Visual Analog Scale (VAS), Labor Comfort Scale (CSC), Intrapartum Fear of Labor Scale, and Women's Perception of Supportive Care Given During Labor Scale. VAS, CSC, and Fear of Labor Scale were applied to women when cervical dilation was 5 cm and 9 cm. After delivery, the Women's Perception of Supportive Care Given During Labor Scale was applied. Receives: Procedure: The group that applied the Intrapartum Care Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of pre-intervention sociodemographic of pregnant women
Sociodemographic of pregnant women will be collected through surveys and compared and reported
Measured: 6 months
Comparison of pre-intervention obstetric features of pregnant women
Obstetric of pregnant women will be collected through surveys and compared and reported.
Measured: 6 months
Comparison of labor characteristics of pregnant women before intervention
Labor Characteristics of pregnant women will be collected through questionnaires and compared and reported.
Measured: 6 months
Comparison of postpartum characteristics of pregnant women
Postpartum characteristics of pregnant women will be collected through surveys and compared and reported.
Measured: 6 months
Comparison of duration of labor of groups
The duration of labor of the groups will be collected through surveys and compared and reported.
Measured: 6 months
Comparison of pregnant women's VAS (pain perception) mean scores by groups
VAS (pain perception) scale will be applied to pregnant women. The pain scale (VAS) is 1-10 points (min-max), and as the score increases, women's pain perception also increases.
Measured: 6 months
Comparison of pregnant women's fear of childbirth average scores by groups
A fear of childbirth scale will be applied to pregnant women. The fear of childbirth scale is 10-100 points (min-max), and as the score increases, women's fear of childbirth increases.
Measured: 6 months
Comparison of pregnant women's birth comfort score averages by groups
A birth comfort scale will be applied to pregnant women. The birth comfort scale is 9-45 points (min-max), and as the score increases, women's birth comfort increases.
Measured: 6 months
Comparison of mean scores of the scale of women's perception of supportive care given during childbirth by groups
A scale of women's perception of supportive care given during childbirth will be applied to pregnant women. The scale of women's perception of supportive care given during childbirth is 33-132 points (min-max), and as the score increases, women's perception of care increases.
Measured: 6 months
Comparison of oxytocin use by groups
Oxytocin use by groups will be collected via survey and reported by comparison.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start1 Sep 2023
- Primary completion1 Dec 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Birth OutcomesStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- 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
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyhan Çankaya, Selcuk University
- Investigators
- Seyhan Çankaya, Assoc.Prof, Principal investigator, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681675
- Sponsor's protocol ID
- 2023/671
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mangir Meler K, Cankaya S. The effect of intrapartum care model given in line with World Health Organization (WHO) recommendations on labor pain, fear of labor, comfort of labor, duration of labor, administration of oxytocin and perception of midwifery care: a randomized controlled study. Postgrad Med. 2025 Jun;137(5):379-395. doi: 10.1080/00325481.2025.2501943. Epub 2025 May 11.
PubMed 40314363
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Intrapartum Care Model Given in Line With WHO Recommendations on Labor Pain, Fear, Comfort, Duration, Oxytocin Use and Midwifery Care Perception: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06681675
- Acronym / sponsor ID
- 2023/671
- Conditions
- Birth Outcomes, Labor Pain and to Reduce Pain, Fear of Birth, Birth Comfort, Perception of Midwifery Care, Birth Period
- Keywords
- WHO intrapartum care recommendations, Labor pain and to reduce pain, fear of birth, birth comfort, perception of midwifery care, Birth period, Oxytocin Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 8 Nov 2024 (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 study aimed to evaluate the effects of the intrapartum care model provided in line with the World Health Organization (WHO) recommendations on labor pain, fear, comfort, duration, oxytocin use and perception of midwifery care.
Detailed description
The research is a randomized controlled trial. The research was conducted with 124 primiparous pregnant women (intervention group n=62, control group n=62) who were hospitalized in the delivery unit of Aksaray Training and Research Hospital between September 2023 and January 2024. The pregnant women in the intervention group were given the intrapartum care model in line with WHO recommendations after cervical dilation reached 5 cm. The control group received only the standard intrapartum care in the hospital. Data were collected using the personal information form, labor and postpartum follow-up form, Visual Analog Scale (VAS), Labor Comfort Scale (DKS), Intrapartum Fear of Labor Scale, and Women's Perception of Supportive Care Given During Childbirth Scale. VAS, DKS, and Fear of Childbirth scale were applied to women in both groups when cervical dilation was 5 cm and 9 cm. After birth, the Women's Perception of Supportive Care Given During Childbirth scale was applied.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | No intervention | –No intervention was made to the primiparous pregnant women in the control group other than routine intrapartum care applied in the hospital. After being admitted to the hospital for delivery, the pregnant women in the control group were informed about the study. Written consent was obtained. A personal information form was applied at the first clinic admission. When the cervical dilatation was 5 cm, VAS, Fear of Childbirth and Childbirth Comfort scales were applied. When the cervical dilatation was 9 cm, the labor monitoring form, VAS, Fear of Childbirth and Childbirth Comfort scales were applied. The routine practices and care of the maternity ward affiliated to the hospital were performed (anamnesis was taken, file was filled, intravenous access was established, routine blood tests were taken, vital signs were taken, enema was performed, vaginal examination every two hours and cervical changes were recorded on the partograph, continuous EFM (Electronic Fetal Monitoring) was applied |
