- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06965647
- Original Trial
Effect of Partner-Conducted Fetal Heart Sound Measurement on Maternal and Paternal Attachment (FHS-ATTACH)
May 2, 2025 updated by: Kader ATABEY, Inonu University
The Effect of Partner-Conducted Fetal Heart Sound Measurement on Maternal-Paternal Expectations and Maternal-Paternal Attachment: An Experimental Study
This randomized controlled study aims to evaluate the effect of fetal heart sound (FHS) measurement performed by the partner on prenatal maternal and paternal expectations and attachment levels.
A total of 120 couples (60 intervention, 60 control) participated in the study.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
This experimental study was conducted to determine the effect of partner-conducted fetal heart sound (FHS) measurement on prenatal maternal and paternal expectations and attachment.
The study included 120 couples (60 intervention, 60 control) whose pregnancies were between 28 and 38 weeks, and who were registered at Hasköy Family Health Center in Muş, Turkey.
In the intervention group, the father was trained in Leopold maneuvers and performed the FHS measurement twice - once during 28-32 weeks and again during 33-38 weeks of gestation.
Data collection tools included the Prenatal Maternity Expectations Scale, Prenatal Paternity Expectations Scale, Prenatal Attachment Inventory, and the Paternal Antenatal Attachment Scale.
Data were collected before the first FHS measurement (pre-test) and after the second (post-test).
The control group received standard prenatal monitoring by healthcare staff without involving the partner.
The study was approved by the Malatya Clinical Research Ethics Committee (Approval No: 2022/3968).
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Malatya, Turkey
- inonu universitesi
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
- Inclusion Criteria: Women between 28 and 38 weeks of gestation
- Age between 18 and 45 years
- Ability to read and write
- No diagnosed psychiatric illness
- Healthy pregnancy
- Attending prenatal visits with their partner
Exclusion Criteria:
- Women with diagnosed psychiatric conditions
- Couples unwilling to participate
- Incomplete data forms
- Those who moved out of the study area during follow-up
- Women without their partners during visits
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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
Couples who met the inclusion criteria were invited from Hasköy Family Health Center.
Based on national prenatal care guidelines, two sessions were scheduled at 28-32 weeks and 33-38 weeks of gestation.
Fathers were trained on Leopold maneuvers and fetal heart sound measurement.
Under midwife supervision, fathers performed Leopold maneuvers and fetal heart sound measurements using a Doppler device.
The intervention was applied twice.
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Expectant fathers in the intervention group were trained in basic Leopold maneuvers and fetal heart sound measurement using a Doppler device.
Under the supervision of a midwife, fathers located the fetus's back, applied gel, and measured the heart sound during prenatal visits at 28-32 and 33-38 weeks of gestation.
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No Intervention: Control Group
Couples in the control group received standard prenatal follow-up.
At 28-32 and 33-38 weeks, data were collected using the same tools without any intervention.
During routine visits, the fetal heart sound measurement and Leopold maneuvers were performed by the midwife as part of standard care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Prenatal Paternal Attachment Level
Time Frame: From 28-38 weeks of gestation (approximately 10 weeks)
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Change in paternal attachment scores, measured using the Prenatal Paternal Attachment Scale (PPAS), before and after partner-conducted fetal heart sound measurement.
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From 28-38 weeks of gestation (approximately 10 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prenatal Maternal Attachment Level
Time Frame: From 28-38 weeks of gestation (approximately 10 weeks)
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Change in maternal attachment scores, measured using the Prenatal Attachment Inventory (PAI), before and after the intervention.
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From 28-38 weeks of gestation (approximately 10 weeks)
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Parental Expectations (Mother and Father)
Time Frame: From 28-38 weeks of gestation (approximately 10 weeks)
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Change in maternal and paternal expectations measured using validated Maternity and Paternity Expectation Scales before and after the intervention.
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From 28-38 weeks of gestation (approximately 10 weeks)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2022
Primary Completion (Actual)
June 15, 2024
Study Completion (Actual)
September 2, 2024
Study Registration Dates
First Submitted
June 18, 2024
First Submitted That Met QC Criteria
May 2, 2025
First Posted (Actual)
May 11, 2025
Study Record Updates
Last Update Posted (Actual)
May 11, 2025
Last Update Submitted That Met QC Criteria
May 2, 2025
Last Verified
December 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 10576553
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is no plan to share individual participant data (IPD).
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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