- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07692100
A Couple-Based Bonding Program During Pregnancy: Testing the Maternal-Fetal Attachment Kit (MaKit) to Strengthen Emotional Connection Between Expectant Mothers and Their Unborn Babies in Antenatal Care ((MaKit))
Effectiveness of the Maternal-Fetal Attachment Kit (MaKit) on Maternal-Fetal Attachment Among Expectant Couples Attending Antenatal Care: A Quasi-Experimental Study
Understanding the Maternal-Fetal Attachment Kit (MaKit) Study What is this study about? This study looked at whether a special program called the Maternal-Fetal Attachment Kit (MaKit) could help pregnant women feel more emotionally connected to their unborn babies. The program was designed to involve both the mother and her partner, making it a couple-based experience during pregnancy.
Why was this study done? Feeling emotionally bonded to an unborn baby during pregnancy is very important. It supports the mother's well-being and helps parents feel more ready for parenthood. However, most routine pregnancy check-ups (antenatal care) focus mainly on the physical health of the mother and baby, with little attention given to emotional bonding or involving the partner. This study aimed to fill that gap.
Who took part in this study?
Thirty pregnant women and their partners attending a primary antenatal care clinic in Indonesia took part in this study. They were divided into two groups:
Intervention group (15 couples): Received standard antenatal care plus the MaKit program.
Control group (15 couples): Received standard antenatal care only.
The study was conducted between March and May 2024. What is MaKit? MaKit is a psychosocial intervention kit designed to be used at home by expectant couples. It provides structured activities that encourage both parents to reflect on and strengthen their emotional bond with their unborn baby. It is designed to complement - not replace - routine antenatal care provided by midwives.
What did the study find? After the intervention, mothers in the MaKit group showed significantly higher emotional bonding scores with their unborn babies compared to mothers in the control group (68.5 vs. 62.7 out of a possible score). This difference was meaningful and statistically significant, suggesting that MaKit genuinely helped improve the mother-baby emotional connection.
What does this mean for patients and families? If you are pregnant, emotional bonding with your baby during pregnancy matters - and it is something you and your partner can actively nurture together. Programs like MaKit offer simple, structured ways to do this at home, alongside your regular antenatal visits. Involving your partner in this process may also strengthen your relationship and your shared readiness for parenthood.
What does this mean for health care providers? MaKit shows promise as a practical, low-cost psychosocial tool that midwives and antenatal care providers can recommend to expectant couples. Integrating such interventions into standard antenatal care could support a more holistic, family-centered model of care - addressing not just the physical, but also the emotional dimensions of pregnancy. This is especially relevant in low- and middle-income settings where psychosocial support during pregnancy is often limited.
What are the limitations? This was a small study involving only 30 couples at a single clinic in Indonesia. While the results are promising, larger studies across different settings are needed to confirm these findings and explore the long-term effects of MaKit on parenting and child development outcomes.
Key Takeaway The Maternal-Fetal Attachment Kit (MaKit) is a promising, couple-focused program that can help expectant mothers feel more emotionally connected to their unborn babies when used alongside routine antenatal care. It is simple, home-based, and designed to involve both parents in the bonding journey.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Special Region of Yogyakarta
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Sleman, Special Region of Yogyakarta, Indonesia, 55292
- Klinik Aisyiyah Moyudan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- pregnant women 16-36 weeks' gestation with a singleton pregnancy, i
- in marital union,
- attending the antenatal care visit with their husband,
- willing partner to participate in the intervention, and
- able to communicate in Indonesian
Exclusion Criteria:
- women ≥37 weeks' gestation (as they would likely deliver before completing the four-week intervention and follow-up).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Maternal-fetal attachment Kit
Participants in this group received standard antenatal care plus the Maternal-Fetal Attachment Kit (MaKit), a structured, brief couple-focused psychosocial intervention.
MaKit was introduced at a single midwife-led session during a routine antenatal visit (approximately 30 minutes) at ≥16 weeks gestation.
The kit consists of four components: (1) a visual guidebook (32 pages) covering prenatal attachment, fetal development, and bonding strategies; (2) a structured couple activity booklet with six guided home-based bonding exercises (e.g., fetal movement awareness, joint relaxation, shared letter-writing to the baby); (3) a partner affirmation card set with structured prompts for daily supportive communication; and (4) a reflective diary for recording daily thoughts, feelings, and attachment-related behaviours.
Following the introductory session, couples independently practised the home-based activities over four weeks.
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makit
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No Intervention: No intervention
Participants in this group received standard antenatal care only, as routinely provided at the 'Aisyiyah Moyudan Clinic, Sleman Regency, Indonesia.
No additional psychosocial intervention or bonding-related materials were provided.
Maternal-fetal attachment was assessed at baseline and at a follow-up antenatal visit approximately four weeks later, under identical measurement conditions as the intervention group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Maternal-Fetal Attachment as Measured by the Prenatal Attachment Inventory (PAI)
Time Frame: up to 4 weeks
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Maternal-fetal attachment will be assessed using the Prenatal Attachment Inventory (PAI), a 21-item self-report questionnaire developed by Muller (1993) to measure the intensity of a pregnant woman's emotional attachment to her unborn child.
Each item is rated on a 4-point Likert scale, yielding a total score ranging from 21 to 84, with higher scores indicating stronger prenatal attachment.
The PAI assesses maternal thoughts, feelings, and behaviors directed toward the fetus, such as attributing characteristics to the unborn child and engaging in interactive behaviors (e.g., talking to or touching the abdomen).
The instrument will be administered [before and after the intervention / at baseline and follow-up] to evaluate changes in attachment scores.
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up to 4 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- No. 4335/KEP-UNISA/III/2025)
- Nomor: 0258.407/I.3/D/2025 (Other Grant/Funding Number: Majelis Pendidikan Tinggi Penelitian dan Pengembangan Pimpinan Pusat (Diktilitbang) Pimpinan Pusat Muhammadiyah.)
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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