Obstetric Flashcards
Immediate delivery vs. expectant for PPROM near term (PPROMT).
Journal, year, author, aim
Lancet, 2016.
Morris et al.
To establish if immediate delivery in PPROM at 34-36+6 reduces neonatal infection without increasing morbidity
Immediate delivery vs. expectant for PPROM near term (PPROMT).
Methodology
Multicentre RCT, 11 countries. 2004-2013.
1839 women.
>16y, singleton pregnancies, PPROM 34-36+6.
IOL within 24h vs. unit led monitoring
Immediate delivery vs. expectant for PPROM near term (PPROMT).
Results
Neonatal sepsis (primary outcome) 2% vs. 3% - not significant. In immediate delivery, neonates had increased respiratory distress, mechanical ventilation and NICU time. Higher CS rate for mothers. Expectant - women had higher APH rate, use of PP antibiotics and longer hospital stay
Immediate delivery vs. expectant for PPROM near term (PPROMT).
Conclusions.
Expectant management should be practised as immediate delivery was shown to increase neonatal complications and likelihood of c-section. However women need to be closely monitored as they had a higher incidence of APH and infection.
Immediate delivery vs. expectant for PPROM near term (PPROMT).
Strengths.
65 centres, 11 countries. RCT. Blinded panel who decided on primary outcome. Good follow up (only 5 women not accounted for)
Immediate delivery vs. expectant for PPROM near term (PPROMT).
Weaknesses
PPROM <34/40 included once 34/40
Study duration 9y.
Expectant management not specified
Broad-spec antibiotics for PPROM - ORACLE I.
Journal, year, author, aim
Lancet, 2001
Kenyon et al
Do antibiotics administered to the mother in PPROM improve neonatal health and long-term outcomes by preventing infectious morbidity in the fetus or delay PTB?
Broad-spec antibiotics for PPROM - ORACLE I.
Methodology
RCT, intention to treat, placebo controlled. UK and other international centres. 4826 women.
4 groups: Erythromycin, augmentin, both, placebo
Broad-spec antibiotics for PPROM - ORACLE I.
Results
Erythromycin - prolonged pregnancy, and reduced surfactant requirement, major cerebral abnormalities, positive blood culture. Composite primary outcome (NND, chronic lung disease, major cerebral abnormality on USS) when look at singleton pregnancies.
Augmentin, and both - prolonged pregnancy but increased NEC
Broad-spec antibiotics for PPROM - ORACLE I.
Conclusions
Erythromycin for women with PPROM has a myriad of health benefits for neonate and probable reduction in childhood disability, particularly in singleton pregnancy. Augmentin associated with increased risk of NEC and therefore not recommended.
Broad-spec antibiotics for PPROM - ORACLE I.
Strengths
Only 2 women lost to follow-up, 15 protocol violations 379 centres participated Large RCT-blinded Clinically very relevant A lot of subanalysis
Broad-spec antibiotics for PPROM - ORACLE I.
Limitations
11 cases had medicines revealed and data was included in analysis
Limited info of study population were collected e.g. previous obstetric history or maternal disease.
