Pregnancy complications: challenge and/or chance for further cardiovascular risk in later life?

Not Applicable

• Conditions: O24; O14; Diabetes mellitus in pregnancy; Pre-eclampsia

• Registration Number: DRKS00024606
• Lead Sponsor: Medizinische Universität Graz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-08-20
• Study Start: 2021-03-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 60

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change of heart rate variability between visit 1 and visit 2 in reference to each group.

Secondary Outcome Measures

Name	Time	Method
- Changes of hemodynamic parameters between visit 1 and visit 2<br>- Changes in psychological parameters between visit 1 and visit 2<br>- Changes in cardiovascular parameters between visit 1 and visit 2<br>