Professional Documents
Culture Documents
CONTENT
1. Introduction
2. Evidence based practices in Gynaecology
3. Evidence based practices in Pregnancy, labour and Puerperium
4. Evidence based practices in Neonatology
INTRODUCTION
Within the nursing profession, it is expected that new information in the form of research
findings will be incorporated constantly and knowledgeably into nursing practice. The staff
nurse is a critical link in bringing research-based changes into clinical practice. Depending
on the environment, a health care organization may or may not have the resources to ensure
critical, succinct, reasonable evaluation and application of research findings as they relate to
the point-of-care delivery. Health care organizations are beginning to create mechanisms to
facilitate the process of information translation from the literature to practice. Evidence
based practice is sometimes indicative of an attempt to avoid the µnature of the evidence
being detained by the bias of a particular professional grouping. The emphasis is on practice
and this determines the nature of evidence that would besought.
The ability to deliver evidence-based practice promotes individualisation of care and
assures the quality of health care for patients today as well as those of tomorrow
Critical thinking is vital to evidence-based nursing practice. Evidence-based practice (EBP)
supports nursing care and can contribute positively to patient outcomes across a variety of
settings and geographic locations. The nature of EBP, its relevance to nursing, and the skills
needed to support it should be required components of baccalaureate education and must be
introduced early in students' development as independent, self-directed learners and
as professional nurses. Among the knowledge, skills, and processes needed to support EBP,
Critical thinking is paramount.
STEPS OF EVIDENCE BASED PRACTICE
1. Skin patch and vaginal ring versus combined oral contraceptivesfor contraception
Laureen M Lopez, David A Grimes, Maria F Gallo, Kenneth F Schulz
Objectives
To compare the contraceptive effectiveness, cycle control, adherence (compliance), and safe
ty of the skin patch or the vaginal ring versus combination oral contraceptives (COs)
Selection criteria
All randomized controlled trials comparing the skin patch or vaginal ring with a COC.
Data collection and analysis
Data were abstracted by two authors and entered into RevMan. For dichotomous variables, t
hePeto odds ratio (OR) with 95% confidence intervals (CI) was calculated. For continuousv
ariables, the mean difference was computed.
Main results
The researchers found 5 trials of the skin patch and 10 of the vaginal ring. Contraceptiveeff
ectiveness was similar for the patch or ring versus the comparison COC. More patch usersdi
scontinued early than COC users: ORs were 1.59 (95% CI 1.26 to 2.00), 1.56 (95% CI 1.18
to2.06), and 2.57 (95% CI 0.99 to 6.64). Patch users also had more discontinuation due to a
dverseevents. Compared to COC users, patch users reported more breast discomfort, dysme
norrhea,nausea, and vomiting. Patch users reported more compliant cycles than the COC us
ers in twotrials: ORs were 2.05 (95% CI 1.83 to 2.29) and 2.76 (95% CI 2.35 to 3.24). The r
ing trialsgenerally showed similar discontinuation for ring and COC users. Ring users repor
ted lessnausea, acne, irritability, and depression than COC users. Ring users had more vagin
itis andleukorrhea but less vaginal dryness. Ring users had similar adherence to COC users i
n two trials but less adherence in one. Cycle control was generally similar for the patch and
COC, and wassimilar or better for the ring versus CoC.
Conclusions
Effectiveness was similar for the methods compared. The patch could lead to morediscontin
uation while the vaginal ring showed little difference. The patch group had better complianc
e than the COC group but more side effects. Ring users generally had fewer adverseevents t
han COC users but more vaginal irritation and discharge. High losses to follow up can
affect the validity of the results.
Objectives
To determine the effects of conservative management (physical interventions and lifestyle
interventions) for women with pelvic organ prolapse in comparison with no treatment or
other treatment options (such as mechanical devices or surgery).
Selection criteria
Randomised and quasi-randomised trials in women with pelvic organ prolapse that included
a physical or lifestyle intervention in at least one arm of the trial.
Data collection and analysis
Two reviewers assessed all trials for inclusion/exclusion and methodological quality. Data
were extracted by the lead reviewer onto a standard form and cross checked by
another.Disagreements were resolved by discussion. Data were processed as described in
the Cochrane Handbook for Systematic Reviews of Interventions.
Main results
Three trials of relevance to this review were identified. The largest of these, of pelvic
floor muscle training in preventing anterior prolapse from worsening, had significant
limitations which affect the generalisability and rigor of the findings. A small feasibility
study (which is to be followed up with a larger trial) randomised 47 women to pelvic floor
muscle training or control and found suggestions of better outcomes (better self-reported
improvement, decreased severity) in the intervention group. The third trial evaluated peri-
operative physiotherapy for women undergoing surgery for prolapse and/or
incontinence. The authors report that urinary symptoms, pelvic floor muscle function and
quality of life were improved more in the treatment group than the control group, but data
were not provided to allow this to be assessed. The trial was small and no prolapse-specific
outcome measures were used. It was not possible to combine data from the three trials.
