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