"Mantou" Screening for GDM Before 20 Weeks of Gestation

NCT06436794 | Not Yet Recruiting

• 1 other identifier: MS-GDM-01
• Study Type: observational
• Target: 5,925
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

GDM

Outcome Measures

Primary Outcomes (1)

• GDM incidence rate

  up to 28 weeks of gestation

Study Arms (3)

12-14 weeks

15-17 weeks

18-20 weeks

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

pregnant woman

Sponsors & Collaborators

• Jiang Ziyan: lead

Study Sites (1)

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Location

Central Study Contacts

ziyan jiang

CONTACT

13512534017; zyjiangchm@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: May 31, 2024
• Study Start: May 20, 2024
• Primary Completion: August 1, 2025
• Study Completion: May 1, 2026
• Last Updated: May 31, 2024

Record last verified: 2024-05

Locations

CN (1)