Conclusions
Despite there now being reports of three eligible trials in this update, the evidence
available is not significant to guide practice. There is some encouragement from a
feasibility study that pelvic floor muscle training, delivered by a physiotherapist to
symptomatic women in an outpatient setting, may reduce severity of prolapse. Further
evidence from larger, better quality randomised control trials is however still necessary.
Objectives
The objectives of the study was to to summarize randomized controlled trials evaluating
advance provision of emergency contraception to explore effects on pregnancy rates,
sexually transmitted infections, and sexual and contraceptive behaviors.
Selection criteria
The researchers included randomized controlled trials comparing advance provision and
standard access (i.e., counseling which may or may not have included information about
emergency contraception, or provision of emergency contraception on request at a clinic
or pharmacy).
Main results
Eleven randomized controlled trials met our criteria for inclusion, representing
7695 patients in the United States, China, India and Sweden. Advance provision did not
decrease pregnancy rates(odds ratio (OR) 0.98, 95% confidence interval (CI) 0.76 to 1.25 in
studies for which we included twelve-month follow-up data; OR 0.48, 95% CI 0.18 to
1.29 in a study with seven-month follow-up data; OR 0.92, 95% CI 0.70 to 1.20 in studies
for which we included six-month follow-up data; OR 0.49, 95% CI 0.09 to 2.74 in a study
with three-month follow-up data),despite reported increased use (single use: OR 2.47, 95%
CI 1.80 to 3.40; multiple use: OR 4.13,95% CI 1.77 to 9.63) and faster use (weighted mean
difference (WMD) -12.98 hours, 95% CI -16.66 to -9.31 hours). Advance provision did not
lead to increased rates of sexually transmitted infections (OR 1.01, 95% CI 0.75 to 1.37),
increased frequency of unprotected intercourse, or changes in contraceptive methods.
Women who received emergency contraception in advance were equally likely to use
condoms as other women.
Conclusions
Advance provision of emergency contraception did not reduce pregnancy rates when
compared to conventional provision. Results from primary analyses suggest that advance
provision doesnot negatively impact sexual and reproductive health behaviors and
outcomes. Women should have easy access to emergency contraception, because it can
decrease the chance of pregnancy. However, the interventions tested thus far have not
reduced overall pregnancy rates in the populations studied.
Selection criteria
We included randomised double-blind, placebo-controlled trials of progesterone on women
with PMS diagnosed by at least two prospective cycles, without current psychiatric
disorder.
Data collection and analysis
Two reviewers (BM and OF) extracted data independently and decided which trials to
include. Of wrote to trial investigators for missing data.
Main results
From 17 studies, only two met our inclusion criteria. Together they had 280 participants
aged between 18 and 45 years. One hundred and fifteen yielded analysable results. Both
studies measured symptom severity using subjective scales. Differing in design,
participants, dose of progesterone and how delivered, the studies could not be combined in
meta-analysis. Adverse events which may or may not have been side effects of the
treatment were described as mild. Both trials had defects. They intended to exclude women
whose symptoms continued after their periods. When data from ineligible women were
excluded from analysis in one trial, the other women were found to have benefited more
from progesterone than placebo. The smaller study found no statistically significant
difference between oral progesterone, vaginally absorbed progesterone and placebo, but
reported outcomes incompletely.
Conclusions
The trials did not show that progesterone is an effective treatment for PMS nor that it is
not. Neither trial distinguished a subgroup of women who benefited, nor examined claimed
success with high doses.
6. Oral oestrogen and combined oestrogen/progestogen therapy versus placebo for
hot flushes
Munira Nurbhai, Jeremy Grimshaw, Margaret Watson, Christine M Bond, Jill A Mollison,
Anne Ludbrook
Objectives
The primary objective of this review was to assess the relative effectiveness of oral versus
intra-vaginal anti-fungals for the treatment of uncomplicated vulvovaginal candidiasis.The
secondary objectives of the review were to assess the cost-effectiveness, safety and
patient preference of oral versus intra-vaginal anti-fungals.
Selection criteria
Randomised controlled trials published in any language.Trials had to compare at least one
oral anti-fungal with one intra-vaginal anti-fungal.Women (aged 16 years or over) with
uncomplicated vulvovaginal candidiasis.The diagnosis of vulvovaginal candidiasis to be
made mycologically (i.e. a positive culture and /or microscopy for yeast).Trials were
excluded if they solely involved subjects who were HIV positive,immunocompromised,
pregnant, breast feeding or diabetic.The primary outcome measure was clinical cure.
Data collection and analysis
Two reviewers screened titles and abstracts of the electronic search results and full text
of potentially relevant papers. Independent duplicate abstraction was performed by two
reviewers. Disagreements regarding trial inclusion or data abstraction were resolved by
discussion between the reviewers. Odds ratios were pooled using the fixed effects models
(except for two analyses when random effects models were used because of potentially
important heterogeneity).
