Research Review: "Making a List and Checking it Twice" Did Not Reduce Infant and Maternal Morbidity and Mortality

Introduction

Checklist BB.jpgMaternal and newborn mortality and morbidity are of great concern to healthcare care providers, governmental agencies, and communities in countries all around the world.  Low-income and middle-income countries are typically more adversely impacted and more parents and babies die or experience severe complications in the first week of after birth than in more financially stable countries. Improvement processes have been implemented with the leadership and assistance of international agencies and non-governmental organizations (NGOs). There have been positive results, but there is still significant room for improvement before giving birth is no longer the second leading cause of death amongst people of childbearing age.

The most common causes of death to in the first 7 days after giving birth are largely preventable. According to current research recognized by the World Health Organization, infection, eclampsia, and hemorrhage are the three largest killers of birthing people worldwide.  With proper handwashing and the use of sterile gloves and equipment as well as monitoring and quick responses to urgent situations, many of these issues could be reduced or severely limited. These items along with others are found on the WHO Safe Childbirth Checklist.

The hypothesis

Researchers from the BetterBirth Program out of Ariadne Labs hypothesized that facilities located in low-resource countries could improve the mortality and morbidity of birthing people and newborns by implementing the WHO Safe Childbirth Checklist along with parallel coaching programs to support birth attendants in compliance.  This checklist is designed to support the delivery of essential maternal and perinatal care practices that will have the most impact on the death of babies and parents and it was developed so as to be effective and reproducible in low-resource areas. Setting up programs that incorporated adherence to the checklist along with coaching was hypothesized to result in "a reduction in a composite outcome of stillbirth, early neonatal death, maternal death, or maternal severe complications during days 0 to 7".

How was the study done?

This study "Outcomes of a Coaching-Based WHO Safe Childbirth Checklist Program in India" was conducted in Uttar Pradesh, the most populated state in India which has had a long history of persistently high neonatal and maternal mortality rates.  Facilities selected had to meet the following requirements:

  • designated as a primary health center, community health center, or first referral unit;
  • had at least 1000 deliveries annually;
  • had at least three birth attendants with the training of at least the level of an auxiliary nurse midwife;
  • had no other concurrent quality-improvement or research programs;
  • and had district and facility leadership willing to participate. 

120 facilities were selected to participate in this Indian state. 60 were assigned to the intervention group and 60 were the control.  The intervention group received intensive coaching by qualified medical professionals and public health officials over the study period to help support and improve adherence to the WHO Safe Childbirth Checklist.  These coaches also helped identify barriers to following the Checklist and work on process improvement to remove these. Data were collected to assess the the rate of compliance with the Checklist and the number of observed events occurring within the first 7 days after delivery, incorporating stillbirth; early neonatal death; maternal death; or self-reported maternal severe complications, including seizures, loss of consciousness for more than 1 hour, fever with foul-smelling vaginal discharge, hemorrhage, or stroke.  Continued surveillance of adverse events occurring after day 7 included maternal death, maternal complications, interfacility transfer (referral), cesarean section, hysterectomy, blood transfusion, and return to the facility for a health problem. Secondary newborn outcomes included stillbirth, early neonatal death, and interfacility transfer. You can find the exact protocol used in this study on the New England Journal of Medicine website.

What were the results?

Of the 163,939 women who were registered for labor and delivery (83,166 in the intervention group and 80,773 in the control group), 98.3% (161,107) were eligible for trial inclusion. Of the eligible women, 97.9% (157,689) provided consent.  7-day outcomes were collected for all but 544 (0.3%) of the consenting women. There were no significant differences between intervention and control groups in facility, maternal, or newborn characteristics.

After two months of twice-weekly coaching, birth attendants in intervention facilities (1259 observations) performed, on average, 72.8% of the 18 measured practices, whereas birth attendants in control facilities (1304 observations) performed 41.7% of the practices.  These practices were established and included on the WHO Safe Childbirth Checklist in order to reduce morbidity and mortality.

