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PEDIATRICS Vol. 109 No. 6 June 2002, pp. 1074-1080

Randomized Trial of Postpartum Care After Hospital Discharge

Anita J. Gagnon, RN, MPH, PhD*,{ddagger}, Geoffrey Dougherty, MDCM, MSc, FRCPC*,§, Vania Jimenez, MD*,|| and Nicole Leduc, PhD

* McGill University, Montreal, Quebec, Canada
{ddagger} McGill University Health Centre-Royal Victoria Hospital Site, Montreal, Quebec, Canada
§ McGill University Health Centre-Montreal Children’s Hospital Site, Montreal, Quebec, Canada
|| Centre locale des services communautaires (CLSC) de Côte des Neiges, Montreal, Quebec, Canada
Université de Montréal, Montreal, Quebec, Canada

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   ABSTRACT
TOP
 ABSTRACT
INTRODUCTION
 METHODS
 RESULTS
 DISCUSSION
 CONCLUSION
 REFERENCES
 
Objective. Harmful effects of short postpartum hospital stays include dehydration and malnutrition of breastfed infants. These may be prevented by adequate breastfeeding frequency; however, rigorous research to determine the relative effectiveness of various follow-up strategies in supporting breastfeeding frequency is absent. This study addressed the question, "Is there a difference in breastfeeding frequency or infant weight gain for singleton infants discharged within 36 hours’ postpartum who received either community nurse (home visit) or hospital nurse (clinic) follow-up?"

Methods. A randomized, controlled trial was conducted at a university teaching hospital (3700 births/y) and affiliated community health centers. A consecutive sample of 586 healthy mother-infant pairs were recruited from January 1997 to September 1998 before discharge; 513 (87.5%) contributed data on 1 or more outcomes. Forty-eight-hour postpartum telephone contact and day 3 nurse contact in the home (experimental) or at the hospital (control) were provided. The main outcomes measured were breastfeeding frequency and infant weight gain assessed at 2 weeks’ postpartum by maternal diary and weight at home by research assistants, masked to group allocation.

Results. No clinically important or statistically significant group differences were found in daily breastfeeding frequency (mean difference experimental minus control = 0.1 feeds [95% confidence interval: -0.1–0.3]) or daily rate of infant weight gain (-1.1 g [-2.5–0.3]) based on intention-to-treat analyses.

Conclusions. Follow-up by nurses after short postpartum hospital stays, in either the home or a hospital-based clinic, of healthy infants discharged at <36 hours seems associated with satisfactory infant breastfeeding outcomes.

Key Words: breastfeeding • nursing care • randomized controlled trials • dehydration • puerperium • community health • newborn

Abbreviations: CI, confidence interval • RR, relative risk


   INTRODUCTION
TOP
 ABSTRACT
 INTRODUCTION
METHODS
 RESULTS
 DISCUSSION
 CONCLUSION
 REFERENCES
 
Fiscal constraint in the health sector has resulted in short postpartum hospital stays. Care previously provided in the hospital has been replaced by nurse home visits, outpatient clinic visits, or other types of services or has not been replaced. Evidence for the effects of short postpartum hospital stays are discrepant.1–5 Reported detrimental effects of short postpartum stays include hospital readmissions for dehydration and malnutrition of breastfed infants within 2 weeks of life. These events are infrequent; however, they have been associated with serious sequelae, including convulsions, hypoglycemia, focal neurologic deficits, disseminated intravascular coagulation, and amputation.6 Unresolved infant jaundice, maternal and infant infection, maternal anxiety, and breastfeeding failure have also been reported. One important reason for the current variation in postdischarge follow-up is that data from rigorously conducted research studies assessing the relative effectiveness of various strategies are absent.7 Our study was meant to gather data in this domain and, thus, to inform health care planners of the optimal mix of postpartum posthospitalization health care services.

Despite the beneficial effects of breastfeeding,8 several cases of malnutrition and dehydration have been reported in otherwise healthy, exclusively breastfed infants within their first month of life.6,9–17 Symptoms of malnutrition included lethargy, poor feeding, and oliguria. Support for the relationship between short hospital stays and such adverse harmful health outcomes is also suggested in observational studies showing increased severity of illness at subsequent admission and increased admissions.1,2,4 Furthermore, these studies suggest that the increased number and severity of admissions for dehydration, hypernatremia, and malnutrition may be a consequence of inadequate strategies for ensuring adequate breastfeeding success.

