Effect of Altitude on Postdural Puncture Headache After Caesarean Delivery
NCT ID: NCT05804448
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
292 participants
OBSERVATIONAL
2023-04-18
2026-04-20
Brief Summary
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Detailed Description
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The investigators will screen the eligible participant admitted to the in-patient obstetric unit. The investigator will also record patient baseline characteristics, preoperative anxiety, antenatal depression, presence of chronic pain conditions or preexisting headache. Spinal anaesthesia will be administered in the sitting position at the L3-L4 or L4-L5 interspace using a 25-G pencil point spinal needle (Pencan® 25-gauge).
The diagnosis of post-dural puncture headache will be based on the international headache society ICDH-3 criteria
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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High-altitude group
Parturient who are native to their resident altitude, i.e. residing at the altitude above 2500 m from sea level will receive spinal anesthesia for caesarean section.
No interventions assigned to this group
Low-altitude group
Parturient who are native to their resident altitude, i.e. residing at the altitude below 500 m from sea level will receive spinal anesthesia for caesarean section.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Karnali Academy of Health Sciences
OTHER
B.P. Koirala Institute of Health Sciences
OTHER
Responsible Party
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Dr Asish Subedi
Principal Investigator
Locations
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Karnali Academy of Health Sciences
Jumla, Karnali, Nepal
BP Koirala Institute of Health Sciences (BPKIHS)
Dharān, Koshi, Nepal
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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533/2022 P
Identifier Type: -
Identifier Source: org_study_id
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