| CTRI Number |
CTRI/2014/01/004352 [Registered on: 27/01/2014] Trial Registered Prospectively |
| Last Modified On: |
07/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Screening |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
A study to reduce pregnancy related complications, and all cause maternal and perinatal mortality and major morbidity in Karnataka State, India |
|
Scientific Title of Study
|
The CLIP (Community Level Interventions for Pre-Eclampsia)Cluster Randomized Controlled Trial |
| Trial Acronym |
CLIP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| H12-00132 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M B Bellad |
| Designation |
Professor |
| Affiliation |
J N Medical College |
| Address |
Department of OBGYN
KLE University
Jawaharlal Nehru Medical College
Nehru Nagar
Belgaum
Department of OBGYN
KLE University
Jawaharlal Nehru Medical College
Nehru Nagar
Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
09448124893 |
| Fax |
08312472891 |
| Email |
mbbellad@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M B Bellad |
| Designation |
Professor |
| Affiliation |
J N Medical College |
| Address |
Department of OBGYN
KLE University
Jawaharlal Nehru Medical College
Nehru Nagar
Belgaum
Department of OBGYN
KLE University
Jawaharlal Nehru Medical College
Nehru Nagar
Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
09448124893 |
| Fax |
08312472891 |
| Email |
mbbellad@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M B Bellad |
| Designation |
Professor |
| Affiliation |
J N Medical College |
| Address |
Department of OBGYN
KLE University
Jawaharlal Nehru Medical College
Nehru Nagar
Belgaum
Department of OBGYN
KLE University
Jawaharlal Nehru Medical College
Nehru Nagar
Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
09448124893 |
| Fax |
08312472891 |
| Email |
mbbellad@hotmail.com |
|
|
Source of Monetary or Material Support
|
| The University of British Columbia, Vancouver, British Columbia, Canada V6T 1Z3 |
|
|
Primary Sponsor
|
| Name |
The University of British Columbia |
| Address |
Vancouver, British Columbia, Canada V6T 1Z3 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India
Mozambique
Nigeria
Pakistan |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr M B Bellad |
KLE University, J N Medical College, Belgaum |
Womens and Childrens Health Research Unit
Above Syndicate Bank
JNMC Campus
Nehru Nagar
Belgaum
KARNATAKA |
09448124893
08312472891
mbbellad@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Directorate of Health & Family Welfare Services, Government of Karnataka |
Approved |
| Indian Council of Medical Research New Delhi |
Approved |
| JNMC Institutional Ethics Committee on Human Subjects Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Blood Pressure more than 160/90 mmhg or patient having high risk symptoms like blurring of vision, stroke, loss of consciousness, vaginal bleeding, (1) ICD-10 Condition: O141||Severe pre-eclampsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intramuscular MgSO4 |
10g MgSO4 intramuscular loading dose (Single dose Only) |
| Intervention |
Oral Methyldopa 750mg |
Methyldopa administration in the community; relative maternal hypertension on arrival at facility (defined as sBP less than 110 mmHg) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
All pregnant women permanent residents in selected clusters of Belgaum and Bagalkot district of Karnataka |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome will be combined maternal and or perinatal outcome (either maternal, fetal or neonatal death or severe morbidity for the mother or baby) |
During Antenatal, Delivery and Postnatal 42 day followup |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Impact of the CLIP intervention on the delays around triage and transport. |
During Antenatal, Delivery and Postnatal 42 day followup |
|
|
Target Sample Size
|
Total Sample Size="81200"
Sample Size from India="16800"
Final Enrollment numbers achieved (Total)= "69330"
Final Enrollment numbers achieved (India)="14500" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2014 |
| Date of Study Completion (India) |
31/10/2016 |
| Date of First Enrollment (Global) |
01/02/2014 |
| Date of Study Completion (Global) |
22/12/2016 |
|
Estimated Duration of Trial
|
Years="2"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
von Dadelszen P, Bhutta ZA, Sharma S, Bone J, Singer J, Wong H, Bellad MB, Goudar SS, Lee T, Li J, Mallapur AA, Munguambe K, Payne BA, Qureshi RN, Sacoor C, Sevene E, Vidler M, Magee LA; CLIP Trials Working Group. The Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised trials in Mozambique, Pakistan, and India: an individual participant-level meta-analysis. Lancet. 2020 Aug 22;396(10250):553-563. doi: 10.1016/S0140-6736(20)31128-4. PMID: 32828187 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Pre-eclampsia remains a leading cause of maternal and perinatal mortality and morbidity. Globally 76000 maternal deaths occurs annually in addition 500000 fetal and newborn lives or lost annually due to the perinatal consequences of pre-eclampsia. Over 99 percent of theses deaths occur in low and middle income countries primarily in south Asia and sub Saharan Africa.
In general, previous research has focused on institutional level interventions with MgSO4 and treatment of severe pregnancy hypertension, However if we limit ourselves to studying in patients, facility level, intervention with fully assessed treatment options, many women will die or be irreversibly affected by pre-eclapmsia prior to arriving at the in-patient facility.
Maternal lives lost from pre-eclampsia and eclampsia as a result of delay in triage, transport and treatment. CLIP study is oriented to overcome these by Community Engagement, Community Health Care Provider training in home based maternity assessment, Diagnosis and triage by miniPIERS and CLIP PIERS on Move mobile applications (ASHA), Lowering severe hypertension by giving - oral methyldopa 750mg and or IM MgSO4 10g loading dose (only one dose is given and then refer to higher level of health care facility) and facility enhancement for management of pre-eclampsia and eclampsia.
|