Pregnant WomenNCT05797363
The Effect of Continuous Midwife Support on Various Parameters Related to Pregnancy, Childbirth and Postpartum Period
A study testing Continuous midwife support in people with Pregnant Women and Childbirth, run by Amasya University.
Trial summary
There is a need for studies with a high level of evidence regarding the effect of supportive care given during the preconceptional period, pregnancy, childbirth and postpartum processes. Read more about this study
- Who is it for?
- Ages 19 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women, Childbirth, Women's Health
- What is being tested?
- Continuous midwife support
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2023to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- She's newly married.
- Women without children.
Who cannot join
- women's desire to stop working
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Continuous Midwife Support During Pregnancy, Childbirth and Postpartum Processes Starting From Preconceptional Period on Various Parameters Related to Pregnancy, Delivery and Postpartum Period: A Randomized Controlled Study"
There is a need for studies with a high level of evidence regarding the effect of supportive care given during the preconceptional period, pregnancy, childbirth and postpartum processes. With this planned study, it is aimed to evaluate the effect of continuous midwife support during pregnancy, birth and postpartum periods, starting from the preconceptional period, on various parameters related to pregnancy, birth and postpartum period. The research is planned as a randomized controlled experimental study. It consists of two groups, the study group and the control group. 75 women out of 150 women will form the control group and 75 women will form the study group. The women in the working group will be given individual training in line with their needs. Data will be collected by using the checklist and many scales used by the control and study groups in preconceptional counseling recommended by ACOG (American College of Obstetricians and Gynecologists).
Read the detailed description
INTRODUCTION Globally, midwives are the primary caregivers of women during pregnancy, childbirth, and postpartum. It is recommended to use a midwife-led care model to provide support and assistance to women during pregnancy, childbirth, and the postpartum period. In midwife-led care, midwifery provides quality health care services to women and newborns during pregnancy, delivery, and the postpartum period. Therefore, the evidence-based literature from developed and developing countries emphasizes that maternal and neonatal mortality can be reduced with midwife-led care. Studies suggest that the constant presence of midwives during pregnancy, childbirth, and postpartum period encourages women. Continuity of care increases women's trust in midwives.
In the literature, no study has been found in which the effect of midwifery care initiated in the preconceptional period on pregnancy, birth or postpartum processes has been investigated. For this reason, it is thought that the research will provide meaningful data to the literature.
METHOD
The research is planned as a randomized controlled experimental study. Randomization is planned to be done by the second researcher in a computer environment using the www.randomizer.org internet address. Women numbered 1-150 will be assigned to the study and control groups. The assignment of women to the groups, analysis, and reporting stages will be done by the second researcher, and data collection, training, and follow-up will be done by the first and third researchers. Thus, data collection, training, and follow-up for the second researcher, and the assignment of women to the group for the first and third researcher, analysis, and reporting will be blinded. It consists of two groups, the study group, and the control group. 150 women who applied to Family Health Centers to get a health report for marriage and agreed to participate in the study will be identified. 75 women out of 150 women will form the control group and 75 women will form the study group. The control list used in preconception counseling recommended by ACOG (American College of Obstetricians and Gynecologists) and the scales will be used by both the control and study groups. The pregnancy, delivery, and postpartum period processes of 150 women will be followed starting from the preconception period. 75 women will be given training in line with their individual needs. 75 women will not be given any training. The data will be analyzed using the SPSS package program. Appropriate statistical analysis tests will be used in the analysis of the data by looking at the normality distribution.