Several studies have examined factors related to early breastfeeding success.18–21 Maternal perception of insufficient milk, maternal anxiety, painful breast engorgement, sore nipples, and maternal lack of confidence in breastfeeding are among the factors shown to affect successful breastfeeding in the early postpartum period and subsequent duration of breastfeeding. It is therefore reasonable to expect that an intervention directed at early preventable breastfeeding problems could result in early breastfeeding success and reduce the risks associated with insufficient feeding. A systematic review of support for breastfeeding has been conducted under the auspices of the Cochrane collaboration.22 These results suggest a beneficial effect of breastfeeding support on breastfeeding duration. The beneficial effects of frequent breastfeeding are particularly relevant to the first week postpartum. Infants who feed more frequently (every 3–4 hours vs "on demand") reach their maximum weight loss sooner, lose less of their birth weight, experience a greater intake of breast milk during the first week, consume significantly more milk on day 15, and gain significantly more weight.23,24

The greatest number of published reports of the effects of postpartum home follow-up to families at low medical and social risk were those that examined nurse home visitation after a postbirth hospital stay of 5 to 7 days. We identified a single published study that compared modes of care after a short hospital stay (<48 hours).25 Breastfeeding discontinuation rates at 14 days, maternal depression and satisfaction, and clinic use were examined. This study found that either a single home visit by a nurse or a pediatric clinic visit is associated with equivalent clinical outcomes, although home visits were associated with markedly higher maternal satisfaction and with higher costs. The issue of breastfeeding frequency was not addressed.

In summary, breastfed infants discharged from the hospital after short postpartum hospital stays seem to be at increased risk for malnutrition, dehydration, hypernatremia, hyperbilirubinemia, feeding difficulties, and breastfeeding failure. Furthermore, the most severe of these harmful health outcomes and several less severe harmful effects are likely to be prevented with establishment and maintenance of adequate breastfeeding frequency in the early postpartum period. Controlled studies have shown the effectiveness of interventions directed at early breastfeeding support, although there is a paucity of rigorously conducted randomized studies examining the impact of such support in the context of short hospital stays.

Our research question was, "Is there a difference in breastfeeding frequency, infant weight gain, maternal anxiety, satisfaction with services, or community or health services use for singleton infants or their mothers discharged within 36 hours’ postpartum from an urban, university hospital who received either community nurse (home visit) follow-up or hospital nurse (clinic) follow-up?" Our hypothesis was that home visits would produce superior outcomes in these domains.


   METHODS
TOP
 ABSTRACT
 INTRODUCTION
 METHODS
RESULTS
 DISCUSSION
 CONCLUSION
 REFERENCES
 
Protocol
Study Population
Women were recruited just before discharge from the postpartum unit of the Sir Mortimer B. Davis Jewish General Hospital, a McGill University teaching hospital with 3700 births per year, into a randomized controlled trial from January 15, 1997, to September 25, 1998. Research Ethics Committee approval was obtained before recruitment. Inclusion criteria were participation in the hospital’s short stay program, infant breastfed at least once in the hospital, and living in a defined catchment area proximal to the hospital. Mothers and newborn infants participated in the short stay program when certain health and psychosocial criteria were met. The program included discharge within 36 hours of birth, telephone follow-up, and a hospital nurse clinic visit. Exclusions from the short stay program included cesarean birth, parity >=5, blood loss at birth >=500 mL, more than second-degree perineal tear, maternal inability to void adequately, nonreceipt of indicated RhoGAM, mother unable to care for self or infant, multiple birth, birth weight <2500 g, gestational age <37 weeks, abnormal neonatal examination, infant unable to maintain body temperature, breastfeeding not tolerated in hospital, language barrier, and the need for social services referral. The only exclusion criterion for this study was nonparticipation in the short stay program.

Interventions
Women were randomized to receive nurse telephone contact at 48 hours postbirth and a nurse visit at 3 to 4 days’ postpartum in 1 of 2 ways: 1) in the woman’s home by the community nurse (experimental) or 2) by the hospital nurse in the hospital clinic (control).

Experimental: Community Follow-up
The home visit was timed (3–4 days) to coincide with peak bilirubin levels in breastfed infants26 and other physical and psychosocial needs of newborns and mothers.27 Home visits were planned to last 1 hour, during which time "usual care" similar to that described in the literature on early postpartum care would be provided.27 Nurse contacts continued when community follow-up was judged to be required. All contacts and referrals were recorded. These home visit nurses were baccalaureate prepared and had a minimum of 3 years of direct clinical experience in maternal-child health. All attended training sessions to ensure that their skills in maternal-newborn assessment and breastfeeding support were adequate.

