| CTRI Number |
CTRI/2025/12/098385 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
02/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Correlation between maternal arterial blood gas parameters with that of neonatal APGAR score in patients with severe pre-eclampsia. |
|
Scientific Title of Study
|
To study the correlation between maternal arterial blood gas parameters with that of neonatal APGAR score in patients with severe pre-eclampsia: a prospective cohort 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 |
Himanshu Bisen |
| Designation |
Junior Resident |
| Affiliation |
AIIMS RAIPUR |
| Address |
B Block, 4th floor, Department of Anesthesia Office, AIIMS Raipur, Tatibandh, Raipur Chhattisgarh.
Raipur CHHATTISGARH 492099 India |
| Phone |
09039242339 |
| Fax |
|
| Email |
himanshubisen7@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Himanshu Bisen |
| Designation |
Junior Resident |
| Affiliation |
AIIMS RAIPUR |
| Address |
B Block, 4th floor, Department of Anesthesia Office, AIIMS Raipur, Tatibandh, Raipur Chhattisgarh.
CHHATTISGARH 492099 India |
| Phone |
09039242339 |
| Fax |
|
| Email |
himanshubisen7@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Himanshu Bisen |
| Designation |
Junior Resident |
| Affiliation |
AIIMS RAIPUR |
| Address |
B Block, 4th floor, Department of Anesthesia Office, AIIMS Raipur, Tatibandh, Raipur Chhattisgarh.
CHHATTISGARH 492099 India |
| Phone |
09039242339 |
| Fax |
|
| Email |
himanshubisen7@gmail.com |
|
|
Source of Monetary or Material Support
|
| B Block, 4th floor, Department of Anesthesia Office, AIIMS Raipur, Tatibandh, Raipur Chhattisgarh, INDIA , PIN CODE 492099. |
|
|
Primary Sponsor
|
| Name |
Himanshu Bisen |
| Address |
B Block, 4th floor, Department of Anesthesia Office, AIIMS Raipur, Tatibandh, Raipur Chhattisgarh, INDIA , PIN CODE 492099. |
| Type of Sponsor |
Research institution |
|
|
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 Himanshu Bisen |
AIIMS Raipur |
B Block, 4th floor, Department of Anesthesia Office, AIIMS Raipur, Tatibandh, Raipur Chhattisgarh. Raipur CHHATTISGARH |
09039242339
himanshubisen7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O141||Severe pre-eclampsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant patients aged more then or equal to 18 years, period of gestation more then or equal to 36 weeks, singleton pregnancy, presenting with features of severe pre-eclampsia, undergoing termination of pregnancy
|
|
| ExclusionCriteria |
| Details |
Patient refusal, patients suffering from cardiac, respiratory, renal or liver disease, antepartum hemorrhage or maternal trauma, positive allen’s test in both hand, congenital fetal anomaly, platelet count less then 50,000/µL.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Arterial blood gas parameters in patients with severe pre-eclampsia may determine the severity of disease to a certain degree in combination with the neonates Apgar score, help monitoring and intervention of infants to be born. |
APGAR score will be noted at 1 minute and 5 minutes after birth of the child. ABG parameters of the patient at the time of admission, 6 hours after admission, before delivery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Neonatal outcome in terms of need for resuscitation, requirement of NICU admission, any other adverse neonatal outcome. |
First 24 hours after delivery. |
|
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Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/12/2025 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
The study will be started after obtaining approval from the Institute Ethics Committee (IEC) and written & informed consent from the participants. Sixty potential participants fulfilling the eligibility criteria and willing to participate will be enrolled in this study. The details of the study will be explained to the participants prior to the procedure. On admission of patients with features of severe pre-eclampsia, demographic and obstetric data of the patients will be noted. Basal vital parameters of the patients including SBP, DBP, MAP, HR, RR, SpO2 will be recorded. As per standard institutional protocol blood sample will be drawn and will be sent to the laboratory for analysis of CBC, LFT, RFT, Serum Electrolytes, Coagulation profile, Blood grouping/ cross matching, Blood sugars, Urine Routine Microscopy, HIV, HBsAg, HCV etc. In Allen’s test, both hands were tested concurrently compressing one artery of each hand simultaneously. But in Modified Allen’s Test (MAT) each hand is examined separately. The subjects were asked to sit comfortably and instructed not to hyperextend their fingers or wrist. The radial artery and ulnar artery are compressed lightly simultaneously using both the thumbs of examiner to occlude both the arteries at wrist level and the subject will asked to clench and relax his hand three times till palm became blanched. The hand will then slowly open to a neutral position, and the examiner will remove the pressure from the ulnar artery. Time taken (in seconds) for the blanched hand to return to its normal color will be recorded by a stop watch. If the palmar arch is patent, then hand will become pink within 3-9 sec. If return of color does not occur within 9 s then it is termed as a positive MAT and is thought to preclude radial artery harvest. After performing the MAT, the results will be categorized as negative (up to 3 s), equivocal (3-6 s), borderline (6-9 s) and abnormal (>9 s) [10]. Under all aseptic precautions, blood sample will be drawn from radial artery and will be sent for arterial blood gas (ABG) analysis at the time of admission, six hours after admission, and then prior to delivery. After extraction of blood, the radial artery will be compressed using the sterile gauze for at least 5 min. The blood sample will be analyzed immediately avoiding any delay. In case if there’s a delay, then the sample will be placed on ice packs and will then be analyzed quickly. Any sample which we will not be able to analyze within half an hour from collection time will be discarded and then a fresh sample will be drawn for ABG analysis. Calibration of ABG machine will be done at regular intervals as per the guidelines of manufacturer. Data regarding date, time, mode of delivery, anesthesia technique used for LSCS will be noted. Fetal APGAR score will be noted at 1 minute and 5 minutes after birth of the child. Any adverse fetal outcome will also be noted
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