The effect of community health educational interventions on newborn survival in developing countries
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
To compare the effectiveness of a health education strategy (vs. existing level of health education), imparted to mothers or their family members in developing country community settings, on neonatal mortality, neonatal morbidity, access to health care, and cost.
We will conduct separate analyses according to the educational strategy used:
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One to one counselling vs. control
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Group counselling vs. control
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Any combination of the above vs. control
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One to one counselling vs. group counselling
The following will be explored in sub‐group analyses:
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Duration and frequency of intervention: number of sessions or visits per person (or per group) per month
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Neonatal mortality rate at baseline: more than or equal to 30 per 1000 live‐births vs. less than 30 per 1000 live births
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Timing of intervention: pre‐conceptual, antenatal vs. post natal
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Who receives intervention: mothers, their spouses or other family members (such as mother in‐laws)
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Who provides counselling: support groups or peers, health professionals, traditional birth attendants, village health workers, etc.
Background
Ninety‐eight percent of the four million neonatal deaths occur each year in middle and low income countries and two‐thirds or more of these deaths occur in the first week of life (SOWN 2001). Extremely high neonatal mortality rates of over 40 per 1000 live births are typical of several Sub‐Saharan African and South Asian countries (SOWN 2001; Hyder 2003). The precise contribution of various causes of neonatal deaths is difficult to ascertain since the vast majority of births and deaths occur in homes, and are thus poorly reported and categorized (Stoll 2001). However, infectious causes are recognized as the major cause of neonatal deaths (Stoll 2001; Lawn 2004; Lawn 2005).
In an effort to improve outcomes for both mothers and their newborn infants, the "Mother‐Baby Package" was introduced by the WHO in 1994 (WHO 1994). The "Mother‐Baby Package" consists of a diverse set of interventions considered essential to maternal and newborn health. These include interventions such as antenatal registration and care, iron/folate supplementation, tetanus toxoid immunization, prevention and management of STDs and HIV in endemic areas, treatment of underlying medical conditions such as malaria and hookworm infestation, nutritional advice, ensuring clean delivery, presence of a trained birth attendant at delivery, recognition and management of maternal and neonatal complications, neonatal resuscitation, early and exclusive breast‐feeding and prevention and management of neonatal hypothermia and infections including ophthalmia neonatorum and cord infections.
Implementation and coverage of the mother‐baby package varies and the services offered are poorly utilized. In the developing world, almost half of mothers lack adequate antenatal care; more than 60% of all births occur in homes and only half take place in the presence of a skilled birth attendant (WHO 1996). In many settings, care for the mother and baby in the critical first few days after delivery occur entirely outside the formal health care sector. In these least developed regions, contraception prevalence is only 32% and fertility rates (the average life‐time number of live births per woman as current fertility rates (UNICEF 2000) are as high as 5.4 live births/woman (UNICEF 2000).
Although the reasons for high neonatal mortality rates are multifactorial, ranging from shortcomings in supply (such as lack of manpower, poor quality or dearth of medical supplies and equipment), poor health‐center to community linkages, malfunctioning referral systems, non‐existent emergency transportation facilities, and inadequately trained service providers and birth attendants, a major factor is the lack of demand for services provided (Osrin 2003; Ensor 2004; Lawn 2004; Lawn 2005). This is the result of numerous socioeconomic and cultural factors operating at an individual and at a collective community level, such as poverty, lack of awareness of services offered, aversion to hospitalization and formal medical care, ignorance of when and how to seek help even if desired, and lack of female participation in family decision‐making (Bhardwaj 1995; de Zoysa 1998; Bang 1999; Ahmed 2001; Bang 2001; Ensor 2004).
In the developing world, health services may be underutilized. Several studies have reported improvements in neonatal outcomes following health education imparted to mothers, either in homes, at health units or in hospitals. However, the evaluation of any health educational strategy, such as one‐to‐one counselling or group counselling via peer or support groups, through the organization of men or women's groups, or delivered by health professionals, requires rigorous assessment of methodological design and quality, as well as an assessment of cost‐effectiveness, affordability, sustainability and reproducibility in diverse health systems.
The "Warmi Project" in rural Bolivia (O'Rourke 1998) achieved significant reductions in perinatal and neonatal mortality rates (from 11.7% pre‐intervention to 4.4% post‐intervention) through support of women's organizations and community health education. In three rural districts of Pakistan, local women were trained to deliver primary health care, health education, and facilitate community organization for health improvement (Barzgar 1997). In a poor urban district of Brazil, significant improvements in maternal knowledge and health behavior were documented following implementation of the 'ProNatal project' that, among other interventions, included the provision of health education at newly established antenatal clinics and in homes (Emond 2002). A year after initiation, significant reductions in infant mortality and diarrhea related mortality as well as an increase in contraception use were reported.
In Bangalore, India, a one‐to‐one educational session with mothers of children under five resulted in significant improvements in most aspects of home management of diarrhea (Mangala 2001).
The proposed systematic review will assess the effectiveness of community health education and community mobilization strategies in reducing neonatal mortality rates and will also attempt to compare the costs of such strategies.
