Effects of The Pregnant Follow-Up Conducted With Home Visits on The Perinatal Outcomes

NCT04628598 | Completed Results DMC

• 1 other identifier: IstanbulUCAycaDemirYıldırım
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pregnancy Related; Prenatal Care

Keywords

Pregnancy; Home Visit; Antenatal Care; Perinatal Period; Antenatal; İnnatal; Postnatal

Outcome Measures

Primary Outcomes (4)

• 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.

  "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.

  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.

  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.

  Thirty (30) weeks

Study Arms (2)

Home visiting pregnant women

EXPERIMENTAL

The pregnant women in the experimental group will be given education and care with home visits.

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.

Interventions

Antenatal care and prenatal education with a home visit BEHAVIORAL

Providing prenatal education and care by home visits to pregnant women

Home visiting pregnant women

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

İstanbul Üniversitesi Cerrahpaşa

Istanbul, Avcılar, 34320, Turkey (Türkiye)

Location

Related Publications (12)

• 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.

  PMID: 30925194 BACKGROUND

• McLaughlin 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.

  PMID: 1727996 BACKGROUND

• Lee 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.

  PMID: 19135906 BACKGROUND

• Ichikawa 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.

  PMID: 26348847 BACKGROUND

• Downe 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.

  PMID: 31194903 BACKGROUND

• Stamuli 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.

  PMID: 26224694 BACKGROUND

• Cluxton-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.

  PMID: 29158913 BACKGROUND

• WHO Recommendations on Antenatal Care for a Positive Pregnancy Experience. Geneva: World Health Organization; 2016. Available from http://www.ncbi.nlm.nih.gov/books/NBK409108/

  PMID: 28079998 BACKGROUND

• Goyal 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.

  PMID: 24187113 BACKGROUND

• Alus 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.

  PMID: 18541350 BACKGROUND

• Korukcu 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.

  PMID: 22260727 BACKGROUND

• Demir Yildirim A, Hotun Sahin N. Does Antenatal Care Integrate with Home Visits Effect Perinatal Outcomes? A Randomized Control Trial. Matern Child Health J. 2025 Dec 17. doi: 10.1007/s10995-025-04202-7. Online ahead of print.

  PMID: 41407980 DERIVED

Related Links

• Law No. 224 on the Socialisation of Health Services
• Building successful home visitor-mother relationships and reaching program goals in two Early Head Start programs: A qualitative look at contributing factors
• The Mother and Infant Home Visiting Program Evaluation-Strong Start: First Annual Report
• GLOBAL ADULT TOBACCO SURVEY, 2012.

MeSH Terms

Interventions

Prenatal Care; Prenatal Education

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Maternal Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Patient Education as Topic; Health Education; Preventive Health Services

Results Point of Contact

• Title: Dr. Ayça Demir Yıldırım
• Organization: İstanbul Üniversitesi Cerrahpaşa

aycademiryildirim@gmail.com

+905066603355

Study Officials

• Ayça Demir Yıldırım, Phd Student

  Student

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The experiment and control group will be put into study at the same time.

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 13, 2020
• Study Start: November 2, 2020
• Primary Completion: June 15, 2021
• Study Completion: February 23, 2022
• Last Updated: April 8, 2026
• Results First Posted: April 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)