Gestational diabetes, Hypertensive pregnancy disorders
Conditions
Interventions
Group 1: Healthy pregnant women from the 1st trimester of gestation
Group 2: Pregnant women with gestational diabetes mellitus (GDM) oder hypertensive pregnancy disorders (pregnancy-induced hypertensi
Sponsors
Universitätsklinikum Leipzig
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Pregnant woman capable of giving consent, aged 18 or over, with good German language and reading comprehension skills, residing in Leipzig (to ensure follow-up examinations) The cohort of healthy pregnant women consists of women who do not have any of the following conditions: chronic hypertension; type 1 (T1D) or type 2 (T2D) diabetes; or risk factors known to correlate with a high risk of pre-eclampsia (PE), such as collagen vascular diseases and vasculitis. Only those who were not diagnosed with SIH, PE, fetal growth restriction, cholestasis or gestational diabetes at the time of delivery remain in the cohort. Gestational diabetes is defined as exceeding one of the reference values in the 75 g oral glucose tolerance test (OGTT). Fasting: >92 mg/dL (5.1 mmol/L); first hour: =180 mg/dL (10.0 mmol/L); second hour: >153 mg/dL (8.5 mmol/L). According to the guideline for the diagnosis and treatment of hypertensive disorders of pregnancy, preeclampsia is defined as newly occurring or pre-existing hypertension (= 140/90 mmHg) during pregnancy with at least one other organ involvement that cannot be attributed to any other cause. The classification into "early-onset" and "late-onset" is based on the time of onset ( 140/90 mmHg) after 20+0 weeks of gestation without accompanying symptoms.
Exclusion criteria
Exclusion criteria: The following general exclusion criteria have been established: - Pre-existing organic diseases of the vocal apparatus, particularly vocal cord paresis - History of vocal cord surgery - Deafness - Illiteracy - Lack of German language comprehension Patients with the following conditions are also excluded: pre-existing chronic hypertension; intrauterine growth restriction; pre-existing structural heart defects or heart failure (according to NYHA criteria); pre-existing nephropathies/glomerulonephritis; pre-existing type 1 or type 2 diabetes mellitus; known vasculitis and/or collagen vascular diseases (e.g. systemic lupus erythematosus), where these conditions lead to pregnancy-independent impairment of kidney function and an increased risk of cardiovascular disease; and fetal chromosomal aberrations or genetic defects associated with fetal growth restriction. Patients with suspected severe fetal structural defects (e.g. heart failure), which can lead to fetal ascites and hydrops fetalis, and are therefore associated with maternal mirror syndrome, are also excluded. Justification for the exclusion criteria: The aforementioned conditions can lead to systemic changes that might distort the endpoints.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Jitter (%) – describes the frequency instability between successive oscillation periods. - Shimmer (%) – measures amplitude instabilities. - Fundamental frequency (f0) - Cepstral Peak Prominence (CPP) at all measurement time points in study arms 1 and 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| - Pitch Perturbation Quotient (PPQ) - Amplitude Perturbation Quotient (APQ) - Harmonics-to-Noise Ratio (HNR) - Signal-to-Noise Ratio (SNR) at all measurement time points in study arms 1 and 2 | — |
Countries
Germany
Contacts
Public ContactAnne Dathan-Stumpf
Universitätsklinikum Leipzig, Abteilung Geburtsmedizin
Outcome results
None listed