Main results
Two new trials reporting three comparisons were found in the update. Nineteen trials are
included in the review, reporting 22 oral versus intra-vaginal anti-fungal comparisons. No
statistically significant differences were shown between oral and intra-vaginal anti-fungal
treatment for clinical cure at short term (OR 0.94, 95% CI, 0.75 to 1.17) and long term (OR
1.07,95% CI, 0.82 to 1.41) follow-up. No statistically significant differences for
mycological cure were observed between oral and intra-vaginal treatment at short term (OR
1.15, 95% CI, 0.94 to1.42). There was a statistically significant difference for long term
follow-up (OR 1.29, 95% CI,1.05 to 1.60) in favour of oral treatment, however the clinical
significance of this result is uncertain. Two trials each reported one withdrawal from
treatment due to an adverse reaction. Treatment preference data were poorly reported.
Conclusions
Daniela D Rosa, Lídia RF Medeiros, Maria I Edelweiss, Mary C Bozzetti, Paula R Pohlmann, Airton T
Stein, Heather O Dickinson
Objectives
To evaluate the effectiveness and safety of platinum-based adjuvant chemotherapy after
radical hysterectomy, radiotherapy, or both in the treatment of early stage cervical cancer
(stages IA2,IB1 or IIA).
Selection criteria
Randomised controlled trials (RCTs) comparing adjuvant radiotherapy with adjuvant
radiotherapy and cisplatin-chemotherapy after radical surgery for early stage cervix cancer
were included.
Data collection and analysis
Two review authors extracted data independently to assess whether the studies met the
specified inclusion criteria. Any discrepancies were solved by a third and a forth review
author. Meta-analysis was performed using a random effects model, with death and disease
progression as outcomes.
Main results
Three trials were included. Two trials enrolling 325 participants, of whom 297 (91%) were
assessed and compared radiotherapy and chemotherapy with radiotherapy alone found that
adjuvant chemotherapy significantly reduced the risk of death (hazard ratio (HR) = 0.56,
95%confidence interval (CI): 0.36 to 0.87) and disease progression (HR = 0.47, 95%CI:
0.30 to0.74), with no heterogeneity between trials (I= 0% for both meta-analyses). One trial
assessing71 participants compared chemotherapy followed by radiotherapy with
radiotherapy alone and found no significant difference between the two groups (HR = 1.34;
95%CI: 0.24 to 7.66). The median follow up of patients varied from 29 to 42 months.
Conclusions
The addition of platinum-based chemotherapy to radiotherapy may offer clinical benefit in
the adjuvant treatment of early stage cervical cancer with risk factors for recurrence.
However, the evidence is limited because the selected studies were quantitatively and
qualitatively limited, with small number of patients and limited period of follow-up
Objectives
To determine the effectiveness of short-course (less than four weeks) metformin plus CC
versus long-course (four weeks or more) metformin plus CC with regard to ovulation and
achievement of pregnancy in infertile PCOS women.
Selection criteria
Randomised controlled trials comparing short-course (less than four weeks) metformin plus
CC versus long-course (four weeks or more) metformin plus CC for ovulation or
achievement of pregnancy in infertile PCOS women.
Data collection and analysis
No trials were found that met the selection criteria.
Main results
No randomised controlled trials were identified.
Conclusions
There are insufficient data to determine whether short-house metformin pretreatment is as
effective as the conventional long-course metformin pretreatment before initiation of
clomiphenecitrate for ovulation induction in infertile PCOS patients. A well-designed
randomised controlled trial is needed to answer this important clinical question.
Objectives
To determine the effectiveness and safety of amniotomy alone for (1) routinely shortening
all labours that start spontaneously, and (2) shortening labours that have started
spontaneously, but have become prolonged.
Selection criteria
Randomised controlled trials comparing amniotomy alone versus intention to preserve the
membranes. We excluded quasi-randomised trials.
Main results
We have included 14 studies in this review, involving 4893 women. There was no
clear statistically significant difference between the amniotomy and control groups in length
of the first stage of labour (weighted mean difference -20.43 minutes, 95% confidence
interval (CI) -95.93 to 55.06), caesarean section (RR 1.26, 95% CI 0.98 to 1.62), maternal
satisfaction with childbirth experience (standardised mean difference 0.27, 95% CI -0.49 to
1.04) or low Apgar score less than seven at five minutes (RR 0.55, 95% CI 0.29 to 1.05).
There was no consistency between papers regarding the timing of amniotomy during labour
in terms of cervical dilatation.
Conclusions
On the basis of the findings of this review, we cannot recommend that amniotomy should
be introduced routinely as part of standard labour management and care. We do recommend
that the evidence presented in this review should be made available to women offered an
amniotomy and may be useful as a foundation for discussion and any resulting decisions
made between women and their caregivers.
Marie Hatem, Jane Sandall, Declan Devane, Hora Soltani, Simon Gates
Objectives
To compare midwife-led models of care with other models of care for childbearing women
and their infants.
Selection criteria
All published and unpublished trials in which pregnant women are randomly allocated to
midwife-led or other models of care during pregnancy, and where care is provided during
the ante and intrapartum period in the midwife-led model.
