Abnormal Post-partum Glucose Metabolism After Gestational Diabetes Diagnosed Before or After 24 Weeks of Gestation (DG Post-Partum)

Frequency of Abnormal Glucose Metabolism (Diabetes, Impaired Glucose Tolerance, Impaired Fasting Glucose) in the Immediate Postpartum Period Following Gestational Diabetes Diagnosed Before or After 24 Weeks of Gestation

The main objective of the study is to estimate and compare the percentage of patients with abnormal glucose metabolism at 4-12 weeks postpartum between two groups: patients diagnosed with gestational diabetes before or after 24 weeks of pregnancy. Abnormal glucose metabolism is defined as type 2 diabetes, glucose intolerance or impaired fasting glucose.

Study Overview

• Status: Completed
• Conditions: Glucose Intolerance; Type 2 Diabetes; Gestational Diabetes
• Intervention / Treatment: Biological: Post-partum oral glucose tolerance test

Detailed Description

The secondary objectives of this study are to compare between the two groups:

A. the rate of type 2 diabetes only, glucose intolerance only, impaired fasting glucose only, and patients requiring insulin at 4-12 weeks postpartum

B. rates of maternal and obstetric complications

C. risk factors (age, body mass index, personal history of gestational diabetes or macrosomia, first degree family history of diabetes).

D. For fasting glucose done before 24SA, we will calculate the optimal threshold for predicting abnormal glucose metabolism in the immediate postpartum period among women with gestational diabetes.

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• France
  • Arles Cedex, France, 13637
    • CH d'Arles - Hôpital Joseph Imbert
  • Montpellier, France, 34295
    • CHU de Montpellier - Hôpital Lapeyronie
  • Montpellier Cedex 5, France, 34295
    • CHU de Montpellier - Hôpital Arnaud de Villeneuve
  • Nîmes Cedex 9, France, 30029
    • CHU de Nimes - Hopital Universitaire Caremeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The study population is composed of pregnant women consulting before 24 weeks of amenorrhea and who have at least one of the following risk factors: age > 35 years; body mass index > 25; a family history of type 2 diabetes; a history of gestational diabetes or macrosomia.

Description

Inclusion Criteria:

• The patient must have given her informed and signed consent
• The patient must be insured or beneficiary of a health insurance plan
• The patient is available for 10 months of follow-up
• The patient is pregnant and consulting before 24 weeks of amenorrhea AND has at least one of the following risk factors: age > 35 years; body mass index > 25; family history of type 2 diabetes; history of gestational diabetes; history of macrosomia.
• The patient has a fasting blood glucose level >= 0.92 g/l before 24 weeks of amenorrhea OR a fasting blood glucose level < 0.92 g/l before 24 weeks of amenorrhea AND an abnormal oral glucose tolerance test (75 g of glucose) between 24 and 28 weeks of amenorrhea (normal values are set at T0 < 0.92 g/l; T60 < 1.80 g/l; T120 < 1.53 g/l).

Exclusion Criteria:

