SUPPORT Summaries
Evidence of the effects of health system interventions
for low- and middle-income countries
Evidence of the effects of health system interventions
for low- and middle-income countries
October, 2016 - SUPPORT Summary of a systematic review | print this article | download PDF
Sepsis is one of the conditions contributing significantly to both maternal and newborn mortality. Poor hygiene during the intrapartum period has been recognised as a critical risk factor for sepsis. Clean birth is an essential intervention estimated to avert 20–30% of newborn deaths due to sepsis and tetanus, and requires the availability of a few essential supplies. Since birth kits have been recommended by the World Health Organization (WHO) as a means of ensuring supplies and to ‘strengthen standards of cleanliness’ in home deliveries, more than 50 low and middle income countries have introduced birth kits, which are now receiving renewed international interest.
-probably reduces neonatal mortality rate
-reduces neonatal tetanus related mortality
-may reduce neonatal sepsis
-probably reduces maternal mortality
-probably reduces haemorrhage
-reduces puerperal sepsis
People making decisions concerning the use of birth kits to improve newborn and maternal outcomes
Hundley VA, Avan BI, Braunholtz D, Graham WJ. Are birth kits a good idea? A systematic review of the evidence. Midwifery 2012; 28(2):204-15.
A summary of studies addressing a clearly formulated question that uses systematic and explicit methods to identify, select, and critically appraise the relevant research, and to collect and analyse data from the included studies.
SUPPORT – was an international project to support the use of policy relevant reviews and trials to inform decisions about maternal and child health in low- and middle-income countries, funded by the European Commission (FP6) and the Canadian Institutes of Health Research.
Achieving clean birth requires the application of skills by the care provider and the availability of a few essential supplies. Births kits vary considerably in name and content. The WHO recommends content that, at a minimum, ensures ‘three cleans’: a clean surface for delivery (e.g. a plastic sheet), clean hands of the birth attendant (e.g. soap), and clean cutting of the umbilical cord (e.g. a razor blade). Three further ‘cleans’ have been added: clean perineum (e.g. soap), clean cord tying (e.g. cord ties or clamps), and clean cord care (e.g. gauze to cover cord stump or surgical spirit). Births kits have been recommended not only for home births but also for use in health facilities that lack the capacity to sterilise equipment.
| Review objectives: To assess the effects of birth kits on newborn and maternal outcomes. | ||
| Type of | What the review authors searched for | What the review authors found |
|---|---|---|
| Study designs & interventions | To assess the effects of birth kits on newborn and maternal outcomes |
9 included studies reporting effects of intervention packages including births kits: randomised trial (1), non-randomised trial (1), before-after studies (2) and cross-sectional studies (5) |
| Participants | Pregnant women in the intrapartum period | Pregnant women (median delivery at home 87%) |
| Settings | Home or health facility | Mostly rural areas from Nepal (2), Egypt (2), Pakistan (1), Kenya & Tanzania (1), Papua New Guinea (1), India (1), Tanzania (1) |
| Outcomes |
Primary outcomes: newborn outcomes and maternal outcomes Secondary outcomes: process measures—clean birth practices |
Newborn outcomes (perinatal mortality, neonatal tetanus, neonatal sepsis, and omphalitis) and maternal outcomes (maternal mortality, puerperal sepsis) Process measures—clean birth practices (clean hands, birth surface, cord cutting, cord tie) |
| Date of most recent search: September 2009 | ||
| Limitations: This is well-conducted systematic review with only minor limitations. | ||
Hundley VA, Avan BI, Braunholtz D, Graham WJ. Are birth kits a good idea? A systematic review of the evidence. Midwifery 2012; 28(2):204-15.
Hundley VA, Avan BI, Braunholtz D, Graham WJ. Are birth kits a good idea? A systematic review of the evidence. Midwifery 2012; 28(2):204-15.
High: This research provides a very good indication of the likely effect. The likelihood that the effect will be substantially different† is low.
