NCT05804448 Effect of Altitude on Postdural Puncture Headache After Caesarean Delivery
| NCT ID | NCT05804448 |
| Status | Recruiting |
| Phase | — |
| Sponsor | B.P. Koirala Institute of Health Sciences |
| Condition | Post-Dural Puncture Headache |
| Study Type | OBSERVATIONAL |
| Enrollment | 292 participants |
| Start Date | 2023-04-18 |
| Primary Completion | 2026-03-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 292 participants in total. It began in 2023-04-18 with a primary completion date of 2026-03-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this study is to examine the effects of altitude (high altitude versus low altitude) on incidence and severity of postural puncture headache (PDPH) following spinal anaesthesia for caesarean delivery. The investigators hypothesized that the risk of PDPH would be higher in highlander parturients than in lowlander parturients.
Eligibility Criteria
Inclusion Criteria: * Parturient, aged more than or equal to 18 years * American society of Anesthesiologist 2 and 3 * Scheduled for elective and non-elective (category 2 \& 3) caesarean delivery with spinal anesthesia * Native to their resident altitude i.e., those born, raised, and have continuously lived at the same altitude, at least for the past 1 year. Exclusion Criteria: * Hypertensive disorder * Cerebrovascular disease * Mental disorder (schizophrenia and other psychotic disorders) * Known fetal anomalies * Contraindication to spinal anaesthesia. * Those requiring general anaesthesia for delivery due to failed spinal anesthesia * Major post-delivery complications (severe haemorrhage, sepsis, or ICU admission) * Those who migrate from their resident altitude (either low to high or vice versa) within 7 days post-delivery will also be excluded.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05804448 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Post-Dural Puncture Headache. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05804448 currently recruiting?
Yes, NCT05804448 is actively recruiting participants. Contact the research team at ashish.subedi@bpkihs.edu for enrollment information.
Where is the NCT05804448 trial being conducted?
This trial is being conducted at Jumla, Nepal, Dharān, Nepal.
Who is sponsoring the NCT05804448 clinical trial?
NCT05804448 is sponsored by B.P. Koirala Institute of Health Sciences. The trial plans to enroll 292 participants.