Influence of Tocolytical Medications on Hemodynamics (Central and Peripheral) and Vascular Function in a Pilot Study to Determine the Design of the Final Study and the Final Study Itself
- Registration Number
- NCT00679705
- Lead Sponsor
- University Hospital, Ghent
- Brief Summary
This trial will consist of two parts:
A pilot study in a three-way cross over trial to determine the highest well tolerated dose of Ritodrine (Pre-Par®), the impact of Atosiban (Tractocile®) on the hemodynamics and hence the design of the final study.
The final study is planned as a three-way crossover trial to investigate and compare the cardiovascular effects of Ritodrine, Atosiban and placebo to relate those effects to the pharmacokinetics of Ritodrine and Atosiban (PK/PD modelling).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 23
Inclusion Criteria
- Age between 20 and 40 years old;
- In good health, especially no cardiovascular diseases, obstructive lung diseases, chronic kidney diseases or diabetes mellitus.
- Using a proper anticonception method (orally, subcutaneously);
- A negative pregnancy test.
Exclusion Criteria
- Intolerance of Ritodrine;
- On chronic medication, except oral and subcutaneous contraception
- History or present presentation of cardiac arrythmias;
- Risk of being pregnant or less than 6 months postpartum;
- Giving breastfeeding;
- Previous uteral surgery;
- Using an intra-uteral device (IUD);
- A severe addiction: nicotine (> 10 cigarettes/day), alcohol (> 3 units/day), caffeine (> 5 units/day) or any extralegally drugs.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 3 Placebo Placebo 1 Ritodrine Ritodrine (Pre-Par) 2 Atosiban Atosiban (Tractocile)
- Primary Outcome Measures
Name Time Method Hemodynamical effects of Ritodrine and Atosiban in comparison of those of placebo. 240 minutes
- Secondary Outcome Measures
Name Time Method Effect of the specific dosing levels of the medications on the level of arterial stiffness 240 minutes Effect of the specific dosing levels of the medications on the effects of the peripheral pulse wave reflections on the central, systolic blood pressure 240 minutes Effect of the specific dosing levels of the medications on the distensibility of the blood vessel wall 240 minutes Effect of the specific dosing levels of the medications on the cardiac output and total peripheral resistance 240 minutes Effect of the specific dosing levels of the medications on peripheral brachial, systolic and diastolic blood pressure 240 minutes
Trial Locations
- Locations (1)
University Hospital Ghent
🇧🇪Ghent, Belgium