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Biophysical profile for fetal assessment in high risk
pregnancies (Review)
Alfirevic Z, Neilson JP
ThisisareprintofaCochranereview,preparedandmaintained byTheCochraneCollaborationandpublishedinTheCochraneLibrary
2007, Issue 2
http://www.thecochranelibrary.com
Biophysical profile for fetal assessment in high risk pregnancies (Review) 1
Copyright©2007 The CochraneCollaboration.Published byJohn Wiley & Sons, Ltd
TABLE OF CONTENTS
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
CRITERIAFORCONSIDERINGSTUDIESFORTHISREVIEW . . . . . . . . . . . . . . . . . . 2
SEARCHMETHODSFORIDENTIFICATIONOFSTUDIES . . . . . . . . . . . . . . . . . . . 2
METHODSOFTHEREVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
DESCRIPTIONOFSTUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
METHODOLOGICALQUALITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
AUTHORS’CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
POTENTIALCONFLICTOFINTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
SOURCESOFSUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Characteristics of included studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Comparison 01. Biophysical profile vs conventional fetal monitoring . . . . . . . . . . . . . . . . . 6
INDEXTERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
COVERSHEET . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
GRAPHSANDOTHERTABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Analysis 01.01. Comparison 01 Biophysical profile vs conventional fetal monitoring, Outcome 01 Induction of labour 7
Analysis 01.02. Comparison 01 Biophysical profile vs conventional fetal monitoring, Outcome 02 Induction for abnormal 8
fetal assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 01.03. Comparison 01 Biophysical profile vs conventional fetal monitoring, Outcome 03 Caesarean section 8
Analysis 01.04. Comparison 01 Biophysical profile vs conventional fetal monitoring, Outcome 04 Caesarean section for 9
fetal distress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 01.05. Comparison 01 Biophysical profile vs conventional fetal monitoring, Outcome 05 Intrapartum fetal 9
distress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 01.06. Comparison 01 Biophysical profile vs conventional fetal monitoring, Outcome 06 Apgar score <7 after 5 10
minutes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 01.07. Comparison 01 Biophysical profile vs conventional fetal monitoring, Outcome 07 Admission to neonatal 10
intensive care unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 01.08. Comparison 01 Biophysical profile vs conventional fetal monitoring, Outcome 08 Birthweight <10th 11
centile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 01.09. Comparison 01 Biophysical profile vs conventional fetal monitoring, Outcome 09 Perinatal deaths 11
excluding major malformations . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 01.10. Comparison 01 Biophysical profile vs conventional fetal monitoring, Outcome 10 Perinatal deaths . 12
Biophysical profile for fetal assessment in high risk pregnancies (Review) i
Copyright©2007 The CochraneCollaboration.Published byJohn Wiley & Sons, Ltd
Biophysical profile for fetal assessment in high risk
pregnancies (Review)
Alfirevic Z, Neilson JP
This record should be cited as:
Alfirevic Z, Neilson JP. Biophysical profile for fetal assessment in high risk pregnancies. Cochrane Database of Systematic Reviews 1996,
Issue 1. Art. No.: CD000038. DOI: 10.1002/14651858.CD000038.
This version first published online: 22 April 1996 in Issue 1, 1996.
Date of most recent substantive amendment: 13 February 1996
ABSTRACT
Background
Biophysical profile usually includes ultrasound monitoring of fetal movements, fetal tone and fetal breathing, ultrasound assessment
of amniotic fluid volume and assessment of fetal heart rate by electronic monitoring.
Objectives
Theobjective of this review was to assess the effects of biophysical profile tests on pregnancy outcome in high risk pregnancies.
Search strategy
WesearchedtheCochrane Pregnancy and Childbirth trials register. Date of last search: October 1998.
Selection criteria
Randomised trials comparing fetal biophysical profile with other forms of fetal assessment in women with high risk pregnancies.
Data collection and analysis
Trial quality was assessed.
Main results
Four studies were included. Most trials were not of high quality. No difference was found between biophysical profile and other forms
of fetal assessment over a range of fetal and neonatal measures.
Authors’ conclusions
Atpresent, there is not enough evidence from randomised trials to evaluate the use of biophysical profile as a test of fetal well-being in
high risk pregnancies.