Control: Hospital Follow-up
Usual care was a 48-hour postpartum telephone contact and a day 3 postpartum hospital visit. Clinic contacts lasted a maximum of 45 minutes, during which time a standardized plan of care was provided. The care provided during each contact (telephone and visit) is similar to that described in the literature on early postpartum care. Nurse contacts were terminated at the completion of the clinic visit, although referral for continued care was available.

Data Collection
Research assistants, blind to both treatment group and research questions, collected all data. Outcomes, measured at 2 weeks postbirth, included breastfeeding frequency (using a 2-day breastfeeding diary for days 12 and 13 postbirth) and infant weight gain (measured at home by research assistants using digital scales). Also measured at 2 weeks were maternal anxiety (using the State-Trait Anxiety Inventory), and postdischarge service satisfaction (using the Client Satisfaction Questionnaire). The State-Trait Anxiety Inventory is validated in a variety of population groups and languages including French.28 The Client Satisfaction Questionnaire 29 is reported to have adequate internal consistency and validity to support its use.30 Behavioral measures of satisfaction including study withdrawal and noncompliance with treatment allocation were recorded. Health and community services use was measured at 2 months’ postpartum using a diary and medical record review.31 Ancillary outcomes included insufficient breastfeeding (defined by us as <4.5 feeds per day), type of feeding (breastfeeding, formula, or mixed), and birth weight not regained at follow-up.

Study sample size requirements were estimated for breastfeeding frequency, our primary outcome, on the basis of the largest standard deviation reported in the literature, 3.9, and an average difference of 2 feeds per day. Proportions, standard deviations, and clinically relevant differences for all other infant and maternal outcomes were based on existing literature. The largest of these estimates was then adjusted to allow for loss to follow-up and nonparticipation. We estimated a sample size (using PASS 6.0 statistical software, Kaysville, UT) of 151 subjects per group to detect clinically relevant differences in breastfeeding frequency, infant weight gain, maternal anxiety, and satisfaction with services, with a power of 0.95 and {alpha} of .05. The required sample size was exceeded.

Statistical Analysis
Subjects were examined for group differences on baseline characteristics. Intention-to-treat analyses were performed. Group differences (means and relative risks) and their corresponding 95% confidence intervals (CI) were estimated. Analyses were performed using SAS statistical software (SAS Institute, Cary, NC).

Assignment
Consenting women who met study criteria were contacted by either the research assistant (experimental) or the clinic nurse (control) by telephone within 24 hours of hospital discharge with notification of group assignment. Subjects were stratified by parity in blocks of 8 using a computer-generated table of random numbers. Randomization was verified post hoc; no allocation errors were identified.

Masking
Given the nature of the intervention, masking of the women and health professionals was not possible. Different research assistants collected outcome data and notified women and clinicians of group assignment; outcome assessors were blind to group assignment and during any contact with subjects were instructed to ask subjects not to divulge their group status. Furthermore, research hypotheses were not divulged to the research assistants. Outcome data were not collected by clinical staff.


   RESULTS
TOP
 ABSTRACT
 INTRODUCTION
 METHODS
 RESULTS
DISCUSSION
 CONCLUSION
 REFERENCES
 
Participant Flow and Follow-up
A total of 4385 women experienced vaginal singleton births during the study interval. A total of 1683 (38.4%) were assigned to the short stay program (Fig 1). Data from 259 dyads (88.7%) randomized to the experimental group were available for analysis of 1 or more outcomes with 252 (86.3%) providing data on breastfeeding frequency. Data from 254 dyads (86.4%) randomized to the control group were available for analysis of 1 or more outcomes with 247 (84.0%) providing data on breastfeeding frequency.



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  		Fig 1. Participant flow diagram for a randomized trial of postpartum care after hospital discharge.

 
Analysis
Baseline characteristics are described in Table 1. Women and infants in both groups were similar, in particular, on planning to breastfeed, planning to exclusively breastfeed for >=3 months, and length of postpartum stay. Overall, randomized women were well educated and ethnically heterogeneous.


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  		TABLE 1. Baseline Characteristics by Group

 
Table 2 shows the study interventions received. More than 95% of women in both groups received the telephone contact. Infants in the experimental group were slightly older (3.5 hours), on average, at the time of that contact (95% CI: 2.8–4.2). The telephone contacts lasted 28% longer in the experimental group (3.8 minutes more [3.2–4.4]). More than 94% of women in both groups received the home or clinic visit at an average time of just over 3 days of age (77 hours). Home visits lasted 82% longer (37.2 minutes more [35.0–39.4]).