Main results
We included 11 trials (12,276 women). Women who had midwife-led models of care were
less likely to experience antenatal hospitalisation, risk ratio (RR) 0.90, 95% confidence
interval (CI)0.81 to 0.99), regional analgesia (RR 0.81, 95% CI 0.73 to 0.91), episiotomy
(RR 0.82, 95% CI0.77 to 0.88), and instrumental delivery (RR 0.86, 95% CI 0.78 to 0.96),
and were more likely to experience no intrapartum analgesia/anaesthesia (RR 1.16, 95% CI
1.05 to 1.29), spontaneous vaginal birth (RR 1.04, 95% CI 1.02 to 1.06), feeling in control
during childbirth (RR 1.74, 95%CI 1.32 to 2.30), attendance at birth by a known midwife
(RR 7.84, 95% CI 4.15 to 14.81) and initiate breastfeeding (RR 1.35, 95% CI 1.03 to 1.76),
although there were no statistically significant differences between groups for caesarean
births (RR 0.96, 95% CI 0.87 to 1.06).Women who were randomised to receive midwife-led
care were less likely to experience fetal loss before 24 weeks' gestation (RR 0.79, 95% CI
0.65 to 0.97), although there were no statistically significant differences in fetal
loss/neonatal death of at least 24 weeks (RR 1.01,95% CI 0.67 to 1.53) or in fetal/neonatal
death overall (RR 0.83, 95% CI 0.70 to 1.00). In addition, their babies were more likely to
have a shorter length of hospital stay (mean difference-2.00, 95% CI -2.15 to -1.85).
Conclusions
Most women should be offered midwife-led models of care and women should be
encouraged to ask for this option although caution should be exercised in applying this
advice to women with substantial medical or obstetric complications.
José Villar, Guillermo Carroli, Dina Khan-Neelofu, Gilda GP Piaggio, A Metin Gülmezoglu
Objectives
The objective of this review was to assess the effects of antenatal care programmes for
low-risk women.
Selection criteria
Randomised trials comparing programmes of antenatal care with varied frequency and
timing of the visits and different types of care providers.
Data collection and analysis
Trial quality was assessed and data were extracted by two reviewers independently. Study
authors were contacted for additional information and they were provided with the final
version of the review.
Main results
Ten trials involving over 60,000 women were included. Seven trials evaluated the number
of antenatal clinic visits, and three trials evaluated the type of care provider. Most trials
were of acceptable quality. A reduction in the number of antenatal visits was not associated
with an increase in any of the negative maternal and perinatal outcomes reviewed.
However, trials from developed countries suggest that women can be less satisfied with the
reduced number of visits and feel that their expectations with care are not fulfilled.
Antenatal care provided by amid wife/general practitioner was associated with improved
perception of care by women. Clinical effectiveness of midwife/general practitioner
managed care was similar to that of obstetrician/gynaecologist led shared care.
Authors' conclusions
A reduction in the number of antenatal care visits with or without an increased emphasis on
the content of the visits could be implemented without any increase in adverse biological
maternal and perinatal outcomes. Women can be less satisfied with reduced visits. Lower
costs for the mothers and providers could be achieved. While clinical effectiveness seemed
similar, women appeared to be slightly more satisfied with midwife/general practitioner
managed care compared with obstetrician/gynaecologist led shared care.
Objectives
To assess the effects of the BPP when compared with conventional monitoring (CTG only
or MBPP) on pregnancy outcome in high-risk pregnancies.
Selection criteria
Randomised and quasi-randomised controlled trials involving a comparison of fetal BPP
with other forms of antepartum fetal assessment in women with high-risk pregnancies.
Data collection and analysis
Two authors independently assessed eligibility, quality and extracted data.
Main results
We included five trials, involving 2974 women. Most trials were not of high quality.
Although the overall incidence of adverse outcomes was low, available evidence from
randomized controlled trials does not support the use of BPP as a test of fetal wellbeing in
high-risk pregnancies. We found no significant differences between the groups in perinatal
deaths (relative risk (RR) 1.33, 95% confidence interval (CI) 0.60 to 2.98) or in Apgar
score less than seven at five minutes (RR 1.27, 95% CI 0.85 to 1.92).Combined data from
the two high-quality trials suggest an increased risk of caesarean section in the BPP group
RR 1.60, 95% CI 1.05 to 2.44, n= 280, interaction test P = 0.03. However, the number of
participating women was relatively small (n = 280). Therefore, additional evidence is
required in order to be definitive regarding the efficacy of this test in high-risk pregnancies.
Furthermore, the impact of the BPP on other interventions, length of hospitalisation, serious
short-term and long-term neonatal morbidity and parental satisfaction requires further
evaluation.
Authors' conclusions
At present, there is insufficient evidence from randomised trials to support the use of BPP
as a test of fetal wellbeing in high-risk pregnancies.
7. Castor oil, bath and/or enema for cervical priming and induction of labour
Selection criteria
Clinical trials comparing castor oil, bath or enemas used for third trimester cervical ripening
or labour induction with placebo/no treatment or other methods listed above it on
a predefined list of labour induction methods.