There was no significant difference between intervention and control facilities in the primary outcome (15.1% in the intervention group and 15.3% in the control group; relative risk, 0.99; 95% confidence interval, 0.83 to 1.18; P=0.90) or in any secondary outcomes. There were no significant differences between the trial groups in the rates of follow-up care required for women or newborns, hysterectomy, blood transfusion, or interfacility transfer (referral) for women or newborns. 

Discussion of the results

Research has shown that the use of the WHO Safe Childbirth Checklist improves quality of care, but there has been some concern that previous studies were possibly not as strict in documenting adherence to the checklist and evaluating the final outcomes for babies and parents. In this research study, the adherence to the Checklist was well documented but yet, there was no difference in outcomes between the intervention and the control group.  During coaching periods, improvements were made to Checklist compliance. Overall levels of adherence and checklist use diminished after coaching ceased, and the rates of some practices never differed significantly between the intervention and control groups. It is possible that checklist use was not sustained owing to lack of checklist stock, staff belief that they knew the items on the checklist, lack of enthusiasm, or other reasons. Specific data was not collected on reasons for unsustained checklist use. The lack of effect on health outcomes despite improvements in performance of recommended practices challenges assumptions that better practice adherence would directly result in decreased mortality.  The theory of the BetterBirth program was that improving the quality of childbirth-related care provided in facilities would translate into improved patient outcomes but this requires some basic assumptions underlying current childbirth work in global health.  Researchers determined that a coaching-based implementation of the checklist could produce broad-based improvement in the quality of care of facility-based childbirth which is a necessary step in effecting improvement in health outcomes.  One potential interpretation of the findings is that increasing adherence to these practices is not a worthwhile goal, because these practices did not lead to improved outcomes. The researchers feel strongly that this conclusion is false. Each of the practices incorporated in the checklist (and therefore in the BetterBirth program) has its own evidence base, including effectiveness with regard to improving maternal outcomes, improving neonatal outcomes, or both.  Several other factors may have affected the results of the trial. Levels of adherence to essential birth practices in the intervention sites may have been insufficient to affect outcomes: for example, birth attendants performed appropriate hand hygiene in only 35% of cases, and although 79% of mother-infant pairs initiated skin-to-skin warming, only 19% of mother-infant pairs maintained that contact for 1 hour. The rate of use of magnesium sulfate was no higher in the intervention facilities than in the control facilities. Persistent gaps in technical skills, management of complications, the quality and quantity of supplies and medicines, access to supportive management, and systems-level accountability — mostly unmeasured — could also have had a substantial effect on the ability to improve health outcomes. Factors that were not targeted by the BetterBirth program may have also limited its effects, including women’s underlying health and nutrition status, the quality of prenatal and postnatal care, and the quality of referral care for those with more complex needs.

Another reason for fact that differences were observed may be attributed to the fact that staff might have practiced much differently when unobserved.  Another consideration may be that the trial was held in only one region of India and that limits the generalizability of the findings. Whether the BetterBirth program could achieve improvement in health outcomes in a setting with, for example, higher baseline adherence to practices, a different health care system or facility-level organization, or a different patient population is not known.

Further evaluation determined that this coaching-based implementation of the WHO Safe Childbirth Checklist had no significant effect on adverse maternal and perinatal health outcomes, despite positive effects on essential birth practices. Researchers believe that further high-quality research on a larger scale should continue to measure both processes and outcomes of care because there is currently a lack a complete understanding of the complexities that determine outcomes. 

Conclusion

Researchers, scientists, health care providers, governmental agencies, and NGOs agree that the rates of maternal and neonatal morbidity and mortality are too high, especially in undeveloped and low resource areas of the world.  Solutions and process improvement programs that are easily implemented and demonstrate successful outcomes must continue to be sourced in order to reduce the impact on parents and babies. Being willing to think out of the box and apply creative solutions to these devastating problems can only result in ultimately finding an appropriate long-term solution.

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