Oral Glucose Tolerance TestNCT04144595
Association Between Low Plasma Glucose After Oral Glucose Tolerance Test in Pregnancy With Impaired Fetal Growth
An observational study of Oral Glucose Tolerance Test and Low Birth Weight, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
Trial summary
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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oral Glucose Tolerance Test, Low Birth Weight
- What is being tested?
- 2 hour 75 g Oral glucose tolerance test
- Type of treatment
- Pill or oral medicine
- How many people
- 300 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jan 2019to 30 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Universitario Dr. José Eleuterio González
Monterrey, Nuevo León, 64460
About this study
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.
Read the 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
- Conditions
- Oral Glucose Tolerance Test, Low Birth Weight
- Being tested
- 2 hour 75 g Oral glucose tolerance test
- Keywords
- Glucose Tolerance Test, Low Birth Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 hour 75 g Oral glucose tolerance testDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: 2 hour 75 g Oral glucose tolerance test | |
| 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. Receives: Diagnostic Test: 2 hour 75 g Oral glucose tolerance test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth weight <10th percentile
Birth weight <10th percentile according to the INTERGROWTH-21st newborn weight standards for gestational age/sex.
Measured: Newborn birth weight delivered on or after 25 week gestation will be recorded within the first hour after delivery
Birthweight <3th percentile
Birthweight <3th percentile according to the INTERGROWTH-21st newborn weight standards for gestational age/sex.
Measured: Newborn birth weight delivered on or after 25 week gestation will be recorded within the first hour after delivery
Birth weight <2500 g
Birth weight <2500 g of newborn delivered on or after 37 week gestation
Measured: Newborn birth weight delivered on or after 37 week gestation will be recorded within the first hour after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start1 Jan 2019
- Primary completion28 Oct 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Oral Glucose Tolerance TestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med Flavio Hernández Castro, Hospital Universitario Dr. Jose E. Gonzalez
- Investigators
- Flavio Hernández Castro, MD PhD, Principal investigator, Obstetrics Department Universidad Autónoma de Nuevo León
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04144595
- Sponsor's protocol ID
- GI19-00006
- Status last verified
- Jan 2020
- First submitted
- 28 Oct 2019
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nayak AU, Vijay AMA, Indusekhar R, Kalidindi S, Katreddy VM, Varadhan L. Association of hypoglycaemia in screening oral glucose tolerance test in pregnancy with low birth weight fetus. World J Diabetes. 2019 May 15;10(5):304-310. doi: 10.4239/wjd.v10.i5.304.
PubMed 31139317Shinohara S, Uchida Y, Hirai M, Hirata S, Suzuki K. Relationship between maternal hypoglycaemia and small-for-gestational-age infants according to maternal weight status: a retrospective cohort study in two hospitals. BMJ Open. 2016 Dec 2;6(12):e013749. doi: 10.1136/bmjopen-2016-013749.
PubMed 27913562Topcu HO, Iskender CT, Celen S, Oskovi A, Uygur D, Erkaya S. Maternal hypoglycemia on 50 g glucose challenge test: outcomes are influenced by fetal gender. J Perinat Med. 2016 May 1;44(4):369-76. doi: 10.1515/jpm-2015-0060.
PubMed 25918915Rogne T, Jacobsen GW. Association between low blood glucose increase during glucose tolerance tests in pregnancy and impaired fetal growth. Acta Obstet Gynecol Scand. 2014 Nov;93(11):1160-9. doi: 10.1111/aogs.12365. Epub 2014 Mar 26.
PubMed 24576054Melamed N, Hiersch L, Peled Y, Hod M, Wiznitzer A, Yogev Y. The association between low 50 g glucose challenge test result and fetal growth restriction. J Matern Fetal Neonatal Med. 2013 Jul;26(11):1107-11. doi: 10.3109/14767058.2013.770460. Epub 2013 Feb 27.
PubMed 23350735Vadakekut ES, McCoy SJ, Payton ME. Association of maternal hypoglycemia with low birth weight and low placental weight: a retrospective investigation. J Am Osteopath Assoc. 2011 Mar;111(3):148-52.
PubMed 21464263Feinberg JH, Magann EF, Morrison JC, Holman JR, Polizzotto MJ. Does maternal hypoglycemia during screening glucose assessment identify a pregnancy at-risk for adverse perinatal outcome? J Perinatol. 2005 Aug;25(8):509-13. doi: 10.1038/sj.jp.7211336.
PubMed 15908987Leng J, Hay J, Liu G, Zhang J, Wang J, Liu H, Yang X, Liu J. Small-for-gestational age and its association with maternal blood glucose, body mass index and stature: a perinatal cohort study among Chinese women. BMJ Open. 2016 Sep 15;6(9):e010984. doi: 10.1136/bmjopen-2015-010984.
