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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
 
Method of Generating Random Sequence   Not Applicable 
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. 
 
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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