Moderate: This research provides a good indication of the likely effect. The likelihood that effect will be substantially different† is moderate.
Low: This research provides some indication of the likely effect. Howevver, the likelihood that it will be substantially different† is high.
Very low: This research does not provide a reliable indication of the likely effect. The likelihood that the effect will be substantially different† is very high.
* This is sometimes referred to as 'quality of evidence' or 'confidence in the estimate'.
† Substantially different = a large enough difference that it might affect a decision.
See last page for more information.
Nine studies examined the effectiveness of an intervention package, which included a birth kit. The other interventions delivered alongside birth kits varied between studies and included, for example, education (from a simple explanation of kit contents to a more detailed training course) or the provision of a topical antimicrobial.
Three cross sectional studies comparing users and non users, , examined areas of practice in relation to birth kit use. There was a consistent higher proportion of birth kit users than non-users among those that applied clean childbirth practices (home and birth attendant hand washing, clean cord tie or clamp being used, clean blade being used, use of a clean delivery surface, the mother's perineum having been washed and clean cord care), but the effects of birth kits on these process outcomes are uncertain.
An intervention package that included a birth kit was associated with reduced newborn mortality in three studies. Two of the studies provided the neonatal mortality rate, while the third reported ‘total mortality’ in the first six weeks of life. Birth kit use was also associated with advantageous outcomes in relation to tetanus related mortality in two of the studies. Four studies investigated the impact of an intervention package including a birth kit on omphalitis or cord infection. An examination of individual components of the birth kit found that only soap showed an association with omphalitis.
In three additional studies where birth kit use was increased because of a community intervention (excluded from the review), the neonatal mortality rate was reduced in two studies: odds ratio (OR)=0.70 (95% CI 0.53, 0.94), OR=0.93 (95% CI 0.80, 1.09), Risk Ratio=0.72 (95% CI 0.56, 0.91).
-probably reduces neonatal mortality rate. The certainty of this evidence is moder-ate.
-reduces neonatal tetanus related mortality. The certainty of this evidence is high.
-may reduce neonatal sepsis. The certainty of this evi-dence is low.
Birth kits - newborn outcomes |
|||
| People: Pregnant women in the intrapartum period Settings: Home or health facility Intervention: Birth kits (as part of an intervention package that also includes education Comparison: Usual care |
|||
| Outcomes | Impact | Certainty of the evidence (GRADE) |
|
| Neonatal mortality rate | Relative decrease ranged from 23% to 83% (95% CI 77-87%). |
Moderate |
|
| Tetanus related mortality | Relative decrease ranged from 99% (95% CI 91-99.9%) to 100%. |
High |
|
| Sepsis | Relative decrease of 88% (95% CI 7-98%) |
Low |
|
| Omphalitis | Median relative decrease of 49% (ranging from an increase of 15% to a reduction of 92%) | Very Low | |
| GRADE: GRADE Working Group grades of evidence (see above and last page) | |||
2) Maternal outcomes
Three studies considered maternal outcomes in relation to an intervention package including a birth kit, and in all of these, there was an impact on the incidence of puerperal sepsis. One study examined maternal mortality as one of the primary outcomes and haemorrhage, the leading cause of maternal mortality in low income countries. The effect on haemorrhage could be explained by co-interventions to clean birth.
In three additional studies where birth kit use was increased because of a community intervention (excluded from the review), the maternal mortality rate showed inconsistent results: odds ratio (OR)=0.22 (95% CI 0.05, 0.90), OR=0.70 (95% CI 0.46, 1.07), OR=2.02 (95% CI 1.11, 3.68).
-probably reduces maternal mortality. The certainty of this evidence is moder-ate.
-probably reduces haemorrhage. The certainty of this evi-dence is moderate.
-reduces puerperal sepsis. The certainty of this evidence is high.
