| CTRI Number |
CTRI/2024/05/066787 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
12/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Requirement of phenylephrine to treat fall in blood pressure after spinal anaesthesia in two different types of preeclampsia patients |
|
Scientific Title of Study
|
Comparison of phenylephrine requirements to treat post-spinal hypotension in early onset and late onset preeclampsia patients undergoing caesarean section – An analytical experimental
study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Medha Mohta |
| Designation |
Director Professor |
| Affiliation |
University College of Medical Sciences and Guru Teg Bahadur Hospital |
| Address |
Department of Anaesthesiology and Critical Care
University College of Medical Sciences and Guru Teg Bahadur Hospital
East
DELHI
110095
India |
| Phone |
9625900626 |
| Fax |
|
| Email |
medhamohta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Medha Mohta |
| Designation |
Director Professor |
| Affiliation |
University College of Medical Sciences and Guru Teg Bahadur Hospital |
| Address |
Department of Anaesthesiology and Critical Care
University College of Medical Sciences and Guru Teg Bahadur Hospital
East
DELHI
110095
India |
| Phone |
9625900626 |
| Fax |
|
| Email |
medhamohta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devika S Prakash |
| Designation |
Post-graduate student |
| Affiliation |
University College of Medical Sciences and Guru Teg Bahadur Hospital |
| Address |
Department of Anaesthesiology and Critical Care
University College of Medical Sciences and Guru Teg Bahadur Hospital
East
DELHI
110095
India |
| Phone |
7428078744 |
| Fax |
|
| Email |
devikaspra@gmail.com |
|
|
Source of Monetary or Material Support
|
| University College of Medical Sciences and Guru Teg Bahadur Hospital, Dilshad Garden, Delhi-110095, India |
|
|
Primary Sponsor
|
| Name |
University College of Medical Sciences and Guru Teg Bahadur Hospital |
| Address |
University College of Medical Sciences and Guru Teg Bahadur Hospital, Dishad Garden, Delhi 110095 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Medha Mohta |
University College of Medical Sciences and Guru Teg bahadur Hospital |
Anaesthesia office, Department of Anaesthesiology and
Critical Care, 2nd Floor,
OT Block
East
DELHI |
9625900626
medhamohta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Human Research (IEC-HR), University College of Medical Sciences, University of Delhi, Delhi -110095 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O149||Unspecified pre-eclampsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Early onset preeclampsia |
Phenylephrine bolus administration for treatment of hypotension in
patients with early onset preeclampsia undergoing caesarean section under spinal
anaesthesia from the time of administration of spinal anaesthesia to the time of delivery of baby |
| Comparator Agent |
Late onset preeclampsia |
Phenylephrine bolus administration for treatment of hypotension in
patients with late onset preeclampsia undergoing caesarean section under spinal
anaesthesia from the time of administration of spinal anaesthesia to the time of delivery of baby |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Preeclamptic females with singleton pregnancy of 34 weeks gestation or more undergoing caesarean
section under spinal anaesthesia
|
|
| ExclusionCriteria |
| Details |
1. Maternal complications other than preeclampsia such as chronic hypertension, other cardiovascular
disease, cerebrovascular disease
2. Multiple gestation
3. Eclampsia
4. Known fetal abnormality
5. Patients with absolute or relative contra-indications for spinal anaesthesia
6. Severe fetal distress or other conditions requiring immediate induction of general anaesthesia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total phenylephrine requirements |
From the time of administration of spinal anaesthesia to the time of delivery of baby |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Maternal haemodynamic variables
2. Total number of hypotensive episodes
3. Incidence of reactive hypertension & bradycardia
4. Neonatal Apgar scores & fetal acid-base status
5. Maternal complications such as nausea, vomiting, dizziness or any other complications |
From the time of administration of spinal anaesthesia to the time of delivery of baby |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Spinal anaesthesia will be administered with hyperbaric 0.5% bupivacaine with 10 microg fentanyl. Hypotension after spinal anaesthesia will be defined as a fall of systolic blood pressure of 20% or more from baseline. Phenylephrine bolus of 50 microg will be administered to treat every hypotensive blood pressure value. Umbilical arterial and venous blood samples of the fetus will be obtained for blood gas analysis. After the procedure, on the basis of history from the patient/relatives and discussion with the
obstetrician, the patient will be allocated to either early or late onset preeclampsia group. The total phenylephrine requirements, maternal haemodynamic variables, number of hypotensive episodes, incidence of reactive hypertension and bradycardia, neonatal Apgar scores, fetal acid-base status and maternal complications will be recorded. |