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Dallas 2015
TFQO: Marilyn Escobedo COI#78EVREV 1: Marilyn Escobedo COI#78EVREV 2: Henry Lee COI#135Taskforce: NRP
Babies born to mothers who are hypothermic or
hyperthermic in laborNRP 804
Dallas 2015
COI Disclosure
EVREV 1 COI# 78 EscobedoCommercial/industry• None
Potential intellectual conflicts• None
EVREV 2 COI#135 LeeCommercial/industry• None
Potential intellectual conflicts • None
Dallas 2015
2010 CoSTR
No review in 2010.
Dallas 2015C2015 PICO
Population: Newborn babiesIntervention: Maternal hypothermia or hyperthermia in labor Comparison: Normal maternal temperature
Outcomes: Adverse neonatal effects 9-Critical Mortality 6-Important Adverse neurological outcome6-Important Incidence of seizures
Dallas 2015Inclusion/Exclusion& Articles Found
InclusionsRCTs, studies with concurrent or historical controls
ExclusionsReviews, animal studies, unpublished studies, abstracts
1426 Number of Articles initially identified, and 22 Finally Included in Evidence Profile tables7 RCTs, 15 non-RCTsRemainder excluded
Dallas 20152015 Proposed Treatment Recommendations
With regard to maternal hyperthermiaAlthough maternal hyperthermia is associated with adverse neonatal outcomes, there is insufficient evidence to make a recommendation on the management of maternal hyperthermia.
With regard to maternal hypothermiaThere is insufficient evidence to make a recommendation about maternal hypothermia.
There are no randomized controlled trials of important or critical neonatal outcomes after interventions to keep mothers normothermic.
Dallas 2015 Risk of Bias in studies
Dallas 2015 Risk of Bias in studies
Dallas 2015 Key data from key studies
First Author YearRCT or Non-RCT
Intervention
Measured
Outcome Measured
Loss to Follow-up?
Intervention or Control?
Number with
Outcome
Total Number
Number with
Outcome
Total Number
Notes relevant to the outcome
Alexander 1999Non-RCT
Maternal hyperthermia = or >38C
neonatal death none 3 5144 36 96026
Retrospective chart review of term infants >2500 g 1988-1997. After adjustment for confounders, intubation, pneumonia and sepsis (but not death) were related to maternal fever.
Petrova 2001Non-RCT
Maternal fever = or > 38C
Early neonatal mortality
(term parous) 91 113750 2588 4E+06
Retrospective cohort study of birth certificate data (US) 1995-1997 with socio-demographic and clinical risk adjustment variables - AOR with clinical and sociodemographic variables: 1.05 (0.75, 1.48)
Petrova 2001Non-RCT
Maternal fever = or > 38C
Early neonatal mortality
(term nulliparous) 49 40833 3744 5E+06
AOR with clinical and sociodemographic variables: 1.67 (1.14, 2.46)
Petrova 2001Non-RCT
Maternal fever = or > 38C
Early neonatal mortality
(preterm parous) 566 10404 12478 458750
AOR with clinical and sociodemographic variables: 1.29 (1.01, 1.64)
Petrova 2001Non-RCT
Maternal fever = or > 38C
Early neonatal mortality
(preterm nulliparous) 699 7989 13643 614550
AOR with clinical and sociodemographic variables: 1.32 (1.11, 1.56)
Dallas 2015 Key data from key studies
First Author Year RCT or Non-RCTIntervention
MeasuredOutcome Measured
Loss to Follow-up? Intervention or
Control?Mean
Standard Deviation
Total Number
MeanStandard Deviation
Total Number
Butwick 2007 RCT
Maternal lower body forced air-warming during spinal anesthesia
neonatal apgar scores at 1 minute none 8 15 9 15
Butwick 2007 RCT
Maternal lower body forced air-warming during spinal anesthesia
neonatal apgar score at 5 minutes none 9 15 9 15
Butwick 2007 RCT
Maternal lower body forced air-warming during spinal anesthesia umbilical venous pH none 7.31 0.06 15 7.3 0.04 15
Butwick 2007 RCT
Maternal lower body forced air-warming during spinal anesthesia umbilical arterial pH none 7.26 0.04 15 7 0.07 15
Intervention Group Control Group
Dallas 2015Evidence profile table(s)
Dallas 2015Proposed Consensus on Science statements
Maternal Hyperthermia
•For the critical outcome of mortality we have identified low quality evidence from 2 non-RCT studies showing an increased risk with maternal hyperthermia (Petrova 2001, 20, Alexander 1999, 274)
•For the important outcome of neonatal seizures we have identified low quality evidence from 7 non RCT studies showing an increased risk with maternal hyperthermia (Alexander 1999, 274, Greenwell 2012, e447, Petrova 2001, 20, Goetzel 2010, 363.e1, Glass 2009, 24, Lieberman 2000, 8, Lieberman 2000, 983)
•For the important outcome of other adverse neurological states (encephalopathy) we have identified low quality evidence from 4 non-RCT studies showing an increased risk with maternal hyperthermia (Badawi 1998, 1554, Impey 2001 49.e1, Impey 2008, 594, Linder 2013, 207)
Dallas 2015Proposed Consensus on Science statements
Maternal hypothermia •For the critical outcome of mortality and the important outcomes of seizures or adverse neurologic states (encephalopathy) we have identified very low quality evidence from 5 RCTs that showed no significant risk of these outcomes with maternal hypothermia (Butwick 2007, 1413, Fallis 2002, 324, Horn 2002, 409, Woolnough 2009, 346, Yokohama 2009, 242). However, these studies did not examine the outcomes of mortality, seizures, or adverse neurologic outcome.
Dallas 20152015 Proposed Treatment Recommendations
With regard to maternal hyperthermiaAlthough maternal hyperthermia is associated with adverse neonatal outcomes, there is insufficient evidence to make a recommendation on the management of maternal hyperthermia.
With regard to maternal hypothermiaThere is insufficient evidence to make a recommendation about maternal hypothermia.
There are no randomized controlled trials of important or critical neonatal outcomes after interventions to keep mothers normothermic.
Dallas 2015
Values & Preferences
Although maternal hyperthermia is associated with adverse neonatal outcomes, it remains unclear if interventions to normalize maternal temperature would change those outcomes. Suggesting avoidance of abnormal maternal temperature places value on the possibility of reducing harm.
Dallas 2015Knowledge Gaps
• Do interventions to achieve normothermia in mothers who are hyperthermic decrease risk of adverse outcomes for newborns?
(Lack of RCTs)• Do interventions to achieve normothermia in
mothers who are hypothermic decrease risk of adverse outcomes for newborns?
(Lack of critical / important outcomes)
Dallas 2015Next Steps
This slide will be completed during Task Force Discussion (not EvRev) and should include:
Consideration of interim statementPerson responsibleDue date
Essential slide (one slide only). Estimated time <30 sec