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Gestational DiabetesDG Post-PartumNCT01839448

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

An observational study of Gestational Diabetes and Type 2 Diabetes, run by Centre Hospitalier Universitaire de Nīmes at 4 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Post-partum oral glucose tolerance test
Type of treatment
Pill or oral medicine
How many people
500 participants
Where
4 sitesFrance
Study dates
27 Mar 2014to 12 Oct 2016
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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).

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

4 sites in 1 country.

France4 sites

  • CH d'Arles - Hôpital Joseph Imbert

    Arles, 13637

  • CHU de Montpellier - Hôpital Arnaud de Villeneuve

    Montpellier, 34295

  • CHU de Montpellier - Hôpital Lapeyronie

    Montpellier, 34295

  • CHU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, 30029

Other trials in France

About this study

Official title: 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.

Read the detailed description

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

  1. the rate of type 2 diabetes only, glucose intolerance only, impaired fasting glucose only, and patients requiring insulin at 4-12 weeks postpartum
  2. rates of maternal and obstetric complications
  3. risk factors (age, body mass index, personal history of gestational diabetes or macrosomia, first degree family history of diabetes).
  4. 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.
Being tested
Post-partum oral glucose tolerance test
Keywords
post partum diabetes, impaired fasting glucose
Medical subject headings
Diabetes, Gestational, Diabetes Mellitus, Type 2, Glucose Intolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Post-partum oral glucose tolerance testBiological

    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.

Study groups in NCT01839448
Study groupRoleWhat they receive
GD diagnosis before 24 weeksPatients 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
Receives: Biological: Post-partum oral glucose tolerance test
GD diagnosed at 24 to 28 weeksPatients 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
Receives: Biological: Post-partum oral glucose tolerance test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Presence/absence of abnormal glucose metabolism

    Includes type 2 diabetes, glucose intolerance and impaired fasting glucose

    Measured: 4 to12 weeks post-partum

Secondary outcomes (15)

  1. Presence/absence of type 2 diabetes

    Measured: 4 to 12 weeks post partum

  2. Presence/absence of glucose intolerance

    Measured: 4 to 12 weeks post-partum

  3. Presence/absence of impaired fasting glucose

    American definition: defined as between 1 and 1.26 g/l

    Measured: 4 to12 weeks post-partum

  4. Presence/absence of impaired fasting glucose

    European definition: defined as between 1.1 and 1.26 g/l

    Measured: 4 to12 weeks post-partum

  5. Patient requiring insulin: yes/no

    Measured: 4 to12 weeks post-partum

  6. 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.

    Measured: 4 to12 weeks post-partum

  7. Baby's weight at birth (kg)

    Measured: 4 to 12 weeks post-partum

  8. Weeks of amenorrhea (duration of pregnancy in weeks/ gestational age)

    Measured: 4 to 12 weeks post-partum

  9. Patient was older than 35 years of age at beginning of pregnancy? yes/no

    Measured: baseline (day 0)

  10. Body mass index > 25 at beginning of pregnancy? yes/no

    Measured: baseline (day 0)

  11. First degree family history of type 2 diabetes? yes/no

    Measured: baseline (day 0)

  12. History of gestational diabetes? yes/no

    Measured: baseline (day 0)

  13. History of macrosomia? yes/no

    Measured: baseline (day 0)

  14. Fasting glucose (g/l)

    Measured: before 24 weeks of amenorrhea

  15. Oral glucose tolerance test results if necessary

    Measured: 24 to 28 weeks of amenorrhea

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2013 (estimated)
  2. Study start27 Mar 2014
  3. Primary completion12 Oct 2016
  4. Study completion12 Oct 2016

Resources

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
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01839448
Sponsor's protocol ID
AOI/2012/VC-01
Other IDs
2013-A00277-38
Acronym
DG Post-Partum
Status last verified
Jan 2018
First submitted
22 Apr 2013
Last updated
19 Nov 2025
Results posted
No
Data monitoring committee
No

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.

    PubMed 34001938

Questions about this trial

What is this clinical trial studying?

An observational study of Gestational Diabetes and Type 2 Diabetes, run by Centre Hospitalier Universitaire de Nīmes at 4 sites in France.

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 5 inclusion and 10 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 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. 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?

Presence/absence of abnormal glucose metabolism (time frame: 4 to12 weeks post-partum). 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 NCT01839448, which also lists 1 linked publication.

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 19 Nov 2025.

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