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CTRI Number  CTRI/2025/01/079586 [Registered on: 27/01/2025] Trial Registered Prospectively
Last Modified On: 02/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The PERFORMANCE trial: Preventing preeclampsia in high risk pregnancies using metformin and aspirin combined. 
Scientific Title of Study   Comparing the efficacy of metformin plus aspirin with aspirin alone in preventing preeclampsia in high risk pregnancies: a randomized controlled trial  
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 Mitul Suhane 
Designation  PG Junior Resident 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RAIPUR  
Address  Department of Obstetrics and Gynaecology, AIIMS Campus, Tatibandh, Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  9340413382  
Fax    
Email  mitulsuhane@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Chandrashekhar Shrivastava 
Designation  Associate Professor 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RAIPUR  
Address  Department of Obstetrics and Gynaecology, AIIMS Campus, Tatibandh, Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  7000599101  
Fax    
Email  chandan_1708@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Mitul Suhane 
Designation  PG Junior Resident 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RAIPUR  
Address  Department of Obstetrics and Gynaecology, AIIMS Campus, Tatibandh, Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  9340413382  
Fax    
Email  mitulsuhane@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Tatibandh, Raipur, Chhattisgarh (492099) 
 
Primary Sponsor  
Name  ALL INDIA INSTITUTE OF MEDICAL SCIENCES RAIPUR  
Address  TATIBANDH RAIPUR (CHHATTISGARH), 492099 
Type of Sponsor  Government medical college 
 
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 Mitul Suhane  All India Institute of Medical Sciences Raipur   Department of Obstetrics and Gynaecology
Raipur
CHHATTISGARH 		 9340413382

mitulsuhane@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, All India Institute of Medical Sciences situated at Department of Pharmacology 2nd Floor South Wing, Medical College Complex Gate No.5 Tatibandh, GE Road Raipur, Chattisgarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O149||Unspecified pre-eclampsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  tablet aspirin 150mg  Once daily orally in night till 36 weeks of gestation  
Intervention  Tablet aspirin 150mg and tablet metformin 1gm  Tablet aspirin 150mg once daily orally in night and Tablet metformin 500mg twice daily orally till 36 weeks of gestation  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Singleton pregnancies,Live fetus at 11 to 13 weeks of gestation,High-risk for preeclampsia at 11 to 13 weeks by FMF algorithm that is greater than or equal to 1 in 100, Consenting for study participation 
 
ExclusionCriteria 
Details  Age less than 18 years old,Multiple pregnancies,Treatment with aspirin and or metformin at the time of screening,Medical conditions complicating the pregnancy like Renal, liver or heart failure, Hyperemesis gravidarum,Pregnancies complicated by major fetal abnormality identified during the first trimester
6.Hypersensitivity to aspirin, metformin hydrochloride and other biguanides ,Concurrent participation in another drug trial or at any time within the previous 28 days,Women with learning difficulties, or serious mental illness ,Active peptic ulceration or gastrointestinal bleeding 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
prevention of early onset preeclampsia  Before 37 weeks of gestation 
 
Secondary Outcome  
Outcome  TimePoints 
comparison of adverse feto-maternal outcomes and incidence of late onset preeclampsia between the two groups  During gestation and post delivery and At and after 37 weeks  
 
Target Sample Size   Total Sample Size="132"
Sample Size from India="132" 
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 2 
Date of First Enrollment (India)   01/02/2025 
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)
Modification(s)  		 Not Applicable 
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   Hypertensive disorders of pregnancy accounts for approximately 18.1% maternal mortality with preeclampsia syndrome, complicating 2% to 3% of pregnancies worldwide. Clinicians are often forced to deliver early on maternal indications to prevent major maternal morbidity but in doing so, inflict severe prematurity on the fetus and put them at significant risk of severe disability including cerebral palsy, stroke (intracerebral bleeding), retinopathy of prematurity, chronic lung disease and death. The use of metformin in pregnancy is gaining pace as it is shown possibly to be efficacious in the prevention of pre-eclampsia as it is shown to reduce soluble fms-like tyrosine kinase-1 levels, which correlate significantly with gestational age at onset of pre-eclampsia and severity and altering maternal endothelial function. It has also been suggested that metformin may prevent pre-eclampsia by improving cardiovascular function and limiting gestational weight gain which is instrumental in the pathogenesis of late onset preeclampsia. The MiG trial’s offspring 2year follow-up showed that infants exposed to metformin had higher total body fat without any adverse outcomes, suggesting a healthier fat distribution. There was also a possible trend towards lower LDL cholesterol levels. 
Hence, with a sample size of 132, we have designed a randomized control trial comparing the efficacy of metformin 1gm/day plus aspirin 150mg/day versus Aspirin 150mg alone (standard of care) in prevention of early onset preeclampsia as the primary outcome and comparison of adverse feto-maternal outcomes and incidence of late onset preeclampsia between the two groups as a secondary outcomes in all women who are deemed high-risk following first trimester combined screening using FMF algorithm [combining Maternal charactericstics, Mean Arterial pressure, Uterine artery Pulsatility Index, PLGF levels] with singleton pregnancies who are attending for their routine hospital visit at 11-13 weeks’ gestation trial. 
Candidates who meet the inclusion criteria, will be enrolled for the study and will be randomly allocated into the 2 intervention groups. Primary outcome will be measured as incidence of preeclampsia developing pre term, diagnosed by ISSHP guidelines. Incidence of adverse maternal outcomes like cardiorespiratory complications, renal complications, hepatological and haematological complications, placental abruption, neurological complications along with core offspring adverse events like stillbirth, neonatal mortality rates gestational age at delivery, small-for-gestational-age, admission to neonatal unit required and respiratory support will be measured secondarily. Student t test will be applied to compare between the 2 groups .Two sided p values will be considered as statistically significant at p<0.05

 
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