NCT05804448

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
292

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 7, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

April 18, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2026

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

2.9 years

First QC Date

March 27, 2023

Last Update Submit

September 16, 2025

Conditions

Post-Dural Puncture Headache

Keywords

Spinal Anesthesia, Cesarean Section

Outcome Measures

Primary Outcomes (1)

  • Number of patients with postdural puncture headache

    The diagnosis of post-dural puncture headache will be based on the international headache society ICDH-3 criteria: a headache that occurs within 5 days of a dural puncture, is located in the occipital and/or frontal areas, worsens within 15 min of sitting or standing and alleviates within 15 min after lying down, associated with at least one of the following features: neck stiffness, nausea, vomiting, photophobia, and tinnitus, and resolves either spontaneously within 1 week or within 48 h after effective treatment.

    up to 7 days after spinal anesthesia

Secondary Outcomes (3)

  • Number of patients with severity of postdural puncture headache

    up to 7 days after spinal anesthesia

  • Number of patients with non-postdural puncture headache

    up to 7 days after spinal anesthesia

  • Number of patients who received treatment for postdural puncture headache

    up to 1 month after occurrence of PDPH

Study Arms (2)

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.

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.

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Parturients planned for elective and non-elective (category 2 \& 3) caesarean section under spinal anaesthesia.

You may qualify if:

  • 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.

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Karnali Academy of Health Sciences

Jumla, Karnali, 2069, Nepal

RECRUITING

BP Koirala Institute of Health Sciences (BPKIHS)

Dharān, Koshi, 56700, Nepal

RECRUITING

MeSH Terms

Conditions

Post-Dural Puncture Headache

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Asish Subedi, MD

CONTACT

9842040604ashish.subedi@bpkihs.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 27, 2023

First Posted

April 7, 2023

Study Start

April 18, 2023

Primary Completion

March 20, 2026

Study Completion

April 20, 2026

Last Updated

September 19, 2025

Record last verified: 2025-09

Locations

NE(2)