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  		TABLE 2. Study Interventions by Group

 
Table 3 shows health outcomes at 2 weeks. No differences were found in breastfeeding outcomes, including frequency (home minus clinic: 0.1 breastfeeds per day; 95% CI: - 0.1–0.3), insufficient breastfeeding (relative risk [RR]: 1.10; 95% CI: 0.71–1.68), or feeding type (RR for exclusive breastfeeding: 1.04; 95% CI: 0.94–1.17). No differences were found in indicators of infant weight gain, including average daily weight gain from birth (-1.1 g/d; 95% CI: -2.5–0.3) and the proportion who had not regained their birth weight by the time of the follow-up visit (RR: 1.40; 95% CI: 0.54–3.62). No differences were found in maternal state anxiety or service satisfaction. Power calculations showed >99% power to detect clinically relevant differences in outcomes defined a priori for breastfeeding frequency (2 feeds per day), state anxiety (4-point difference), and service satisfaction (2-point difference). There was 80% power to detect a 10% difference in insufficient breastfeeding, 72% power to detect a 10% difference in the proportion exclusively breastfeeding, 94% power to detect a 5 g/d difference in infant daily weight gain, and 34% power to detect a doubling in the proportion who did not regain their birth weight.


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  		TABLE 3. Health Outcomes at 2 Weeks’ Postpartum by Group

 
Table 4 shows health and community service use at 2 months. No differences were found in the percentage who ever made a visit to a physician or hospital or ever made or received a visit to/from a nurse or other health/community worker. The CI for the RR of visitation to/from other community workers is larger than the others as a result of the small event rate. No differences were found in the percentage who ever telephoned or received a telephone contact from a physician, other hospital employee, or other health/community worker. A statistically significant difference was found in the percentage who ever telephoned or received a telephone contact from a nurse, although a difference of 5% is unlikely to be clinically important. Post hoc power calculations varied. There was 93% power to detect a 10% difference in physician visits and 76% to detect such a difference in physician telephone contacts. There was 62% power to detect a 10% difference in nurse visits with 98% power to detect such a difference in nurse telephone contacts. Power available for the remaining service use comparisons ranged from 7% to 52%.


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  		TABLE 4. Health and Community Services Use During Initial 60 Days’ Postpartum by Group

 
There were a total of 5 (1.9%) hospital admissions in the experimental group: 3 infant admissions (2 for fever/viral episodes and 1 for whooping cough) and 2 maternal admissions (1 for trauma and 1 for respiratory arrest). There were a total of 9 (3.5%) hospital admissions in the control group, nearly twice that in the experimental group: 7 infant admissions (2 for jaundice, 2 for fever/viral episodes, 1 for cord infection, 1 for ear infection, and 1 for lethargy) and 2 maternal admissions (both for mastitis).


   DISCUSSION
TOP
 ABSTRACT
 INTRODUCTION
 METHODS
 RESULTS
 DISCUSSION
CONCLUSION
 REFERENCES
 
In this randomized controlled trial of 2 approaches to nurse follow-up (home versus clinic visit) of infants discharged from the hospital at <36 hours of age, we observed equivalent breastfeeding frequency (at power >99%), mean infant weight gain, maternal anxiety, health service satisfaction, and health and community services use. In addition, the incidence of insufficient breastfeeding and insufficient weight gain were low and similar in both groups.

Alternative explanations for these findings might include analytical bias and insufficient strength of the experimental intervention. We believe that analytic bias is unlikely in this study because careful attention was paid to study design, including blinding (when feasible) and reducing the potential effects of unmasking to group assignment. Furthermore, hospital nurses provided postdischarge care only for the control group and community nurses only for the experimental group.

We believe that insufficient strength or appropriateness of the experimental intervention is unlikely. The quantity, timing, and content of the telephone visits and home contacts were thought to be correct on the basis of physiologic and psychological parameters; skilled, experienced nurses provided the care. Nurses in the hospital arm were somewhat more familiar with early postpartum care, although refresher sessions were provided to the community nurses. There is no evidence of a systematic difference in the professional background and experience of nurses who provided care in the 2 arms. Reasons for longer home than clinic visits remain unclear.

