1. Effect of a participatory intervention with women’s groups on birth outcomes and maternal depression in Jharkhand and Orissa, India: a cluster-randomised controlled trial Tripathy P, Nair N, Barnett S et.al. Lancet 2010; 375: 1182–92 This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN21817853. Journal Club Presenter: Anil Koparkar Moderator: Prof. A. M. Mehendale

2. To Study methodology of ‘Randomised Control Trial’ Has good, comprehensive description of methodology Has similar women’s group as in our field practice area. Comparative other similar studies are available.

3. Estimated number of maternal deaths, 2008

4. Mortality in children under 5 years old in 1990 and 2009

5. Under 5 mortality rate and MDG track

6. India accounts for 20% of maternal deaths worldwide, 21% of all child (<5 years) deaths, and 25% of all neonatal deaths. Maternal depression - increasing public health concern in low-income countries (-Engle PL, Am J Clin Nutr 2009) Introduction

7. Hypothesis Participatory intervention with women’s groups could Reduce neonatal mortality by at least 25% Improve home-care practices and health seeking behavior of pregnant and postnatal women, Reduce maternal depression by 30%.

8. Objective of study To improve birth outcomes and maternal depression in Jharkhand and Orissa, India

9. Study Area 3 contiguous districts of Jharkhand & Orissa—Saraikela Kharswan, West Singhbhum, and Keonjhar. Methods

10. Methods (….contd.) Study period: July 31, 2005, to July 30, 2008 Study design: cluster-randomised controlled trial Study subjects: Women aged 15–49 years, residing in the project area, and had given birth during the study. The study population was an open cohort. Consent : Women who chose to participate gave their consent. Ethical consideration: Ethical approval was obtained from an independent ethical committee in Jamshedpur, India. Women having symptoms of severe depression were referred to the nearest tertiary mental health centre at Ranchi.

11. Sample size calculation : N=Sample size p1 = baseline prevalence (NMR=58) p2= prevalence after expected reduction (25%) = 1.96 = -0.84 Sample size desired = 8536 Methods (….contd.)

12. Randomisation 36 clusters (12 per district) West Singhbum district 12 clusters 6 allocated to intervention 6 allocated to control Saraikela district 12 lusters 6 allocated to intervention 6 allocated to control Keonjhar district 12 clusters 6 allocated to intervention 6 allocated to control

13. Key informer – 1 per 250 Households Births Interviewer interviews family member -information 6 weeks after delivery Interviewer ascertains all information about LivebirthsStillbirths Supervisor does verbal autopsy with family member Neonatal deaths Deaths in women of reproductive age Interviewer ascertains all information about Maternal deaths Pregnancy related deaths Supervisor does verbal autopsy with provider Clinicians assign cause of death Late maternal deaths Data collection method

14. Data entry Data were double-entered in an electronic database. Surveillance supervisors manually checked information The field surveillance manager, data input officer, and data manager undertook manual and systematic data checks Analysis Interim analysis - 2007 Final review -Dec, 2008. Analysis was by intention to treat at cluster & participant levels. For comparison of mortality outcome, they used multivariate logistic regression in Stata (version 10.0) Methods

15. Clusters and coverage of women’s groups In 18 intervention clusters, participatory action cycle with 172 existing groups and additional newly created 72 groups. Coverage of Ekjut groups - 1 per 468 population. Newly pregnant women attended the groups In 1 st year, 546 (18%) of 3119. In 3 rd year1718 (55%) of 3126. Recorded 111 006 group attendances over 3 years. 74 715 (67%) married women of reproductive age, 15 030 (14%) from adolescent girls, 10 452 (9%) from men, and 10 809 (10%)from elderly women.

16. Women’s group intervention Each group - 20 meetings per month Local woman selected – c/a Facilitators attended 13 meetings/mnth Groups took part in a participatory learning and action cycle Activities Information about - clean delivery practices and care-seeking behaviour was shared through stories and games, rather than presented as key messages. Group members identified and prioritised maternal and newborn health problems in the community Collectively selected relevant strategies to address these problems & Implemented the strategies (……..Cont)

17. Meetings in women’s group cycle

18. 36 clusters randomised with stratified allocation (18 with existing groups) 228 186 estimated population 6338 mean cluster population 18 clusters -intervention (9 with existing women’s groups) 9770 births 9469(96.9%) livebirths, 301(3.08%) stillbirths, 406(4.15%) neonatal deaths Excluded from analyses – 2 mothers refused interview Excluded from adjusted analyses -84 births (9 neonatal deaths, 3 stillbirths) - 81 mothers For mortality outcomes Data from 8662 mothers, 9686 births, 397 neonatal deaths, 298 stillbirths was analysed - For depression outcome - data from 6452 mothers was Analyzed 18 clusters - control (9 with existing women’s groups) 9260 births 8980 livebirths(96.9%), 80 stillbirths(0.8%), 531(5.7%) neonatal deaths Excluded from analyses – 2 mothers refused interview Excluded from adjusted analyses - 171 births (13 neonatal deaths, 10 stillbirths) -167 mothers For mortality outcomes Data from 8125 mothers, 9089 births, 518 neonatal deaths, 270 stillbirths was analysed - For depression - data from 5979 mothers was Analyzed Trial profile

19. Results All 18 selected clusters had the intervention. Loss to follow-up was 86 (<1%) of 9770 women in intervention clusters & 173 (2%) of 9260 in control clusters. Home Deliveries:- 37% - by a relative, friend, or neighbor, 36% - by traditional birth attendants, 13% - by husbands.

20. Baseline characteristics of identified births

22. Comparison of mortality rates in intervention and control clusters

23. Scatter-plot of cluster-specific neonatal mortality rates in year 3 with rates at baseline

24. Kessler-10 depression scores in mothers

25. Discussion Mortality reduction was not associated with increased care- seeking behaviour or health-service use. The most likely mechanism of mortality reduction was through improved hygiene and care practices, generating increased social awareness and support for clean delivery practices. Women’s groups seemed to generate more demand for safe delivery kits in intervention clusters Most striking reduction in mortality rate was noted in early neonatal deaths, which might be explained by strong focus on intrapartum and early neonatal periods in several case studies and stories discussed during the cycle.

26. Large reduction in moderate depression seen in the third year could have occurred through improvements in social support and problem-solving skills of the groups Discussion

27. Weaknesses (mentioned by authors) the intervention and surveillance teams were not unaware of allocation cannot rule out some intercluster migration when women married out of their home cluster

28. Critical comments Very comprehensive description of methodology No clarification of ‘Worsening of various indicators (NMR, PMR, MMR) in control group. Topographical mistakes - % of deliveries in text (36%- pg1187) and table 5 (33%) is different. What about intervention in control group – ethical issue

29. References Prasanta Tripathy, Nirmala Nair et. al. Effect of a participatory intervention with women’s groups on birth outcomes and maternal depression in Jharkhand and Orissa, India: a cluster-randomised controlled trial. Published online on March 8, 2010 at URL: www.thelancet.com 375: 1182–92www.thelancet.com Borghi J, Thapa B, Osrin D, et al. Economic assessment of a women’s group intervention to improve birth outcomes in rural Nepal. Lancet 2005; 366: 1882–84. Bhalwar R. et.al. Textbook of Public Health and Community Medicine.1 st ed.2009. Fletcher RH, Fletcher WF clinical epimoys;Clinical Epidemiology- The esentials. Third Indian… 3 rd reprint World health statistics 2011 Hayes RJ et.al. Simple sample size calculation for cluster-randomised trials. IJE 1999; 28:319-326. Manandhar DS, Osrin D, Shrestha BP, et al. Eff ect of a participatory intervention with women’s groups on birth outcomes in Nepal: cluster-randomised controlled trial. Lancet 2004; 364: 970–79. Engle PL. Maternal mental health: program and policy implications. Am J Clin Nutr 2009; 89: 963S– 66S. Kumar V, Mohanty S, Kumar A, et al. Eff ect of community-based behaviour change management on neonatal mortality in Shivgarh, Uttar Pradesh, India: a cluster-randomised controlled trial. Lancet 2008; 372: 1151–62.