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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • Malatya, Turkey
        • İnönü Üniversitesi

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Partner-Conducted Fetal Heart Sound Measurement
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Prenatal Paternal Attachment Level
Time Frame: From 28-38 weeks of gestation (approximately 10 weeks)
Change in paternal attachment scores, measured using the Prenatal Paternal Attachment Scale (PPAS), before and after partner-conducted fetal heart sound measurement.
From 28-38 weeks of gestation (approximately 10 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Prenatal Maternal Attachment Level
Time Frame: From 28-38 weeks of gestation (approximately 10 weeks)
Change in maternal attachment scores, measured using the Prenatal Attachment Inventory (PAI), before and after the intervention.
From 28-38 weeks of gestation (approximately 10 weeks)
Parental Expectations (Mother and Father)
Time Frame: From 28-38 weeks of gestation (approximately 10 weeks)
Change in maternal and paternal expectations measured using validated Maternity and Paternity Expectation Scales before and after the intervention.
From 28-38 weeks of gestation (approximately 10 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Inonu University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 2, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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