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CTRI Number  CTRI/2024/07/070024 [Registered on: 04/07/2024] Trial Registered Prospectively
Last Modified On: 03/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study to prevent a serious life threatening condition characterised by high blood pressure and protein in urine, by doing a blood test and planned delivery.  
Scientific Title of Study   A multicenter randomized trial of screening with sFlt1/ PlGF and planned delivery to prevent preeclampsia at term. 
Trial Acronym  PE-37 
Secondary IDs if Any  
Secondary ID  Identifier 
NCT04766866  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  K. Aparna Sharma 
Designation  Professor 
Affiliation  AIIMS New Delhi, Department of Obstetrics and Gynaecology 
Address  New Delhi, Ansari Nagar, All India Institute of Medical Sciences, Mother and Child Block, Department of Obstetrics and Gynaecology, Room no. 711.

New Delhi
DELHI
110029
India 
Phone  9711824415  
Fax    
Email  kaparnasharma@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  K Aparna Sharma  
Designation  Professor  
Affiliation  AIIMS New Delhi, Department of Obstetrics and Gynaecology 
Address  New Delhi, Ansari Nagar, All India Institute of Medical Sciences, Mother and Child Block, Department of Obstetrics and Gynaecology, Room no. 711.

New Delhi
DELHI
110029
India 
Phone  9711824415  
Fax    
Email  kaparnasharma@gmail.com  
 
Details of Contact Person
Public Query  
Name  K Aparna Sharma  
Designation  Professor  
Affiliation  AIIMS New Delhi, Department of Obstetrics and Gynaecology 
Address  New Delhi, Ansari Nagar, All India Institute of Medical Sciences, Mother and Child Block, Department of Obstetrics and Gynaecology, Room no. 711.

New Delhi
DELHI
110029
India 
Phone  9711824415  
Fax    
Email  kaparnasharma@gmail.com  
 
Source of Monetary or Material Support  
Roche Diagnostics International Ltd,Forrenstrasse 2, 6343 Rotkreuz, Switzerland 
 
Primary Sponsor  
Name  Roche International 
Address  Maroussi Greece 
Type of Sponsor  Other [Diagnostic Firm] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Belgium
India
Poland
Spain
Czech Republic  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr K Aparna Sharma  All India Institute of Medical Sciences  New Delhi, Ansari Nagar, Mother and Child Block, Department of Obstetrics and Gynaecology, Room no. 711.
South
DELHI 		 9711824415

kaparnasharma@gmail.com 
Dr Sangeeta Gupta  Maulana Azad Medical College   Department of Obstetrics and Gynaecology, Maulana Azad Medical College, Bahadur Shah Zafar Marg, Near Delhi Gate, Balmiki Basti, New Delhi
North
DELHI 		 8268199481

drsangeetamamc@gmail.com 
Dr Sumitra Bachani  Safdarjung Hospital  Department of Obstetrics and Gynaecology, VMMC & Safdarjung Hospital, Ansari nagar west, New Delhi
South
DELHI 		 9212129161

sumitrabachani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE ALL INDIA INSTITUTE OF MEDICAL SCIENCES  Approved 
Institutional ethics committee, Maulana Azad Medical College  Approved 
Vardhman Mahavir Medical College and Safdarjung Hospital Institutional Ethics Committee  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  Concealed group(sflt/plgf ratio unknown to clinicians)  Women randomized to concealed group, will not undergo any intervention, routine follow up and spontaneous delivery. 
Intervention  Induction of labor(IOL) at 37 weeks period of gestation  Asymptomatic women will be screened for term Preeclampsia by doing a blood test, sflt/plgf ratio at 35 to 37 weeks period of gestation. Women will be randomized to revealed(sflt/plgf ratio known to clinicians) versus concealed groups(sflt/plgf ratio unknown to clinicians). Women in revealed group with sflt/plgf ratio more than 90th centile will be offered IOL at 37 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Nulliparous women
2. Singleton pregnancies
3. 318 years old
4. 35.0-36.6 weeks of gestation
5. Maternal written consent form 
 
ExclusionCriteria 
Details  1.Fetuses neonates with major malformations or genetic anomalies that could modify the
timing of delivery or has an impact on obstetric outcome.
2. Participation in another interventional study that could modify the delivery timing.
3. Gest HT Chr HT 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Impact of a policy of planned delivery from 37 weeks of gestation in nulliparous women at risk for preeclampsia as defined by a sFlt1/PlGF ratio more than 90th centile at
35.0-36.6 weeks of gestation on the prevalence of term PE.
 		 37 or more than 37 weeks of gestation  
 
Secondary Outcome  
Outcome  TimePoints 
evaluate the impact of the sFlt1 PlGF screening on:
1. Perinatal morbidity
2. Cesarean section rates
3. Maternal pregnancy-related morbidity.
 		 During and end of pregnancy 
 
Target Sample Size   Total Sample Size="8302"
Sample Size from India="500" 
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)   15/07/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   Preeclampsia (PE) remains a leading cause of maternal morbidity and mortality in the world. Prediction and prevention of term PE remains unsolved. Recent evidence showsthatsFlt1-PlGF ratio at 35-37 weeks predicts term PE with 80% detection rate. Likewise, recent studies demonstrate that induction of labor from 37 weeks is safe. • The investigators hypothesize that a single-step universal screening for term PE based on sFlt1/PlGF ratio at 35.0-36.6 weeks followed by planned delivery (e.g. induction of labor) from 37.0 weeks would reduce the prevalence of term PE, without increasing cesarean section rates or adverse neonatal outcomes. The investigators propose a randomized clinical trial to evaluate the impact of a screening of term PE with sFlt-1/PlGF ratio in asymptomatic nulliparous women at 35.0-36.6 weeks. Women will be assigned to revealed (sFlt-1/PlGF known to clinicians and participants) versus concealed (unknown to clinicians and participants) arms. A cutoff of >90th centile will be used to define high risk of term PE and planned delivery will be offered from 37.0 weeks. If successful, the results of this trial will provide evidence to support a simple universal screening strategy to reduce the prevalence of term PE, which could be applicable in most healthcare settings and have enormous implications on perinatal outcomes and public health policies worldwide. 
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