The Effect of Self-made Fetal Movement and Position Tracking During Pregnancy on Maternal Attachment

July 1, 2022 updated by: AYSUN BADEM

The Effect of Self-made Fetal Movement and Position Tracking During Pregnancy on Maternal Attachment in the Postpartum Period

This study was conducted to determine the effect of self-made fetal movement counting and fetal position tracking on maternal attachment in prenatal period.

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

The first attachment between mother and baby begins in the prenatal period. It is expected to increase as pregnancy progresses.The more the mother tries to communicate and interact with her baby, the stronger her attachment to her baby. The baby can be accepted by the mother as an individual, and the attachment between the mother and baby can increase.The early development of safe and positive attachment composes the basis of healthy development. In the later years of childhood, safe attachment is effective on healthy processes, such as being more positive, establishing close, constructive and respectful relationships, and a high sense of trust, while unsafe attachment is associated with emotional, social, physical and mental psychopathologies. The mother's touching her baby over her abdomen, trying to guess the parts of the baby, following baby movements, communicating with the baby by focusing and spending private time with the baby increase the physical and psychological contact with the baby. Fetal movement counting is defined as tracking uninterrupted fetal movements for at least 15-20 minutes by lying on the left side in a calm environment at any time during the day when this baby is awake. Fetal position tracking is described as trying to guess the parts of the baby by placing the mother's hand on the abdomen. In the literature, it is stated that prenatal attachment affects postpartum maternal attachment, contributes positively to infant care and provides rapid adaptation to motherhood. In addition, secure/insecure attachment styles are thought to be associated with postpartum depression. It is stated that the babies of mothers with strong prenatal attachment show healthier growth and development and even affect their personality positively in adulthood. In the literature, it is stated that the prenatal period can be an indicator of mother-infant interaction in the postpartum period.This study was carried out as a continuation of the previous study, NCT05313113 Clinical ID, to determine maternal attachment in the postpartum period of pregnant women whose fetal movement and position were followed.

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.
85

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
      • Kayseri̇, Turkey, 38280
        • Erciyes University

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

19 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • literate
  • between the ages of 19-35
  • Effective communication
  • first pregnancy
  • having a single fetus
  • Pregnancy week between 24 and 28. between the ages of 19-35
  • Effective communication
  • first pregnancy
  • having a single fetus
  • Pregnancy week between 24 and 28.

Exclusion Criteria:

  • Pregnancy using assisted reproductive techniques
  • Having a risky pregnancy (preeclampsia, placenta previa, gestational diabetes etc.)
  • Pregnant women with a chronic disease (heart, systemic, circulatory disorder, psychiatric, etc.) were not included in the study.

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: Experimental Arms
Prenatal attachment scale answered. In the first stage, pregnant women were trained to implement fetal movement count and position tracking. The training was provided face to face and lasted 30-45 minutes. How to determine the position of the fetus and I. and II. Leopold maneuvers are also taught. In the second stage, the pregnant women were interviewed twice a week by telephone.Thus, it was provided that pregnant women had fetal tracked at least once a day, at any time of the day, when the fetus was awake and most active, in a suitable position and a comfortable environment, for at least 15-20 minutes continuously for four weeks. Pregnant women phoned the researcher when they wanted. At the same time, the participants continued to their routine prenatal care. The mother attachment scale was answered at least 1 month after the birth of the women.
Behavioral: Fetal movement and position tracking training
In the first stage, pregnant women were trained to implement fetal movement count and position tracking. The training was provided face to face and lasted 30-45 minutes. How to determine the position of the fetus and I. and II. Leopold maneuvers are also taught. In the second stage, the pregnant women were interviewed twice a week by telephone.Thus, it was provided that pregnant women had fetal tracked at least once a day, at any time of the day, when the fetus was awake and most active, in a suitable position and a comfortable environment, for at least 15-20 minutes continuously for four weeks. Pregnant women phoned the researcher when they wanted. At the same time, the participants continued to their routine prenatal care.
No Intervention: No İntervention Arms
Prenatal attachment scale answered. The pregnant women continued to their routine prenatal care. No intervention was applied to the pregnant women in addition to their routine prenatal care.The pregnant women were called about whether continuing their routine care or having any problems during the research. The mother attachment scale was answered at least 1 month after the birth of the women.

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 attachment inventory (PAI)
Time Frame: between 24-28 gestational weeks and after 30 days
The mean prenatal attachment level (mean±SD) The mean prenatal attachment was assessed using ''Prenatal attachment inventory''. The inventory consists of 21 Likert-type items. Each item is scored between 1 and 4. Therefore, the minimum score of the inventory is 21, while the maximum score of the inventory is 84. The pregnant between 24-28 gestational weeks were filled with face-to-face interviews at the first interview and 30 days after the training. [Time Frame: between 24-28 gestational weeks and after 30 days]
between 24-28 gestational weeks and after 30 days

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
Maternal attachment inventory (MAI)
Time Frame: 1-6 months after birth
The mean maternal attachment was assessed using ''Maternal attachment inventory (MAI)''. The inventory consists of 26 Likert-type items. Each item is scored between 1 and 4. Therefore, the minimum score of the inventory is 26, while the maximum score of the inventory is 104. A high score indicates high maternal attachment. The scale can be applied between 1 month and 24 months postpartum. The scale was answered via telephone.
1-6 months after birth

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.
AYSUN BADEM

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aysun BADEM, asst. prof., Erciyes 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.
May 20, 2020

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.
September 30, 2020

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.
December 30, 2020

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 27, 2022

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.
July 1, 2022

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.
July 5, 2022

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.
July 5, 2022

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.
July 1, 2022

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.
July 1, 2022

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.
  • Maternal attachment

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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