The Effect of Two Different Self-Assessment Methods for Fetal Movement Monitoring on Maternal Psychosocial Status

NCT ID: NCT06558162

Last Updated: 2024-08-20

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

RECRUITING

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-30

Study Completion Date

2024-11-30

Brief Summary

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

Antenatal care is essential for a successful delivery, a healthy baby and a happy mother. The main aim of antenatal care is to take appropriate interventions to assess, protect and improve maternal and fetal health during pregnancy. There are many methods to assess fetal health during pregnancy, such as ultrasonography (USG) and non stress test (NST). Along with these methods, maternal perception and counting of fetal movements is the only method that can be easily used by the mother without the need for clinicians or equipment. When a pregnant woman begins to feel fetal movements, it is one of the first signs of fetal life and is considered an indicator of fetal well-being. Decrease or absence of fetal movements has been stated to be an important parameter in the assessment of fetal health and may be associated with the risk of intrauterine fetal death. Therefore, feeling and counting of fetal movements is the basis for the assessment of fetal health.

Detailed Description

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

Two methods are recommended for the identification of fetal movements. These are the Cardiff method and the Sadovsky method. In the assessment of fetal health, not only the number of movements per unit of time is important, but also the strength and nature of these movements. To take this into account, in 2012 Radestad introduced another method of observing the character of the movement, called "Mindfetalness". The method is based on women who develop maternal awareness of the health of the foetus and note the quality of the perceived movements. The method requires the mother to lie on her left side while her baby is awake and focus for 15 minutes on exactly how the baby is moving, taking into account the strength, type and frequency of movement. However, the number of fetal movements is not counted during this time period. This method, which helps women to note fetal movements in order to minimise and/or eliminate adverse birth outcomes, is also reported to cause unnecessary stress to the mother, as with other methods.Although there are studies reporting that counting fetal movements contributes to maternal attachment by increasing the possibility of connecting with the unborn baby, there are also studies that found no difference in maternal-fetal attachment scores. However, it is thought that focusing on the quality rather than the quantity of movements will increase the opportunity to connect with the fetus.

There is no previous comparison in the literature between a self-assessment method that focuses on qualitative variables and a counting method to measure fetal movements. Although there is one study that used both methods, this study did not differentiate between experimental and control groups, but used the crossover method and tested both methods on the same pregnant women. Therefore, our study was planned to determine the effect of fetal movement counting with two different self-assessment methods on prenatal attachment and psychosocial status.

Conditions

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

Fetal Movement Mental Health Issue

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

Pregnant women included in the study were randomized into two groups. One group will have fetal movements assessed using the Sadovsky method. The other group will use the Mindfetalness method.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Pregnant women assigned to groups will not know which method (name) they are using. The person who will conduct the research analyses will be someone independent of the researchers.

Study Groups

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

Mindfetalness Group

The method is based on noting the quality of perceived movements, which develops maternal awareness of the health of the foetus. The method requires the mother to lie on her left side while her baby is awake and for 15 minutes focus on exactly how the baby moves, taking into account the strength, type and frequency of movement. However, the number of fetal movements is not counted during this time.

It is also very important to understand the attitudes of the pregnant women, because a positive attitude may improve the perception of the pregnant woman and thus increase compliance with the method, whereas a negative attitude may hinder compliance with the method. Therefore, it will be important to create a positive attitude during the counselling of pregnant women in this group.

Group Type EXPERIMENTAL

Mindfetalness

Intervention Type BEHAVIORAL

They will be instructed to lie on their left side and focus on the fetal movements for 15 minutes every day while the foetus is awake. They will also be instructed to monitor the character, strength and frequency of fetal movements (not to count them) and to seek medical advice if they feel any change in this pattern.

After two weeks, the pregnant women will be invited back to the organisation for a follow-up interview to check whether they have performed the practice and recorded correctly. An interview will be conducted again after four weeks.

Sadovsky Group

This method involves counting the movements over a set period of time (usually 30 minutes to 2 hours). The mother should count the fetal movements at the same time every day. In this counting technique, mothers are especially asked to count after 3 meals during the day. Fetal movements are usually active in the evening. During the counting process, the mother should make sure that the baby is awake and should be calm, resting, eating, using the toilet, lying on her side and placing her hands on her abdomen. When the mother perceives the first movement of the baby, she should start recording on the monitoring chart given to her and continue counting and recording until the 10th movement is completed. If she counts less than 10 movements in the first 30 minutes, she should continue recording.

Group Type ACTIVE_COMPARATOR

Sadovsky

Intervention Type BEHAVIORAL

They will be asked to continue this procedure every morning, noon or evening for one month (depending on the movements of the pregnant woman and her baby, the time will be left to the pregnant woman, but it should be at the same time every day). Since the aim of the study is to increase maternal awareness rather than to determine fetal well-being, mothers will be asked to count at least 10 movements based on the "count to ten" and "Sadovsky" method, and will be asked to record the start and completion time of the movements each time. A follow-up will be made after two weeks and a final follow-up will be made after one month

Interventions

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

Mindfetalness

They will be instructed to lie on their left side and focus on the fetal movements for 15 minutes every day while the foetus is awake. They will also be instructed to monitor the character, strength and frequency of fetal movements (not to count them) and to seek medical advice if they feel any change in this pattern.

After two weeks, the pregnant women will be invited back to the organisation for a follow-up interview to check whether they have performed the practice and recorded correctly. An interview will be conducted again after four weeks.

Intervention Type BEHAVIORAL

Sadovsky

They will be asked to continue this procedure every morning, noon or evening for one month (depending on the movements of the pregnant woman and her baby, the time will be left to the pregnant woman, but it should be at the same time every day). Since the aim of the study is to increase maternal awareness rather than to determine fetal well-being, mothers will be asked to count at least 10 movements based on the "count to ten" and "Sadovsky" method, and will be asked to record the start and completion time of the movements each time. A follow-up will be made after two weeks and a final follow-up will be made after one month

Intervention Type BEHAVIORAL

Eligibility Criteria

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

Inclusion Criteria

* Volunteering to participate in the research
* Over 18 years of age
* Single pregnancy
* Being between 28-32 weeks of gestation
* Primiparity
* At least primary school graduation
* No diagnosed problems related to the health of the fetus (such as fetal anomaly, intrauterine growth retardation) No risky pregnancy (such as pre-eclampsia, diabetes, heart disease, placenta previa, oligohydramnios)

Exclusion Criteria

* Not having any disabilities that may prevent communication (speech, hearing, mental)
* No chronic or psychiatric illness
* Conception with assisted reproductive techniques
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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

Kırklareli University

OTHER

Sponsor Role lead

Responsible Party

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

Neriman Guducu

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Neriman Güdücü, Dr.

Role: STUDY_DIRECTOR

Kırklareli University

Locations

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

Neriman Güdücü

Kırklareli, Center, Turkey (Türkiye)

Site Status RECRUITING

Countries

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

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Aleyna Yıldız, Midwife

Role: CONTACT

05077136955

Neriman Güdücü, Dr.

Role: CONTACT

05548327328

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Neriman Güdücü, Dr.

Role: primary

05548327328

Other Identifiers

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

PR0478R1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

FETAL MOVEMENT COUNTING
NCT05361265 COMPLETED NA