Clinical trial NCT05797363: The Effect of Continuous Midwife Support on Various Parameters Related to Pregnancy, Childbirth and Postpartum Period
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"
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pregnant Women
Childbirth
Women's Health
Lead sponsor: Amasya University
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 150
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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).

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

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 "

Eligibility criteria: Inclusion Criteria:

* She's newly married.
* Women without children.

Exclusion Criteria:

* women's desire to stop working

Primary outcomes:
measure: Perception of Pregnancy Risk Scale (PPRS)
timeFrame: average of 1 year
measure: Pregnancy-related Anxiety Scale (PrAS)
timeFrame: average of 1 year
measure: CHILDBIRTH FEAR - PRIOR TO PREGNANCY SCALE (CFPPS)
timeFrame: average of 1 year
measure: Antenatal Perceived Stress Scale (APSS)
timeFrame: average of 1 year
measure: Prenatal breastfeeding self efficacy scale (PBSeS)
timeFrame: average of 1 year
measure: Family Planning Attitude Scale (FPAS)
timeFrame: average of 1 year
measure: Prenatal Care Satisfaction Scale (PCSS)
timeFrame: average of 1 year
measure: Oxford Birth Anxiety Scale (OBAS)
timeFrame: average of 2 year
measure: Pregnancy Experience Scale (PES)
timeFrame: average of 2 year
measure: Self-perception of Pregnants Scale (SPS)
timeFrame: average of 2 year
measure: HEALTH PRACTICES QUESTIONNAIRE IN PREGNANCY
timeFrame: average of 2 year
measure: Childbirth Comfort Questionnaire (CCQ)
timeFrame: average of 3 year
measure: MOTHERS' POSTNATAL SENSE OF SECURITY SCALE (MPSSS)
timeFrame: average of 3 year
measure: Postpartum Quality of Life Questionnaire (PQLQ)
timeFrame: average of 3 year
measure: SCALE OF WOMAN'S PERCEPTION OF SUPPORTIVE CARE GIVEN TO WOMAN IN LABOR
timeFrame: average of 3 year
measure: Childbirth Self-Efficacy Scale (CSES)
timeFrame: average of 3 year
measure: Postpartum Sleep Quality Scale (PSQS)
timeFrame: average of 3 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: duygu.murat@hotmail.com
name: duygu murat, öztürk
role: STUDY_DIRECTOR
References: