Pregnancy RelatedNCT04628598
Effects of The Pregnant Follow-Up Conducted With Home Visits on The Perinatal Outcomes
A study testing Antenatal care and prenatal education with a home visit in people with Pregnancy Related and Prenatal Care, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The World Health Organization (WHO) developed a safe motherhood program in 1987 to reduce maternal and infant mortality. Safe motherhood is maximizing maternal and child health. This is only possible with the highest level of prenatal, delivery and postnatal care. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Prenatal Care
- What is being tested?
- Antenatal care and prenatal education with a home visit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Nov 2020to 23 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The pregnant woman is primiparas.
- Detection of the pregnant woman in family medicine software
- The pregnant woman does not have a high risk pregnancy.
- Finding a single fetus in the pregnant woman.
- Not having received infertility treatment.
- The pregnant woman did not have a psychiatric diagnosis.
- The pregnant woman's acceptance to participate in the research.
Who cannot join
- Being in the high risk category of the pregnant woman
- The mother tongue is not Turkish
- Having attended a planned, periodic pregnancy school course
- Being multiparous
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul Üniversitesi Cerrahpaşa
Istanbul, Avcılar, 34320
About this study
The World Health Organization (WHO) developed a safe motherhood program in 1987 to reduce maternal and infant mortality. Safe motherhood is maximizing maternal and child health. This is only possible with the highest level of prenatal, delivery and postnatal care. Care has a priority and special place in primary health care services. It increases access to preventive services such as monitoring prenatal and postnatal follow-ups in primary care, pregnant, postpartum and newborn health, immunization, training and counseling, early detection of risk, and decreases unwanted consequences. Home visits are a non-pharmacological and priority method in prenatal care. With this method, when healthcare providers (nurses, midwives) provide healthcare services to women in their own homes, it ensures the support and development of prenatal, maternal, infant and child health together with social, psychological, economic, familial and other factors. Prenatal care in Turkey is such that there will be at least four follow-ups. Current antenatal care guides suggest more contact with pregnant women.
This study will examine the effects of pregnancy follow-up with home visits on perinatal outcomes.
Read the detailed description
Implementing a home visit program during pregnancy is a comprehensive and important strategic step to prevent adverse birth outcomes during pregnancy. Studies in the literature suggest that care provided at home or by one-on-one healthcare personnel can encourage healthy prenatal behaviors with psychosocial support, social service and nutritional support. Home visit programs instead of standard antenatal care (ANC) have the potential to make a difference. For home visits to be effective, home visitors should not only inform women about the risks and values of certain behaviors, but also help them develop individualized strategies for behavior change.
The importance of home visits in prenatal pregnancy follow-up in the nineteen century has been demonstrated by many studies. Today, home visits are supported by studies in the literature, as it is a healthy start to life and a more promising model for reaching pregnant women. A Cochrane study published moderate evidence that women prefer flexible home visits rather than a rigid appointment system.
Turkey Demographic and Health Survey (DHS) prior to birth by the 2018 four and older care-taking rate in care increased by a certain momentum until 2013, there has been a significant change in the ratio between said from 2013 to 2018. Although the total fertility rate in Turkey is 2.3, it varies according to the regions. The age at marriage for adolescents is 15%, and the rate of becoming an adolescent mother is 4%. Delivery methods of women result in 54% of cesarean delivery. 29% of women are overweight and 30% are obese. Turkey Statistical Institute (TSI), according to the women's smoking rate was 13.1%. There are a limited number of studies reflecting the smoking status of pregnant women in the country. In a study conducted on this subject, the rate of smoking during pregnancy was reported as 37% of women who smoke before pregnancy. Considering the data on women's health and reproductive health, new models are needed for the provision of preventive health services that will realize the goals of "maternal mortality" and "healthy and quality life", which are among the sustainable development indicators of the country. Antenatal care is an important key for lowering the maternal mortality rate and for a healthy and quality life in pregnancy. Prenatal care in Turkey is such that there will be at least four follow-ups. Current antenatal care guidelines recommend more contact with pregnant women. Models are needed to monitor and increase the results of antenatal care. For Turkey, there is a need to present the 'Antenatal Care Guide' published by the Ministry of Health with a model designed in accordance with the data and culture of the country for primary care follow-up. There is currently no strong evidence that home visits improve the use of routine antenatal services, but most studies do not yet shed detailed light on this issue.