Objectives
To compare the effectiveness of a health education strategy (vs. existing level of health education), imparted to mothers or their family members in developing country community settings, on neonatal mortality, neonatal morbidity, access to health care, and cost.
We will conduct separate analyses according to the educational strategy used:
-
One to one counselling vs. control
-
Group counselling vs. control
-
Any combination of the above vs. control
-
One to one counselling vs. group counselling
The following will be explored in sub‐group analyses:
-
Duration and frequency of intervention: number of sessions or visits per person (or per group) per month
-
Neonatal mortality rate at baseline: more than or equal to 30 per 1000 live‐births vs. less than 30 per 1000 live births
-
Timing of intervention: pre‐conceptual, antenatal vs. post natal
-
Who receives intervention: mothers, their spouses or other family members (such as mother in‐laws)
-
Who provides counselling: support groups or peers, health professionals, traditional birth attendants, village health workers, etc.
Methods
Criteria for considering studies for this review
Types of studies
Community‐based (home, Basic Health Unit (BHU) or first level health facility) randomized controlled, cluster‐randomized or quasi‐randomized controlled trials. We will obtain disaggregated data for neonates for trials conducted on neonates as well as older age groups.
A BHU providing primary level health care is either "a dispensary, health post or Maternal and Child health/ Family planning (MCH/FP) clinic which provides basic health services, such as health education, simple laboratory tests and treatment".
A first level health facility or the first referral level is a "district hospital with around 20 beds, providing inpatient services with staff of one or more physicians and few medical specialists, and equipment necessary to carry out most life‐saving surgical and medical procedures" (JHU 2003).
Types of participants
Types of participants may include the following groups:
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Married women with the potential to conceive; or
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Pregnant women at any period of gestation; or
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Mothers of neonates (up to 28 days of life); or
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Their spouses/partners;
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Other family members (such as mother in‐laws);
All participants will reside in developing countries
Types of interventions
Intervention Community health education for maternal and newborn care implemented via:
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One to one counselling
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Group counselling
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Any combination of the above
Control not receiving the additional educational intervention or receiving conventional level of health education
Types of outcome measures
PRIMARY OUTCOMES
Neonatal mortality:
The number of neonatal deaths from any cause among all live births during the trial period
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Early neonatal mortality: from birth through six completed days of life
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Late neonatal mortality: from seven to 28 completed days of life
SECONDARY OUTCOMES
1. Perinatal mortality:
The number of still births and newborn deaths within a week of life among all still births and live births during the trial period
2. Neonatal infections:
The number of neonates diagnosed with infection (as defined by authors) among all live births during the trial period. Infections will include:
i) sepsis
ii) pneumonia
iii) meningitis
iv) gastroenteritis
v) tetanus
vi) any combination of the above
3. Any antenatal care:
The number of pregnant women among all pregnant women who were attended for reasons relating to pregnancy by skilled health personnel (a doctor, and/or persons with midwifery skills who can manage normal deliveries and diagnose or refer obstetric complications) at least once during pregnancy. Both trained traditional and untrained traditional birth attendants will be excluded (WHO 2004).
4. Use of any method of contraception:
The number of women of reproductive age (15 ‐ 49) or their spouse who reported to have used any contraceptive method during the trial period (any contraceptive method such as female and male sterilization, injectable and oral hormones, intrauterine devices, diaphragms, spermicides and condoms, natural family planning and lactational amenorrhea) (WHO 2004).
5. Skilled attendance at delivery:
Number of births among all live births during trial period which were attended by skilled health personnel (such as doctor or skilled attendant capable of managing normal deliveries and referring obstetric complications, excluding trained or untrained traditional birth attendants) (WHO 2004).
6. Delivery attended by unskilled or semi‐skilled birth attendant:
Number of births among all live births during trial period that were attended by an unskilled (such as an untrained traditional birth attendant, or a relative) or semi‐skilled birth attended (such as trained traditional birth attendant).
7. Use of clean delivery kit:
The number of deliveries occurring during the trial period for which a clean delivery kit was used by the birth attendant [typically containing a plastic sheet delivery surface, a clean cutting instrument (a new razor blade), clean ties for the cord, soap for ensuring clean hands of the birth attendant, and instructions] (Beun 2003; PATH 2005).
8. Care seeking:
The number of mothers among all mothers of neonates who sought or were reported to have sought medical care for their neonate's illness during the trial period.
9. Use of colostrum:
The number of women who used colostrum among all women who delivered live born babies during the trial period.
10. Timely initiation of breast feeding:
The number of women who initiated breast feeding within an hour of birth among all women who delivered live born babies during the trial period.
11. Mothers' understanding of each of the following "healthy" behaviors, among all women interviewed:
i) ways to prevent neonatal infections (such as hand washing, cord care)
ii) signs of neonatal infections
iii) advantages of breast‐feeding
iv) family planning methods
v) willingness to seek formal medical care for neonatal illness
vi) knowledge of health services offered in community
12. Total cost of intervention:
In US $ for intervention (including of recruiting and training personnel to deliver intervention, conducting sessions) among all recipients of the intervention.
13. Cost per neonatal life saved:
Cost in US $ for each neonatal life saved among all live births in the trial period.