Data collection and analysis
A strategy was developed to deal with the large volume and complexity of trial data relating
to labour induction. This involved a two-stage method of data extraction.
Main results
In the one included study of 100 women, which compared a single dose of castor oil versus
no treatment, no evidence of a difference was found between caesarean section rates
(relative risk (RR) 2.31, 95% confidence interval (CI) 0.77, 6.87). No data were presented
on neonatal or maternal mortality or morbidity. There was no evidence of a difference
between either the rate of meconium stained liquor (RR 0.77, 95% CI 0.25 to 2.36) or
Apgar score less than seven at five minutes (RR 0.92, 95% CI 0.02 to 45.71) between the
two groups. The number of participants was small hence only large differences in outcomes
could have been detected. All women who ingested castor oil felt nauseous (RR 97.08, 95%
CI 6.16 to 1530.41).
Authors' conclusions
The only trial included in this review attempts to address the role of castor oil as
an induction agent. The trial was small and of poor methodological quality. Further research
is needed to attempt to quantify the efficacy of castor oil as an induction agent.
Lale Say, Dalia Brahmi, Regina Kulier, Aldo Campana, A Metin Gülmezoglu
Objectives
To evaluate medical methods in comparison to surgical methods for first-trimester abortion
with respect to efficacy, side effects and acceptability.
Selection criteria
Randomised trials of any surgical abortion method compared with any medical abortion
method in the first trimester.
Data collection and analysis
Trial quality was assessed and data extraction was made independently by two reviewers.
Main results
Seven studies mostly with small sample sizes, comparing 4 different
interventions(prostaglandins alone, mifepristone alone, and mifepristone/misoprostol and
methotrexate/misoprostol versus vacuum aspiration) were included. Results are sometimes
based on one trial only. Prostaglandins vs vacuum aspiration: the rate of abortions not
completed with the intended method was statistically significant higher in the prostaglandin
group (2.7, 95% CI 1.1 to 6.8)compared to surgery. There are no data on the most
commonly medical(mifepristone/misoprostol) and surgical abortion available to be included
in the review. Duration of bleeding was longer in the medical abortion groups compared to
vacuum aspiration. There was only one major complication (uterine perforation) in one trial
in the surgical group. There was no difference between the groups for ongoing pregnancies
at the time of follow-up or pelvic infections. No data on acceptability, side effects or
women's satisfaction with the procedure were availbale for inclusion in the review.
Authors' conclusions
The results are derived from relatively small trials. Prostaglandins used alone seems to be
less effective and more painful compared to surgical first-trimester abortion. However, there
is inadequate evidence to comment on the acceptability and side effects of medical
compared to surgical first-trimester abortions. There is a need for trials to address the
efficacy of currently used methods and women's preferences more reliably.
Objectives
To determine the efficacy and the safety of progestogens in the treatment of
threatenedmiscarriage.
Search strategy
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (December
2009) and bibliographies of all located articles for any unidentified articles.
Data collection and analysis
At least two authors assessed the trials for inclusion in the review and extracted the data.
Main results
Two studies (84 participants) were included in the meta-analysis. In one study, all
the participants met the inclusion criteria and in the other study, only the subgroup of
participants who met the inclusion criteria was included in the meta-analysis. There was no
evidence of effectiveness with the use vaginal progesterone compared to placebo in
reducing the risk of miscarriage (risk ratio 0.47; 95% confidence interval 0.17 to 1.30).
Authors' conclusions
Based on scarce data from two methodologically poor trials, there is no evidence to support
the routine use of progestogens for the treatment of threatened miscarriage. Information
about potential harms to the mother or child, or both, with the use of progestogens is
lacking. Further, larger, randomized controlled trials on the effect of progestogens on the
treatment of threatened miscarriage, which investigate potential harms as well as benefits,
are needed.
Objectives
Primary: to assess the effects, on mothers and their babies, of continuous, one-to-one
intrapartum support compared with usual care. Secondary: to determine whether the effects
of continuous support are influenced by: (1) routine practices and policies in the birth
environment that may affect a woman's autonomy, freedom of movement and ability to
cope with labour; (2) whether the caregiver is a member of the staff of the institution; and
(3) whether the continuous support begins early or later in labour.
Selection criteria
All published and unpublished randomized controlled trials comparing continuous support
during labour with usual care.
Data collection and analysis
We used standard methods of the Cochrane Collaboration Pregnancy and Childbirth Group.
All authors participated in evaluation of methodological quality. One author and a research
assistant independently extracted the data. We sought additional information from the trial
authors. We used relative risk for categorical data and weighted mean difference for
continuous data to present the results.
Main results
Sixteen trials involving 13,391 women met inclusion criteria and provided usable outcome
data. Primary comparison: women who had continuous intrapartum support were likely to
have as lightly shorter labour, were more likely to have a spontaneous vaginal birth and
less likely to have intrapartum analgesia or to report dissatisfaction with their childbirth
experiences. Subgroup analyses: in general, continuous intrapartum support was associated
with greater benefits when the provider was not a member of the hospital staff, when it
began early in labour and in settings in which epidural analgesia was not routinely
available.
Authors' conclusions
All women should have support throughout labour and birth.
James P Neilso
Objectives
The objective of this review was to assess the effects of routine use of symphysis-fundal
height measurements (tape measurement of the distance from the pubic symphysis to the
uterine fundus) during antenatal care on pregnancy outcome.
Selection criteria
Acceptably controlled trials comparing symphysis-fundal height measurement with
assessment by abdominal palpation alone.
Data collection and analysis
One reviewer assessed trial quality and extracted data.
Main results
One trial involving 1639 women was included. No obvious differences were detected in any
of the outcomes measured.
Authors' conclusions
There is not enough evidence to evaluate the use of symphysis-fundal height measurements
during antenatal care
16. Music during caesarean section under regional anaesthesia forimproving maternal
and infant outcomes
Malinee Laopaiboon, Pisake Lumbiganon, Ruth Martis, Patravoot Vatanasapt, BusabaSomjaivong
Objectives
To evaluate the effectiveness of music during caesarean section under regional
anaesthesia for improving clinical and psychological outcomes for mothers and infants.
Selection criteria
We included randomised controlled trials comparing music added to standard care during
caesarean section under regional anaesthesia to standard care alone.
Data collection and analysis
Two review authors, Malinee Laopaiboon and Ruth Martis, independently assessed
eligibility,risk of bias in included trials and extracted data. We analysed continuous
outcomes using a mean difference (MD) with a 95% confidence interval (CI).
Main results
One trial involving 76 women who planned to have their babies delivered by caesarean
section met the inclusion criteria, but data were available for only 64 women. This trial was
of low quality with unclear allocation concealment and only a few main clinical outcomes
reported for the women. The trial did not report any infant outcomes. It appears that music
added to standard care during caesarean section under regional anaesthesia had some impact
on pulse rate at the end of maternal contact with the neonate in the intra-operative period
(MD -7.50 fewer beats per minute, 95% CI -14.08 to -0.92) and after completion of skin
suture for the caesarean section(MD -7.37 fewer beats per minute, 95% CI -13.37 to -1.37).
There was also an improvement in the birth satisfaction score (maximum possible score of
35) (MD of 3.38, 95%CI 1.59 to 5.17).Effects on other outcomes were either not significant
or not reported in the one included trial.
Authors' conclusions
The findings indicate that music during planned caesarean section under regional
anaesthesia may improve pulse rate and birth satisfaction score. However, the magnitude of
these benefits is small and the methodological quality of the one included trial is
questionable. Therefore, the clinical significance of music is unclear. More research is
needed to investigate the effects of music during caesarean section under regional
anaesthesia on both maternal and infant outcomes ,in various ethnic pregnant women, and
with adequate sample sizes.
18.Fundal pressure versus controlled cord traction as part of the active management
of the third stage of labour
Guiomar E Peña-Martí, Gabriella Comunián-Carrasco
.
Objectives
To determine the efficacy of fundal pressure versus controlled cord traction as part of the
activemanagement of the third stage of labour.
Selection criteria
We searched for published and unpublished randomised and quasi-randomised controlled
trials.
Data collection and analysis
Two review authors independently identified potential studies from the literature search and
assessed them for methodological quality and appropriateness of inclusion.
Main results
The search strategies yielded five studies for consideration of inclusion. However, none of
these studies fulfilled the requirements for inclusion in this review.
Authors' conclusions
We identified no randomised controlled trials comparing the efficacy of fundal pressure
versus controlled cord traction as part of the active management of the third stage of labour.
Hence controlled cord traction, after awaiting signs of placental separation, should remain
the third component of the active management of third stage of labour, and follow the
routine administration of a uterotonic drug and cord clamping.
21. Position in the second stage of labour for women without epidural anaesthesia
Objectives
To assess the benefits and risks of the use of different positions during the second stage of
labour (i.e. from full dilatation of the cervix).
Selection criteria
Trials that used randomised or quasi-randomised allocation and appropriate follow up and
compared various positions assumed by pregnant women during the second stage of labour.
Data collection and analysis
We independently assessed the trials for inclusion and extracted the data.
Main results
Results should be interpreted with caution as the methodological quality of the 20 included
trials(6135 participants) was variable. Use of any upright or lateral position, compared with
supine or lithotomy positions, was associated with: reduced duration of second stage of
labour (9 trials:mean 4.28 minutes, 95% confidence interval (CI) 2.93 to 5.63 minutes) -
this was largely due to a considerable reduction in women allocated to the use of the birth
cushion; a small reduction in assisted deliveries (19 trials: relative risk (RR) 0.80, 95% CI
0.69 to 0.92); a reduction in episiotomies (12 trials: RR 0.83, 95% CI 0.75 to 0.92); an
increase in second degree perineal tears (11 trials: RR 1.23, 95% CI 1.09 to 1.39); increased
estimated blood loss greater than 500ml (11 trials: RR 1.63, 95% CI 1.29 to 2.05); reduced
reporting of severe pain during second stage of labour (1 trial: RR 0.73, 95% CI 0.60 to
0.90); fewer abnormal fetal heart rate patterns(1 trial: RR 0.31, 95% CI 0.08 to 0.98).
