Colloid Co-hydration and Vasoconstrictor Infusion for Prevention of Hypotension During Cesarean S… (NCT04404946) | Clinical Trial Compass
CompletedNot Applicable
Colloid Co-hydration and Vasoconstrictor Infusion for Prevention of Hypotension During Cesarean Section
Greece120 participantsStarted 2020-05-23
Plain-language summary
This will be a double-blind randomized study, aiming at investigating a fixed rate phenylephrine infusion versus a fixed rate norepinephrine infusion versus placebo in combination with co-hydration with colloids for the prevention of maternal hypotension in elective cesarean section
Who can participate
Age range
18 Years – 48 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* adult parturients, American Society of Anesthesiologists (ASA) I-II,
* singleton gestation\>37 weeks
* elective cesarean section
Exclusion Criteria:
* Body Mass Index (BMI) \>40 kg/m2
* Body weight \<50 kg
* Body weight\>100 kg
* height\<150 cm
* height\>180 cm
* multiple gestation
* fetal abnormality
* fetal distress
* active labor
* cardiac disease
* pregnancy-induced hypertension
* thrombocytopenia
* coagulation abnormalities
* use of antihypertensive medication during pregnancy
* communication or language barriers
* lack of informed consent
* contraindication for regional anesthesia
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial looked at using colloid fluids alongside a vasoconstrictor drip to prevent blood pressure drops during a C-section — is that kind of combination approach something you'd consider for my procedure, and what are the pros and cons compared to what you'd normally do?
2The study specifically measured how often patients developed low blood pressure and slow heart rate during spinal anesthesia for a C-section — how common are those problems in your practice, and how do you currently manage them if they happen?
3Since this trial is now completed, have the results been published or shared anywhere, and do the findings change how you think about managing my blood pressure during the C-section?
4The trial involved a vasoconstrictor being given as a continuous infusion rather than just as needed — is that something available at your hospital, and would it be appropriate for my specific situation?
5Are there standard protocols already in place at your hospital for preventing low blood pressure during spinal anesthesia for a C-section that are similar to what this trial tested, or would this represent a different approach from what I'd normally receive?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.