Effect of Partner-Conducted Fetal Heart Sound Measurement on Maternal and Paternal Attachment

NCT ID: NCT06965647

Last Updated: 2025-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-15

Study Completion Date

2024-09-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prenatal Attachment, Maternal Expectations, Paternal Involvement

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled design with parallel groups
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Partner-Conducted Fetal Heart Sound Measurement

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Inonu University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kader ATABEY

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

İnönü üniversitesi

Malatya, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

10576553

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.