MaternityNCT06691854
Women's Perception of Respectful Maternity Care, Birth Experiences and Perception of Traumatic Birth
A study testing The group that applied the Intrapartum Care Model in people with Maternity and Birth, First, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
The effect of the ıntrapartum care model given in line with the world health organization (WHO) recommendations on women's perception of respectful maternity care, birth experiences and perception of traumatic birth Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternity, Birth, First, Traumatic Birth
- What is being tested?
- The group that applied the Intrapartum Care Model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 1 Jul 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Those who are 18 years of age or older,
- Those who are in term pregnancy (38-41 weeks),
- Those who are primiparous,
- Those who have a single, healthy, vertex positioned fetus,
- Those who have cervical dilatation of 5 cm or more,
- Those who can speak and understand Turkish,
- Those who voluntarily agree to participate in the research.
Who cannot join
- Those with chronic diseases (hypertension, diabetes, etc.),
- Those with a diagnosed mental illness (depression, anxiety or other psychotic disorder, etc.),
- 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, cord prolapse, etc.),
- Those with any complications that prevent vaginal birth (cephalopelvic disproportion, etc.),
- Elective cesarean section,
- Those who became pregnant with assisted reproductive techniques,
- Those who received childbirth preparation training.
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 the World Health Organization (WHO) Recommendations on Women's Perception of Respectful Maternity Care, Birth Experiences and Perception of Traumatic Birth.
The effect of the ıntrapartum care model given in line with the world health organization (WHO) recommendations on women's perception of respectful maternity care, birth experiences and perception of traumatic birth
Read the detailed description
The research is a randomized controlled trial. The research will 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 will given the intrapartum care model in line with WHO recommendations after cervical dilation reached 5 cm. The control group will received only the standard intrapartum care in the hospital. Data will be collected using the personal information form, birth follow-up form, respectful maternal care scale, birth experience scale, and traumatic birth perception scale.
- Conditions
- Maternity, Birth, First, Traumatic Birth, Intrapartum Fetal Distress
- Being tested
- The group that applied the Intrapartum Care Model
- Keywords
- Respectful maternity care scale, Birth experience scale, Traumatic birth perception scale, WHO Intrapartum Care Recommendations
- Medical subject headings
- Birth Injuries
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 ModelOther
Pregnant women who apply to the hospital for delivery, have cervical dilatation of 5 cm and above, agree to participate in the study and are assigned to the intervention group;
A Personal Information form will be applied at the first clinic admission. All primiparous pregnant women assigned to the intervention group will be applied the intrapartum care model by the research midwife during the labor process and after birth in line with the WHO positive birth recommendations.
The labor process of the pregnant woman will be recorded on the birth experience follow-up form.
After birth, the Respectful maternity care scale, Birth experience scale, Traumatic birth perception scale will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | No intervention | Pregnant women who apply to the hospital for delivery, have a cervical dilatation of 5 cm or more, agree to participate in the study and are assigned to the control group; * A personal information form will be applied at the first clinic admission. * Pregnant women assigned to the control group will receive routine intrapartum care provided at the hospital. * The labor process of the pregnant woman will be recorded on the birth experience monitoring form. * The mother and baby will receive routine postpartum care provided at the hospital. * After delivery, the Respectful maternity care scale, Birth experience scale, Traumatic birth perception scale will be applied. |
| The group that applied the Intrapartum Care Model | Experimental | Pregnant women who apply to the hospital for delivery, have cervical dilatation of 5 cm and above, agree to participate in the study and are assigned to the intervention group;
* A Personal Information form will be applied at the first clinic admission.
* All primiparous pregnant women assigned to the intervention group will be applied the intrapartum care model by the research midwife during the labor process and after birth in line with the WHO positive birth recommendations (Table 1).
* The labor process of the pregnant woman will be recorded on the birth experience follow-up form.
* After birth, the Respectful maternity care scale, Birth experience scale, Traumatic birth perception scale will be applied. Receives: Other: 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 sociodemographic characteristics of pregnant women before the intervention with the questionnaire
Sociodemographic of pregnant women will be collected through surveys and compared and reported
Measured: 6 months
Comparison of pre-intervention obstetric characteristics of pregnant women with a questionnaire
Obstetric of pregnant women will be collected through surveys and compared and reported
Measured: 6 months
Comparison of the delivery times of pregnant women through a survey
The duration of labor of the groups will be collected through surveys and compared and reported
Measured: 6 months
Comparison of the means of the respectful birth care scale among pregnant women by group
The respectful maternity care scale will be applied to pregnant women. The respectful maternity care scale is 19-95 points (min-max), and as the score increases, women's respectful maternity care increases.
Measured: 6 months
Comparison of the means of the birth experience scale among pregnant women by group
The birth experience scale will be applied to pregnant women. The birth experience scale is 22-88 points (min-max), and as the score increases, it indicates that the expectant mother has a good birth experience.
Measured: 6 months
Comparison of the means of the traumatic birth perception scale among pregnant women by group
The traumatic birth perception scale will be applied to pregnant women. The traumatic birth perception scale is 0-130 points (min-max). The scale shows that the 0-26 point range is "very low", the 27-52 point range is "low", the 53-78 point range is "medium", the 79-104 point range is "high", and the 105-130 point range is "very high" traumatic birth perception level.
