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Attachment(MaKit)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

A study testing Makit in people with Attachment and Pregnant Women, run by Universitas Aisyiyah Yogyakarta at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
Makit
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteIndonesia
Study dates
1 Mar 2025to 26 May 2025
Phase
Interventional
Are there results?
None posted in the registry

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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • women ≥37 weeks' gestation (as they would likely deliver before completing the four-week intervention and follow-up).

Trial locations and contacts

1 site in 1 country.

Indonesia1 site
  • Klinik Aisyiyah Moyudan

    Sleman, Special Region of Yogyakarta, 55292

Other trials in Indonesia

About this study

Official title: 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.

Read more

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.

Being tested
Makit
Keywords
indonesia, pregnancy, psychosocial intervention, maternal-fetal attachment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MakitBehavioural

    makit

Study groups in NCT07692100
Study groupRoleWhat they receive
Maternal-fetal attachment KitExperimentalParticipants 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.
Receives: Behavioral: Makit
No interventionNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Maternal-Fetal Attachment as Measured by the Prenatal Attachment Inventory (PAI)

    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.

    Measured: up to 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2026
  2. Study start1 Mar 2025
  3. Primary completion25 May 2025
  4. Study completion26 May 2025

Resources

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
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07692100
Sponsor's protocol ID
No. 4335/KEP-UNISA/III/2025)
Other IDs
Nomor: 0258.407/I.3/D/2025
Acronym
(MaKit)
Status last verified
Jul 2026
First submitted
24 Apr 2026
Last updated
9 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Makit in people with Attachment and Pregnant Women, run by Universitas Aisyiyah Yogyakarta at 1 site in Indonesia.

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 5 inclusion and 1 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 9 Jul 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 Indonesia. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in Maternal-Fetal Attachment as Measured by the Prenatal Attachment Inventory (PAI) (time frame: up to 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 9 Jul 2026.

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