NCT05314257

Brief Summary

Cardiac disease in pregnancy is a high-risk condition and a major cause of maternal mortality and morbidity. Although direct or immediate death due to cardiovascular disease is rare, it is an important indirect cause of maternal death worldwide, with an attributable rate of two deaths per 100,000 pregnancies. Cardiovascular physiological changes during pregnancy impose an additional load on the cardiovascular system of women with underlying heart disease which increases morbidity and mortality during pregnancy and at the time of delivery. Among cardiac diseases, Rheumatic Heart Disease is the commonest cardiac disease complicating pregnancy.

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
102

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2022

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

First Submitted

Initial submission to the registry

March 29, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

April 6, 2022

Status Verified

March 1, 2022

Enrollment Period

7 months

First QC Date

March 29, 2022

Last Update Submit

March 29, 2022

Conditions

Granisetron

Outcome Measures

Primary Outcomes (1)

  • post-spinal hypotension, and bradycardia

    post-spinal hypotension, and bradycardia in rheumatic patients undergoing elective cesarean section

    24 hours postoperative

Study Arms (2)

Group G

ACTIVE COMPARATOR

IV granisetron 1mg

Drug: Granisetron Hydrochloride

Group C

PLACEBO COMPARATOR

IV 5ml of 0.9% normal saline

Other: 0.9% normal saline

Interventions

Granisetron HydrochlorideDRUG

IV granisetron 1mg

Also known as: granisetron
Group G
0.9% normal salineOTHER

IV 5ml of 0.9% normal saline

Also known as: normal saline
Group C

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Rheumatic female patients in the childbearing period scheduled for elective cesarean sections

You may not qualify if:

  • Patients with eclampsia and pre-eclampsia history,
  • uncontrolled diabetes mellitus, morbid obesity,
  • coagulation abnormalities,
  • vertebral deformities, also patients who refused regional anesthesia,
  • having contraindications to spinal anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut governorate

Asyut, 715715, Egypt

RECRUITING

Related Publications (3)

  • Chatterjee A, Gudiwada B, Mahanty PR, Kumar H, Nag DS, Ganguly PK, Shukla R. Effectiveness of Granisetron in Prevention of Hypotension Following Spinal Anaesthesia in Patients Undergoing Elective Caesarean Section. Cureus. 2020 Dec 16;12(12):e12113. doi: 10.7759/cureus.12113.

    PMID: 33489528BACKGROUND

  • Fakherpour A, Ghaem H, Fattahi Z, Zaree S. Maternal and anaesthesia-related risk factors and incidence of spinal anaesthesia-induced hypotension in elective caesarean section: A multinomial logistic regression. Indian J Anaesth. 2018 Jan;62(1):36-46. doi: 10.4103/ija.IJA_416_17.

    PMID: 29416149BACKGROUND

  • Sharma B, Koirala E, Regmi S, Dhungana J, Neupane BK, Bhattarai S. Rheumatic Heart Disease among Pregnant Women with Cardiac Diseases in a Tertiary Care Center of Nepal: A Descriptive Cross-sectional Study. JNMA J Nepal Med Assoc. 2021 May 25;59(237):468-472. doi: 10.31729/jnma.6177.

    PMID: 34508429BACKGROUND

MeSH Terms

Interventions

GranisetronSaline Solution

Intervention Hierarchy (Ancestors)

Azabicyclo CompoundsAza CompoundsOrganic ChemicalsIndazolesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 29, 2022

First Posted

April 6, 2022

Study Start

April 1, 2022

Primary Completion

November 1, 2022

Study Completion

December 1, 2022

Last Updated

April 6, 2022

Record last verified: 2022-03

Locations

EG(1)