Hyperglycaemia and adverse pregnancy outcomes (HAPO)
Journal, year, author, aim
NEJM, 2008
HAPO study cooperative research group (Metzfer et al)
To assess whether maternal hyperglycaemia below the threshold for diabetes Dx was a/w adverse pregnancy outcomes
Hyperglycaemia and adverse pregnancy outcomes (HAPO)
Methodology
Observational study
~23,000
75g OGTT - stratified into 7 groups depending on result
Patients and staff blinded
Hyperglycaemia and adverse pregnancy outcomes (HAPO)
Results
Frequency of primary outcomes (BW >90th, cord blood C peptide >90th, primary CS and neonatal hypoglycaemia) increased with increasing glucose category
- Strongest for birthweight and C peptide
Also positive associations with 5 secondary outcomes (should dystocia or birth injury, prematurity, need for NICU, PET, hyperbilirubinaemia)
Hyperglycaemia and adverse pregnancy outcomes (HAPO)
Strengths
Multi-centre observational study, OGTTs validated at single lab
Adds weight to ACHOSIS (reduced perinatal morbidity and mortality with treatment of GDM)
Clinicians and patients blinded to result of OGTT
Biologically plausible – results support the Pedersen hypothesis (maternal hyperglycaemia –> fetal hyperglycaemia –> exaggerated response to insulin)
Limited caregiver bias as patients and staff (other than lab staff) were blinded to result of OGTT
Hyperglycaemia and adverse pregnancy outcomes (HAPO)
Limitations
Statistically underpowered for rare severe outcomes (e.g. perinatal deaths)
Threshold effect not established
No info on BMI or weight gain of mothers
Hyperglycaemia and adverse pregnancy outcomes (HAPO)
Conclusions
On average, maternal glucose levels (less than those meeting the criteria for DM diagnosis at the time) are associated with increased birth weight and neonatal insulin levels
Effect of treatment of gestational diabetes mellitus on pregnancy outcomes (ACHOIS)
Journal, year, author, aim
NEJM, 2005
Crowther et al
To establish that screening and treatment of women with gestational diabetes reduces the risk of perinatal complications
Effect of treatment of gestational diabetes mellitus on pregnancy outcomes (ACHOIS)
Methodology
RCT
1000 women
Dietary advice, glucose monitoring and insulin treatment vs. routine care
Effect of treatment of gestational diabetes mellitus on pregnancy outcomes (ACHOIS)
Results
Composite serious neonatal outcomes were lower in intervention group - 1% vs 4%, NNT 34
Intervention group had more:
- NICU admissions 71 vs 61% (but no increase in secondary outcomes such as hypoglycaemia requiring IV etc)
- IOL 39 vs 29%
- Better post-partum health survey results
No difference in the rate of caesarean sections and phototherapy requirements
Effect of treatment of gestational diabetes mellitus on pregnancy outcomes (ACHOIS)
Conclusions
Treatment of mild GDM for glycaemic control reduces the rate of serious perinatal complications without increasing the rate of caesarean section
Effect of treatment of gestational diabetes mellitus on pregnancy outcomes (ACHOIS)
Limitations
OGTT those in routine told no GDM regardless of result of OGTT - ?ethics of this once
WHO guidelines changed
Nil criteria for routine care (depended on local guidelines) may have varied
?appropriateness of use of composite outcomes given rare neonatal outcomes
?power of study with numbers given rare neonatal outcomes
Outcomes measured are not unique to GDM
- 5 stillbirths in intervention group (APH, 2 unexplained, 1 lethal abnormality, 1 IUGR + PET)
Magpie trial
Journal, year, author, aim
Do women with pre-eclampsia, and their babies, benefit from magnesium sulphate?
Lancet, 2002
Magpie Trial Collaberative group
Aim = title
Magpie trial
Methodology
International, double blind, placebo controlled, RCT
10,100 women
Intention to treat
Antenatal or <24hr post-partum
Women with PET and there was uncertainty about whether to use MgSO4
Magpie trial
Results
Primary outcomes
- Eclampsia - reduced risk by 58%. NNT 91, 63 for severe PET.
- Death of baby before discharge - no difference
Secondary outcomes:
- Not significant reduction in maternal death (45%)
- 24% experienced side effects vs. 5%
- 27% lower RR of abruption
Magpie trial
Conclusions
MgSO4 reduces the risk of eclampsia, likely reduces the risk of maternal death
At this dosage, it does not have any substantive harmful effects on the mother or child, although a quarter of women will have side effects
Magpie trial
Strengths
Multi-centre, large study Double blind Randomised Generalisabled to a large range of clinical settings (both rich and poor countries) Good follow up - 99.7% of women Intention to treat analysis
Magpie trial
Weakness
IV and IM - variable route of administration
Side effects may have allowed the allocation to be guessed
Eligibility dependent on attending clinicians’ beliefs about MgSO4 - unable to keep an accurate record of those eligible but not recruited
TRUFFLE
Journal, year, author, aim
2 year neurodevelopmental and intermediate perinatal outcomes in infants with very preterm fetal growth restriction (TRUFFLE): a randomised trial
Lees et al
The Lancet, 2015
Aim: To establish is changes in fetal ductus venosus doppler waveform could be used as indications for delivery instead of CTG short-term variation (STV)
TRUFFLE
Methodology
Multicentre, randomised management trial
Europe
Women admitted to hospital with singleton pregnancies and diagnosed with FGR
- AC <10th and abnormal UA PI >95th (+/- AREDF)
- EFW >500g
- Normal DV and short term variation
Group 1 = STV <3.5ms (<29/40), <4ms (>/=29/40)
Group 2 = early ductus changes
Group 3 = DV no A wave
TRUFFLE
Conclusions
No significant difference in the proportion of infants surviving without neuroimpairment. However timing of delivery based on late changes in DV waveform might product an improvement in developmental outcomes at 2y.