Search methods for identification of studies
The standard search methods of the Cochrane Collaboration and the Cochrane Neonatal Group will be used (Cochrane Handbook). Trials of educational or mobilization interventions in community settings will be identified from MEDLINE (1966 to July 2008), EMBASE (1974 to July 2008), CENTRAL (The Cochrane Library, Issue 3, 2008), Cochrane Specialized Trials Register (Neonatal and Pregnancy and Childbirth Group; July 2008) and LILACS (www.bireme.br; July 2008).
We will use the following search terms, which will be adapted as necessary for each database listed above: Limited to: "Clinical Trials"; and "Randomized Controlled Trials" .
We will use combinations of the following words in the format: Participants AND Intervention AND Setting
Participants
Text words: Birth OR Delivery OR Infant* OR Neonate* OR Newborn* OR Mother OR Woman OR Maternal OR Pregnancy* OR Antenatal OR Prenatal OR Postnatal OR Periconcept*
MeSH words: Parturition OR Infant, Newborn OR Mothers OR Women OR Pregnancy
Intervention
Text words: Intervention* OR Package* OR Promotion* OR Participate* OR Support* OR Group* OR Discussion* OR Education* OR Worker* OR Services OR Program* OR Improve* OR Lower* OR Reduce* OR Utilization OR Use
MeSH words: Health education OR Community Health Services OR Counseling OR Intervention studies OR Community Health Aides
Setting
Text words: "Basic health unit" OR Community* OR Community‐based OR Domiciliary OR Developing OR Facility OR Home OR home‐based OR Peripheral OR Poor OR Rural OR Underdeveloped OR Unit* OR Village*
MeSH words: Rural population OR Developing countries
We will include relevant studies regardless of language or publication status (published, unpublished, in press, and in progress). We will check the reference lists of all trials identified by the above methods. We will also search the following conference proceedings for relevant abstracts: Federation of Asia and Oceania Perinatal Societies (FAOPS), World Congress on Perinatology, International Association for Maternal and Neonatal Health (IAMANEH), Indian Academy of Pediatrics (IAP), International Pediatric Association (IPA). We will contact organizations and researchers in the field for information on unpublished and ongoing trials, including all South Asian and African community‐based newborn care trials such as the Saving Newborn Lives (SNL) funded projects in Hala, Pakistan, Bangladesh (Projahnmo trials), India (Ankur and Shivgarh trials), Nepal and Mali, and trials in Makwanpur (Nepal) and of the Maternal and Infant Nutrition in Matlab (MINIMAT) project.
Data collection and analysis
The standard review methods of the Cochrane Collaboration (Cochrane Handbook) (Higgins 2005) and the Cochrane Neonatal Group will be used.
Study selection and eligibility
One review author (BAH) will screen the titles and abstracts acquired from all sources listed above for relevance, and retrieve full‐text of all relevant and potentially relevant trials. Two reviewer authors (BAH and AO) will independently determine the eligibility of retrieved trials using pre‐defined eligibility forms and will resolve any disagreements through discussion. If these methods fail to clarify any doubts, we will consult a third reviewer (AZ or ZB) and/or contact the study authors. We will tabulate the excluded studies along with the reasons for excluding them. We will ensure that data from duplicate publications are entered only once in our review.
Assessment of methodological quality
Two review authors (BAH and AO) will independently assess the methodological quality of each included trial using the following criteria, categorized as A (adequate), B (unclear) C (inadequate):
(1) method of randomization (A, B, or C)
(2) allocation concealment (blinding of randomization) where relevant
(3) blinding of outcome assessment (for health educational intervention: blinding of intervention or of participants is not relevant)
(4) completeness of follow up (we will classify it as adequate if > = 90% randomized participants are followed‐up).
Disagreements will be resolved through discussion or by consulting the third reviewer (AZ or ZB). If any method is found to be unclear, we will attempt to contact the study authors.
Data extraction
Two review authors (BAH and AO) will independently use a piloted data form to extract data. We will compare data, correct errors and resolve any disagreements by discussion or consultation with third review author (AZ or ZB). We will attempt to contact study authors to obtain additional data, or to clarify data. For dichotomous outcomes, such as neonatal mortality, we will extract the total number of participants and number of participants who experienced the event. For continuous outcomes, such as cost, we will extract the mean and standard deviation or compute same if the data are available. We will attempt to extract data on all participants randomized. If this information is not provided, and the denominator is less than the number originally randomized to that group, we will derive the percent loss to follow up and tabulate these results.
Data analysis
We will analyze data using Review Manager 5. For dichotomous data, we will use relative risk (RR) and for continuous outcomes we will use the weighted mean difference (WMD), or the standardized mean difference (SMD) if necessary. We will use 95% Confidence Intervals (CI). We will perform a sensitivity analysis to asses the impact of methodological quality. We will check for heterogeneity by using an I2 test. We will use a fixed effects model. We will use a funnel plot to determine possibility of publication bias, variations in methodological quality, or heterogeneity in results. We will use Cochrane Neonatal Review Group's (CNRG) methodology recommendations for analyzing cluster‐randomized trials.
