DSIR recognized | FWA approved-FWA00012971
 

CHAMPION Study

12 June, 2017 Uncategorized
UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction
Timeline: 2016-2017 (On Going)

Principal Investigator: Dr. Archana Patel, Dr. Vaishali Khedikar, Smita Puppalwar, Dr. Takshashila Taksande, Dr. Vaishali Shelekar, Poonam Dehenkar, Ashwini Pachare, Pushpa Iyangar, Madhurani Umate, Monali Chachere, Rupali Naik, Archana Sathawane.

Background Research Work: Postpartum haemorrhage (PPH) is defined as a blood loss of 500 mL or more within 24 hours of delivery, while severe PPH (sPPH) is defined as a blood loss of 1000 mL or more within the same time frame. PPH is the leading cause of maternal mortality in low-income countries and it contributes to nearly a quarter of maternal deaths globally. PPH is a significant contributor to severe maternal morbidity and long term disability, as well as to a number of other severe maternal conditions, generally associated with more substantial blood loss, including shock and organ dysfunction.
The majority of deaths due to PPH could be avoided through the use of prophylactic uterotonics during the third stage of labour and by timely and appropriate management. Oxytocin (Intramuscular/intravenous [IM/IV] 10 IU) is recommended as the uterotonic drug of choice.
Despite oxytocin being a well-known peptide hormone, there is limited information on its stability at tropical temperatures. The manufacturer recommends storage under refrigeration in most countries and there is general acknowledgement that cold storage would help to maintain quality of oxytocin especially in settings where it is difficult to obtain cold storage regularly.
Carbetocin appears to be a promising agent in the prevention of PPH. The clinical and pharmacological properties of carbetocin are similar to those of oxytocin.

Objective: The trial has two primary objectives:

  1. To evaluate non-inferiority of carbetocin RTS 100 μg IM versus oxytocin 10 IU IM after vaginal delivery in the prevention of the composite endpoint “blood loss of 500 mL or more or the use of additional uterotonics” at one hour and up to two hours for women who continue to bleed after one hour.
  2. To evaluate non-inferiority of carbetocin RTS 100 µg IM versus oxytocin 10 IU IM in the prevention of sPPH (≥1000 mL blood loss) at one hour and up to two hours for women who continue to bleed after one hour.

ASPIRIN coordinators training at Belagavi, India- 11th to 17th Nov’16

2 December, 2016 News, Uncategorized
ASPIRIN coordinators training at Belagavi, India- 11th to 17th Nov’16

ASPIRIN coordinators training was held at Belagavi, India from 11th to 17th November 2016. This training was attended by Dr.Prabirkumar Das from Lata Medical Research Foundation, Nagpur. Pictures below:

 
 
 
 
 

Aspirin Supplementation for Pregnancy Indicated Risk Reduction in Nulliparas (ASPIRIN).

10 September, 2016 Uncategorized
Aspirin Supplementation for Pregnancy Indicated Risk Reduction in Nulliparas (ASPIRIN).

Study Timeline: 2016 – 2018

Study Team:

Dr.Archana Patel, MD, DNB, MSCE, Dr.Patricia L. Hibberd, MD, PhD, ,Dr. Prabir Kumar B. Das, MD, Dr.Savita Bhargav, Dr.Kunal Kurhe, Dr.Atul Chopde, Dr.Atul Andelkar, Dr.Nitesh Nikose, Dr.Manisha Chikte, Dr.Anukampa Kumbhare, Dr.Takshashila Taksande

Background: Preterm birth (PTB) remains the leading cause of neonatal mortality and long term Disability throughout the world. Though complex in its origins, a growing body of evidence suggests that first trimester administration of low dose aspirin (LDA) holds promise to reduce the rate of PTB substantially.

