| CTRI Number |
CTRI/2017/10/010178 [Registered on: 24/10/2017] Trial Registered Retrospectively |
| Last Modified On: |
29/03/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Observing the influence of Anesthetic Technique on Maternal and Fetal outcome in Category 1 Cesarean Section |
|
Scientific Title of Study
|
Influence of Anesthetic Technique on Maternal and Fetal outcome in Category 1 Cesarean Section: An Observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chitra Rajeswari T |
| Designation |
Assistant Professor |
| Affiliation |
JIPMER |
| Address |
Department of Anaesthesiology and critical care, JIPMER, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9487087311 |
| Fax |
|
| Email |
dr.chitrarajeswari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Chitra Rajeswari T |
| Designation |
Assistant Professor |
| Affiliation |
JIPMER |
| Address |
Department of Anaesthesiology and critical care, JIPMER, Puducherry
PONDICHERRY
605006
India |
| Phone |
9487087311 |
| Fax |
|
| Email |
dr.chitrarajeswari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chitra Rajeswari T |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
Department of Anaesthesiology and critical care, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9487087311 |
| Fax |
|
| Email |
dr.chitrarajeswari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India |
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
Dhanvantri nagar, JIPMER, Gorimedu, Puducherry-605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Chitra Rajeswari T |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
Department of Anaesthesiology and critical care, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Dhanvantri nagar, Gorimedu, Pondicherry
Pondicherry
PONDICHERRY |
919487087311
dr.chitrarajeswari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee (Human studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients coming for Category 1 cesarean section to JIPMER hospital, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Patients coming for category 1 cesarean section |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| i. Fetal outcomes in terms of cord blood Ph, APGAR scores, Admission to NICU and Duration of stay in NICU |
1. At the time of delivery of fetus |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ii. Maternal wellbeing in terms of intra operative complications, postoperative complications and Mortality |
At the time of discharge of the patient |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2016 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
All patients undergoing cesarean section for category 1 indication will be included in this observational study. Pre anaesthetic assessment, premedication and monitoring (ECG, NIBP and SpO2) will be done according to the standard departmental protocol. Anaesthesia technique will be decided by the concerned anesthesiologist. After the delivery of the baby, the umbilical cord blood Ph will be taken by the operating obstetrician. The APGAR scores will be noted. Baby will be shifted to mother’s side or NICU as advised by the attending peadiatrician. If admitted to NICU, the indication and duration of stay will be noted. Any intraoperative complication to the mother will also be observed. Postoperatively all the patients will be followed for any post-operative complications and CCU admission. If admitted to CCU, then the reason for CCU admission, Duration of mechanical ventilation, Duration of hospital stay and Mortality will be noted |