Intervention group
- Meeting- Preconception ACOG Preconception Counseling Checklist and personal information form
- Meeting- Preconception Education
- Meeting- Preconception Education and the Childbirth Fear - Prior to Pregnancy Scale and family planning scale
- Meeting (First Trimester in Pregnancy) Education in pregnancy
- Meeting (First Trimester in pregnancy) Education in pregnancy and Health Practices Questionnaire In Pregnancy
- Meeting (First Trimester in pregnancy) Education and the scale of Self-perception of Pregnants, Pregnancy Experience Scale (PES)
- Meeting (Second Trimester in pregnancy) Education and Perception of Pregnancy Risk Scale
- Meeting (Second Trimester in pregnancy) Education and Pregnancy-related Anxiety Scale
- Meeting (Third Trimester in pregnancy) Education and Pregnancy Experience Scale, Prenatal Care Satisfaction Scale
- Meeting (Third Trimester in pregnancy) "Education and Prenatal Breastfeeding Self-Efficacy Scale, Health Practices Questionnaire in Pregnancy-II"
- Meeting (Third Trimester in pregnancy) Education and Scale of Childbirth of Self Efficacy, Antenatal Perceived Stress Scale, The Oxford Worries About Labour Scale
- Meeting ( Labour) "Education- supportive and Scale Of Woman's Perception Of Supportive Care Given To Woman In Labor, Partograph, the Childbirth Comfort Questionnaire"
- Meeting (Postpartum - first day) Postpartum follow-up breastfeeding support
- Meeting (Postpartum - 1-7 days) Postpartum follow-up, education
- Meeting (Postpartum - 7-21 days) Postpartum follow-up, education
- Meeting (Postpartum - 30-42 days) "Education and Maternal Postpartum Quality of Life Questionnaire, the Mothers' Postnatal Sense of Security Scale and Postpartum Sleep Quality Scale
Control Group
- Meeting- Preconception ACOG Preconception Counseling Checklist and personal information form
- Meeting- Preconception
- Meeting- Preconception the Childbirth Fear - Prior to Pregnancy Scale and family planning scale
- Meeting (First Trimester in Pregnancy)
- Meeting (First Trimester in pregnancy) Health Practices Questionnaire In Pregnancy
- Meeting (First Trimester in pregnancy) the scale of Self-perception of Pregnants, Pregnancy Experience Scale (PES)
- Meeting (Second Trimester in pregnancy) Perception of Pregnancy Risk Scale
- Meeting (Second Trimester in pregnancy) Pregnancy-related Anxiety Scale
- Meeting (Third Trimester in pregnancy) Pregnancy Experience Scale, Prenatal Care Satisfaction Scale
- Meeting (Third Trimester in pregnancy) " Prenatal Breastfeeding Self-Efficacy Scale, Health Practices Questionnaire in Pregnancy-II"
- Meeting (Third Trimester in pregnancy) Scale of Childbirth of Self Efficacy, Antenatal Perceived Stress Scale, The Oxford Worries About Labour Scale
- Meeting ( Labour) "Scale Of Woman's Perception Of Supportive Care Given To Woman In Labor, Partograph, the Childbirth Comfort Questionnaire"
- Meeting (Postpartum - first day)
- Meeting (Postpartum - 1-7 days)
- Meeting (Postpartum - 7-21 days)
- Meeting (Postpartum - 30-42 days) "Maternal Postpartum Quality of Life Questionnaire, the Mothers' Postnatal Sense of Security Scale and Postpartum Sleep Quality Scale "
- Conditions
- Pregnant Women, Childbirth, Women's Health
- Being tested
- Continuous midwife support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous midwife supportOther
The individuals included in the experimental group will be provided with consultancy services on many issues from the pre-pregnancy period to the postpartum period.
| Study group | Role | What they receive |
|---|---|---|
| Experiment | Experimental | Continuous midwifery support will be applied to the intervention group. The women included in the experimental group will be counseled on many issues such as nutrition, vaccinations, family planning, pregnancy follow-ups, normal birth and cesarean section surgery, coping with labor pain, puerperium process, baby care, starting from the pre-pregnancy period, during pregnancy, childbirth and postpartum periods. Receives: Other: Continuous midwife support |
| Control Group | No intervention | No action will be taken against this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perception of Pregnancy Risk Scale (PPRS)
PPRS: An increase in the score obtained from the scale is interpreted as an increase in the risk perception of the pregnant woman and her baby.
Measured: average of 1 year
Pregnancy-related Anxiety Scale (PrAS)
PrAS: The cut-off score calculated for the scale is 75.5. A total score of 75.5 and above indicates an increased anxiety level due to pregnancy.
