Tripathy P, Nair N, Barnett S et.al. Lancet 2010; 375: 1182–92

1. Journal Club Effect of a participatory intervention with women’s groupson birth outcomes and maternal depression in Jharkhandand 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. Presenter: Anil Koparkar Moderator: Prof. A. M. Mehendale

2. Learning objective Rationale of selecting this article 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. Introduction • 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 ClinNutr2009)

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. Methods Study Area • 3 contiguous districts of Jharkhand & Orissa—SaraikelaKharswan, West Singhbhum, and Keonjhar.

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. Methods (….contd.) • 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

12. Randomisation

13. Data collection method

14. Methods • 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)

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 Ekjutgroups - 1 per 468 population. • Newly pregnant women attended the groups • In 1st year, 546 (18%) of 3119. • In 3rd 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 behaviourwas 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. 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

21. 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. Discussion • 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

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 • PrasantaTripathy, 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.com375: 1182–92 • 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.1st ed.2009. • Fletcher RH, Fletcher WF clinical epimoys;Clinical Epidemiology- The esentials. Third Indian… 3rdreprint • 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. Effect of a participatory intervention with women’s groups on birth outcomes in Nepal: cluster-randomisedcontrolled 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. Effect of community-based behaviourchange management on neonatal mortality in Shivgarh, Uttar Pradesh, India: a cluster-randomised controlled trial. Lancet 2008; 372: 1151–62.