Birth, FirstNCT05955053
Childbirth Performed in Collaboration With Midwife-Pregnant
A study testing Midwifery care applied in line with Midwife-Pregnant cooperation in people with Birth, First and Care Pattern, Maternal, run by Munzur University at 1 site in Turkey (Türkiye).
Trial summary
With the medicalization of midwifery care; It has been reported that the autonomy of midwives is reduced, and their relationships with care and care recipients are under threat. For this reason, the midwife had to move away from the concept of being with the woman and face the ideology of being with the institution. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Birth, First, Care Pattern, Maternal, Care
- What is being tested?
- Midwifery care applied in line with Midwife-Pregnant cooperation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 1 May 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18-35,
- Childbirth started and hospitalized,
- Having a live, single, healthy fetus,
- In the active phase (dilatation= 4 cm and above),
- No maternal and fetal complications that may affect labor,
- At least primary school graduate and no language-communication problem,
- Pregnant women who accepted to participate in the study and whose consent was obtained will be included in the study.
Who cannot join
- Those with a chronic disease,
- Those with multiparous pregnancy,
- Adolescent pregnant women under the age of 18,
- Advanced age pregnant women over 35 years old,
- Being unable to speak Turkish and having communication difficulties,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Munzur University
Tunceli
Habibe YAŞAR YETİŞMİŞ, Master, habibeyasar@munzur.edu.tr
About this study
Official title: The Effect of Childbirth Performed in Collaboration With Midwife-Pregnant Under the Partnership Model on Childbirth Experience and Childbirth Satisfaction: A Randomized Controlled Study
With the medicalization of midwifery care; It has been reported that the autonomy of midwives is reduced, and their relationships with care and care recipients are under threat. For this reason, the midwife had to move away from the concept of being with the woman and face the ideology of being with the institution. In this context, it is thought that there is a need for care models that enable the midwife and woman to work in cooperation. It is thought that establishing a collaborative relationship based on the partnership model between the midwife and the pregnant will be possible with the continuity of care. There are studies in the literature showing that the continuity of midwifery care has positive results at birth. However, no study has been found regarding the partnership or cooperation of the midwife with the pregnant woman during delivery with standards. It is thought that this research to be conducted has a unique value in terms of meeting the need for scientific information on the effect of midwife-pregnant cooperation on birth experience and birth satisfaction. In the study, continuous midwifery care will be given to pregnant women during delivery based on midwife-pregnant cooperation in line with the midwifery care model checklist. It is thought that this midwifery care given during birth will positively affect the birth experience and birth satisfaction.
Read the detailed description
It has been reported that the medical care model has become widespread, the autonomy of midwives has decreased within the scope of medical care, the care is more medical, the relations of the midwife with the care recipients are under threat and holistic care is avoided. Due to the inability to provide one-to-one holistic care to pregnant women, pregnant women perceive their births as traumatic and experience negative births. In this context, the aim of the research is to evaluate the effect of midwife-pregnant cooperation on birth experience and birth satisfaction within the scope of partnership model. A total of 154 (Intervention; 77, Control; 77) people are planned to be included in the research by performing power analysis. Within the scope of the partnership model, one-to-one care will be given to the pregnant woman in the intervention group during delivery, according to the partnership model, and no intervention will be applied to the control group. Voluntary consent will be obtained from the volunteers to be included in the study and will be randomly included in the groups. Pregnant Information Form, Midwife-Pregnant Collaboration Scale at Birth, Birth Experience Scale, Birth Satisfaction Scale and Midwifery Birth Care Model Checklist will be used to collect research data. Number, percentage distribution, mean and standard deviation, correlation/regression test and t-test for independent groups will be used in the analysis of the research. It is thought that with the care given at the end of the research, the birth experience of the pregnant women will be positive and they will be satisfied with the birth. In the research, it is thought that the positive birth experience and satisfaction of the pregnant women will indirectly give a positive perspective to the normal birth.
- Conditions
- Birth, First, Care Pattern, Maternal, Care, Pregnancy Related
- Being tested
- Midwifery care applied in line with Midwife-Pregnant cooperation
- Keywords
- Childbirth satisfaction, Midwife-pregnant partnership, Midwife-pregnant cooperation, Childbirth experience, Partnership model, Midwifery, Childbirth, Delivery, Care, Randomized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midwifery care applied in line with Midwife-Pregnant cooperationOther
Pregnant women who apply to the obstetrics clinic will be informed about the research by the doctor and the pregnant woman whose labor has started will be sent to the delivery room. The researcher will be welcomed by the midwife from the first time the pregnant woman arrives in labor (delivery room), and firstly she will be informed about the purpose of the research and an informative consent form and a pregnant identification form will be filled in that she agrees to participate in the research. During labor and labor, the research midwife (HYY) will be with a pregnant woman until she gives birth and care will be given according to the items in the midwifery care checklist prepared based on the partnership model. After giving birth to a pregnant woman and applying the scales, another pregnant woman will be transferred and care will be given in the same way according to the midwifery care model checklist.
