Comparison of the Effect of Aminophylline, Magnesium Sulphate and Placebo in Prevention of Post Dural Puncture Headache in Parturient Undergoing Caesarean Section.
1 other identifier
observational
630
0 countries
N/A
Brief Summary
This study will be conducted to better comprehend the effect of aminophylline in comparison to magnesium sulphate on preventing and/or treating PDPH.
Trial Health
Trial Health Score
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participants targeted
Target at P75+ for all trials
Started Mar 2024
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2024
CompletedFirst Posted
Study publicly available on registry
February 22, 2024
CompletedStudy Start
First participant enrolled
March 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedFebruary 22, 2024
February 1, 2024
1.1 years
February 15, 2024
February 16, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Effect of the study drugs on the incidence and severity of PDPH
100ml of the prepared study drug intravenously immediately after the baby was delivered and umbilical cord was clamped.
Study Arms (1)
sample size of 630 cases was calculated, divided equally into three groups.
For sample size calculation using Yousefshahi et al. (14) as a reference, a sample size of 630 cases was calculated, divided equally into three groups. This sample size achieves 80% power when the effect size is moderate (=0.12) and using 2 degrees of freedom Chi-Squared test with a significant level of 0.05. Using computer generated randomization program, patients were randomly divided into three equal groups. Group 1: patient received 100 ml IV infusion of normal saline (control group). Group 2: patient received Aminophylline 1.5 mg/kg IV infusion diluted in normal saline with a total volume of 100 ml. Group 3: patient received 50 mg/ kg Magnesium sulfate IV infusion diluted in normal saline with a total volume of 100ml.
Interventions
Comparison of the Effect of Aminophylline, Magnesium Sulphate and Placebo in Prevention of Post Dural Puncture Headache in Parturient Undergoing Caesarean Section
Eligibility Criteria
All parturient who underwent cesarean section under spinal anesthesia. * Patients who are willing to participate in the trial gave an informed consent. * ASA physical status II. * The age ranged from 20 to 40. * Body Mass Index (BMI) ranged from 25 to 30 kg/m2.
You may qualify if:
- All parturient who underwent cesarean section under spinal anesthesia.
- Patients who are willing to participate in the trial gave an informed consent.
- ASA physical status II.
- The age ranged from 20 to 40.
- Body Mass Index (BMI) ranged from 25 to 30 kg/m2.
You may not qualify if:
- Patient refusal.
- Allergy to the studied drugs.
- Patients with contraindications to spinal anesthesia.
- Those with past history of chronic headache or recent onset of acute headache were excluded.
- Women who had multiple punctures (\>2) during the spinal anesthesia procedure were excluded from the study.
- Patients with advanced decompensated cardiac, renal, hepatic disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- doctor
Study Record Dates
First Submitted
February 15, 2024
First Posted
February 22, 2024
Study Start
March 1, 2024
Primary Completion
April 1, 2025
Study Completion
June 1, 2025
Last Updated
February 22, 2024
Record last verified: 2024-02