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Glycemic control as a predictive factor of rectovaginal Group B Streptococcus colonization in pregnant women with gestational diabetes mellitus: A cohort study

Glycemic control as a predictive factor of rectovaginal Group B Streptococcus colonization in pregnant women with gestational diabetes mellitus: A prospective cohort study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
TCTR
Registry ID
TCTR20251027013
Enrollment
215
Registered
2025-10-27
Start date
2025-12-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational diabetes mellitus and Group B Streptococcus colonization in pregnancy. Glycemic control , Group B Streptococcus colonization , gestational diabetes mellitus

Interventions

pregnant women with gestational diabetes mellitus whose self-monitoring blood glucose (SMBG) target levels greater than or equal to 30 percent of 56 measurements before rectovaginal swab collection ha
Prevention
gestational diabetes mellutus

Sponsors

HRH Princess Maha Chakri Sirindhorn Medical Center
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Pregnant women, both primigravida and multigravida, aged over 18 years. 2. Diagnosed with gestational diabetes mellitus (GDM) according to ACOG 2018 criteria. 3. Underwent Group B Streptococcus (GBS) culture screening between 35 weeks 0 days and 37 weeks 6 days of gestation. 4. Complete self-monitoring blood glucose (SMBG) records available for 56 measurements (covering approximately two weeks) prior to GBS rectovaginal swab collection. SMBG data include fasting, 1-hour postprandial, and/or 2-hour postprandial glucose values. If the participant forgets to record some measurements, data will be retrieved from the glucometer device. In cases of missing data, investigators will retrospectively collect daily SMBG values until a total of 56 readings is achieved. If some readings are incomplete for a given day, those available values will still be included and subsequent days will be reviewed until all 56 readings are obtained. Participants will be categorized into two groups based on glycemic control level: Well-controlled GDM: less than 30 percent of SMBG values exceed target levels. Poorly controlled GDM: At least 30 percent of SMBG values exceed target levels.

Exclusion criteria

Exclusion criteria: 1. Received any antibiotic therapy for greater than or equal to 7 days within 4 weeks before the scheduled rectovaginal swab collection. 2. Presence of immunocompromised conditions that may interfere with GBS detection, such as HIV infection with CD4 count less than 200 , current chemotherapy, or high-dose immunosuppressive therapy. 3. Pregnancy complications requiring preterm delivery before 34 weeks of gestation, such as pregnancy-induced hypertension with severe features, eclampsia, or severe fetal growth restriction. 4. Pregnant women with pregestational diabetes mellitus, or those previously diagnosed with diabetes before the current pregnancy.

Design outcomes

Primary

MeasureTime frame
GBS colonization by rectovaginal swab culture between 35 weeks 0 days and 37 weeks 6 days of gestation 4 weeks Glycemic control

Secondary

MeasureTime frame
To identify factors associated with Group B Streptococcus (GBS) colonization among pregnant women diagnosed with gestational diabetes mellitus (GDM). 4 weeks BMI , mutiparity , neonatal outcome

Countries

Thailand

Contacts

Public ContactMonchai Santipap

Srinakharinwirot university

monchai@g.swu.ac.th0373954515

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026