tripathy p, nair n, barnett s et.al. lancet 2010; 375: 1182–92

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.

Journal Club

Presenter: Anil KoparkarModerator: Prof. A. M. Mehendale

Learning objective•To Study methodology of ‘Randomised Control Trial’

Rationale of selecting this article

•Has good, comprehensive description of methodology•Has similar women’s group as in our field practice area.•Comparative other similar studies are available.

Estimated number of maternal deaths, 2008

Mortality in children under 5 years old in 1990 and 2009

Under 5 mortality rate and MDG track

• 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

HypothesisParticipatory 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%.

Objective of studyTo improve birth outcomes and maternal depression in

Jharkhand and Orissa, India

Study Area3 contiguous

districts of Jharkhand & Orissa—Saraikela Kharswan, West Singhbhum, and Keonjhar.

Methods

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.

Sample size calculation :

N=Sample sizep1 = baseline prevalence (NMR=58)p2= prevalence after expected reduction (25%) = 1.96 = -0.84Sample size desired = 8536

Methods (….contd.)

Randomisation36 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

Key informer – 1 per 250 Households

Births

Interviewer interviews family member

-information 6 weeks after delivery

Interviewer ascertains all

information about

Livebirths

Stillbirths

Supervisor doe

s 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

Data entryData were double-entered in an electronic database.Surveillance supervisors manually checked informationThe field surveillance manager, data input officer, and data

manager undertook manual and systematic data checks Analysis

Interim analysis - 2007Final 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

Clusters and coverage of women’s groupsIn 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 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.

Women’s group interventionEach group - 20 meetings per monthLocal woman selected – c/a Facilitators attended 13 meetings/mnthGroups took part in a participatory learning and action cycleActivities

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)

Meetings in women’s group cycle

36 clusters randomised with stratified allocation (18 with existing groups)228 186 estimated population6338 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 deathsExcluded 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 deathsExcluded 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

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.

Baseline characteristics of identified births

Baseline characteristics of identified births

Comparison of mortality rates in intervention and control clusters

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

Kessler-10 depression scores in mothers

DiscussionMortality 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.

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

Weaknesses (mentioned by authors)the intervention and surveillance teams were not

unaware of allocationcannot rule out some intercluster migration when

women married out of their home cluster

Critical commentsVery comprehensive description of methodologyNo 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

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: 1182–92

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… 3rd 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.