There are 50 different home visit models serving in different areas around the world. Main goals; to play a common role in maternal, child health and healthy shaping of parents' lives. Most of these models work on the basis of evidence. There are 16 models with maternal results. While some of the models have a very good effect on maternal outcome, there is research showing that some are lower. Each model also differs in terms of follow-up time and service providers. Some home visit patterns start with pregnancy and continue until the newborn is two years old, while some home visits may be shorter. Some models are run by nurses, some are assistant professionals in nurse supervision (a job title given to people who are trained but not professionally licensed to assist professionals in various professions such as education, health, engineering, and law) and non-professionals (mentor mothers who give birth and breastfeed) done by. In other models, social workers, psychologists, child mental health assistant specialists and / or assistant assistants in this field are managers.
In Turkey, ANC is among the routine services in order to increase the level of maternal health and reduce maternal mortality, and it is applied throughout the country. According to the "Antenatal Care Management Guideline", pregnant women are followed up at least four times if there is no risk. The guide recommends that each pregnant should be followed up for at least four times. It is recommended to perform once between 24 weeks, third follow-up between 28-32 weeks and fourth follow-up between 36-38 weeks.
Today's understanding of health in Turkey and developing countries still focuses on the treatment of diseases and patient care. However, nurses working in primary health care, preventive health care, healthy individuals and healthy families have taken important steps to develop individual family functionality. The duration, frequency and intensity of home visits raise many evidence-based results. It is among the results that it decreases the risks especially related to lifestyle and preterm birth. Home visits during the prenatal period are seen as a part of continuous and comprehensive health care that enables pregnant women and their families to be evaluated as a whole within their own living space. In Turkey, home visits to pregnant women were first started to be carried out by health centers with the socialization law of health in 1960, and especially the pregnant women were identified by home visits. The family medicine system was switched to the whole country in 2010 and a new system was introduced with the health transformation law. Home visits are defined in the Family Medicine Regulation, but there are deficiencies in practice.
In this context, the antenatal care process carried out in primary care is supported by pregnant home visits as a new model, increasing the satisfaction of women from the service procurement, getting qualified prenatal care and consequently reducing the risks, being educated about pregnancy and birth, postpartum periods, and normal birth. It will help the mother to be prepared, reduce depression and increase her self-efficacy in breastfeeding.
- Conditions
- Pregnancy Related, Prenatal Care
- Being tested
- Antenatal care and prenatal education with a home visit
- Keywords
- Pregnancy, Home Visit, Antenatal Care, Perinatal Period, Antenatal, İnnatal, Postnatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antenatal care and prenatal education with a home visitBehavioural
Providing prenatal education and care by home visits to pregnant women
| Study group | Role | What they receive |
|---|---|---|
| Home visiting pregnant women | Experimental | The pregnant women in the experimental group will be given education and care with home visits. Receives: Behavioral: Antenatal care and prenatal education with a home visit |
| Control Group | No intervention | Home visits will not be made to the control group, only the primary care antenatal care will be followed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prenatal Education Knowledge Rate
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.
Measured: "assessed pre-test (baseline) and post-test (13 weeks), week 13 reported"
Spontaneous Vaginal Birth Rate
After the home visits of pregnant women, a questionnaire will be applied in the postpartum period and delivery methods will be asked.
Measured: Thirty (30) weeks
Breastfeeding Self-efficacy
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.
Measured: Thirty (30) weeks
Postpartum Depression
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.
Measured: Thirty (30) weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start2 Nov 2020
- Primary completion15 Jun 2021
- Study completion23 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Model description
- The experiment and control group will be put into study at the same time.
