- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07667374
Effects of Hybrid Family Planning Counseling on Postpartum Maternal Health
THE EFFECTS OF HYBRID FAMILY PLANNING COUNSELING IN THE POSTPARTUM PERIOD ON MATERNAL HEALTH: A LONGITUDINAL STUDY
This research aims to examine the effects of hybrid family planning counseling on maternal health in the postpartum period. The study is unique and innovative in that it evaluates the effectiveness of hybrid counseling models, which are gaining importance in the literature but have been the subject of a limited number of studies, particularly in Turkey. The World Health Organization recommends a minimum interval of 24 months between births, and it is known that early postpartum pregnancies have negative effects on maternal and neonatal health. In this context, the hybrid family planning counseling model to be developed will contribute to reducing maternal mortality and morbidity by supporting women in making informed and correct contraceptive choices. Furthermore, it is predicted that the findings of the study will be directly related to the United Nations Sustainable Development Goals, namely gender equality, healthy living, and quality education. The research is planned as a randomized controlled longitudinal study. Data collection is planned for August 2026 at the Adana City Training and Research Hospital antenatal clinic. The sample will consist of a total of 96 pregnant women, 48 in the experimental group and 48 in the control group, determined by power analysis. A counseling module will be created by gathering expert opinions. The module will consist of 3 sessions. Each session will last 45 minutes, including 30 minutes of interactive presentation and 15 minutes of question and answer. The module sessions will have a dynamic structure that takes into account the needs of the mother during pregnancy and the postpartum period. The first meeting will be held face-to-face in the hospital at 34-38 weeks of pregnancy, the second meeting will be online within the first 4 weeks postpartum, and the third meeting will be online at 6 weeks postpartum. During the implementation phase, quantitative measurements of the research will be carried out using the "Antenatal Pregnancy Information Form", "Postnatal Mother Information Form", "Postpartum Family Planning Attitude Scale", "Edinburgh Postpartum Depression Scale" and "Sexual Life Quality Scale".
Research hypotheses:
H0: Longitudinal hybrid family planning counseling (antenatal-postpartum period) does not affect maternal health. H1: Longitudinal (antenatal-postpartum) hybrid family planning counseling affects maternal health.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Postpartum family planning is an approach that aims to encourage women to have at least 24 months between pregnancies, starting within the first 6-24 hours after delivery. Within this scope, providing appropriate contraceptive methods within six weeks of delivery, even if the woman is breastfeeding or amenorrhea, and providing couples with counseling on sexual health issues are among the basic practices.
A pregnancy immediately after delivery increases the risk of pregnancy complications, shortens the duration of breastfeeding, and jeopardizes maternal and child health. While the World Health Organization (WHO) recommends that the time between two pregnancies should be at least 24 months for the physiological and psychosocial health of the mother in the postpartum period, the American College of Obstetrics and Gynecology (ACOG) recommends that this period should be 18 months.
Family planning; It encompasses all techniques and practices aimed at helping couples have children of their own free will, at the time and in the number they desire, determining the interval between pregnancies, and preventing unwanted pregnancies. Because the exact timing of resuming sexual activity in the postpartum period and the duration of fertility in breastfeeding women are not precisely known, the most appropriate time for contraceptive method counseling is the antenatal period. If the mother has not made a decision about contraceptive methods during this period, the choice of contraceptive method must be determined before discharge. Therefore, midwives play an important role in pre-pregnancy and post-natal contraceptive counseling and care
Postpartum family planning counseling aligns directly with the United Nations Sustainable Development Goals (SDGs) by helping women avoid unwanted or closely spaced pregnancies in the postpartum period, ensuring a minimum of 24 months between pregnancies, and enabling couples to consciously choose birth control methods that align with their reproductive preferences. Specifically, SDG 2 (End Hunger) and SDG 3 (Healthy Individuals) aim to promote exclusive breastfeeding for the first six months and continued breastfeeding with complementary foods until the age of two, thereby reducing maternal mortality and morbidity, preventing infant and child deaths, and ensuring universal access to reproductive health services. Research indicates that effective family planning services can reduce maternal mortality by approximately 30%. As stated in a summary of the results on the effects of family planning on nutrition, "malnutrition, including stunting, low weight, weakness, and vitamin deficiencies, contributes to almost half of all childhood deaths. This means that approximately 3.1 million children under the age of 5 die each year from malnutrition-related causes.