• The patient is participating in another study
• The patient is in an exclusion period determined by a previous study, with the exception of the following studies: Papillo PMA (RCB 2013-A00538-37), LXRs (RCB 2009-A00968-49), GrossPath (RCB 2014-A01120-47), BAKRI (RCB 2013-A00914-41), OASIS II (RCB 2013-A00773-42), ElastoMAP (RCB 2013-A01148-37), ElastoDéclench (RCB 2014-A00828-39) and UpSideDown (RCB 2014-A01921-46).
• The patient is under judicial protection, under tutorship or curatorship
• The patient refuses to sign the consent
• It is impossible to correctly inform the patient
• The patient cannot read French
• The patient has a known history of type 2 diabetes
• The patient is diagnosed with type 2 diabetes during pregnancy (fasting blood glucose level > 1.26 g/l)
• The patient has a contra-indication for a treatment necessary for this study
• The patient is taking chronic or intermittent oral or inhaled corticosteroids, or a β2 agonist treatment for a previous disease or a disease discovered during pregnancy within one week preceding the fasting glucose or oral glucose tolerance test.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
GD diagnosis before 24 weeks; Patients in this group are diagnosed with gestational diabetes (GD) before 24 weeks of amenorrhea by means of a fasting blood glucose test >= 0.92 g/l. Intervention: Post-partum oral glucose tolerance test	Biological: Post-partum oral glucose tolerance test; All patients will have an oral glucose tolerance test at 4 to 12 weeks after the end of pregnancy. Study representatives will contact patients by phone to remind them of the necessity of this test, and its importance for their health.
GD diagnosed at 24 to 28 weeks; Patients in this group are diagnosed with gestational diabetes between 24 and 28 weeks of amenorrhea based on a normal fasting blood glucose level before 24 weeks of amenorrhea AND an abnormal oral glucose tolerance test between 24 and 28 weeks of amenorrhea. Intervention: Post-partum oral glucose tolerance test	Biological: Post-partum oral glucose tolerance test; All patients will have an oral glucose tolerance test at 4 to 12 weeks after the end of pregnancy. Study representatives will contact patients by phone to remind them of the necessity of this test, and its importance for their health.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence/absence of abnormal glucose metabolism	Includes type 2 diabetes, glucose intolerance and impaired fasting glucose	4 to12 weeks post-partum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence/absence of type 2 diabetes		4 to 12 weeks post partum
Presence/absence of glucose intolerance		4 to 12 weeks post-partum
Presence/absence of impaired fasting glucose	American definition: defined as between 1 and 1.26 g/l	4 to12 weeks post-partum
Presence/absence of impaired fasting glucose	European definition: defined as between 1.1 and 1.26 g/l	4 to12 weeks post-partum
Patient requiring insulin: yes/no		4 to12 weeks post-partum
Presence/absence of complications	This includes a yes/no response for each of the following: caesarean section, hypertension, preeclampsia, urinary tract infection, macrosomia, dystocia, neonatal transfer, respiratory distress, threat of premature birth.	4 to12 weeks post-partum
Baby's weight at birth (kg)		4 to 12 weeks post-partum
Weeks of amenorrhea (duration of pregnancy in weeks/ gestational age)		4 to 12 weeks post-partum
Patient was older than 35 years of age at beginning of pregnancy? yes/no		baseline (day 0)
Body mass index > 25 at beginning of pregnancy? yes/no		baseline (day 0)
First degree family history of type 2 diabetes? yes/no		baseline (day 0)
History of gestational diabetes? yes/no		baseline (day 0)
History of macrosomia? yes/no		baseline (day 0)
Fasting glucose (g/l)		before 24 weeks of amenorrhea
Oral glucose tolerance test results if necessary		24 to 28 weeks of amenorrhea

Other Outcome Measures

Outcome Measure	Time Frame
Body mass index	baseline (day 0)
Age	baseline (day 0)
Number of pregnancies	baseline (day 0)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Study Director: Valéria Cosma, MD, Centre Hospitalier Universitaire de Nîmes; Principal Investigator: Anne-Marie Guedj, MD, Centre Hospitalier Universitaire de Nîmes

Publications and helpful links

General Publications

• Cosma V, Imbernon J, Zagdoun L, Boulot P, Renard E, Brunet C, Mares P, Rodier M, Kabani S, Demattei C, Guedj AM. A prospective cohort study of postpartum glucose metabolic disorders in early versus standard diagnosed gestational diabetes mellitus. Sci Rep. 2021 May 17;11(1):10430. doi: 10.1038/s41598-021-89679-2.

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2014
• Primary Completion (Actual): August 16, 2017
• Study Completion (Actual): August 16, 2017

Study Registration Dates

• First Submitted: April 22, 2013
• First Submitted That Met QC Criteria: April 22, 2013
• First Posted (Estimate): April 24, 2013

Study Record Updates

• Last Update Posted (Actual): January 3, 2018
• Last Update Submitted That Met QC Criteria: January 2, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: impaired fasting glucose; post partum diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Hyperglycemia; Diabetes Mellitus; Glucose Intolerance; Diabetes, Gestational
• Other Study ID Numbers: AOI/2012/VC-01; 2013-A00277-38 (Other Identifier: RCB number)