Actively Recruiting
Effect of Altitude on Postdural Puncture Headache After Caesarean Delivery: a Prospective, Multicentre Cohort Study
Led by B.P. Koirala Institute of Health Sciences · Updated on 2025-09-19
292
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
Sponsors
B
B.P. Koirala Institute of Health Sciences
Lead Sponsor
K
Karnali Academy of Health Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of altitude on the occurrence and severity of postdural puncture headache (PDPH) after spinal anesthesia during caesarean delivery. This observational study compares women living at high altitude (above 2500 m) with those living at low altitude (below 500 m) in Nepal. The goal is to understand if living at higher elevations increases the risk of PDPH following spinal anesthesia. The study involves two groups: parturients native to high altitudes and those native to low altitudes, both receiving spinal anesthesia for caesarean section using a 25-gauge pencil point spinal needle. Researchers will collect baseline information including anxiety, depression, chronic pain, or previous headaches. The diagnosis of PDPH will follow international headache criteria and will be assessed up to 7 days after spinal anesthesia. Participants will be monitored for headache occurrence, severity, and whether treatments were needed within one month after PDPH onset. Data on other types of headaches will also be collected. The study will record patient characteristics and anesthesia details, with follow-up for up to one month after delivery. Participants will be observed for any complications, and results will help clarify how altitude influences PDPH risk.
CONDITIONS
Brief Title
Effect of Altitude on Postdural Puncture Headache After Caesarean Delivery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female parturient aged 18 years or older
- Classified as American Society of Anesthesiologists (ASA) physical status 2 or 3
- Scheduled for elective or non-elective caesarean delivery (category 2 or 3) with spinal anesthesia
- Native to their resident altitude, living continuously at the same altitude for at least 1 year
You will not qualify if you...
- Hypertensive disorder
- Cerebrovascular disease
- Mental disorders including schizophrenia and other psychotic disorders
- Known fetal anomalies
- Contraindication to spinal anesthesia
- Need for general anesthesia due to failed spinal anesthesia
- Major post-delivery complications such as severe hemorrhage, sepsis, or ICU admission
- Migration from resident altitude within 7 days after delivery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 7 days after spinal anesthesia
Participants who undergo caesarean delivery with spinal anesthesia at their resident altitude are observed for postdural puncture headache and related outcomes.
Daily assessments up to 7 days post-procedure
Duration - Up to 1 month after occurrence of postdural puncture headache
Participants who develop postdural puncture headache are followed up to monitor any treatment received.
Follow-up visits as needed depending on headache occurrence
Trial Site Locations
Total: 2 locations
1
Karnali Academy of Health Sciences
Jumla, Karnali, Nepal, 2069
Actively Recruiting
2
BP Koirala Institute of Health Sciences (BPKIHS)
Dharān, Koshi, Nepal, 56700
Actively Recruiting
Research Team
A
Asish Subedi, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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