Effect of Altitude on Postdural Puncture Headache After Caesarean Delivery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Post-Dural Puncture Headache. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Nepal
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Altitude on Postdural Puncture Headache After Caesarean Delivery: a Prospective, Multicentre Cohort Study
Overview
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.
Detailed description
This will be a prospective cohort study conducted in two different altitudes in Nepal. The high-altitude site is in Jumla, approximately 2514 m above the sea level, and a low altitude city is Dharan, located at 350 m from sea level.
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
Primary outcome measures
- Number of patients with postdural puncture headache [Time frame: up to 7 days after spinal anesthesia]
Secondary outcome measures (3)
- Number of patients with severity of postdural puncture headache [Time frame: up to 7 days after spinal anesthesia]
- Number of patients with non-postdural puncture headache [Time frame: up to 7 days after spinal anesthesia]
- Number of patients who received treatment for postdural puncture headache [Time frame: up to 1 month after occurrence of PDPH]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Nepal · 2 centers
- Karnali Academy of Health Sciences — Jumla
- BP Koirala Institute of Health Sciences (BPKIHS) — Dharān
Identifiers
NCT: NCT05804448 · 533/2022 P