Birth kits - newborn outcomes |
|||
| People: Pregnant women in the intrapartum period Settings: Home or health facility Intervention: Birth kits (as part of an intervention package that also includes education or a topical antimicrobial) Comparison: Usual care |
|||
| Outcomes | Impact | Certainty of the evidence (GRADE) |
|
| Mortality | Odds Ratio=0.74 (95% CI 0.45, 1.23) |
Moderate |
|
| Hemorrhage | Odds Ratio=0.61 (95% CI 0.47, 0.79) |
Moderate |
|
| Puerperal sepsis |
Odds Ratio=0.17 (95% CI 0.13, 0.23) Two observational sutudies showed consistent results: OR=0.11 (95% CI 0.01, 1.06) and OR=0.31 (95% CI 0.18, 0.54) |
High |
|
| GRADE: GRADE Working Group grades of evidence (see above and last page) | |||
|
Summary includes:
Doesn’t include:
|
| Findings | Interpretation* |
|---|---|
| APPLICABILITY | |
| Most of the included studies were conducted in low-income countries. |
Given the setting of the included studies and the low cost and simplicity of birth kits, the findings are likely to be applicable to low-income countries. However, the availability, acceptability and cost of the birth kits should be considered. |
| EQUITY | |
|
The studies were mostly conducted in rural, underserved areas.
|
If the use of birth kits is targeted at underserved populations or other disadvantaged populations, it will likely decrease inequities.
|
| ECONOMIC CONSIDERATIONS | |
| The systematic review did not address economic considerations. |
Scaling up the use of birth kits requires resources. Local costings should be undertaken.
|
| MONITORING & EVALUATION | |
|
There is no evidence of the effects of birth kits separate from those achieved by a broader intervention package.
|
Larger and more rigorous studies are required to determine the benefits, harms and the cost-effectiveness of birth kits.
|
|
*Judgements made by the authors of this summary, not necessarily those of the review authors, based on the findings of the review and consultation with researchers and policymakers in low-income countries. For additional details about how these judgements were made see: http://www.support-collaboration.org/summaries/methods.htm |
|
Blencowe H, Cousens S, Mullany LC, et al. Clean birth and postnatal care practices to reduce neonatal deaths from sepsis and tetanus: a systematic review and Delphi estimation of mortality effect. BMC Public Health 2011; 11 Suppl 3:S11.
Blencowe H, Cousens S. Addressing the challenge of neonatal mortality. Tropical Medicine & International Health 2013; 18(3):303-12.
Seward N, Osrin D, Li L, et al. Association between clean delivery kit use, clean delivery practices, and neo-natal survival: pooled analysis of data from three sites in South Asia. PLoS Medicine 2012; 9(2):e1001180.
Bhutta ZA, Darmstadt GL, Hasan BS, Haws RA. Community-based interventions for improving perinatal and neonatal health outcomes in developing countries: a review of the evidence. Pediatrics 2005; 115(2 Suppl):519-617.
Hundley VA, Avan BI, Braunholtz D, et al. Lessons regarding the use of birth kits in low resource countries. Midwifery 2011; 27(6):e222-e230.
Hundley VA, Avan BI, Ahmed H, et al. Clean birth kits to improve birth practices: development and testing of a country level decision support tool. BMC Pregnancy and Childbirth 2012; 12:158.
Seward N, Prost A, Copas A, et al. Using observational data to estimate the effect of hand washing and clean delivery kit use by birth attendants on maternal deaths after home deliveries in rural Bangladesh, India and Nepal. PloS One 2015; 10(8):e0136152.
Agustín Ciapponi, Instituto de Efectividad Clínica y Sanitaria, Buenos Aires, Argentina
None declared. For details, see: www.supportsummaries.org/coi
This summary has been peer reviewed by: Vanora Hundley and Nadine Seward.
Ciapponi A. Do birth kits improve newborn and maternal outcomes? A SUPPORT Summary of a systematic review. October 2016. www.supportsummaries.org
evidence-informed health policy, evidence-based, systematic review, health systems research, health care, low and middle-income countries, developing countries, primary health care, birth kits, clean birth practices, newborn, maternal mortality
