Changes in Ventilation Inhomogeneity and Respiratory Function Following Elective Caesarean Sectio… (NCT02714556) | Clinical Trial Compass
WithdrawnNot Applicable
Changes in Ventilation Inhomogeneity and Respiratory Function Following Elective Caesarean Section Under Regional Anaesthesia
Stopped: Ethical approval not obtained yet as questioning the danger of providing 100% oxygen to parturients.
Switzerland0Started 2016-05
Plain-language summary
Pregnancy is associated with physiological changes affecting the cardiorespiratory system as a consequence of an increase in both cardiac output and intra-abdominal pressure. The aim of this prospective observational study is to examine the perioperative changes in ventilation inhomogeneity and respiratory function measured by the non-invasive nitrogen multiple breath washout and forced oscillation techniques.
Who can participate
Age range
18 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:
* Written informed consent
* Pregnant woman in the third trimester (37-40 weeks gestational age)
* Scheduled for elective caesarean section under regional (spinal or combined spinal-epidural) anaesthesia
Exclusion Criteria:
* Pregnant women outside 37-40 weeks gestational age
* Non-singleton pregnancy
* Previous history of ≥2 caesarean sections
* History or clinical signs of cardiopulmonary disease in the last 12 months (chronic hypertension, gestational hypertension, preeclampsia, asthma, acute or chronic bronchitis, others)
* Positive current smoking status
* Pre-pregnant body mass index (BMI) \>30 kg/m2 (based on booking records)
* Respiratory infection \<2 weeks prior to surgery
* Inability to perform the respiratory function tests
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
What they're measuring
1
Perioperative changes in ventilation inhomogeneity (LCI) following delivery by caesarean section
Timeframe: 1-3 days prior to caesarean section until 5 days postoperative