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayça Demir Yıldırım, PhD, Istanbul University - Cerrahpasa
- Investigators
- Ayça Demir Yıldırım, Phd Student, Principal investigator, Student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04628598
- Sponsor's protocol ID
- IstanbulUCAycaDemirYıldırım
- Status last verified
- Mar 2026
- First submitted
- 6 Nov 2020
- Last updated
- 8 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not discussed and resolved among investigators
Publications
Liu N, Li P, Wang J, Chen D, Sun W, Zhang W. Effects of home visits for pregnant and postpartum women on premature birth, low birth weight and rapid repeat birth: a meta-analysis and systematic review of randomized controlled trials. Fam Pract. 2019 Oct 8;36(5):533-543. doi: 10.1093/fampra/cmz009.
PubMed 30925194McLaughlin FJ, Altemeier WA, Christensen MJ, Sherrod KB, Dietrich MS, Stern DT. Randomized trial of comprehensive prenatal care for low-income women: effect on infant birth weight. Pediatrics. 1992 Jan;89(1):128-32.
PubMed 1727996Lee E, Mitchell-Herzfeld SD, Lowenfels AA, Greene R, Dorabawila V, DuMont KA. Reducing low birth weight through home visitation: a randomized controlled trial. Am J Prev Med. 2009 Feb;36(2):154-60. doi: 10.1016/j.amepre.2008.09.029.
PubMed 19135906Ichikawa K, Fujiwara T, Nakayama T. Effectiveness of Home Visits in Pregnancy as a Public Health Measure to Improve Birth Outcomes. PLoS One. 2015 Sep 8;10(9):e0137307. doi: 10.1371/journal.pone.0137307. eCollection 2015.
PubMed 26348847Downe S, Finlayson K, Tuncalp O, Gulmezoglu AM. Provision and uptake of routine antenatal services: a qualitative evidence synthesis. Cochrane Database Syst Rev. 2019 Jun 12;6(6):CD012392. doi: 10.1002/14651858.CD012392.pub2.
PubMed 31194903Stamuli E, Richardson G, Duffy S, Robling M, Hood K. Systematic review of the economic evidence on home visitation programmes for vulnerable pregnant women. Br Med Bull. 2015 Sep;115(1):19-44. doi: 10.1093/bmb/ldv032. Epub 2015 Jul 28.
PubMed 26224694Cluxton-Keller F, Donnelly CL, Williams M, Buteau J, Stolte P, Monroe-Cassel M, Bruce ML. An implementation-effectiveness hybrid trial of video-based family therapy for peripartum depression in home visited mothers: a protocol for a pilot trial. Pilot Feasibility Stud. 2017 Nov 13;3:55. doi: 10.1186/s40814-017-0203-2. eCollection 2017.
PubMed 29158913WHO Recommendations on Antenatal Care for a Positive Pregnancy Experience. Geneva: World Health Organization; 2016. Available from http://www.ncbi.nlm.nih.gov/books/NBK409108/
PubMed 28079998Goyal NK, Hall ES, Meinzen-Derr JK, Kahn RS, Short JA, Van Ginkel JB, Ammerman RT. Dosage effect of prenatal home visiting on pregnancy outcomes in at-risk, first-time mothers. Pediatrics. 2013 Nov;132 Suppl 2(Suppl 2):S118-25. doi: 10.1542/peds.2013-1021J.
PubMed 24187113Alus Tokat M, Okumus H, Dennis CL. Translation and psychometric assessment of the Breast-feeding Self-Efficacy Scale-Short Form among pregnant and postnatal women in Turkey. Midwifery. 2010 Feb;26(1):101-8. doi: 10.1016/j.midw.2008.04.002. Epub 2008 Jun 9.
PubMed 18541350Korukcu O, Kukulu K, Firat MZ. The reliability and validity of the Turkish version of the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) with pregnant women. J Psychiatr Ment Health Nurs. 2012 Apr;19(3):193-202. doi: 10.1111/j.1365-2850.2011.01694.x. Epub 2012 Jan 20.
PubMed 22260727Demir Yildirim A, Hotun Sahin N. Does Antenatal Care Integrate with Home Visits Effect Perinatal Outcomes? A Randomized Control Trial. Matern Child Health J. 2026 Jan;30(1):105-116. doi: 10.1007/s10995-025-04202-7. Epub 2025 Dec 17.
