Trial Outcomes & Findings for Effects of The Pregnant Follow-Up Conducted With Home Visits on The Perinatal Outcomes (NCT NCT04628598)

On November 2, 2020, primiparous pregnant women registered in the family health center in Kadıköy, Istanbul, were randomly assigned to the intervention and control groups using a simple random method. The first group formed the intervention group. The pregnant women in the list corresponding to the randomly assigned numbers were assigned to the intervention and control groups.

The study population consisted of 433 pregnant women in the appropriate first trimester. The 433 pregnant women in the universe were listed and numbered in an Excel spreadsheet. From the random.org site, 64 pregnant women were listed in number order as 2 unique groups. 64 pregnant women were included in the study as 32 intervention and 32 control.

Race and Ethnicity were not collected from any participant.

Perinatal Information Form is a form consisting of a total of 35 questions in which data on the participants' knowledge about pregnancy, birth and postnatal process were collected. Kuder Richardson reliability method was used to translate the data of the Perinatal Information Form into scoring. A reliability coefficient of 0.80 and above is recommended (Bademci, 2011). This form was used twice in the study as pre-test and post-test. The reliability coefficient of the Perinatal Information Form was 0.83 for the pretest and 0.87 for the posttest. The 35 questions on the form assess the level of knowledge about pregnancy, childbirth and the postnatal period and are scored as correct or incorrect (0.1) (the average ratio reflects the number of items answered correctly or incorrectly by participants). The highest possible score on the questionnaire is 35 and the lowest is 0.

After the home visits of pregnant women, a questionnaire will be applied in the postpartum period and delivery methods will be asked.

Breastfeeding Self-Efficacy Scale will be applied to look at the effect of breastfeeding training in the postpartum period during home visits during pregnancy. Breastfeeding Self-Efficacy Scale; Breastfeeding Self-Efficacy Scale is a 33-item scale developed by Dennis in 1999. It was first applied to 130 English-speaking Canadian women, the Cronbach alpha value was found to be 0.96, and the item-total correlation of 73% of the items was 0.30-0.70. He then developed the Brief Breastfeeding Self-Efficacy Scale by reducing the scale to a 14-item scale in 2003. Cronbach alpha value was found to be 0.94. Breastfeeding Self-Efficacy Short Form Scale is a 5-point Likert Type scale 1 = "Not sure at all" and 5 = "I'm always sure". As suggested by Bandura (1998), all items are in positive direction. The minimum score that can be obtained from the scale is 14 maximum 70. High score is an indicator of high breastfeeding self-efficacy.

Edinburgh Postpartum Depression Scale will be applied to examine the effect of home visits and prenatal education on postpartum depression. Edinburgh Postpartum Depression Scale (EPDS); EPDS is a 4-point Likert style self-report scale consisting of 10 items. PRES was adapted to Turkish by Engindeniz. In Engindeniz's validity and reliability study, this scale had an internal consistency coefficient of 0.79, a split-half reliability, a cut-off of 0.80 of 12/13, a sensitivity of 0.84, a specificity of 0.88, a positive predictive value of 0.69, and a negative predictive value of 0.94. The Edinburgh Postnatal Depression Scale is a 10-item self-report scale assessing the common symptoms of depression. Each item is scored on a 4 point scale (O-3), the minimum and maximum total score ranging from O-30, respec- tively. The highest score is 30 points. If it is less than 9 points, there is no risk for depression, if it is 13 and above, there is a high risk for depression.