BACKGROUND assessment of the fetal heart rate by electronic monitoring. The
biophysical profile is based on the association between chronic fe-
The biophysical profile is a form of fetal assessment which was tal compromise and changes in the fetal heart pattern, decreased
derived, as a concept, from the Apgar score which is used to assess fetal body and breathing movements, and redistribution of re-
the condition of the newborn. The biophysical profile was intro- gional blood flow leading to a reduction in fetal renal blood flow
duced in the early 1980s (Manning et al 1980). Several groups and fetal oliguria and, thus, less amniotic fluid.
have described minor refinements of the original test, but they
usually include assessment of five features proposed by Manning The physiological and pathophysiological basis for the biophys-
ie ultrasound monitoring of fetal movements, fetal tone and fetal ical profile, together with the very extensive observational liter-
breathing, ultrasound assessment of amniotic fluid volume, and ature accumulated over the years suggesting a link between low
Biophysical profile for fetal assessment in high risk pregnancies (Review) 1
Copyright©2007 The CochraneCollaboration.Published byJohn Wiley & Sons, Ltd
biophysical scores and poor pregnancy outcome has resulted in METHODS OF THE REVIEW
its widespread clinical use, particularly in the United States and
Canada. All trials were assessed for methodological quality using the
criteria in the Cochrane Handbook, (Mulrow 1997) with
a grade allocated to each trial on the basis of allocation
OBJECTIVES concealment. Allocation concealment was scored as A (adequate)
for placebo controlled trials, telephone randomization and use of
To determine whether biophysical profile is an effective and safe consecutively numbered sealed envelopes; B (unclear) for trials
test for the assessment of fetal well-being in high risk pregnancies. whererandomization is not clearly described or prone to bias (e.g.
open cards, toss of a coin) or C for quasi-randomized designs,
such as alternate allocation and use of record numbers. No other
formal or informal qualitative analysis was planned as there were
CRITERIA FOR CONSIDERING no planned exclusions based on quality.
STUDIES FOR THIS REVIEW
The data were extracted on the ’hard-copy’ data sheets, entered
Types of studies ontotheRevMancomputerprogramme(ReviewManager1998),
checked for accuracy, and analysed using the RevMan software.
Publishedandunpublishedrandomizedtrialscomparingfetalbio- The data were extracted by allocated intervention, irrespective
physical profile (scoring system derived from B-mode ultrasound of compliance with allocated intervention, in order to allow an
monitoring of fetal movements, tone and breathing, ultrasound ’intention-to-treat’ analysis. Women who were randomized and
assessment of amniotic fluid volume, and electronic fetal heart theneitherexcluded or lost to follow-up were assumed to have no
rate monitoring) with other forms of antepartum fetalassessment. event in the main analysis.
Weanticipated that early trials may not have used strictly random In the presence of significant heterogeneity a sensitivity analysis
allocation and, therefore, we planned to include trials that used a was planned based on the quality of allocation concealment.
quasi-randomized methodoftreatmentallocationsuchasalterna-
tion by hospital number or woman’s date of birth.
DESCRIPTION OF STUDIES
Types of participants
Women with high-risk pregnancies (hypertension, intrauterine See ’Characteristics of included studies’.
growth retardation, post-term, diabetes, previous stillbirth, de-
creased fetal movements, antepartum haemorrhage, premature METHODOLOGICAL QUALITY
labour, Rhesus disease).
Types of intervention Four trials met our inclusion criteria. Two trials included in the
Biophysical profile versus alternative forms of antepartum fetal review ran the risk of biased allocation through the use of coin flip
monitoring. (Manning 1984) or unblinded alternate allocation (Platt 1985).
There was a significant and unexplained imbalance in the num-
Types of outcome measures bers of randomized participants in the trial of Platt 1985 (279 in
the experimental group compared with 373 in the control group)
Perinatal mortality, short term and long term neonatal morbidity, which suggests biased recruitment. For one trial it is not clear
antenatal hospital admissions, onset of labour, mode of delivery. whether there was adequate concealment of allocation (Nageotte
1994).
SEARCH METHODS FOR An’intention to treat analysis’ was used in three of the four trials
I D E N T I F I C A T I O N O F S T U D I E S (Manning 1984; Nageotte 1994; Alfirevic 1995). The original
report by Platt (Platt 1985) included only women who delivered
within seven days of a test (76% in the experimental group and
See: Cochrane Pregnancy and Childbirth Group methods used 74% in the control group). Additional unpublished data on the
in reviews. other women recruited in this trial were supplied by Dr Platt.
This review has drawn on the search strategy developed for the In two trials (Manning 1984; Platt 1985) the biophysical profile
Pregnancy and Childbirth Group as a whole. Relevant trials were was performed in all women but, if the woman had been allo-
identified in the Group’s Specialised Register of Controlled Trials. cated to the control group, cardiotocographic results alone were
Date of last search: October 1998. disclosed to clinicians. There was no attempt to conceal allocation
Biophysical profile for fetal assessment in high risk pregnancies (Review) 2
Copyright©2007 The CochraneCollaboration.Published byJohn Wiley & Sons, Ltd
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