O24 O14
Conditions
Interventions
Group 1: Women with complication-free pregnanciens that will attend two visits after giving childbirth participating in non-invasive physiological, cardiovascular, psychological and hormonal measureme
Sponsors
Medizinische Universität Graz
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: Group 1, uncomplicated pregnancy: - uncomplicated singleton pregnancy with term delivery Group 2, pregnancies complicated by gestational diabetes if the woman has either: - a fasting plasma glucose level of 5.6mmol/litre or above or - a 2-hour plasma glucose level of 7.8mmol/litre or above. [NICE guideline, 2015] or Plasma glucose values exceeding the following criteria (within 24th -28th week of gestation): - fasting: = 92 mg/dl (5.1 mmol/l) - 1h: = 180 mg/dl (10.0 mmol/l) - 2h: = 153 mg/dl (8.5 mmol/l) Group 3, pregnancies complicated by preeclampsia Systolic blood pressure = 140 mmHg and/or diastolic blood pressure = 90 mmHg, present = 20 weeks’ gestation and return to normotensive values within 12 weeks postpartum. Blood pressure measured twice, at least 4 h apart. - Proteinuria (one of the following): o Protein = 300 mg per 24-h urine collection o Protein/creatinine ratio =0.3 o Protein =30 mg/dL or 1+ on urine dipstick - Same as preeclampsia defined above, except one of the following must be present and proteinuria is not required (defined as subgroup “severe features of preeclampsia”): o Systolic blood pressure =160 mmHg, measured twice at least 15 min apart o Diastolic blood pressure =110 mmHg, measured twice at least 15 min apart o Thrombocytopenia: platelet count <100,000/microliter o Impaired liver function: AST or ALT =70 units/L or twice the normal concentration o Renal insufficiency: serum creatinine =1.1 mg/dL or doubled from baseline values o Pulmonary edema o Symptoms indicating possible cerebral or neurologic involvement: head-ache or visual changes (e.g. flashing, blurring, visual loss, blindness)
Exclusion criteria
Exclusion criteria: Group 1, uncomplicated pregnancy: - Elective caesarean section - Medical history with pathological findings Group 2, pregnancies complicated by gestational diabetes Preexisting Tpye1 Diabetes mellitus - Renal disease - Chronic hypertension - Antiphosholipid antibody syndrome - Kidney transplant - Hypothyroidism - Pre-existing cardiovascular problems - Seizures Group 3, pregnancies complicated by preeclampsia - Diabetes mellitus - Renal disease - Chronic hypertension - Antiphosholipid antibody syndrome - Kidney transplant - Hypothyroidism - Pre-existing cardiovascular problems - Seizures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of heart rate variability between visit 1 and visit 2 in reference to each group. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Changes of hemodynamic parameters between visit 1 and visit 2 - Changes in psychological parameters between visit 1 and visit 2 - Changes in cardiovascular parameters between visit 1 and visit 2 | — |
Countries
Austria
Contacts
Public ContactHelmut Lackner
Medizinische Universität Graz
Outcome results
None listed