| The group that applied the Intrapartum Care Model | Experimental | Procedure: The group that applied the Intrapartum Care ModelIn pregnant women with cervical dilatation of 5 cm, the Personal Information Form was completed at the initial clinic admission. •The Intrapartum Care Model was implemented for all primiparous pregnant women assigned to the intervention group during labor and after delivery by the researcher midwife, in accordance with the World Health Organization's positive birth recommendations. Data were collected using the Personal Information Form, Labor and Postpartum Follow-up Form, Visual Analog Scale (VAS), Labor Comfort Scale (CSC), Intrapartum Fear of Labor Scale, and Women's Perception of Supportive Care Given During Labor Scale. VAS, CSC, and Fear of Labor Scale were applied to women when cervical dilation was 5 cm and 9 cm. After delivery, the Women's Perception of Supportive Care Given During Labor Scale was applied. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Being 18 years of age or older,
- History of term pregnancy (38-42 weeks),
- Having a primiparous,
- Single, healthy, vertex positioned fetus,
- Having no complications that may cause dystocia in labor (such as contraction anomalies, birth object,
Key exclusion criteria (5 listed)
- Those with maternal and fetal complications (oligohydramnios and polyhydramnios, placenta previa, preeclampsia, premature membrane rupture, presentation anomalies, intrauterine growth retardation, fetal anomalies, intrauterine death, macrosomic baby, etc.),
- Those with any complications that prevent vaginal delivery,
- Elective caesarean section, those who became pregnant with assisted reproductive techniques,
- Those who are multiparous,
- Those who have chronic diseases (such as hypertension, diabetes, heart disease).
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 |
|---|---|---|
| The group that applied the Intrapartum Care ModelIn pregnant women with cervical dilatation of 5 cm, the Personal Information Form was completed at the initial clinic admission. •The Intrapartum Care Model was implemented for all primiparous pregnant women assigned to the intervention group during labor and after delivery by the researcher midwife, in accordance with the World Health Organization's positive birth recommendations. Data were collected using the Personal Information Form, Labor and Postpartum Follow-up Form, Visual Analog Scale (VAS), Labor Comfort Scale (CSC), Intrapartum Fear of Labor Scale, and Women's Perception of Supportive Care Given During Labor Scale. VAS, CSC, and Fear of Labor Scale were applied to women when cervical dilation was 5 cm and 9 cm. After delivery, the Women's Perception of Supportive Care Given During Labor Scale was applied. | Procedure or surgery | The group that applied the Intrapartum Care Model |
Primary outcome
Comparison of pre-intervention sociodemographic of pregnant women
Time frame: 6 months
Sociodemographic of pregnant women will be collected through surveys and compared and reported
Comparison of pre-intervention obstetric features of pregnant women
Time frame: 6 months
Obstetric of pregnant women will be collected through surveys and compared and reported.
Comparison of labor characteristics of pregnant women before intervention
Time frame: 6 months
Labor Characteristics of pregnant women will be collected through questionnaires and compared and reported.
Comparison of postpartum characteristics of pregnant women
Time frame: 6 months
Postpartum characteristics of pregnant women will be collected through surveys and compared and reported.
Comparison of duration of labor of groups
Time frame: 6 months
The duration of labor of the groups will be collected through surveys and compared and reported.
Comparison of pregnant women's VAS (pain perception) mean scores by groups
Time frame: 6 months
VAS (pain perception) scale will be applied to pregnant women. The pain scale (VAS) is 1-10 points (min-max), and as the score increases, women's pain perception also increases.
Comparison of pregnant women's fear of childbirth average scores by groups
Time frame: 6 months
A fear of childbirth scale will be applied to pregnant women. The fear of childbirth scale is 10-100 points (min-max), and as the score increases, women's fear of childbirth increases.
Comparison of pregnant women's birth comfort score averages by groups
Time frame: 6 months
A birth comfort scale will be applied to pregnant women. The birth comfort scale is 9-45 points (min-max), and as the score increases, women's birth comfort increases.
Comparison of mean scores of the scale of women's perception of supportive care given during childbirth by groups
Time frame: 6 months
A scale of women's perception of supportive care given during childbirth will be applied to pregnant women. The scale of women's perception of supportive care given during childbirth is 33-132 points (min-max), and as the score increases, women's perception of care increases.
Comparison of oxytocin use by groups
Time frame: 6 months
Oxytocin use by groups will be collected via survey and reported by comparison.
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 8 Nov 2024.
- Derived from this study: PubMed 40314363Mangir Meler K, Cankaya S. The effect of intrapartum care model given in line with World Health Organization (WHO) recommendations on labor pain, fear of labor, comfort of labor, duration of labor, administration of oxytocin and perception of midwifery care: a randomized controlled study. Postgrad Med. 2025 Jun;137(5):379-395. doi: 10.1080/00325481.2025.2501943. Epub 2025 May 11.
- Individual participant dataSharing planned: No
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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.
Seyhan Çankaya, Assoc.Prof principal investigator
Selcuk 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 The group that applied the Intrapartum Care Model in people with Birth Outcomes and Labor Pain and to Reduce Pain, run by Selcuk 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 9 inclusion and 5 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 8 Nov 2024. 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?
Comparison of pre-intervention sociodemographic of pregnant women (time frame: 6 months). The study lists 10 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 NCT06681675, which also lists 1 linked publication.
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 8 Nov 2024.