Authors' conclusions
The tentative findings of this review suggest several possible benefits for upright posture,
with the possibility of increased risk of blood loss greater than 500 ml. Women should be
encouraged to give birth in the position they find most comfortable. Until such time as the
benefits and risks of various delivery positions are estimated with greater certainty,
when methodologically stringent trials' data are available, women should be allowed to
make informed choices about the birth positions in which they might wish to assume for
delivery of their babies.
22. Placental cord drainage after spontaneous vaginal delivery as part of the
management of the third stage of labour
Selection criteria
Randomised trials of any treatment for nausea and/or vomiting in early pregnancy.
Data collection and analysis
Two reviewers assessed the trial quality and extracted the data independently.
Main results
Twenty-eight trials met the inclusion criteria. For milder degrees of nausea and vomiting,
21trials were included. These trials were of variable quality. Nausea treatments were:
different antihistamine medications, vitamin B6 (pyridoxine), the combination
tablet Debendox (Bendectin), P6 acupressure and ginger. For hyperemesis gravidarum,
seven trials were identified testing treatments with oral ginger root extract, oral or injected
corticosteroids or injected adrenocorticotropic hormone (ACTH), intravenous diazepam and
acupuncture. Based on12 trials, there was an overall reduction in nausea from anti-emetic
medication (odds ratio 0.16,95% confidence interval 0.08 to 0.33).
Authors' conclusions
Anti-emetic medication appears to reduce the frequency of nausea in early pregnancy.
There is some evidence of adverse effects, but there is very little information on effects on
fetal outcomes from randomised controlled trials. Of newer treatments, pyridoxine (vitamin
B6) appears to be more effective in reducing the severity of nausea. The results from trials
of P6 acupressure areequivocal. No trials of treatments for hyperemesis gravidarum show
any evidence of benefit. Evidence from observational studies suggests no evidence of
teratogenicity from any of these treatments.
28.Interventions for preventing and treating pelvic and back pain in pregnancy
Objectives
To assess the effect of prophylactic intratracheal administration of animal derived surfactant
extract on mortality, broncho pulmonary dysplasia (BPD) and other morbidities in preterm
newborns at risk for developing RDS. Subgroup analysis were planned according to the
specific surfactant product and the degree of prematurity.
Selection criteria
Randomized or quasi-randomized controlled trials that compared the effect of
prophylacticanimal derived surfactant extract administration (surfactant obtained from
human, porcine or bovine sources, either modified with additional phospholipids or not)
administered to high risk preterm newborns at or shortly after birth in order to prevent
RDS, mortality and other complications of prematurity.
Data collection and analysis
Data extraction and analysis was done in accordance with the standards of the CNRG.
Main results
All nine of the included studies note an initial improvement in respiratory status and a
decrease in the risk of RDS in infants who receive prophylactic animal derived surfactant
extract. The meta-analysis supports a decrease in the risk of pneumothorax (typical relative
risk 0.40, 95% CI0.29, 0.54; typical risk difference -0.12, 95% CI -0.16, -0.09), a decrease
in the risk pulmonary interstitial emphysema (PIE) (typical relative risk 0.46, 95% CI
0.36, 0.59; typical risk difference-0.16, 95% CI -0.21, -0.11), a decrease in the risk of
neonatal mortality (typical relative risk 0.60,95% CI 0.47, 0.77; typical risk difference -
0.07, 95% CI -0.12, -0.03), and a decrease in the risk of BPD or death (typical relative risk
0.80, 95% CI 0.72, 0.88; typical risk difference -0.10, 95%CI -0.16, -0.04). No differences
are reported in the risk of intra ventricular hemorrhage, patent ductus arteriosus,
necrotizing enterocolitis or retinopathy of prematurity. Few data are available on long-term
follow-up of treated infants.
Authors' conclusions
Prophylactic intratracheal administration of animal derived surfactant extract to
infants judged to be at risk of developing respiratory distress syndrome has been
demonstrated to improve clinical outcome. Infants who receive prophylactic animal derived
surfactant extract have a decreased risk of pneumothorax, a decreased risk of PIE, a
decreased risk of mortality, and a decreased risk of BPD or death.
Selection criteria
Randomized and quasi-randomized clinical trials comparing continuous vs. intermittent
bolusnasogastric milk feeding in premature infants less than 1500 grams.
Data collection and analysis
Two review authors independently assessed all trials for relevance and methodologic
quality.The standard methods of the Cochrane Neonatal Review Group were used to extract
data.
