NCT07765784

Brief Summary

This prospective cross-sectional study examined the relationship between placental weight and early neonatal outcomes, such as blood glucose levels within the first 24 hours and early neonatal morbidities in infants born to mothers with gestational diabetes. levels in the first 24 hours of life and early neonatal morbidities, in infants born to mothers with gestational diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

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

April 1, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2026

Completed
Last Updated

August 14, 2026

Status Verified

August 1, 2026

Enrollment Period

8 months

First QC Date

August 10, 2026

Last Update Submit

August 10, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hypoglycemia

    If the infants had a blood glucose level below the predefined limits, they would be included in the hypoglycemia group.

    8 months

Study Arms (1)

Infants of Gestational Diabetic Mothers

The indants whose mothers has gestational diabetes

Diagnostic Test: Blood Glucose Level

Interventions

Blood Glucose LevelDIAGNOSTIC_TEST

Blood glucose levels of the infants enrolled in the study were checked at the first 30 minutes after birth and at the end of 1,2, 6,24 hours of life.

Infants of Gestational Diabetic Mothers

Eligibility Criteria

Age0 Hours - 2 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Newborn infants who are born to gestational diabetic mothers

You may qualify if:

  • Infants born at the study center
  • a gestational age of ≥35 weeks
  • singleton pregnancies
  • maternal ages between 18 and 35 years

You may not qualify if:

  • preterm birth (\<35 weeks of gestation)
  • referral to another center after delivery
  • presence of chromosomal and/or congenital anomalies
  • maternal conditions other than gestational diabetes
  • lack of parental consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences GOP Training and Research Hospital

Istanbul, Gaziosmanpasa, 34020, Turkey (Türkiye)

Location

Related Publications (1)

  • Sathasivam R, Selliah P, Sivalingarajah R, Mayorathan U, Munasinghe BM. Placental weight and its relationship with the birth weight of term infants and body mass index of the mothers. J Int Med Res. 2023 May;51(5):3000605231172895. doi: 10.1177/03000605231172895.

    PMID: 37194202BACKGROUND

MeSH Terms

Conditions

Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
8 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

August 10, 2026

First Posted

August 14, 2026

Study Start

April 1, 2025

Primary Completion

November 29, 2025

Study Completion

January 1, 2026

Last Updated

August 14, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations