| CTRI Number |
CTRI/2024/08/072516 [Registered on: 14/08/2024] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Incidence of lung problem (accumulation of water) in pregnant women having high blood pressure during delivery time. |
|
Scientific Title of Study
|
Incidence of pulmonary interstitial syndrome using point of care ultrasound in pregnant women with severe features of pre-eclampsia. A 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 |
Dr Aswini Kuberan |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Anesthesiology and Critical Care,
Gorimedu,
Dhanvantri Nagar
Pondicherry - 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9914017949 |
| Fax |
|
| Email |
ashdoctor.kuberan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kowsika R M |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Anesthesiology and Critical Care,
Gorimedu,
Dhanvantri Nagar
Pondicherry - 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9894726099 |
| Fax |
|
| Email |
kowsikamani11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kowsika R M |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
Department of Anesthesia
JIPMER Gorimedu,
Dhanvantri Nagar
Pondicherry, India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9894726099 |
| Fax |
|
| Email |
kowsikamani11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research, Gorimedu, Puducherry, India- 605006 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research, Gorimedu, Puducherry, India- 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 |
| Kowshika RM |
JIPMER, Puducherry |
Eclampsia Room, Ground floor, Women and Child Health Building, Department of Anaesthesiology and critical care.
Pondicherry
PONDICHERRY |
9894726099
kowsikamani11@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Instituional Ethics Comittee For Observational Studies |
Approved |
| Instituional Ethics Comittee For Observational Studies |
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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Pregnant Women of aged more than 18 years
2. More than 34 weeks of gestation
3. Diagnosed case of severe pre-eclampsia as per ACOG (American College of Obstetrics and Gynaecology )guidelines |
|
| ExclusionCriteria |
| Details |
1.Chronic pulmonary disease
2.Sepsis
3.Chronic renal failure
4.Chronic hepatic dyfunction |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe the incidence of Pulmonary Interstitial Syndrome (PIS) using point of care ultrasound in pregnant women having pre-eclampsia with severe features |
within 30 mins of admission |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To determine the association between pulmonary interstitial syndrome with diastolic dysfunction
2.The correlation of serum albumin and NT-pro-BNP(N-terminal pro brain natriuretic peptide with pulmonary interstitial syndrome) |
From time of admission to 24 hrs |
|
|
Target Sample Size
|
Total Sample Size="107"
Sample Size from India="107"
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)
|
30/09/2024 |
| 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="3"
Months="0"
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
|
BACKGROUND: Acute pulmonary oedema (APE) isthe leading cause of respiratory failure in severe pre-eclamptic patients. The incidence of APE is reported to be 2.9%.and it contributes to significant maternal and neonatal morbidity and mortality. (1) Recently many studies have found that point of care lung ultrasound (LUS) identifies pulmonary oedema earlier than Chest x ray. (2) Point-of-care ultrasound (POCUS) is being used increasingly in preeclampsia for diagnostic purposes. (3) Using lung ultrasound, studies detected pulmonary interstitial syndrome (PIS) in 25% of women presenting with preeclampsia with severe features. In a study by Ortner et al, they found the incidence PIS of 24%,diastolic dysfunction of 33%,systolic dysfunction of 10% and raised left ventricular end-diastolic pressure (LVEDP) of 20%in pre-eclampsia patients with severe features. (4) Since there are no studies in our population, we wanted to observe the incidence of PIS and its association with diastolic dysfunction in preeclampsia with severe features. Also, there are no studies which associated these POCUS findings with adverse maternal outcomes. RATIONALE: Circulating angiogenic factors, decreased colloid oncotic pressure, diastolic dysfunction, and endothelial cell dysfunction, have been reported as factors that predispose preeclamptic women to pulmonary edema, a dangerous complication that further increases the risk of morbidity and mortality. Due to this, pre-eclamptic women are more prone to develop pulmonary interstitial syndrome (PIS) (radiological diagnosis of increased accumulation of fluid in the lung), a preclinical manifestation of pulmonary edema. Although previous studies have reported the incidence and association of PIS with diastolic dysfunction, we would like to observe the incidence of PIS and its association with diastolic dysfunction in our population because of ethnic differences in the incidence and complications of pre- eclampsia with severe features. NOVELTY: There is lack of literature regarding the incidence of pulmonary interstitial syndrome and its association with diastolic dysfunction in pre-eclamptic patients with severe features in our population. EXPECTED OUTCOME: With the above knowledge, it will help us to find out the incidence and association of PIS with diastolic dysfunction in our population. This will help us to know the incidence of PIS and identify subset of population who has more tendency to develop adverse maternal outcomes. |