Main results
Overall, the seven included trials, involving 511 infants, found no differences in time to
achieve full enteral feeds between feeding methods (weighted mean difference (WMD) 2
days; 95% CI -0.3, 3.9) . In the subgroup analysis of those studies comparing continuous
nasogastric vs.intermittent bolus nasogastric milk feedings the findings remained
unchanged (WMD 2 days,95% CI -0.4, 4.1). There was no significant difference in somatic
growth and incidence of NEC between feeding methods irrespective of tube placement. One
study noted a trend toward more apneas during the study period in infants fed by the
continuous tube feeding method compared tothose fed by intermittent feedings delivered
predominantly by orogastric tube placements [mean difference (MD) 14.0 apneas during
study period; 95% CI -0.2, 28.2]. In subgroup analysis based on weight groups, one study
suggested that infants less than 1000 grams and 1000 - 1250 grams birth weight gained
weight faster when fed by the continuous nasogastric tube feeding method compared to
intermittent nasogastric tube feeding method (MD 2.0 g/day; 95% CI 0.5, 3.5; MD2.0
g/day; 95% CI 0.2, 3.8, respectively). A trend toward earlier discharge for infants less
than1000 grams birth weight fed by the continuous tube feeding method compared to
intermittent nasogastric tube feeding method (MD -11 days; 95% CI -21.8, -0.2).
Authors' conclusions
Small sample sizes, methodologic limitations, inconsistencies in controlling variables that
may affect outcomes, and conflicting results of the studies to date make it difficult to make
universal recommendations regarding the best tube feeding method for premature infants
less than 1500grams. The clinical benefits and risks of continuous vs. intermittent
nasogastric tube milk feeding cannot be reliably discerned from the limited information
available from randomized trials to date.
4. Nasal versus oral route for placing feeding tubes in preterm orlow birth weight
infants
To determine the effect of nasal compared with oral placement of enteral feeding tubes on
feeding, growth and development, and the incidence of adverse consequences in preterm or
low birth weight infants.
Selection criteria
Randomised or quasi-randomised controlled trials that compared the use of the nasal versus
oral route for placing enteral feeding tubes in preterm or low birth weight infants.
Data collection and analysis
The standard methods of the Cochrane Neonatal Review Group were used, with separate
evaluation of trial quality and data extraction by two authors. Data synthesis using a fixed
effects model and reporting typical relative risk, typical risk difference and weighted mean
difference was planned.
Main results
Two small randomised trials were identified. Only one trial reported data on the pre-
specified primary outcomes for this review. This trial found no evidence of effect on the
time taken to establish enteral feeding nor the time taken to regain birth weight. However,
the trial was underpowered (N= 46) to exclude modest effect sizes.
Authors' conclusions
There are insufficient data available to inform practice. A large randomised controlled trial
is required to determine if the use of naso- vs. oro-enteric feeding tubes affects feeding,
growth and development, and the incidence of adverse consequences in preterm or low birth
weight infants.
6.Kangaroo mother care to reduce morbidity and mortality in low birth weight infants
Agustin Conde-Agudelo, José M Belizán
Objectives
To determine whether there is evidence to support the use of KMC in LBW infants as
analternative to conventional care after the initial period of stabilization with conventional
care.
Selection criteria
Randomized trials comparing KMC and conventional neonatal care in LBW infants.
Data collection and analysis
Trial quality was assessed and data were extracted independently by two reviewers.
Statistical analysis was conducted using the standard Cochrane Collaboration methods.
Main results
Three studies, involving 1362 infants, were included. All the trials were conducted in
developing countries. The studies were of moderate to poor methodological quality. The
most common shortcomings were in the areas of blinding procedures for those who
collected the out comes measures, handling of drop outs, and completeness of follow-up.
The great majority of results consist of results of a single trial. KMC was associated with
the following reduced risks :nosocomial infection at 41 weeks' corrected gestational age
(relative risk 0.49, 95% confidence interval 0.25 to 0.93), severe illness (relative risk 0.30,
95% confidence interval 0.14 to 0.67),lower respiratory tract disease at 6 months follow-up
(relative risk 0.37, 95% confidence interval0.15 to 0.89), not exclusively breastfeeding at
discharge (relative risk 0.41, 95% confidence interval 0.25 to 0.68), and maternal
dissatisfaction with method of care (relative risk 0.41, 95%confidence interval 0.22 to 0.75).
KMC infants had gained more weight per day by discharge (weighted mean difference 3.6
g/day, 95% confidence interval 0.8 to 6.4). Scores on mother's sense of competence
according to infant stay in hospital and admission to NICU were better in KMC than in
control group (weighted mean differences 0.31 [95% confidence interval 0.13 to0.50] and
0.28 [95% confidence interval 0.11 to 0.46], respectively). Scores on mother's perception of
social support according to infant stay in NICU were worse in KMC group than in control
group (weighted mean difference -0.18 (95% confidence interval -0.35 to -
0.01).Psychomotor development at 12 months' corrected age was similar in the two groups.
There was no evidence of a difference in infant mortality. However, serious concerns about
the methodological quality of the included trials weaken credibility in these findings.
Authors' conclusions
Although KMC appears to reduce severe infant morbidity without any serious deleterious
effect reported, there is still insufficient evidence to recommend its routine use in LBW
infants. Well designed randomized controlled trials of this intervention are needed.
BIBLIOGRAPHY
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