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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).


Clinical Trial 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 " ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05797363
Study type Interventional
Source Amasya University
Contact Duygu Murat Öztürk, PhD
Phone +905555151053
Email duygu.murat@hotmail.com
Status Not yet recruiting
Phase N/A
Start date April 15, 2023
Completion date December 30, 2027

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