The Effect of Continuous Midwife Support on Various Parameters Related to Pregnancy, Childbirth and Postpartum Period

Pregnant Women Clinical Trial

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"

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05797363
• Other study ID #: AmasyaU-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 15, 2023
• Est. completion date: December 30, 2027

Study information

• Verified date: April 2023
• Source: Amasya University
• Contact: Duygu Murat Öztürk, PhD
• Phone: +905555151053
• Email: duygu.murat[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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

1. Meeting- Preconception ACOG Preconception Counseling Checklist and personal information form

2. Meeting- Preconception Education

3. Meeting- Preconception Education and the Childbirth Fear - Prior to Pregnancy Scale and family planning scale

4. Meeting (First Trimester in Pregnancy) Education in pregnancy

5. Meeting (First Trimester in pregnancy) Education in pregnancy and Health Practices Questionnaire In Pregnancy

6. Meeting (First Trimester in pregnancy) Education and the scale of Self-perception of Pregnants, Pregnancy Experience Scale (PES)

7. Meeting (Second Trimester in pregnancy) Education and Perception of Pregnancy Risk Scale

8. Meeting (Second Trimester in pregnancy) Education and Pregnancy-related Anxiety Scale

9. Meeting (Third Trimester in pregnancy) Education and Pregnancy Experience Scale, Prenatal Care Satisfaction Scale

10. Meeting (Third Trimester in pregnancy) "Education and Prenatal Breastfeeding Self-Efficacy Scale, Health Practices Questionnaire in Pregnancy-II"

11. Meeting (Third Trimester in pregnancy) Education and Scale of Childbirth of Self Efficacy, Antenatal Perceived Stress Scale, The Oxford Worries About Labour Scale

12. Meeting ( Labour) "Education- supportive and Scale Of Woman's Perception Of Supportive Care Given To Woman In Labor, Partograph, the Childbirth Comfort Questionnaire"

13. Meeting (Postpartum - first day) Postpartum follow-up breastfeeding support

14. Meeting (Postpartum - 1-7 days) Postpartum follow-up, education

15. Meeting (Postpartum - 7-21 days) Postpartum follow-up, education

16. 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

1. Meeting- Preconception ACOG Preconception Counseling Checklist and personal information form

2. Meeting- Preconception

3. Meeting- Preconception the Childbirth Fear - Prior to Pregnancy Scale and family planning scale

4. Meeting (First Trimester in Pregnancy)

5. Meeting (First Trimester in pregnancy) Health Practices Questionnaire In Pregnancy

6. Meeting (First Trimester in pregnancy) the scale of Self-perception of Pregnants, Pregnancy Experience Scale (PES)

7. Meeting (Second Trimester in pregnancy) Perception of Pregnancy Risk Scale

8. Meeting (Second Trimester in pregnancy) Pregnancy-related Anxiety Scale

9. Meeting (Third Trimester in pregnancy) Pregnancy Experience Scale, Prenatal Care Satisfaction Scale

10. Meeting (Third Trimester in pregnancy) " Prenatal Breastfeeding Self-Efficacy Scale, Health Practices Questionnaire in Pregnancy-II"

11. Meeting (Third Trimester in pregnancy) Scale of Childbirth of Self Efficacy, Antenatal Perceived Stress Scale, The Oxford Worries About Labour Scale

12. Meeting ( Labour) "Scale Of Woman's Perception Of Supportive Care Given To Woman In Labor, Partograph, the Childbirth Comfort Questionnaire"

13. Meeting (Postpartum - first day)

14. Meeting (Postpartum - 1-7 days)

15. Meeting (Postpartum - 7-21 days)

16. Meeting (Postpartum - 30-42 days) "Maternal Postpartum Quality of Life Questionnaire, the Mothers' Postnatal Sense of Security Scale and Postpartum Sleep Quality Scale "

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 30, 2027
• Est. primary completion date: April 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 35 Years

Eligibility

Inclusion Criteria:

• She's newly married.

• Women without children.

Exclusion Criteria:

• women's desire to stop working

Related Conditions & MeSH terms

• Childbirth
• Pregnant Women
• Women's Health

Intervention

Other:
• Continuous midwife support
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amasya University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	average of 1 year
Primary	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.	average of 1 year
Primary	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.	average of 1 year
Primary	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.	average of 1 year
Primary	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.	average of 1 year
Primary	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.	average of 1 year
Primary	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.	average of 1 year
Primary	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.	average of 2 year
Primary	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.	average of 2 year
Primary	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.	average of 2 year
Primary	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.	average of 2 year
Primary	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.	average of 3 year
Primary	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.	average of 3 year
Primary	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.	average of 3 year
Primary	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.	average of 3 year
Primary	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.	average of 3 year
Primary	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.	average of 3 year