TRUFFLE
Strengths
Randomised
Intention to treat study
Independent review of data yearly
Paediatrics doing f/u were masked to allocation group
TRUFFLE
Weaknesses
Women were closely looked after by specialist MFM experts, this may be generalisable as not all women have access to this
CTG monitoring was based on computerised assessment of fetal heart STV
- Not all hospitals have this
High proportion of infants triggered safety net delivery criteria
- 38% overall
- 52% in late DV changes group
CLASP
Journal, year, author, aim
A randomised trial of low-dose aspirin for the prevention and treatment of pre-eclampsia among 9364 pregnant women.
Redman et al
Lancet, 1994
To determine the safety of LDA and if it reduces fetal / neonatal morbidity and mortality, either overall or in selected high risk groups
CLASP
Methodology
Multicentre RCT
>9000 women
Double blinded trial - 60mg Aspirin or matching placebo tablet
Inclusion criteria:
>8//40
Prophylactic: history of PET or IUGR, chronic HTN, renal disease or other risk factors e.g. maternal age
Therapeutic: signs or symptoms in current pregnancy
CLASP
Results
Statistically significant reduction in proteinuria PET if entered the study before 20/40 - NNT 100
Reduced likelihood of delivery before 37/40
No statistically significant change for:
- IUGR
- Stillbirths and neonatal deaths
For evidence for bleeding side effects (e.g. abruption)
All outcomes were more statistically significant for early onset PET <32 weeks
CLASP
Conclusions
Use low dose aspirin in those women who may be justified as high risk of early onset PET <32 weeks and start before 20 weeks gestation
CLASP
Strengths
Double blind RCT – low risk of bias
Large cohort of entrants
Intention to treat analysis
Clinically relevant in a New Zealand setting
- MMH was a trial centre as well as several Australian centres
CLASP
Weakness
PET diagnosis not standard
- E.g. rise in DBP >25mg if <90 at booking or 15mmHg is greater
ACTORDS
Journal, year, author, aim
Neonatal Respiratory Distress Syndrome after repeat exposure to antenatal corticosteroids: a randomised controlled trial (ACTORDS)
Crowther et al
Lancet, 2006
Establish if repeat prenatal corticosteroids given to women at risk of preterm birth can reduce neonatal morbidity without harm
ACTORDS
Methodology
982 women
Australia and NZ
Double-Blind RCT
Intention to treat analysis
Women at risk of preterm birth <32/40 (singleton or multiple)
≥7 days after receiving first course of steroids
Ongoing risk for PTB
IM 11.4mg Betamethasone or Placebo (Saline) given weekly, if women remained undelivered and <32/40 with ongoing risks of preterm birth
ACTORDS
Results
Primary outcomes
- Less RDS (NNT 14) - Less oxygen therapy (NNT 15) - Shorter duration of mechanical ventilation - No difference in weight/length/HCat birth or discharge
Steroid group
- Fewer severe lung disease (NNT 14) - CS birth and more minor maternal side-effects
No difference in
- Rates of NICU admission
- Length of stay
- IVH
- Necrotising enterocolitis
- Chorioamnionitis requiring intrapartum IV abx or pyrexia ≥ 38.0 ®C
ACTORDS
Conclusions
Repeat doses of antenatal corticosteroids reduced neonatal morbidity
ACTORDS
Strengths
Similar 2 groups RCT Independent data monitoring committee Blinded Given information regarding the safety profile of steroids for maternal and fetal Did follow up at 2y and 6-8y
ACTORDS
Weakness
Only studied up to 32/40
Wide range of gestational age, treatment doses and number of doses