In addition, postpartum family planning contributes to SDG 5 (Gender Equality) by supporting women's right to make decisions about their fertility. Furthermore, planning and regulating the intervals between pregnancies aligns with SDG 1 (Poverty Reduction) by easing the economic burden on families, SDG 4 (Quality Education) by supporting girls' education through the prevention of early and unplanned pregnancies, and SDG 8 (Decent Work and Economic Growth) by increasing women's participation in the workforce. Therefore, postpartum family planning counseling is not only It plays a strategic role not only in terms of maternal and child health, but also in terms of social development, gender equality, and economic sustainability.
Across Turkey, 11.5% of women have unmet family planning needs, with 3.9% needing to space out births and 7.6% needing to terminate pregnancies. Furthermore, 3.9% of women in Turkey have an unmet need for modern methods of contraception. The need for family planning among married women doubled in the five years following 2013. Considering the number of married women and the level of need in 2018, approximately 600,000 women needed family planning to space out births, and 1 million women needed it to terminate pregnancies. The use of contraceptive methods, particularly modern methods, has steadily increased in Turkey. As a result of this increase, the share of women with unmet family planning needs decreased from 15% in 1993 to approximately one-third (6%) in 2013. However, this situation has recently changed; the needs gap revealed by the 2018 Turkish National Health Survey (TNSA) points to levels as high as those approximately 20 years ago. Unmet family planning needs are not unique to women with many children. The unmet need is higher among women with two or fewer births compared to other groups. The disruptions in the provision of family planning services and the demand for healthcare services due to the Covid-19 pandemic, as well as the postpartum period, indicate a high level of unmet family planning needs among women. Since the need for family planning services continues under all circumstances, uninterrupted access is essential. During pandemics and natural disasters, women faced difficulties accessing healthcare facilities, disruptions in pregnancy and postpartum follow-ups, and delays in seeking help for risky situations. During this period, women also did not have adequate access to preventive healthcare services for maternal and child health. This situation highlighted the need for different counseling methods to ensure uninterrupted access to counseling for women, and the necessity of providing telehealth services.
Therefore, family planning counseling services for postpartum contraception can be provided through various methods during antenatal care, before discharge after delivery, during postpartum follow-ups, and/or during infant monitoring. Midwives, who are in constant contact with women, provide couples with qualified family planning counseling using their equipment and knowledge, helping them choose an appropriate method and use it correctly. Midwives who establish good communication with women after delivery identify women's unmet family planning needs and provide the necessary support.