Measured: average of 1 year
CHILDBIRTH FEAR - PRIOR TO PREGNANCY SCALE (CFPPS)
CFPPS: While the minimum score on the scale is 10, the maximum score is 60. A high item total score indicates a high level of fear.
Measured: average of 1 year
Antenatal Perceived Stress Scale (APSS)
APSS: The perceived stress score during pregnancy is obtained by summing the item scores in the scale and then dividing by the number of items. While the lowest score that can be obtained from the scale is 1, the highest score is 5. The high total score obtained from the scale indicates the highest perceived stress level in pregnant women.
Measured: average of 1 year
Prenatal breastfeeding self efficacy scale (PBSeS)
PBSeS: Each item of the scale is graded as a 5-point Likert type. The lowest score that can be obtained from the total of the scale is 20, and the highest score is 100. The higher the score, the higher the perception of breastfeeding self-efficacy.
Measured: average of 1 year
Family Planning Attitude Scale (FPAS)
FPAS: The scale is a five-point Likert-type scale consisting of 34 items. The lowest 34 and the highest 170 points can be obtained from the scale, and an increase in the total score means a more positive family planning attitude.
Measured: average of 1 year
Prenatal Care Satisfaction Scale (PCSS)
PCSS: There is no cut-off point in the evaluation of the scale. The higher the score obtained from the scale, the higher the satisfaction, and the lower it is, the lower the satisfaction.
Measured: average of 1 year
Oxford Birth Anxiety Scale (OBAS)
OBAS: The scale is evaluated over the total score (min=10, max=40). As the score increases, it is interpreted that the anxiety level of women increases.
Measured: average of 2 year
Pregnancy Experience Scale (PES)
PES: A total of six sub-dimension scores (positive emotions frequency score, negative emotions frequency score, positive emotions intensity score, negative emotions intensity score, frequency ratio and intensity ratio) are obtained in GDS.
Measured: average of 2 year
Self-perception of Pregnants Scale (SPS)
SPS: When evaluating the scores of the Pregnancy Body Perception sub-dimension, high scores indicate negative pregnancy body perception, and low scores indicate positive pregnancy body perception. The highest score that can be obtained in the Pregnancy Body Perception sub-dimension is 20, and the lowest score is 5.
Measured: average of 2 year
HEALTH PRACTICES QUESTIONNAIRE IN PREGNANCY
The highest score that can be obtained from the scale is 165, and the lowest score is 33. High scores indicate good health practices.
Measured: average of 2 year
Childbirth Comfort Questionnaire (CCQ)
CCQ: The minimum score that can be obtained from the scale is 14, the highest score is 70. As the score increases, it is said to be high-level comfort, and as the score decreases, low-level comfort is mentioned.
Measured: average of 3 year
MOTHERS' POSTNATAL SENSE OF SECURITY SCALE (MPSSS)
MPSSS: Scores from the scale range from 18 to 72, and high scores indicate good feelings of security.
Measured: average of 3 year
Postpartum Quality of Life Questionnaire (PQLQ)
PQLQ: The higher the score obtained from the scale, the higher the person's postpartum quality of life, and lower scores the lower the postpartum quality of life.
Measured: average of 3 year
SCALE OF WOMAN'S PERCEPTION OF SUPPORTIVE CARE GIVEN TO WOMAN IN LABOR
At least 33 from the scale; maximum 132 points are taken. There is no cut-off point in the scale. The higher the score from the scale, the better the supportive nursing care received.
Measured: average of 3 year
Childbirth Self-Efficacy Scale (CSES)
CSES: The lowest total score that can be obtained from the scale is 32, and the highest total score is 320. High scores from the scale show that pregnant women have high self-efficacy levels in labor.
Measured: average of 3 year
Postpartum Sleep Quality Scale (PSQS)
PSQS: The lowest 0 and the highest 56 points can be obtained from the scale and there is no cut-off point. An increase in the score indicates a decrease in sleep quality.