Objectives of the study

  • Nulliparous women with no more than two previous first trimester. Pregnancy losses that are treated with LDA daily beginning between 6 0/7 weeks and 13 6/7 weeks GA through 36 0/7 weeks GA will reduce the rate of preterm birth from all causes.
  • Women who take antenatal daily LDA initiated at 6 0/7 to 13 6/7 weeks GA will have lower rates of:
  • Small for gestational age (SGA)
  • Eclampsia and preeclampsia
  • Perinatal Mortality

Geographic area:

Study Population: Nulliparous women between the ages of 18 and 40, with a singleton pregnancy between 60/7 weeks and 13 6/7 weeks gestational age (GA) confirmed by ultrasound prior to enrollment, no more than two previous first trimester pregnancy losses, and no contraindications to aspirin.

Intervention: Daily administration of low dose (81 mg) aspirin, initiated between 6 0/7 weeks and 13 6/7 weeks GA and continued to 36 0/7 weeks GA, compared to an identical appearing placebo. Compliance and outcomes will be assessed biweekly.

Expected Outcomes:

Primary outcome: To determine whether daily LDA initiated between 6 0/7 ‐13 6/7 weeks GA and continued to 36 0/7 weeks GA reduces the risk of PTB (birth prior to 37 0/7 weeks GA).

Secondary outcomes of interest are the rate of preeclampsia/eclampsia, small for gestational age (SGA), and perinatal mortality.

Health staff trained for ASPIRIN study:

Sr. No. Participants Number
1 Medical Officers 26
2 ANMs & LHVs 177
3 Pharmacists 19
4 Other Staff 6
5 Total PHC Staff Trained 288
6 Sensitization of ASHAs 580

 

Simplified Gestation Age Score (SGAS)

3 September, 2016 Uncategorized
Simplified Gestation Age Score (SGAS)

Simplified Gestation Age Score (SGAS)

Timeline- August 2015-March 2016

Team: Dr. Archana Patel, MD, DNB, MSCE, Dr. Patricia L. Hibberd, MD, PhD, Dr. Prabir Kumar B. Das, MD, Dr. Vaishali Khedikar, DGO, Dr. Savita Bhargav, Dr. Kunal Kurhe, Ms. Shraddha Agrawal, Mr. Amber Prakash

The study, “Validation of a new simplified score for assessing gestational age (SGAS)  of newborns”  was a cross sectional observational study was conducted at the 3 referral hospitals in central India, viz. Daga memorial women’s hospital, Nagpur; General hospital, Bhandara & General hospital, Wardha was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development [NICHD’s] Global Network for Women’s and Children’s Health Research.

This study was designed to test the validity, accuracy of SGAS to assess the GA of newborn also it gives the data on proportion of LBWs as well as preterm babies, perspectives of birth attendants i.e. ANMs about the SGAS scale.

 

Background research work

  • Two cross sectional studies were conducted to determine the characteristics most predictive of GA from 3 scales – New Ballard Score, Dubowitz and Meherban Singh with the reference standard i.e. GA assessed by LMP using Naegeles 6 rule and validated by gestational age assessed by at least one ultrasound (GA-USG), in newborns delivered at the hospital
  • This SGAs (3 physical and 1 neurological attribute) was validated against New Ballard Score and inter-observer agreement (pediatric residents) was assessed for 4 categories of GA <32, ≥32-<35,  ≥35-<37, and,  > 37 weeks

 

Objectives:

To validate a pictorial, tablet based “Simplified Gestational Age assessment Score” (SGAS) that categorizes the newborns in 4 gestational age categories for –

  • Accuracy when compared to the BOE, in newborns within 24 hrs of birth
  • Ease of use by community birth attendants/auxillary nurse midwives (ANMs)
  • Inter-observer agreement between ANM

 

   App development: SGAS android based GA assessment

 

This app developed by the team at Research Triangle Institute (RTI) was installed on Sim enabled Android Tablets followed by testing for reliability and usability by field staff.

 

To make the SGAS tool more user friendly, images of diff. GA categories were used along with description.

 

Study Implementation

  • Each labor room at facility was allocated two teams, each consisting of 1 ANM-I, 1 ANM-II & 1 Data Collector so as to work in morning and evening shift to cover all the deliveries within 24 hrs of birth.
  • Data Quality Assurance process: Master Trainers, senior pediatricians, neonatologists, obstetrician provided training to the study staff and overall study oversight and quality assurance.
  • All Data was collected and transmitted ‘real time’.

