CClinicalTrials.gg
Status unknownNCT05202574Updated Jan 21, 2022

Comparing the Effects of Ondansetron Versus Dexamethasone on the Incidence of Post-dural Puncture Headache (PDPH) , Nausea and Vomiting After Spinal Anaesthesia of Parturients Undergoing Caesarean Section

A Phase 2 interventional study of Intravenous drug in Post-Dural Puncture Headache, sponsored by Minia University. Status unknown at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2022-01-21.

Sponsored by Minia University · Phase 2, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Sep 2021, registered Jan 2022).
Phase
Phase 2
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Female
01

Study summary

Comparing dexamethasone and ondanestrone injection in ncidence of postdural puncture headache and post-partum nausea and vomiting

02

Conditions studied

  • Post-Dural Puncture Headache
03

In context

Post-Dural Puncture Headache

125 studies on the registry are indexed under Post-Dural Puncture Headache; 25 are open to participants now.

This study's planned enrollment of 150 is above the median of 80 across 82 interventional studies indexed under Post-Dural Puncture Headache.

Browse Post-Dural Puncture Headache studies →

Lead sponsor

Minia University is the lead sponsor of 356 studies on the registry; 115 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • A total of one hundred and fifty parturients in child bearing period (20-40 years), with BMI of 23-27, and ASA physical status II, who were candidate for elective caesarean section, were enrolled in this prospective randomized study.

Exclusion criteria

Exclusion Criteria:

1 - Lady refusal to participate. 2. All pregnant women candidate for emergency caesarean section elligible for general anaesthesia (GA).

3.presence of any contraindications of dexamethasone (as DM and uncontrolled infection ) or any contraindication of ondansetron (as prolonged QT interval 6. Presence of cardiac, respiratory, hepatic, renal and mental diseases. 7. Coagulopathy, or any contraindication to spinal anaesthesia. 8. Presence of complicated pregnancies (such as pregnancy induced hypertension, placenta previa or eclmpsia).

05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
150 participants (estimated)

Study arms

  • Active comparator
    dexamethasone

    Drug: Intravenous drug

  • Active comparator
    ondanestrone

    Drug: Intravenous drug

  • Placebo comparator
    control group

    Drug: Intravenous drug

Interventions

  • DrugIntravenous drug

    intravenous drug injection

06

What researchers measure

Primary outcomes

  1. incidence of post-dural puncture hedache

    Time frame: 24 hours post-partum

Secondary outcomes

  1. incidence of post-partum nausea and vomiting

    Time frame: 24 hours post-partum

07

Study locations

1 of 1 sites recruiting
  • Mina Raouf
    ALMinya, Minia 6115, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05202574
Lead sponsor
Minia University
Responsible party
Mina Maher (Lecturer of anesthesia and ICU, Minia University) — Principal investigator
First posted
Jan 21, 2022
Start date
Sep 1, 2021
Primary completion
Feb 1, 2022 (estimated)
Completion
Mar 1, 2022 (estimated)
Last update
Jan 21, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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