Measured: average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start15 Apr 2023 (estimated)
- Primary completion15 Apr 2025 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomenStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- duygu murat, öztürk, Study director, duygu.murat@hotmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05797363
- Sponsor's protocol ID
- AmasyaU-1
- Status last verified
- Apr 2023
- First submitted
- 20 Sep 2021
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data obtained is planned to be published as a scientific article.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Continuous Midwife Support During Pregnancy, Childbirth and Postpartum Processes Starting From Preconceptional Period on Various Parameters Related to Pregnancy, Delivery and Postpartum Period: A Randomized Controlled Study"
- ClinicalTrials.gov ID
- NCT05797363
- Acronym / sponsor ID
- AmasyaU-1
- Conditions
- Pregnant Women, Childbirth, Women's Health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 15 Apr 2023 (estimated)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 4 Apr 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.
There is a need for studies with a high level of evidence regarding the effect of supportive care given during the preconceptional period, pregnancy, childbirth and postpartum processes. With this planned study, it is aimed to evaluate the effect of continuous midwife support during pregnancy, birth and postpartum periods, starting from the preconceptional period, on various parameters related to pregnancy, birth and postpartum period. The research is planned as a randomized controlled experimental study. It consists of two groups, the study group and the control group. 75 women out of 150 women will form the control group and 75 women will form the study group. The women in the working group will be given individual training in line with their needs. Data will be collected by using the checklist and many scales used by the control and study groups in preconceptional counseling recommended by ACOG (American College of Obstetricians and Gynecologists).
Detailed description
INTRODUCTION Globally, midwives are the primary caregivers of women during pregnancy, childbirth, and postpartum. It is recommended to use a midwife-led care model to provide support and assistance to women during pregnancy, childbirth, and the postpartum period. In midwife-led care, midwifery provides quality health care services to women and newborns during pregnancy, delivery, and the postpartum period. Therefore, the evidence-based literature from developed and developing countries emphasizes that maternal and neonatal mortality can be reduced with midwife-led care. Studies suggest that the constant presence of midwives during pregnancy, childbirth, and postpartum period encourages women. Continuity of care increases women's trust in midwives.
In the literature, no study has been found in which the effect of midwifery care initiated in the preconceptional period on pregnancy, birth or postpartum processes has been investigated. For this reason, it is thought that the research will provide meaningful data to the literature.
METHOD
The research is planned as a randomized controlled experimental study. Randomization is planned to be done by the second researcher in a computer environment using the www.randomizer.org internet address. Women numbered 1-150 will be assigned to the study and control groups. The assignment of women to the groups, analysis, and reporting stages will be done by the second researcher, and data collection, training, and follow-up will be done by the first and third researchers. Thus, data collection, training, and follow-up for the second researcher, and the assignment of women to the group for the first and third researcher, analysis, and reporting will be blinded. It consists of two groups, the study group, and the control group. 150 women who applied to Family Health Centers to get a health report for marriage and agreed to participate in the study will be identified. 75 women out of 150 women will form the control group and 75 women will form the study group. The control list used in preconception counseling recommended by ACOG (American College of Obstetricians and Gynecologists) and the scales will be used by both the control and study groups. The pregnancy, delivery, and postpartum period processes of 150 women will be followed starting from the preconception period. 75 women will be given training in line with their individual needs. 75 women will not be given any training. The data will be analyzed using the SPSS package program. Appropriate statistical analysis tests will be used in the analysis of the data by looking at the normality distribution.