PubMed 41407980
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of The Pregnant Follow-Up Conducted With Home Visits on The Perinatal Outcomes
- ClinicalTrials.gov ID
- NCT04628598
- Acronym / sponsor ID
- IstanbulUCAycaDemirYıldırım
- Conditions
- Pregnancy Related, Prenatal Care
- Keywords
- Pregnancy, Home Visit, Antenatal Care, Perinatal Period, Antenatal, İnnatal, Postnatal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 23 Feb 2022 (actual)
- First posted
- 13 Nov 2020 (actual)
- Results
- Posted 8 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The World Health Organization (WHO) developed a safe motherhood program in 1987 to reduce maternal and infant mortality. Safe motherhood is maximizing maternal and child health. This is only possible with the highest level of prenatal, delivery and postnatal care. Care has a priority and special place in primary health care services. It increases access to preventive services such as monitoring prenatal and postnatal follow-ups in primary care, pregnant, postpartum and newborn health, immunization, training and counseling, early detection of risk, and decreases unwanted consequences. Home visits are a non-pharmacological and priority method in prenatal care. With this method, when healthcare providers (nurses, midwives) provide healthcare services to women in their own homes, it ensures the support and development of prenatal, maternal, infant and child health together with social, psychological, economic, familial and other factors. Prenatal care in Turkey is such that there will be at least four follow-ups. Current antenatal care guides suggest more contact with pregnant women.
This study will examine the effects of pregnancy follow-up with home visits on perinatal outcomes.
Detailed description
Implementing a home visit program during pregnancy is a comprehensive and important strategic step to prevent adverse birth outcomes during pregnancy. Studies in the literature suggest that care provided at home or by one-on-one healthcare personnel can encourage healthy prenatal behaviors with psychosocial support, social service and nutritional support. Home visit programs instead of standard antenatal care (ANC) have the potential to make a difference. For home visits to be effective, home visitors should not only inform women about the risks and values of certain behaviors, but also help them develop individualized strategies for behavior change.
The importance of home visits in prenatal pregnancy follow-up in the nineteen century has been demonstrated by many studies. Today, home visits are supported by studies in the literature, as it is a healthy start to life and a more promising model for reaching pregnant women. A Cochrane study published moderate evidence that women prefer flexible home visits rather than a rigid appointment system.
Turkey Demographic and Health Survey (DHS) prior to birth by the 2018 four and older care-taking rate in care increased by a certain momentum until 2013, there has been a significant change in the ratio between said from 2013 to 2018. Although the total fertility rate in Turkey is 2.3, it varies according to the regions. The age at marriage for adolescents is 15%, and the rate of becoming an adolescent mother is 4%. Delivery methods of women result in 54% of cesarean delivery. 29% of women are overweight and 30% are obese. Turkey Statistical Institute (TSI), according to the women's smoking rate was 13.1%. There are a limited number of studies reflecting the smoking status of pregnant women in the country. In a study conducted on this subject, the rate of smoking during pregnancy was reported as 37% of women who smoke before pregnancy. Considering the data on women's health and reproductive health, new models are needed for the provision of preventive health services that will realize the goals of "maternal mortality" and "healthy and quality life", which are among the sustainable development indicators of the country. Antenatal care is an important key for lowering the maternal mortality rate and for a healthy and quality life in pregnancy. Prenatal care in Turkey is such that there will be at least four follow-ups. Current antenatal care guidelines recommend more contact with pregnant women. Models are needed to monitor and increase the results of antenatal care. For Turkey, there is a need to present the 'Antenatal Care Guide' published by the Ministry of Health with a model designed in accordance with the data and culture of the country for primary care follow-up. There is currently no strong evidence that home visits improve the use of routine antenatal services, but most studies do not yet shed detailed light on this issue.
