Impact of altitude on headaches after cesarean delivery
Effect of Altitude on Postdural Puncture Headache After Caesarean Delivery: a Prospective, Multicentre Cohort Study
This study is testing how living at different altitudes affects the headaches that women experience after having a cesarean delivery with spinal anesthesia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 292 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | B.P. Koirala Institute of Health Sciences Academic / other |
| Locations | 2 sites (Jumla, Karnali and 1 other locations) |
| Trial ID | NCT05804448 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate how altitude affects the incidence and severity of post-dural puncture headache (PDPH) in parturients undergoing spinal anesthesia for cesarean delivery. Conducted in Nepal, the study compares outcomes between high-altitude (Jumla) and low-altitude (Dharan) settings. Eligible participants will be screened based on specific criteria, and their baseline characteristics, including anxiety and chronic pain conditions, will be recorded. The diagnosis of PDPH will follow the international headache society's criteria.
Who should consider this trial
Good fit: Ideal candidates are parturients aged 18 and older, native to their resident altitude, and scheduled for cesarean delivery with spinal anesthesia.
Not a fit: Patients with hypertensive disorders, cerebrovascular diseases, or those requiring general anesthesia due to failed spinal anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how altitude influences PDPH, potentially guiding better management strategies for parturients.
How similar studies have performed: While studies on PDPH exist, this specific investigation into altitude effects is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Jumla, Karnali and 1 other locations
- Karnali Academy of Health Sciences — Jumla, Karnali, Nepal (Recruiting)
- BP Koirala Institute of Health Sciences (BPKIHS) — Dharān, Koshi, Nepal (Recruiting)
Study contacts
- Study coordinator: Asish Subedi, MD
- Email: ashish.subedi@bpkihs.edu
- Phone: 9842040604
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.