PubMed 27633632Hernandez-Castro F, Berlanga-Garza A, Cruz-Gutierrez MD, Soria-Lopez JA, Villagomez-Martinez GE, Davila-Escamilla IV. Prediction of low birth weight with hypoglycemia in glucose tolerance test. Rev Saude Publica. 2021 May 17;55:30. doi: 10.11606/s1518-8787.2021055002543. eCollection 2021.
PubMed 34008784
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Low Plasma Glucose After Oral Glucose Tolerance Test in Pregnancy With Impaired Fetal Growth
- ClinicalTrials.gov ID
- NCT04144595
- Acronym / sponsor ID
- GI19-00006
- Conditions
- Oral Glucose Tolerance Test, Low Birth Weight
- Keywords
- Glucose Tolerance Test, Low Birth Weight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 28 Oct 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 30 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low plasma glucose | – | Diagnostic Test: 2 hour 75 g Oral glucose tolerance testThis 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. |
| Normal plasma glucose | – | Diagnostic Test: 2 hour 75 g Oral glucose tolerance testThis 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2 hour 75 g Oral glucose tolerance testIn 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 | Diagnostic test | Low plasma glucose, Normal plasma glucose |
Primary outcome
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.
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Results publication: PubMed 31139317Nayak AU, Vijay AMA, Indusekhar R, Kalidindi S, Katreddy VM, Varadhan L. Association of hypoglycaemia in screening oral glucose tolerance test in pregnancy with low birth weight fetus. World J Diabetes. 2019 May 15;10(5):304-310. doi: 10.4239/wjd.v10.i5.304.
- Results publication: PubMed 27913562Shinohara S, Uchida Y, Hirai M, Hirata S, Suzuki K. Relationship between maternal hypoglycaemia and small-for-gestational-age infants according to maternal weight status: a retrospective cohort study in two hospitals. BMJ Open. 2016 Dec 2;6(12):e013749. doi: 10.1136/bmjopen-2016-013749.
- Results publication: PubMed 25918915Topcu HO, Iskender CT, Celen S, Oskovi A, Uygur D, Erkaya S. Maternal hypoglycemia on 50 g glucose challenge test: outcomes are influenced by fetal gender. J Perinat Med. 2016 May 1;44(4):369-76. doi: 10.1515/jpm-2015-0060.
- Results publication: PubMed 24576054Rogne T, Jacobsen GW. Association between low blood glucose increase during glucose tolerance tests in pregnancy and impaired fetal growth. Acta Obstet Gynecol Scand. 2014 Nov;93(11):1160-9. doi: 10.1111/aogs.12365. Epub 2014 Mar 26.
- Results publication: PubMed 23350735Melamed N, Hiersch L, Peled Y, Hod M, Wiznitzer A, Yogev Y. The association between low 50 g glucose challenge test result and fetal growth restriction. J Matern Fetal Neonatal Med. 2013 Jul;26(11):1107-11. doi: 10.3109/14767058.2013.770460. Epub 2013 Feb 27.
- Results publication: PubMed 21464263Vadakekut ES, McCoy SJ, Payton ME. Association of maternal hypoglycemia with low birth weight and low placental weight: a retrospective investigation. J Am Osteopath Assoc. 2011 Mar;111(3):148-52.
- Results publication: PubMed 15908987Feinberg JH, Magann EF, Morrison JC, Holman JR, Polizzotto MJ. Does maternal hypoglycemia during screening glucose assessment identify a pregnancy at-risk for adverse perinatal outcome? J Perinatol. 2005 Aug;25(8):509-13. doi: 10.1038/sj.jp.7211336.
- Results publication: PubMed 27633632Leng J, Hay J, Liu G, Zhang J, Wang J, Liu H, Yang X, Liu J. Small-for-gestational age and its association with maternal blood glucose, body mass index and stature: a perinatal cohort study among Chinese women. BMJ Open. 2016 Sep 15;6(9):e010984. doi: 10.1136/bmjopen-2015-010984.
- Derived from this study: PubMed 34008784Hernandez-Castro F, Berlanga-Garza A, Cruz-Gutierrez MD, Soria-Lopez JA, Villagomez-Martinez GE, Davila-Escamilla IV. Prediction of low birth weight with hypoglycemia in glucose tolerance test. Rev Saude Publica. 2021 May 17;55:30. doi: 10.11606/s1518-8787.2021055002543. eCollection 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Flavio Hernández Castro, MD PhD principal investigator
Obstetrics Department Universidad Autónoma de Nuevo León
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Glucose Tolerance Test and Low Birth Weight, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04144595, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.