The project has unique value for a sustainable future in terms of its impact on maternal health in particular, and family and community health in general. Ensuring that every mother and couple has access to uninterrupted family planning services is a fundamental human right essential for a healthy sexual life and the future of pregnancies. Another unique value is that it is a longitudinal study that uses innovative methods and provides early information at the national level to quickly compensate for the lost momentum in family planning, especially during pandemics and natural disasters. Counseling will begin face-to-face during pregnancy and then continue in a hybrid format. The continuity of counseling will ensure that the mother has access to the necessary information on family planning on the right platform. Another unique value of this study is that it will provide data for comparing innovative counseling methods with traditional methods. Thus, it will help to improve or regulate future initiatives. In line with this purpose, the objectives are:
- Development of a hybrid counseling model in family planning counseling,
- Evaluation of the effectiveness of innovative methods in hybrid family planning counseling,
- Determination of the effects of hybrid family planning counseling in the postpartum period on the time between pregnancies,
- Maternal mortality and morbidity risks,
- Maternal psychosocial well-being,
- Determination of mothers' attitudes towards family planning,
- Determination of the effect on women's quality of sexual life,
- Evaluation of the advantages of telehealth-based counseling in terms of accessibility and sustainability.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: tuğçe sönmez, pHD
- Phone Number: +905541804484
- Email: tugcesonmez@tarsus.edu.tr
Study Locations
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Mersin
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Toroslar, Mersin, Turkey (Türkiye)
- Tarsus University
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Contact:
- tuğçe sönmez
- Phone Number: 05541804484
- Email: tugcesonmez@tarsus.edu.tr
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Sub-Investigator:
- Şule Gökyıldız Sürücü, Prof.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being over 18 years old Not having received family planning counseling before Being pregnant for the first time Being able to use technological/online systems and having a communication device that can install these systems (smartphone, messaging, Google Forms, Zoom, WhatsApp) Not having vision or hearing problems Being able to read and write Being in the last trimester (34 weeks of pregnancy or more)
Exclusion Criteria:
- The mother having a condition that prevents her from using family planning methods (reproductive organ conditions, hormonal disorders, etc.) Having been diagnosed with a chronic or psychological disorder (cardiovascular diseases, depression, epilepsy, asthma, etc.).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention Group
Mothers who receive hybrid family planning counseling
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The study will begin with the randomization of samples meeting the inclusion and exclusion criteria to assign them to the intervention and control groups. The first interview will be conducted in person at the hospital between weeks 34-38 of pregnancy. The second interview will be conducted online (Zoom or WhatsApp) within the first four weeks postpartum. Pre-test measurements will be taken. The third interview will be conducted online at week 6 postpartum. After the modules are completed, follow-ups will be conducted at 3, 6, and 12 months, and interim and post-test measurements will be taken. The purpose of the interim measurement is to evaluate the effect of the training more accurately, permanently, and reliably over time. The aim here is not just to use a pre-test-post-test approach, but to evaluate it in a more detailed and dynamic way. The researcher will share contact information with the participants, and women will be able to contact the researcher at any time. Data will be |
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No Intervention: Control Group
Mothers who receive routine childcare
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Antenatal Pregnancy Information Form
Time Frame: Baseline
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Prepared by researchers in line with the literature, this form consists of 15 questions about the socio-demographic characteristics, obstetric characteristics, and family planning of pregnant women.
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Baseline
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Postnatal Mother Information Form
Time Frame: Baseline
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Prepared in accordance with literature reviews, this form consists of 11 questions covering mothers' information regarding the postpartum period, family planning, and childbirth.
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Baseline
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Postpartum Family Planning Attitude Scale
Time Frame: 3, 6, and 12 months after the intervention
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Developed by Varol and Çiçeklioğlu (2023), this scale consists of 27 items.
16 of the items contain positive statements, and 11 contain negative statements.
The scale items are rated using a Likert-type scoring system ranging from 1 to 5. The lowest possible score on the scale is 27, and the highest is 135.
Items 1-3 represent "Perceived Risk"; items 4-6 represent "Perceived Seriousness"; Items 7-10 represent "Perceived Benefits", items 11-18 "Perceived Barriers", items 19-23 "Taking Action", and items 24-27 "Self-Efficacy".
The highest possible score on the scale indicates a higher belief in health regarding perceived risk, perceived severity, perceived barriers, perceived benefits, taking action, and self-efficacy; therefore, a more positive attitude towards postpartum depression.
In the development study, the Cronbach's alpha coefficient was found to be 0.878, and the scale was considered reliable.
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3, 6, and 12 months after the intervention
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Edinburgh Postnatal Depression Scale
Time Frame: 3, 6, and 12 months after the intervention
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Developed by Cox et al. in 1987 to determine the risk of depression in women during the postpartum period.