Intervention group
- Meeting- Preconception ACOG Preconception Counseling Checklist and personal information form
- Meeting- Preconception Education
- Meeting- Preconception Education and the Childbirth Fear - Prior to Pregnancy Scale and family planning scale
- Meeting (First Trimester in Pregnancy) Education in pregnancy
- Meeting (First Trimester in pregnancy) Education in pregnancy and Health Practices Questionnaire In Pregnancy
- Meeting (First Trimester in pregnancy) Education and the scale of Self-perception of Pregnants, Pregnancy Experience Scale (PES)
- Meeting (Second Trimester in pregnancy) Education and Perception of Pregnancy Risk Scale
- Meeting (Second Trimester in pregnancy) Education and Pregnancy-related Anxiety Scale
- Meeting (Third Trimester in pregnancy) Education and Pregnancy Experience Scale, Prenatal Care Satisfaction Scale
- Meeting (Third Trimester in pregnancy) "Education and Prenatal Breastfeeding Self-Efficacy Scale, Health Practices Questionnaire in Pregnancy-II"
- Meeting (Third Trimester in pregnancy) Education and Scale of Childbirth of Self Efficacy, Antenatal Perceived Stress Scale, The Oxford Worries About Labour Scale
- Meeting ( Labour) "Education- supportive and Scale Of Woman's Perception Of Supportive Care Given To Woman In Labor, Partograph, the Childbirth Comfort Questionnaire"
- Meeting (Postpartum - first day) Postpartum follow-up breastfeeding support
- Meeting (Postpartum - 1-7 days) Postpartum follow-up, education
- Meeting (Postpartum - 7-21 days) Postpartum follow-up, education
- Meeting (Postpartum - 30-42 days) "Education and Maternal Postpartum Quality of Life Questionnaire, the Mothers' Postnatal Sense of Security Scale and Postpartum Sleep Quality Scale
Control Group
- Meeting- Preconception ACOG Preconception Counseling Checklist and personal information form
- Meeting- Preconception
- Meeting- Preconception the Childbirth Fear - Prior to Pregnancy Scale and family planning scale
- Meeting (First Trimester in Pregnancy)
- Meeting (First Trimester in pregnancy) Health Practices Questionnaire In Pregnancy
- Meeting (First Trimester in pregnancy) the scale of Self-perception of Pregnants, Pregnancy Experience Scale (PES)
- Meeting (Second Trimester in pregnancy) Perception of Pregnancy Risk Scale
- Meeting (Second Trimester in pregnancy) Pregnancy-related Anxiety Scale
- Meeting (Third Trimester in pregnancy) Pregnancy Experience Scale, Prenatal Care Satisfaction Scale
- Meeting (Third Trimester in pregnancy) " Prenatal Breastfeeding Self-Efficacy Scale, Health Practices Questionnaire in Pregnancy-II"
- Meeting (Third Trimester in pregnancy) Scale of Childbirth of Self Efficacy, Antenatal Perceived Stress Scale, The Oxford Worries About Labour Scale
- Meeting ( Labour) "Scale Of Woman's Perception Of Supportive Care Given To Woman In Labor, Partograph, the Childbirth Comfort Questionnaire"
- Meeting (Postpartum - first day)
- Meeting (Postpartum - 1-7 days)
- Meeting (Postpartum - 7-21 days)
- Meeting (Postpartum - 30-42 days) "Maternal Postpartum Quality of Life Questionnaire, the Mothers' Postnatal Sense of Security Scale and Postpartum Sleep Quality Scale "
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experiment | Experimental | Other: Continuous midwife supportContinuous midwifery support will be applied to the intervention group. The women included in the experimental group will be counseled on many issues such as nutrition, vaccinations, family planning, pregnancy follow-ups, normal birth and cesarean section surgery, coping with labor pain, puerperium process, baby care, starting from the pre-pregnancy period, during pregnancy, childbirth and postpartum periods. |
| Control Group | No intervention | –No action will be taken against this group. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- She's newly married.
- Women without children.
Key exclusion criteria (1 listed)
- women's desire to stop working
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 midwife supportThe individuals included in the experimental group will be provided with consultancy services on many issues from the pre-pregnancy period to the postpartum period. | Other | Experiment |
Primary outcome
Perception of Pregnancy Risk Scale (PPRS)
Time frame: average of 1 year
PPRS: An increase in the score obtained from the scale is interpreted as an increase in the risk perception of the pregnant woman and her baby.
Pregnancy-related Anxiety Scale (PrAS)
Time frame: average of 1 year
PrAS: The cut-off score calculated for the scale is 75.5. A total score of 75.5 and above indicates an increased anxiety level due to pregnancy.
CHILDBIRTH FEAR - PRIOR TO PREGNANCY SCALE (CFPPS)
Time frame: average of 1 year
CFPPS: While the minimum score on the scale is 10, the maximum score is 60. A high item total score indicates a high level of fear.
