Association Between Low Plasma Glucose After Oral Glucose Tolerance Test in Pregnancy With Impaired Fetal Growth

January 9, 2020 updated by: Dr. med Flavio Hernández Castro, Hospital Universitario Dr. Jose E. Gonzalez

Objective: To study the association of low maternal plasma glucose in 2 hour 75 g oral glucose tolerance test (OGTT) in women with impaired birth weight and determinate if this result is predictive of low birth weight (<10th percentile according to the INTERGROWTH-21st newborn weight standards for gestational age/sex).

Materials and methods: OGTT at 24-34 week gestation will be performed in pregnant women, the birth weight will be compared between women with low fasting plasma glucose (FPG) (<10th percentile, <65 mg/dL) and normal FPG (≥10th percentile, ≥ 65 mg/dL) also for 1 and 2-hour plasma glucose (1-h PG/2-h PG). Receiver operating characteristic curve analysis will be used to determine the optimal lower OGTT threshold for the prediction of low birth weight.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Maternal hypoglycemia has been reported to be linked with low birth weight and poor neonatal outcome. OGTT is performed routinely in pregnancy and hypoglycemia following this screening test is often encountered and the implication of this finding for the fetal growth is unclear.

The aim of study will be determinate the association of low maternal plasma glucose in OGTT in women with impaired birth weight and determinate if this result is predictive of low birth weight (<10th percentile according to the INTERGROWTH-21st newborn weight standards for gestational age/sex).

The study population will consist of patients with singleton pregnancies who will undergo OGTT at 24-34 weeks, have regular medical checkups throughout their entire pregnancy, deliver on or after 25 week gestation and fulfill inclusion criteria.

The birth weight will be compared between women with low fasting plasma glucose (FPG) (<10th percentile, <65 mg/dL*) and normal FPG (≥10th percentile, ≥ 65 mg/dL) also for 1 and 2-hour plasma glucose (1-h PG/2-h PG). Receiver operating characteristic curve analysis will be used to determine the optimal lower OGTT threshold for the prediction of low birth weight.

This study will be performed according to the standards of the Helsinki Declaration and approval was obtained from the ethics and educational issues coordinating committee of our University Hospital.

*Determinated previously in a pilot study

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Hospital Universitario Dr. Jose Eleuterio González

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

The study population consisted of patients with singleton pregnancies who underwent OGTT at 24-34 weeks, had regular medical checkups throughout their entire pregnancy, had delivered on or after 25 week gestation and had fulfilled inclusion criteria. This study was performed according to the standards of the Helsinki Declaration and approval was obtained from the ethics and educational issues coordinating committee of our University Hospital.

Description

Inclusion Criteria:

  • Women with singleton pregnancy who underwent OGTT at 24-34 weeks and had regular medical checkups throughout their entire pregnancy.
  • Gestational age was determined based on the last menstrual period. If gestational age according to the last menstrual period differed by more than 7 days from that according to ultrasonography at <11 weeks, the latter was used to assign gestational age.

Exclusion Criteria:

  • Inaccurate gestational age
  • OGTT being drawn outside the prescribed window of 24 to 34 weeks gestation.
  • Patients who could not swallow the OGTT solution or vomited afterward were excluded from the study.
  • Patients who were diagnosed with gestational diabetes at any time during their pregnancy were excluded.
  • The following comorbidities or complications that could affect fetal growth also were excluded: cardiac disease, preeclampsia, gestational hypertension, tobacco use, alcohol intake, stimulant drugs use, maternal systemic diseases (e.g., hypertension, pregestational diabetes, autoimmune disease, thrombotic disease, thyroid disease), intrauterine infectious diseases (e.g., cytomegalovirus, rubella, toxoplasmosis, syphilis), major neonatal anomalies or genetic and structural disorders (e.g., trisomy 21, trisomy 18, trisomy 13, congenital heart disease), placental disorders, and umbilical cord abnormalities.
  • Patients with high risk for preeclampsia, intrauterine growth restriction, trisomy 21, trisomy 18 and trisomy 13 in the first trimester screening test.
  • Patients with incomplete or missing data were also excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Low plasma glucose
This group will be formed by women with low plasma glucose: fasting plasma glucose (<10th percentile, <65 mg/dL), 1 or 2-hour low plasma glucose results after OGTT.
Diagnostic test: 2 hour 75 g Oral glucose tolerance test
In pregnant women between 24 and 34 weeks of gestational age, plasma glucose was recorded after an overnight fast. Following consumption of 75 g glucose in 200 mL water over 10 min, the equivalent 1 hour and 2 hour values was recorded
Normal plasma glucose
This group will be formed by women with normal plasma glucose: fasting plasma glucose ( ≥10th percentile, ≥65 mg/dL but < 92 mg/dL), 1 or 2-hour normal glucose (< 180 mg/dL and 153 mg/dL, respectively) results after OGTT.
Diagnostic test: 2 hour 75 g Oral glucose tolerance test
In pregnant women between 24 and 34 weeks of gestational age, plasma glucose was recorded after an overnight fast. Following consumption of 75 g glucose in 200 mL water over 10 min, the equivalent 1 hour and 2 hour values was recorded

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Birth weight <10th percentile
Time Frame: Newborn birth weight delivered on or after 25 week gestation will be recorded within the first hour after delivery
Birth weight <10th percentile according to the INTERGROWTH-21st newborn weight standards for gestational age/sex.
Newborn birth weight delivered on or after 25 week gestation will be recorded within the first hour after delivery
Birthweight <3th percentile
Time Frame: Newborn birth weight delivered on or after 25 week gestation will be recorded within the first hour after delivery
Birthweight <3th percentile according to the INTERGROWTH-21st newborn weight standards for gestational age/sex.
Newborn birth weight delivered on or after 25 week gestation will be recorded within the first hour after delivery
Birth weight <2500 g
Time Frame: Newborn birth weight delivered on or after 37 week gestation will be recorded within the first hour after delivery
Birth weight <2500 g of newborn delivered on or after 37 week gestation
Newborn birth weight delivered on or after 37 week gestation will be recorded within the first hour after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Investigators

  • Principal Investigator: Flavio Hernández Castro, MD PhD, Obstetrics Department Universidad Autónoma de Nuevo León

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

October 28, 2019

Study Completion (Actual)

November 30, 2019

Study Registration Dates

First Submitted

October 28, 2019

First Submitted That Met QC Criteria

October 28, 2019

First Posted (Actual)

October 30, 2019

Study Record Updates

Last Update Posted (Actual)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 9, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GI19-00006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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