| Study group | Role | What they receive |
|---|---|---|
| Midwifery care applied in line with Midwife-Pregnant cooperation | Experimental | The group that received care in line with the midwifery care model checklist Receives: Other: Midwifery care applied in line with Midwife-Pregnant cooperation |
| Control group | No intervention | The group with routine hospital protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Childbirth Experience
In order to determine the birth experiences of women, the birth experience scale score averages of the pregnant women in the experimental and control groups will be compared. The scale consists of 22 items. The lowest score to be taken from the scale is 22, and the highest score is 88. A high birth experience scale score indicates that the mother had a good birth experience. In this context, at the end of the study, the birth experience scale score averages of both groups will be examined in order to evaluate the birth experience.
Measured: 12 hours after childbirth
Childbirth Satisfaction
In order to determine the birth satisfaction of the women, the mean birth satisfaction scale scores of the pregnant women in the experimental and control groups will be compared. The scale consists of 30 items. The lowest score to be taken from the scale is 30 and the highest score is 150. A high birth satisfaction scale score indicates a high mother's birth satisfaction. In this context, at the end of the study, the mean birth satisfaction scale scores of both groups will be examined in order to evaluate birth satisfaction.
Measured: 12 hours after childbirth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start1 May 2023
- Primary completion30 Jan 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Birth, FirstStudies 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
- Model description
- Paralel designed randomized two armed study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Munzur University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Habibe YAŞAR YETİŞMİŞ, Munzur University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955053
- Sponsor's protocol ID
- habibe47
- Status last verified
- Feb 2024
- First submitted
- 14 Jun 2023
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I can share in case a meta analysis is done
Publications
Boyle S, Thomas H, Brooks F. Women's views on partnership working with midwives during pregnancy and childbirth. Midwifery. 2016 Jan;32:21-9. doi: 10.1016/j.midw.2015.09.001. Epub 2015 Sep 9.
PubMed 26597110Fleming VE. Women-with-midwives-with-women: a model of interdependence. Midwifery. 1998 Sep;14(3):137-43. doi: 10.1016/s0266-6138(98)90028-6.
PubMed 9856020Fleming VE. Women and midwives in partnership: a problematic relationship? J Adv Nurs. 1998 Jan;27(1):8-14. doi: 10.1046/j.1365-2648.1998.00474.x.
PubMed 9515602
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Childbirth Performed in Collaboration With Midwife-Pregnant Under the Partnership Model on Childbirth Experience and Childbirth Satisfaction: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05955053
- Acronym / sponsor ID
- habibe47
- Conditions
- Birth, First, Care Pattern, Maternal, Care, Pregnancy Related
- Keywords
- Childbirth satisfaction, Midwife-pregnant partnership, Midwife-pregnant cooperation, Childbirth experience, Partnership model, Midwifery, Childbirth, Delivery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Munzur UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Jan 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 21 Jul 2023 (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.
With the medicalization of midwifery care; It has been reported that the autonomy of midwives is reduced, and their relationships with care and care recipients are under threat. For this reason, the midwife had to move away from the concept of being with the woman and face the ideology of being with the institution. In this context, it is thought that there is a need for care models that enable the midwife and woman to work in cooperation. It is thought that establishing a collaborative relationship based on the partnership model between the midwife and the pregnant will be possible with the continuity of care. There are studies in the literature showing that the continuity of midwifery care has positive results at birth. However, no study has been found regarding the partnership or cooperation of the midwife with the pregnant woman during delivery with standards. It is thought that this research to be conducted has a unique value in terms of meeting the need for scientific information on the effect of midwife-pregnant cooperation on birth experience and birth satisfaction. In the study, continuous midwifery care will be given to pregnant women during delivery based on midwife-pregnant cooperation in line with the midwifery care model checklist. It is thought that this midwifery care given during birth will positively affect the birth experience and birth satisfaction.
Detailed description
It has been reported that the medical care model has become widespread, the autonomy of midwives has decreased within the scope of medical care, the care is more medical, the relations of the midwife with the care recipients are under threat and holistic care is avoided. Due to the inability to provide one-to-one holistic care to pregnant women, pregnant women perceive their births as traumatic and experience negative births. In this context, the aim of the research is to evaluate the effect of midwife-pregnant cooperation on birth experience and birth satisfaction within the scope of partnership model. A total of 154 (Intervention; 77, Control; 77) people are planned to be included in the research by performing power analysis. Within the scope of the partnership model, one-to-one care will be given to the pregnant woman in the intervention group during delivery, according to the partnership model, and no intervention will be applied to the control group. Voluntary consent will be obtained from the volunteers to be included in the study and will be randomly included in the groups. Pregnant Information Form, Midwife-Pregnant Collaboration Scale at Birth, Birth Experience Scale, Birth Satisfaction Scale and Midwifery Birth Care Model Checklist will be used to collect research data. Number, percentage distribution, mean and standard deviation, correlation/regression test and t-test for independent groups will be used in the analysis of the research. It is thought that with the care given at the end of the research, the birth experience of the pregnant women will be positive and they will be satisfied with the birth. In the research, it is thought that the positive birth experience and satisfaction of the pregnant women will indirectly give a positive perspective to the normal birth.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Paralel designed randomized two armed study
| Arm | Type | Receives |
|---|---|---|
| Midwifery care applied in line with Midwife-Pregnant cooperation | Experimental | Other: Midwifery care applied in line with Midwife-Pregnant cooperationThe group that received care in line with the midwifery care model checklist |
| Control group | No intervention | –The group with routine hospital protocol |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Between the ages of 18-35,
- Childbirth started and hospitalized,
- Having a live, single, healthy fetus,
- In the active phase (dilatation= 4 cm and above),
- No maternal and fetal complications that may affect labor,
Key exclusion criteria (5 listed)
- Those with a chronic disease,
- Those with multiparous pregnancy,
- Adolescent pregnant women under the age of 18,
- Advanced age pregnant women over 35 years old,
- Being unable to speak Turkish and having communication difficulties,
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 |
|---|---|---|
| Midwifery care applied in line with Midwife-Pregnant cooperationPregnant women who apply to the obstetrics clinic will be informed about the research by the doctor and the pregnant woman whose labor has started will be sent to the delivery room. The researcher will be welcomed by the midwife from the first time the pregnant woman arrives in labor (delivery room), and firstly she will be informed about the purpose of the research and an informative consent form and a pregnant identification form will be filled in that she agrees to participate in the research. During labor and labor, the research midwife (HYY) will be with a pregnant woman until she gives birth and care will be given according to the items in the midwifery care checklist prepared based on the partnership model. After giving birth to a pregnant woman and applying the scales, another pregnant woman will be transferred and care will be given in the same way according to the midwifery care model checklist. | Other | Midwifery care applied in line with Midwife-Pregnant cooperation |
Primary outcome
Childbirth Experience
Time frame: 12 hours after childbirth
In order to determine the birth experiences of women, the birth experience scale score averages of the pregnant women in the experimental and control groups will be compared. The scale consists of 22 items. The lowest score to be taken from the scale is 22, and the highest score is 88. A high birth experience scale score indicates that the mother had a good birth experience. In this context, at the end of the study, the birth experience scale score averages of both groups will be examined in order to evaluate the birth experience.
Childbirth Satisfaction
Time frame: 12 hours after childbirth
In order to determine the birth satisfaction of the women, the mean birth satisfaction scale scores of the pregnant women in the experimental and control groups will be compared. The scale consists of 30 items. The lowest score to be taken from the scale is 30 and the highest score is 150. A high birth satisfaction scale score indicates a high mother's birth satisfaction. In this context, at the end of the study, the mean birth satisfaction scale scores of both groups will be examined in order to evaluate birth satisfaction.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Background: PubMed 26597110Boyle S, Thomas H, Brooks F. Women's views on partnership working with midwives during pregnancy and childbirth. Midwifery. 2016 Jan;32:21-9. doi: 10.1016/j.midw.2015.09.001. Epub 2015 Sep 9.
- Background: PubMed 9856020Fleming VE. Women-with-midwives-with-women: a model of interdependence. Midwifery. 1998 Sep;14(3):137-43. doi: 10.1016/s0266-6138(98)90028-6.
- Background: PubMed 9515602Fleming VE. Women and midwives in partnership: a problematic relationship? J Adv Nurs. 1998 Jan;27(1):8-14. doi: 10.1046/j.1365-2648.1998.00474.x.
- Individual participant dataSharing planned: No. I can share in case a meta analysis is done
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midwifery care applied in line with Midwife-Pregnant cooperation in people with Birth, First and Care Pattern, Maternal, run by Munzur 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 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: status not confirmed, as of the sponsor's last update on 5 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Habibe YAŞAR YETİŞMİŞ, Master (+90 213 17 94, habibeyasar@munzur.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Childbirth Experience (time frame: 12 hours after childbirth). 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 NCT05955053, which also lists 3 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 5 Feb 2024.