NCT06900257

Brief Summary

In this study, we aimed to evaluate fetal cardiac functions after a fasting period of at least 10 days. The purpose of this study was to determine the unexpected effects of fasting on fetal cardiac functions.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

March 1, 2025

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 28, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

4 months

First QC Date

March 23, 2025

Last Update Submit

November 16, 2025

Conditions

Keywords

FastingPregnancyFetal echocardiographyFetal health

Outcome Measures

Primary Outcomes (1)

  • Singleton uncomplicated pregnancies with at least 10 days of fasting.

    Fetal echocardiographic findings after at least 10 days of fasting.

Study Arms (2)

Singleton uncomplicated pregnancies with at least 10 days of fasting.

Procedure: Pregnant women who present for routine antenatal follow-up between 24-34 weeks of gestation.

The control group will consist of healthy pregnant women who do not fast, with singleton uncomplicat

Procedure: Pregnant women who present for routine antenatal follow-up between 24-34 weeks of gestation.

Interventions

All singleton uncomplicated pregnancies that present to our hospital for routine antenatal follow-up between 24-34 weeks of gestation will be included in this study.

Singleton uncomplicated pregnancies with at least 10 days of fasting.The control group will consist of healthy pregnant women who do not fast, with singleton uncomplicat

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Singleton uncomplicated pregnancies that present for routine antenatal follow-up between 24-34 weeks of gestation.

You may qualify if:

  • Singleton, uncomplicated pregnancies that have been fasting for at least the last 10 days
  • Present for routine antenatal follow-up between 24-34 weeks of gestation

You may not qualify if:

  • Multiple pregnancy
  • Premature rupture of membranes
  • Chorioamnionitis
  • Placental abruption
  • Severe fetal growth restriction
  • Congenital fetal anomalies
  • Preeclampsia
  • Oligohydramnios
  • Maternal diabetes -Conditions where fasting is contraindicated for the mother. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanliurfa Education and Research Hospital

Sanliurfa, 63100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fasting

Interventions

Pregnancy

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

ReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2025

First Posted

March 28, 2025

Study Start

March 1, 2025

Primary Completion

June 30, 2025

Study Completion

November 30, 2025

Last Updated

November 18, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations