NCT05202574

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 21, 2022

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

January 21, 2022

Status Verified

January 1, 2022

Enrollment Period

5 months

First QC Date

January 9, 2022

Last Update Submit

January 9, 2022

Conditions

Post-Dural Puncture Headache

Outcome Measures

Primary Outcomes (1)

  • incidence of post-dural puncture hedache

    24 hours post-partum

Secondary Outcomes (1)

  • incidence of post-partum nausea and vomiting

    24 hours post-partum

Study Arms (3)

dexamethasone

ACTIVE COMPARATOR
Drug: Intravenous drug

ondanestrone

ACTIVE COMPARATOR
Drug: Intravenous drug

control group

PLACEBO COMPARATOR
Drug: Intravenous drug

Interventions

Intravenous drugDRUG

intravenous drug injection

control groupdexamethasoneondanestrone

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mina Raouf

ALMinya, Minya Governorate, 6115, Egypt

RECRUITING

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

Infusion Pumps

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Equipment and SuppliesArtificial OrgansSurgical Equipment

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia and ICU

Study Record Dates

First Submitted

January 9, 2022

First Posted

January 21, 2022

Study Start

September 1, 2021

Primary Completion

February 1, 2022

Study Completion

March 1, 2022

Last Updated

January 21, 2022

Record last verified: 2022-01

Locations

EG(1)