There are 50 different home visit models serving in different areas around the world. Main goals; to play a common role in maternal, child health and healthy shaping of parents' lives. Most of these models work on the basis of evidence. There are 16 models with maternal results. While some of the models have a very good effect on maternal outcome, there is research showing that some are lower. Each model also differs in terms of follow-up time and service providers. Some home visit patterns start with pregnancy and continue until the newborn is two years old, while some home visits may be shorter. Some models are run by nurses, some are assistant professionals in nurse supervision (a job title given to people who are trained but not professionally licensed to assist professionals in various professions such as education, health, engineering, and law) and non-professionals (mentor mothers who give birth and breastfeed) done by. In other models, social workers, psychologists, child mental health assistant specialists and / or assistant assistants in this field are managers.
In Turkey, ANC is among the routine services in order to increase the level of maternal health and reduce maternal mortality, and it is applied throughout the country. According to the "Antenatal Care Management Guideline", pregnant women are followed up at least four times if there is no risk. The guide recommends that each pregnant should be followed up for at least four times. It is recommended to perform once between 24 weeks, third follow-up between 28-32 weeks and fourth follow-up between 36-38 weeks.
Today's understanding of health in Turkey and developing countries still focuses on the treatment of diseases and patient care. However, nurses working in primary health care, preventive health care, healthy individuals and healthy families have taken important steps to develop individual family functionality. The duration, frequency and intensity of home visits raise many evidence-based results. It is among the results that it decreases the risks especially related to lifestyle and preterm birth. Home visits during the prenatal period are seen as a part of continuous and comprehensive health care that enables pregnant women and their families to be evaluated as a whole within their own living space. In Turkey, home visits to pregnant women were first started to be carried out by health centers with the socialization law of health in 1960, and especially the pregnant women were identified by home visits. The family medicine system was switched to the whole country in 2010 and a new system was introduced with the health transformation law. Home visits are defined in the Family Medicine Regulation, but there are deficiencies in practice.
In this context, the antenatal care process carried out in primary care is supported by pregnant home visits as a new model, increasing the satisfaction of women from the service procurement, getting qualified prenatal care and consequently reducing the risks, being educated about pregnancy and birth, postpartum periods, and normal birth. It will help the mother to be prepared, reduce depression and increase her self-efficacy in breastfeeding.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The experiment and control group will be put into study at the same time.
| Arm | Type | Receives |
|---|---|---|
| Home visiting pregnant women | Experimental | Behavioral: Antenatal care and prenatal education with a home visitThe pregnant women in the experimental group will be given education and care with home visits. |
| Control Group | No intervention | –Home visits will not be made to the control group, only the primary care antenatal care will be followed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The pregnant woman is primiparas.
- Detection of the pregnant woman in family medicine software
- The pregnant woman does not have a high risk pregnancy.
- Finding a single fetus in the pregnant woman.
- Not having received infertility treatment.
Key exclusion criteria (4 listed)
- Being in the high risk category of the pregnant woman
- The mother tongue is not Turkish
- Having attended a planned, periodic pregnancy school course
- Being multiparous
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 |
|---|---|---|
| Antenatal care and prenatal education with a home visitProviding prenatal education and care by home visits to pregnant women | Behavioural | Home visiting pregnant women |
Primary outcome
Prenatal Education Knowledge Rate
Time frame: "assessed pre-test (baseline) and post-test (13 weeks), week 13 reported"
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.
Spontaneous Vaginal Birth Rate
Time frame: Thirty (30) weeks
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
Time frame: Thirty (30) weeks
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.
Postpartum Depression
Time frame: Thirty (30) weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30925194Liu N, Li P, Wang J, Chen D, Sun W, Zhang W. Effects of home visits for pregnant and postpartum women on premature birth, low birth weight and rapid repeat birth: a meta-analysis and systematic review of randomized controlled trials. Fam Pract. 2019 Oct 8;36(5):533-543. doi: 10.1093/fampra/cmz009.
- Background: PubMed 1727996McLaughlin FJ, Altemeier WA, Christensen MJ, Sherrod KB, Dietrich MS, Stern DT. Randomized trial of comprehensive prenatal care for low-income women: effect on infant birth weight. Pediatrics. 1992 Jan;89(1):128-32.
- Background: PubMed 19135906Lee E, Mitchell-Herzfeld SD, Lowenfels AA, Greene R, Dorabawila V, DuMont KA. Reducing low birth weight through home visitation: a randomized controlled trial. Am J Prev Med. 2009 Feb;36(2):154-60. doi: 10.1016/j.amepre.2008.09.029.