Data management: Daily monitoring and generation of edit reports for timely corrective actions.

Diabetes In Sindhi Families In Nagpur (DISFIN): An Observational Study

12 August, 2016 Uncategorized

Research Information

Who is conducting the research?


Principal Investigator:
Dr. Manju Mamtani, MD
Trustee, Lata Medical Research Foundation, Nagpur, India and Assistant Professor, South Texas Diabetes and Obesity Institute, University of Texas, Rio Grande Valley, Brownsville, Texas 78520, USA Phone: +1 (210) 602-5199 Email: [email protected]

 

Co-Principal Investigator:
Dr. Hemant Kulkarni, MD
Trustee, Lata Medical Research Foundation, Nagpur, India and Associate Professor, South Texas Diabetes and Obesity Institute, University of Texas, Rio Grande Valley, Brownsville, Texas 78520, USA Phone: +1 (210) 602-5537 Email: [email protected]

 
Why is this research being conducted?

This study is being conducted to better understand the prevalence of and risks associated with type 2 diabetes in Sindhi families.

Your participation is voluntary

You are free to choose if you want to participate in this study and you are free to withdraw from this research at any time without comment or penalty.  We will provide you with a nominal time compensation upon completion of the study.

What are you required to do if you choose to participate?

As a participant, you will be interviewed and medically examined. Specifically, information on your demography, family history, dietary history and physical activity will be collected. Your blood pressure, height, weight and body girth will be measured; and your ECG will be recorded. Your random blood sugar will be checked, urine sample will be collected and this will be followed by a subsequent appointment to collect fasting blood sample for additional biochemical investigations like fasting blood sugar and blood lipid profile.
If you would like to participate in this research study, call Dr. Manju Mamtani at +1 (210) 602-5199 or the Project Manager [TBD] at XXX. At the beginning of the study, we will first obtain your informed consent and then collect the data.

Any questions?

You are welcome to contact any of the researchers with any question related to this study.
If you have any questions regarding your rights as a participant, please contact Dr. Swaminiji (Phone no. 8805024450), Chairman of Ethics Committee, Lata Medical Research Foundation, Nagpur or the Institutional Review Board (IRB) by telephone at +1 (956) 665-2889 or by email at [email protected]

This research has been reviewed and approved by the Institutional Review Board for Human Subjects Protection (IRB).

Training & Workshops

27 July, 2016 Uncategorized
Training & Workshops

 

LMRF conducts numerous workshops and seminars to train researchers, academicians, students and clinicians in various aspects of research methodology. These include our in-house workshops and training focused on capacity building of the staff. These are also open for faculties from other organizations, academia, medical schools and public health institutions. The training conducted in this series included Ethics in Research, Scientific writing workshop, Basic Statistics, Data analysis using Excel etc. In addition to these the Research officers at LMRF also attend regional, national and international training workshops from reputed research organizations across the world like RTI (Research Triangle Institute), North Carolina, University of Sydney, PATH, USAID (United States Agency for International Development), World Bank (SARDM – South Asia Research Development Marketplace) etc to develop their research and data management skills.

Field training are conducted at primary health centers, sub centers and taluka/block level to train the public health staff (number trained till date for MNH- 2393, EmONC- 1309) for project activities, so as to ensure data quality. For our hospital based studies, we have trained in ACT- 1610, HBB- 1027 health providers at primary, secondary and tertiary level health facilities. These are followed by periodic retraining and refresher training based on their performance in order to ensure optimal functioning and data quality assurance. We have also trained about 165 ASHAs (Accredited Social Health Activists) who are the rural front line health workers from Nagpur and Bhandara district in the use of m Health applications on android phones for data collection and imparting health and nutrition advise to rural pregnant mothers and their families.

LMRF also hosts overseas students for medical and statistical internships including medical graduates, post graduate students and doctoral fellows, policy planning graduates etc for guiding them in research methodology, scientific writing, research skills development and data analysis techniques. They also acquire field experience in developing nations and are then certified at successful completion of their internship with LMRF.