Antenatal Perceived Stress Scale (APSS)
Time frame: average of 1 year
APSS: The perceived stress score during pregnancy is obtained by summing the item scores in the scale and then dividing by the number of items. While the lowest score that can be obtained from the scale is 1, the highest score is 5. The high total score obtained from the scale indicates the highest perceived stress level in pregnant women.
Prenatal breastfeeding self efficacy scale (PBSeS)
Time frame: average of 1 year
PBSeS: Each item of the scale is graded as a 5-point Likert type. The lowest score that can be obtained from the total of the scale is 20, and the highest score is 100. The higher the score, the higher the perception of breastfeeding self-efficacy.
Family Planning Attitude Scale (FPAS)
Time frame: average of 1 year
FPAS: The scale is a five-point Likert-type scale consisting of 34 items. The lowest 34 and the highest 170 points can be obtained from the scale, and an increase in the total score means a more positive family planning attitude.
Prenatal Care Satisfaction Scale (PCSS)
Time frame: average of 1 year
PCSS: There is no cut-off point in the evaluation of the scale. The higher the score obtained from the scale, the higher the satisfaction, and the lower it is, the lower the satisfaction.
Oxford Birth Anxiety Scale (OBAS)
Time frame: average of 2 year
OBAS: The scale is evaluated over the total score (min=10, max=40). As the score increases, it is interpreted that the anxiety level of women increases.
Pregnancy Experience Scale (PES)
Time frame: average of 2 year
PES: A total of six sub-dimension scores (positive emotions frequency score, negative emotions frequency score, positive emotions intensity score, negative emotions intensity score, frequency ratio and intensity ratio) are obtained in GDS.
Self-perception of Pregnants Scale (SPS)
Time frame: average of 2 year
SPS: When evaluating the scores of the Pregnancy Body Perception sub-dimension, high scores indicate negative pregnancy body perception, and low scores indicate positive pregnancy body perception. The highest score that can be obtained in the Pregnancy Body Perception sub-dimension is 20, and the lowest score is 5.
HEALTH PRACTICES QUESTIONNAIRE IN PREGNANCY
Time frame: average of 2 year
The highest score that can be obtained from the scale is 165, and the lowest score is 33. High scores indicate good health practices.
Childbirth Comfort Questionnaire (CCQ)
Time frame: average of 3 year
CCQ: The minimum score that can be obtained from the scale is 14, the highest score is 70. As the score increases, it is said to be high-level comfort, and as the score decreases, low-level comfort is mentioned.
MOTHERS' POSTNATAL SENSE OF SECURITY SCALE (MPSSS)
Time frame: average of 3 year
MPSSS: Scores from the scale range from 18 to 72, and high scores indicate good feelings of security.
Postpartum Quality of Life Questionnaire (PQLQ)
Time frame: average of 3 year
PQLQ: The higher the score obtained from the scale, the higher the person's postpartum quality of life, and lower scores the lower the postpartum quality of life.
SCALE OF WOMAN'S PERCEPTION OF SUPPORTIVE CARE GIVEN TO WOMAN IN LABOR
Time frame: average of 3 year
At least 33 from the scale; maximum 132 points are taken. There is no cut-off point in the scale. The higher the score from the scale, the better the supportive nursing care received.
Childbirth Self-Efficacy Scale (CSES)
Time frame: average of 3 year
CSES: The lowest total score that can be obtained from the scale is 32, and the highest total score is 320. High scores from the scale show that pregnant women have high self-efficacy levels in labor.
Postpartum Sleep Quality Scale (PSQS)
Time frame: average of 3 year
PSQS: The lowest 0 and the highest 56 points can be obtained from the scale and there is no cut-off point. An increase in the score indicates a decrease in sleep quality.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Individual participant dataSharing planned: Yes. The data obtained is planned to be published as a scientific article.
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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.
duygu murat, öztürk study director
duygu.murat@hotmail.com
Questions about this trial
What is this clinical trial studying?
A study testing Continuous midwife support in people with Pregnant Women and Childbirth, run by Amasya University.
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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Duygu Murat Öztürk, PhD (+905555151053, duygu.murat@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perception of Pregnancy Risk Scale (PPRS) (time frame: average of 1 year). The study lists 17 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 4 Apr 2023.