- Background: PubMed 26348847Ichikawa K, Fujiwara T, Nakayama T. Effectiveness of Home Visits in Pregnancy as a Public Health Measure to Improve Birth Outcomes. PLoS One. 2015 Sep 8;10(9):e0137307. doi: 10.1371/journal.pone.0137307. eCollection 2015.
- Background: PubMed 31194903Downe S, Finlayson K, Tuncalp O, Gulmezoglu AM. Provision and uptake of routine antenatal services: a qualitative evidence synthesis. Cochrane Database Syst Rev. 2019 Jun 12;6(6):CD012392. doi: 10.1002/14651858.CD012392.pub2.
- Background: PubMed 26224694Stamuli E, Richardson G, Duffy S, Robling M, Hood K. Systematic review of the economic evidence on home visitation programmes for vulnerable pregnant women. Br Med Bull. 2015 Sep;115(1):19-44. doi: 10.1093/bmb/ldv032. Epub 2015 Jul 28.
- Background: PubMed 29158913Cluxton-Keller F, Donnelly CL, Williams M, Buteau J, Stolte P, Monroe-Cassel M, Bruce ML. An implementation-effectiveness hybrid trial of video-based family therapy for peripartum depression in home visited mothers: a protocol for a pilot trial. Pilot Feasibility Stud. 2017 Nov 13;3:55. doi: 10.1186/s40814-017-0203-2. eCollection 2017.
- Background: PubMed 28079998WHO Recommendations on Antenatal Care for a Positive Pregnancy Experience. Geneva: World Health Organization; 2016. Available from http://www.ncbi.nlm.nih.gov/books/NBK409108/
- Background: PubMed 24187113Goyal NK, Hall ES, Meinzen-Derr JK, Kahn RS, Short JA, Van Ginkel JB, Ammerman RT. Dosage effect of prenatal home visiting on pregnancy outcomes in at-risk, first-time mothers. Pediatrics. 2013 Nov;132 Suppl 2(Suppl 2):S118-25. doi: 10.1542/peds.2013-1021J.
- Background: PubMed 18541350Alus Tokat M, Okumus H, Dennis CL. Translation and psychometric assessment of the Breast-feeding Self-Efficacy Scale-Short Form among pregnant and postnatal women in Turkey. Midwifery. 2010 Feb;26(1):101-8. doi: 10.1016/j.midw.2008.04.002. Epub 2008 Jun 9.
- Background: PubMed 22260727Korukcu O, Kukulu K, Firat MZ. The reliability and validity of the Turkish version of the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) with pregnant women. J Psychiatr Ment Health Nurs. 2012 Apr;19(3):193-202. doi: 10.1111/j.1365-2850.2011.01694.x. Epub 2012 Jan 20.
- Derived from this study: PubMed 41407980Demir Yildirim A, Hotun Sahin N. Does Antenatal Care Integrate with Home Visits Effect Perinatal Outcomes? A Randomized Control Trial. Matern Child Health J. 2026 Jan;30(1):105-116. doi: 10.1007/s10995-025-04202-7. Epub 2025 Dec 17.
- Law No. 224 on the Socialisation of Health ServicesLink provided by the sponsor.
- Building successful home visitor-mother relationships and reaching program goals in two Early Head Start programs: A qualitative look at contributing factorsLink provided by the sponsor.
- The Mother and Infant Home Visiting Program Evaluation-Strong Start: First Annual ReportLink provided by the sponsor.
- GLOBAL ADULT TOBACCO SURVEY, 2012.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Not discussed and resolved among investigators
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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. This study is not recruiting at the moment.
Ayça Demir Yıldırım, Phd Student principal investigator
Student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antenatal care and prenatal education with a home visit in people with Pregnancy Related and Prenatal Care, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 7 inclusion and 4 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: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 8 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prenatal Education Knowledge Rate (time frame: "assessed pre-test (baseline) and post-test (13 weeks), week 13 reported"). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04628598, which also lists 12 linked publications.
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 8 Apr 2026.