CClinicalTrials.gg
Not yet recruitingNCT06436794Updated May 31, 2024

"Mantou" Screening for GDM Before 20 Weeks of Gestation

An observational study in GDM, sponsored by Jiang Ziyan. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-31.

Sponsored by Jiang Ziyan · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 2 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,925
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

Gestational diabetes mellitus (GDM) can occur in overweight, hyperinsulinemia, insulin resistance pregnant women, or lean, insulin deficiency pregnant women. At least 5% of all pregnant women will develop GDM, which is even higher among Asians. Poor control of GDM in late pregnancy will increase the following risks: macrosomia, preeclampsia, shoulder dystocia, cesarean section, stillbirth and other risks. At present, the screening method for GDM is 75g of glucose OGTT test. However, when drinking sugared water on an empty stomach, the pregnant women will feel nausea, stomach burning, and hunger when waiting for blood drawing. Some women vomit after drinking sugared water, resulting in inaccurate test results and poor compliance, affecting the accuracy of diagnosis of GDM. "Sugar tolerance Mantou" has been used for screening diabetes since 1982. It is made of 100g flour and contains 75g glucose of the same amount. It is a feasible method to use Mantou instead of sugar powder to screen GDM. Mantou is an acceptable diet for Chinese people, which greatly reduces nausea, vomiting, hunger and other discomfort, and increases GDM screening rate. At present, the cesarean section rate in China remains high, and the weight and nutritional management of pregnant women are not satisfied. Many pregnant women, especially those in country-level areas, have already gained excessive weight when referred from to delivery hospitals, leading to an increase in pregnancy complications such as preeclampsia and macrosomia, increasing the cesarean section rate and delivery risk. Therefore, it is necessary to screen GDM in advance. Moving forward the screening of GDM and strengthening the management of pregnant women's weight can effectively reduce the occurrence of pregnancy complications.

02

Conditions studied

  • GDM
03

In context

Lead sponsor

This is the only study on the registry with Jiang Ziyan as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

pregnant woman

Eligibility criteria

Inclusion Criteria:Singleton , before 20 weeks of gestation, aged 18-40 years old, able to understand the experimental requirements, willing and able to follow the experimental and follow-up procedures.

Exclusion Criteria: diabetes diagnosed before pregnancy, serious heart disease, blood disease, immune system disease and other unsuitable for pregnancy, twin or multiple pregnancy, age\<18 or>40, fetal death in utero before 28 weeks, serious mental illness, and inability to communicate.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,925 participants (estimated)
Patient registry
No

Groups and cohorts

  • 12-14 weeks
  • 15-17 weeks
  • 18-20 weeks
06

What researchers measure

Primary outcomes

  1. GDM incidence rate

    Time frame: up to 28 weeks of gestation

07

Study locations

1 site
  • First Affiliated Hospital of Nanjing Medical University
    Nanjing, Jiangsu, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06436794
Lead sponsor
Jiang Ziyan
Responsible party
Jiang Ziyan (MD, The First Affiliated Hospital with Nanjing Medical University) — Sponsor-investigator
First posted
May 31, 2024
Start date
May 20, 2024 (estimated)
Primary completion
Aug 1, 2025 (estimated)
Completion
May 1, 2026 (estimated)
Last update
May 31, 2024

Study contacts

ziyan jiang
Contact
zyjiangchm@163.com
13512534017

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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