NCT05443152

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 5, 2022

Completed
Last Updated

July 5, 2022

Status Verified

July 1, 2022

Enrollment Period

4 months

First QC Date

June 27, 2022

Last Update Submit

July 1, 2022

Conditions

Keywords

AttachmentPregnancyMaternal attachment

Outcome Measures

Primary Outcomes (1)

  • Prenatal attachment inventory (PAI)

    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 Outcomes (1)

  • Maternal attachment inventory (MAI)

    1-6 months after birth

Study Arms (2)

Experimental Arms

EXPERIMENTAL

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

No İntervention Arms

NO INTERVENTION

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.

Interventions

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.

Experimental Arms

Eligibility Criteria

Age19 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfocused on pregnancy women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University

Kayseri, 38280, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Fetal Movement

Intervention Hierarchy (Ancestors)

Fetal DevelopmentEmbryonic and Fetal DevelopmentMorphogenesisGrowth and DevelopmentPhysiological PhenomenaReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Aysun BADEM, asst. prof.

    ERCİYES UNIVERSİTY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 27, 2022

First Posted

July 5, 2022

Study Start

May 20, 2020

Primary Completion

September 30, 2020

Study Completion

December 30, 2020

Last Updated

July 5, 2022

Record last verified: 2022-07

Locations