NCT06733272

Brief Summary

Pregnancy is a significant phase in women's lives, marked by psychological, biological, and emotional changes. It lasts for approximately nine months and is divided into three trimesters. Identifying risk factors such as maternal age, gestational age, ethnicity, and lifestyle habits is crucial for managing pregnancy effectively. Anxiety, depression, and stress can significantly impact pregnancy-related responsibilities and overall well-being, making collaboration with a multidisciplinary healthcare team essential. Physical activity during pregnancy offers numerous benefits, including better physical fitness, improved psychological health, weight management, and reduced risk of gestational diabetes. However, studies show that many women are not sufficiently active, particularly in the first trimester, where activity levels tend to be lower. Regular monitoring of thyroid function (TSH levels) and liver enzymes (ALT, AST) is essential to avoid complications, as pregnancy can affect thyroid function and liver health. Additionally, monitoring hemoglobin and hematocrit levels is necessary to manage pregnancy anemia. The proposed study aims to evaluate healthy lifestyle behaviors, physical activity, and biochemical markers among pregnant women in the first trimester, using various questionnaires and laboratory tests. This study will provide valuable insights into maternal health and guide clinical practices during early pregnancy to reduce complications and enhance overall outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
649

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 13, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

July 14, 2025

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

November 27, 2024

Last Update Submit

July 9, 2025

Conditions

Keywords

PregnancyBlood TestsPhysical ActivityHealthy Lifestyle Behaviors

Outcome Measures

Primary Outcomes (1)

  • Biochemistry result

    LOWER AND UPPER LIMIT VALUES FOR SERUM TSH; 0.1 - 2.5 mU/L for the first trimester, 0.2 - 3.0 mU/L for the second trimester and 0.3 - 3.0 mU/L for the third trimester. Reference values should be between AST: 5-40 U/L and ALT: 7-56 U/L.

    1 day

Secondary Outcomes (2)

  • Healthy Lifestyle Behaviors Scale During Pregnancy

    1 day (A one-time survey when the patient first arrives)

  • Pregnancy Physical Activity Questionnaire

    1 day (A one-time survey when the patient first arrives)

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study will be conducted between 15.08.2024 and 15.08.2025. The research will be conducted in Kayseri City Hospital Gynecology and Obstetrics Polyclinic and will be conducted as a single center.

You may qualify if:

  • Singleton pregnancy
  • Maternal age between 18 and 40 years
  • In the first trimester of pregnancy
  • Literate and capable of understanding written materials

You may not qualify if:

  • Multiple pregnancies
  • Non-natural pregnancies
  • Family history of thyroid dysfunction
  • Presence of thyroid dysfunction and/or autoimmunity
  • Clinical diagnosis of Diabetes Mellitus
  • Clinical diagnosis of liver disease
  • Presence of any physical or mental disability
  • Chronic endocrine, autoimmune, or metabolic diseases
  • Voluntary withdrawal from the study
  • Inability to complete the questionnaires included in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kayseri City Hospital

Kayseri, Turkey, 38030, Turkey (Türkiye)

Location

Kayseri City Hospital

Kayseri, 30080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

November 27, 2024

First Posted

December 13, 2024

Study Start

August 15, 2024

Primary Completion

February 15, 2025

Study Completion

April 1, 2025

Last Updated

July 14, 2025

Record last verified: 2024-11

Locations