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 posted15 Nov 2024
- Study start1 Dec 2024
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MaternityStudies 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, PhD, Principal investigator, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06691854
- Sponsor's protocol ID
- 2024/982
- Status last verified
- Sep 2025
- First submitted
- 13 Nov 2024
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. 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 the World Health Organization (WHO) Recommendations on Women's Perception of Respectful Maternity Care, Birth Experiences and Perception of Traumatic Birth.
- ClinicalTrials.gov ID
- NCT06691854
- Acronym / sponsor ID
- 2024/982
- Conditions
- Maternity, Birth, First, Traumatic Birth, Intrapartum Fetal Distress
- Keywords
- Respectful maternity care scale, Birth experience scale, Traumatic birth perception scale, WHO Intrapartum Care Recommendations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 15 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.
The effect of the ıntrapartum care model given in line with the world health organization (WHO) recommendations on women's perception of respectful maternity care, birth experiences and perception of traumatic birth
Detailed description
The research is a randomized controlled trial. The research will 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 will given the intrapartum care model in line with WHO recommendations after cervical dilation reached 5 cm. The control group will received only the standard intrapartum care in the hospital. Data will be collected using the personal information form, birth follow-up form, respectful maternal care scale, birth experience scale, and traumatic birth perception scale.
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 | –Pregnant women who apply to the hospital for delivery, have a cervical dilatation of 5 cm or more, agree to participate in the study and are assigned to the control group; * A personal information form will be applied at the first clinic admission. * Pregnant women assigned to the control group will receive routine intrapartum care provided at the hospital. * The labor process of the pregnant woman will be recorded on the birth experience monitoring form. * The mother and baby will receive routine postpartum care provided at the hospital. * After delivery, the Respectful maternity care scale, Birth experience scale, Traumatic birth perception scale will be applied. |
| The group that applied the Intrapartum Care Model | Experimental | Other: The group that applied the Intrapartum Care ModelPregnant women who apply to the hospital for delivery, have cervical dilatation of 5 cm and above, agree to participate in the study and are assigned to the intervention group; * A Personal Information form will be applied at the first clinic admission. * All primiparous pregnant women assigned to the intervention group will be applied the intrapartum care model by the research midwife during the labor process and after birth in line with the WHO positive birth recommendations (Table 1). * The labor process of the pregnant woman will be recorded on the birth experience follow-up form. * After birth, the Respectful maternity care scale, Birth experience scale, Traumatic birth perception scale will be applied. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Those who are 18 years of age or older,
- Those who are in term pregnancy (38-41 weeks),
- Those who are primiparous,
- Those who have a single, healthy, vertex positioned fetus,
- Those who have cervical dilatation of 5 cm or more,
Key exclusion criteria (7 listed)
- Those with chronic diseases (hypertension, diabetes, etc.),
- Those with a diagnosed mental illness (depression, anxiety or other psychotic disorder, etc.),
- 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, cord prolapse, etc.),
- Those with any complications that prevent vaginal birth (cephalopelvic disproportion, etc.),
- Elective cesarean section,
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 ModelPregnant women who apply to the hospital for delivery, have cervical dilatation of 5 cm and above, agree to participate in the study and are assigned to the intervention group; A Personal Information form will be applied at the first clinic admission. All primiparous pregnant women assigned to the intervention group will be applied the intrapartum care model by the research midwife during the labor process and after birth in line with the WHO positive birth recommendations. The labor process of the pregnant woman will be recorded on the birth experience follow-up form. After birth, the Respectful maternity care scale, Birth experience scale, Traumatic birth perception scale will be applied. | Other | The group that applied the Intrapartum Care Model |
Primary outcome
Comparison of sociodemographic characteristics of pregnant women before the intervention with the questionnaire
Time frame: 6 months
Sociodemographic of pregnant women will be collected through surveys and compared and reported
Comparison of pre-intervention obstetric characteristics of pregnant women with a questionnaire
Time frame: 6 months
Obstetric of pregnant women will be collected through surveys and compared and reported
Comparison of the delivery times of pregnant women through a survey
Time frame: 6 months
The duration of labor of the groups will be collected through surveys and compared and reported
Comparison of the means of the respectful birth care scale among pregnant women by group
Time frame: 6 months
The respectful maternity care scale will be applied to pregnant women. The respectful maternity care scale is 19-95 points (min-max), and as the score increases, women's respectful maternity care increases.
Comparison of the means of the birth experience scale among pregnant women by group
Time frame: 6 months
The birth experience scale will be applied to pregnant women. The birth experience scale is 22-88 points (min-max), and as the score increases, it indicates that the expectant mother has a good birth experience.
Comparison of the means of the traumatic birth perception scale among pregnant women by group
Time frame: 6 months
The traumatic birth perception scale will be applied to pregnant women. The traumatic birth perception scale is 0-130 points (min-max). The scale shows that the 0-26 point range is "very low", the 27-52 point range is "low", the 53-78 point range is "medium", the 79-104 point range is "high", and the 105-130 point range is "very high" traumatic birth perception level.
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 29 Sep 2025.
- 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, PhD 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 Maternity and Birth, First, 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 7 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 29 Sep 2025. 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 sociodemographic characteristics of pregnant women before the intervention with the questionnaire (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2025.