The current study adds to the existing body of literature on postpartum care by comparing the effects of 2 administratively feasible modes of nursing care after short postpartum hospital stays on breastfeeding frequency and infant weight gain. Although home versus clinic visits were previously compared in a randomized, controlled trial,25 the population studied was part of a health maintenance organization, whereas ours is a general population delivering at a university teaching hospital. Our study included only infants who were breastfeeding at discharge. Care in both arms was provided exclusively by nurses (versus nurses and physicians). Clinical outcomes in the previous study were limited to breastfeeding discontinuation, maternal depression, and satisfaction. The comparison of breastfeeding discontinuation rates at 14 days had only 28.4% power to detect group differences according to our post hoc calculations. Furthermore, the examination of maternal depression is of general interest, although the literature suggests that maternal anxiety is a more relevant determinant of breastfeeding success. The earlier study did not measure breastfeeding frequency or infant weight gain. Our study examined these key outcome measures.

We believe that we have avoided several methodological weaknesses identified in most previous intervention studies through randomization, controlling other potential sources of analytic bias, clearly defining interventions and methods to verify their implementation, and using reliable and valid questionnaires. Furthermore, losses to follow-up were minimized, and our sample size was large enough to estimate effects with adequate precision and power.

Limitations
Certain limitations to our study remain. Recipients of care were not masked to treatment, a common problem in trials of health services. Exactly what nurses said during the telephone conversations and did during the home or clinic visits is not precisely known. Generalizability of our findings may be reduced because the study was conducted in a single setting. The results may not apply to high-risk populations. Our study was not designed to study differences in admission rates or mortality. It is interesting to note that although none of the experimental group admissions seem to have been preventable, 6 of the 9 control group admissions may have been preventable (mastitis, jaundice, cord infection, and lethargy). We achieved only 20% power for these differences; higher power would have required a much larger study.

Implications and Conclusion
Future research should address the effectiveness of physician visits and telephone "visits." Women and infants at high-risk for medical or social complications also need to be studied. The precise medical or nursing activities provided need to be measured directly.

In many places in North America, insurers are required to pay for a 48-hour length of stay. However, because jaundice and significant breast milk production do not occur before the third or fourth postpartum day, close surveillance of infants discharged after 48 hours remains important for at least the first 4 days of life. Thus, our study results remain relevant to the current clinical context.

Our results suggest that either mode of nursing care delivery postpartum, hospital clinic or community home care, is appropriate for a population of women and children at low risk of social and health complications. Furthermore, hospital follow-up seems to require fewer overall resources and is acceptable to women. It may be more cost-effective, although a detailed economic analysis was not part of the current report.


   CONCLUSION
TOP
 ABSTRACT
 INTRODUCTION
 METHODS
 RESULTS
 DISCUSSION
 CONCLUSION
REFERENCES
 
Community and hospital nursing follow-up both are associated with satisfactory outcomes for the clinical dimensions measured in this study, although experimental-arm nurse telephone contacts were longer and home visits took nearly twice as long as clinic visits. The variables most directly linked to harmful infant health outcomes—breastfeeding frequency and infant weight gain—did not differ at 14 days postdischarge. These results suggest that either approach to follow-up is clinically reasonable for the majority of low-risk infants.


   ACKNOWLEDGMENTS
 
This study was conducted at the Sir Mortimer B. Davis Jewish General Hospital and referring community health centers. It was supported by the Fonds de la recherche en santé du Québec (FRSQ). Drs Gagnon and Dougherty are research scholars of the FRSQ. At the time of this study, Dr Gagnon was also a research scholar of the Fondation de recherche en sciences infirmières du Québec. Dr Leduc is a research scholar of the National Health Research and Development Program of Health Canada.

We thank Kathy Waghorn for study coordination, Tamara Rader for administrative support, and the staff of the Sir Mortimer B. Davis Jewish General Hospital Postpartum Unit and Birthing Center and the affiliated CLSCs for facilitating the study.


   FOOTNOTES
 
Received for publication Apr 3, 2001; Accepted Dec 17, 2001.

Address correspondence to Anita J. Gagnon, RN, MPH, PhD, School of Nursing, McGill University, 3506 University St, Montreal, Quebec H3A 2A7. E-mail: anita.gagnon{at}mcgill.ca

Presented, in part, at the Pediatric Academic Societies; May 1, 1999; San Francisco, CA.


   REFERENCES
TOP
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 INTRODUCTION
 METHODS
 RESULTS
 DISCUSSION
 CONCLUSION
 REFERENCES
 

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PEDIATRICS (ISSN 1098-4275). ©2002 by the American Academy of Pediatrics



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