WOMEN’S AND CHILDREN’S RESEARCH UNIT

Improving mothers, infants, and children’s well-being is an important public health goal for our country. Their well-being determines the health of the next generation and can help predict future public health challenges for families, communities, and the health care system. Despite the remarkable progress made in reducing women’s and children’s deaths, many of them still die each year. Since healthy women and children are the cornerstones for healthy and thriving societies, investing in their health is vital to achieving the new Sustainable Development Goals (SDGs) agenda.

Despite these benefits, blatant gaps must still be filled to reduce the mortality rate, provide equitable access to quality health care among women and children and improve outcomes for children who survive past the age of five. With this objective, our Women’s and Children’s Research unit was started in the year 2009 and has conducted many clinical trials and community-based research projects since then in collaboration with Women’s and Children’s Health Research Unit Jawaharlal Nehru Medical College, KLE Academy of Higher Education and Research, Belagavi under the able leadership of India Site Principal Investigator Dr.Shivprasad S Goudar. The studies carried out under this research unit intent to bring significant community impact and witness to this is the inclusion of Misoprostol in the prevention of postpartum hemorrhage(PPH)by the Government of India and its endorsement by the World Health Organisation, which was tested in one of our trials undertaken and approval of  drug Carbetocin (CHAMPION Trial) by the Indian Drug Regulatory Authorities for prevention of PPH

BLDE(DU) ‘s Research unit makes a perpetual effort to gather evidence to incorporate more substantial treatment and preventive modalities to benefit the community by improving women’s and children’s health. We hope our efforts are strengthened by cooperation from all the stakeholders, and together we aid in our mission of building a healthy nation.

PROJECTS UNDERTAKEN

1.Two community strategies comparing use of Misoprostol for early treatment/secondary prevention to primary prevention for postpartum hemorrhage: a randomized cluster non-inferiority study in Bijapur district, Karnataka, India  (2009-2014) in collaboration with Gynuity Health Projects, New York, USA and the University of Illinois at Chicago, and the University of California at San Francisco, USA

Sponsored by: Gynuity Health Projects, New York, USA

Funded by:Bill & Melinda Gates Foundation, USA

Team:

Global Health Impact: Misoprostol drug is included by

• Misoprostol in the prevention of postpartum hemorrhage (PPH) by Government of India and its endorsement by the World Health Organisation
• WHO list of Essential Medicine
• The International Confederation of Midwives (ICM) and the International Federation of Gynecology and Obstetrics (FIGO) in their guidelines

2.CHAMPION TRIAL-Protocol no.:A65870 (2015 – 2017)

“A phase III, randomized, double-blind, active, controlled, multinational, multicenter, a non-inferiority trial using carbetocin room temperature stable (RTS) for the prevention of postpartum hemorrhage during the third stage of labor in women delivering vaginally.”

Sponsored by: Department of Reproductive Health & Research, World Health Organization, Geneva

Funded By:Bill & Melinda Gates Foundation, USA

Team:

Global Health Impact:

Drug Carbetocin  is included by the Indian Drug Regulatory Authorities for Prevention of PPH

3.ACTION TRIALS- Protocol no.: A65913 & A65916 (2017- 2020)

“The WHO ACTION (Antenatal CorticosTeroids for Improving Outcomes in preterm Newborns) Trials:”

1. WHO ACTION-I TRIAL – A65913: A multi-country, multicenter, two-arm, parallel, double-blind, placebo-controlled, randomized trial of antenatal corticosteroids for women at risk of imminent birth in the early preterm period in hospitals in low-resource countries to improve newborn outcomes.
2. WHO ACTION-II TRIAL – A65916: A multi-country, multicenter, two-arm, parallel, double-blind, placebo-controlled, randomized trial of antenatal corticosteroids for women at risk of imminent birth in the late preterm period in hospitals in low-resource countries to improve newborn outcomes. Sponsored by: World Health Organization, Geneva

Funded By:Bill & Melinda Gates Foundation, USA

Team:

Impact: “Antenatal Dexamethasone for Early PretermBirth in Low-Resource Countries” Published in NEJM Oct 2020 issue

4.A-PLUS TRIAL-Protocol no.:NCT03871491(2019-2022)

“Prevention of Maternal and Neonatal Death/Infections With a Single Oral Dose of Azithromycin in Women in Labor (in Low- and Middle-income Countries): a Randomized Controlled Trial”

Funded By: Global Network for Women’s and Children’s Health Research of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, USA and Bill & Melinda Gates Foundation, USA

Team:

5.The CryoPop Study – Protocol no.:  IRB 00006198 (2020-2021)

“Performance, Safety and Efficacy of a New Cryotherapy Device for Cervical Dysplasia in Low and Middle Income Countries” project in collaboration with Johns Hopkins Medical Institutions Baltimore, USA.

Funded By: National Institute of Health/National Cancer Institute (NIH/NCI), USA

Team:

PUBLICATIONS

1. Widmer M, Piaggio G, Nguyen TMH, Osoti A, Owa OO, Misra S, Coomarasamy A, Abdel-Aleem H, Mallapur AA, Qureshi Z, Lumbiganon P, Patel AB, Carroli G, Fawole B, Goudar SS, Pujar YV, Neilson J, Hofmeyr GJ, Su LL, Ferreira de Carvalho J, Pandey U, Mugerwa K, Shiragur SS, Byamugisha J, Giordano D, Gülmezoglu AM; WHO CHAMPION Trial Group. Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth. N Engl J Med. 2018 Jun 27. DOI: 10.1056/NEJMoa PMID: 29949473.
2. Raghavan S, Geller S, Miller S, Goudar SS, Anger H, Yadavannavar MC, Dabash R, Bidri SR, Gudadinni MR, Udgiri R, Koch AR, Bellad MB, Winikoff B. Misoprostol for primary versus secondary prevention of postpartum hemorrhage: a cluster-randomized non-inferiority community trial. BJOG. 2015 Sep 1. doi: 10.1111/1471-0528.13540. PMID: 26333044.
3. WHO ACTION Trials Collaborators; The World Health Organization ACTION-I (Antenatal CorTicosteroids for Improving Outcomes in preterm Newborns) Trial: a multi-country, multi-center, two-arm, parallel, double-blind, placebo-controlled, individually randomized trial of antenatal corticosteroids for women at risk of imminent birth in the early preterm period in hospitals in low-resource countries; Trials. 2019 Aug 16;20(1):507. DOI: 10.1186/s13063-019-3488-z; PMID: 31420064.
4. WHO ACTION (Antenatal CorticosTeroids for Improving Outcomes in preterm Newborns) Trials Collaborators. Antenatal Dexamethasone for Early Preterm Birth in Low-Resource Countries. N Engl J Med. Oct 23, 2020