In Turkey, the validity and reliability study of the scale was conducted by Engindeniz et al., with a cutoff score of ≥13.
The scale consists of 10 items, each arranged in a four-option Likert scale.
Response options are scored between 0 and 3. Items 1, 2, and 4 are scored as 0-1-2-3; items 3, 5, 6, 7, 8, 9, and 10 are scored as 3-2-1-0.
The total score obtainable from the scale ranges from 0 to 30.
The total score obtained by summing the item scores indicates that individuals with a score of 13 or higher are considered to be in the risk group.
The Cronbach's alpha value of the scale is 0.87.
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3, 6, and 12 months after the intervention
|
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Sexual Life Quality Scale-Female
Time Frame: 3, 6, and 12 months after the intervention
|
Developed by Symonds et al. in 2005 and adapted into Turkish by Tuğut and Gölbaşı, the scale consists of 18 items designed to assess problems related to sexual life over the past four weeks.
The scale, answered using a six-point Likert scale, can be used with different scoring methods.
In this study, a system where items are scored from 1 to 6 was preferred.
The total score obtainable from the scale ranges from 18 to 108.
A higher score indicates better sexual life quality.
The Cronbach's alpha coefficient of the scale was determined to be 0.83.
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3, 6, and 12 months after the intervention
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Family planning counseling
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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Clinical Trials on Postpartum Family Planning Counseling
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Jacaranda HealthHarvard School of Public Health (HSPH); Jhpiego; IPSOSRecruitingPostpartum Family PlanningKenya
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Stanford UniversityCompletedPostpartum Contraception | Family PlanningUnited States
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Rush University Medical CenterUniversity of Illinois at Chicago; AllianceChicagoCompletedContraception | Family Planning | PostPartumUnited States
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Services Institute of Medical Sciences, PakistanCompletedPostpartum Contraception | Family Planning | Reproductive HealthPakistan
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Jimma UniversityWollo UniversityCompletedPostpartum Family Planning | Modern Contraceptive UseEthiopia
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Aga Khan UniversityCompletedPostpartum Family PlanningPakistan
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JhpiegoUnited States Agency for International Development (USAID); Bill and Melinda...CompletedPregnancy | Contraception | Contraceptive Usage | Prenatal Care | Postpartum Family PlanningEthiopia
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Population Services InternationalActive, not recruitingAntenatal Care | Postpartum Family Planning | Pre-conceptual Care | Adolescent Maternal HealthKenya
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John James ParkerClínica de Familia La Romana, Dominican RepublicEnrolling by invitationMental Health | Care Coordination | Family Planning | Primary Care | Postpartum CareDominican Republic
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Assiut UniversityNot yet recruiting
Clinical Trials on Hybrid family planning counseling
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Adiyaman UniversityNot yet recruitingContraceptionTurkey (Türkiye)
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Johns Hopkins Bloomberg School of Public HealthBill and Melinda Gates Foundation; Kwame Nkrumah University of Science and...CompletedContraceptionGhana, United States
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St. Paul's Hospital Millennium Medical College,...Not yet recruitingPostpartum ContraceptionEthiopia
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Hawassa UniversityEngenderHealthCompleted
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University of IbadanBill and Melinda Gates Foundation; International Center for Research on WomenCompletedCouples | Literacy | Gender Role | Woman's Role | Family SizeNigeria
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Planned Parenthood League of MassachusettsSociety for Family Planning Research FundCompletedFocus: Contraceptive Counseling | Focus: Postpartum ContraceptionPalestinian Territories, Occupied
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Oregon Health and Science UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...Completed
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University of UtahDepartment of Health and Human ServicesCompletedPregnancy | FertilityUnited States, Canada
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University of VictoriaUniversity of British Columbia; Canadian Institutes of Health Research (CIHR); Dalhousie UniversityCompleted
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Jacaranda HealthHarvard School of Public Health (HSPH); Jhpiego; IPSOSRecruitingPostpartum Family PlanningKenya