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Landmark Trials > Obstetrics > Flashcards

Obstetrics Flashcards

1
Q

What was the aim of the TRUFFLE trial? (Lancet 2015)

A

To assess whether changes in the fetal ductus venosus doppler waveform (DV) could be used as indications for delivery instead of CTG short-term variation (STV).

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2
Q

What type of the study was the TRUFFLE trial?

A

Prospective, European multicentre, unblinded, RCT

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3
Q

What was the inclusion criteria in the TRUFFLE trial?

A

Singleton fetuses 26-32/40 (assigned by dating scan) with very preterm fetal growth restriction (AC <10th centile and UAPI >95th)

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4
Q

What were the interventions in the TRUFFLE trial?

A

Delivery of the fetus according to the criteria of the randomisation group
1. CTG STV - delivery if reduced STV (<3.5ms <29/40 and <4.0ms >29/40)
2. DV p95 - delivery with DV >95th centile with forward flowing EDF (early changes)
3. DV no A - delivery with absent or reversed A wave on DV (late changes)

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5
Q

What was the primary outcome of the TRUFFLE trial?

A

Survival without cerebral palsy or neurosensory impairment at 2 years of age (corrected for prematurity)
or
Bayley III development score of less than 85 at 2 years of age (corrected for prematurity)

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6
Q

What was the secondary outcome of the TRUFFLE trial?

A

Composite of adverse neonatal outcome
- perinatal mortality or 1 or more of other neonatal morbidities

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7
Q

What were the main findings of the TRUFFLE trial?

A
  • No statistically significant difference in the primary outcome between groups (the proportion of infants surviving without neurodevelopmental impairment).
  • Off survivors, more infants in the DV no A group were free of neuroimpairment when compared to those in the CTG STV group, but this was accompanied by a non-significant increase in perinatal and infant mortality.
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8
Q

What was the conclusion of the TRUFFLE trial?

A

Although the difference in the proportion of infants surviving without neuroimpairment was non-significant at the primary endpoint, timing of delivery based on the study protocol using late changes in the DV waveform might produce an improvement in developmental outcomes at 2 years of age.

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9
Q

TRUFFLE study strengths

A

High powered/large numbers
Randomised control trial
Those assessing outcomes were blinded to intervention
Low numbers lost to follow-up

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10
Q

TRUFFLE study weaknesses

A

Randomisation not blinded
11% of women were delivered for maternal reasons (not by the randomised delivery criteria)
11% of women were delivered for fetal distress (not by the randomised delivery criteria)

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11
Q

What was the aim of the MAGPIE trial (Lancet 2002)?

A

Whether women with PET and their babies benefit from magnesium sulfate

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12
Q

What type of study was the MAGPIE trial?

A

Large (10,000), multi-centre, multi-country (33), placebo-controlled, double blinded RCT

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13
Q

What was the inclusion criteria for the MAGPIE trial?

A

Pregnant women or women within 24h postpartum with a diagnosis of PET (BP 140/90 or more and proteinuria of 1+ (30mg/dL) or more) + clinical uncertainty about magnesium sulfate

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14
Q

What was the intervention and comparison in the MAGPIE trial?

A

Intervention - 4mg loading dose MgSO4 IV bolus over 10-15 minutes, then 1g/hr infusion or 5g q4h IM
Comparison - Placebo (normal saline)

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15
Q

What were the primary outcomes in the MAGPIE trial?

A

Eclampsia
Stillbirth or neonatal death before discharge from hospital (in women randomised antenatally)

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16
Q

What were the secondary outcomes in the MAGPIE trial?

A

Composite of serious maternal morbidity
Magnesium sulfate toxicity and side effects
Labour and delivery complications
Neonatal morbidity
Maternal deaths

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17
Q

What were the main results of the MAGPIE trial?

A

Statistically significant reduction in eclampsia in the MgSO4 group - 0.8% vs 1.9%, RR 0.42, NNT 91

No difference in perinatal mortality (in women randomised prior to birth)

Statistically significant reduction in placental abruption RR 0.67

Non-significant reduction in maternal mortality (0.2% 11 vs 0.4% 20)

No statistically significant difference in severe maternal morbidity, however more side effects reported in MgSO4 group

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18
Q

What is the conclusion of the MAGPIE trial?

A

MgSO4 significantly reduces the risk of eclampsia by greater than half and probably reduces the risk of maternal death. There does not appear to be substantive harmful effects to mother or baby in the short term

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19
Q

MAGPIE study strengths

A

Double blinded RCT
High power/large numbers (10,000)
Included 33 countries, so high level of generalisability
Provided a specific dosing regimen
Low level lost to follow-up

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20
Q

MAGPIE study limitations

A

Underpowered to give statistically significant data on deaths
Variability in route of administration

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21
Q

What was the aim of the CLASP study (Lancet 1994)?

A

To establish if low dose aspirin can prevent PET and whether it is safe

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22
Q

What type of study was the CLASP study?

A

Multi-centre, placebo-controlled RCT

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23
Q

What was the inclusion criteria of the CLASP trial?

A

Prophylactic entry: Women 12-32/40 at risk of PET (prev PET/IUGR, chronic HTN, renal disease, risk factors such as AMA, FHx, multiples)
Therapeutic entry: Women 12-32/40 with signs or symptoms of PET or IUGR in current pregnancy

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24
Q

What was the intervention and comparison in the CLASP study?

A

Intervention - 60mg/day aspirin
Comparison - placebo tablet

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25
Q

What was the primary outcomes of the CLASP trial?

A

Development of PET
Gestation at birth
LBW <3rd centile
Perinatal mortality

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26
Q

What were the main findings of the CLASP trial?

A

Statistically insignificant reduction in PET (12%)
No statistically significant reduction in perinatal mortality or LBW

Statistically significant reduction in preterm delivery <37/40 - 14%

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27
Q

What were the conclusions of the CLASP trial?

A

Findings do not support routine low dose aspirin in all women with PET/IUGR risk factors, however may be justified in women thought to be at high risk of PET severe enough to cause preterm birth

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28
Q

CLASP trial strengths

A

RCT
Double blinded
Large numbers (9300)
Multi-country (16)

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29
Q

CLASP trial weaknesses

A

60mg/day aspirin used (lower dose than most other studies)
Only 80% compliance
Only 2/3 commenced aspirin before 20 weeks gestation

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30
Q

What was the aim of the ACTORDS study (Lancet 2006)?

A

To establish whether repeat prenatal corticosteroids given to women at risk of preterm birth can reduce neonatal morbidity without harm

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31
Q

What type of study was ACTORDS?

A

International (Aus/NZ) double blinded, placebo controlled RCT

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32
Q

What was the ACTORDS inclusion criteria?

A

<32/40 who had received corticosteroids 7 or more days previously and deemed at continued risk of preterm birth

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33
Q

What was the intervention and comparison in the ACTORDS trial?

A

Intervention - Single dose IM 11.4mg Betamethasone
Comparison - Single dose IM normal saline placebo

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34
Q

What were the primary outcomes of the ACTORDS trial?

A

Occurrence and severity of RDS
Use and duration of oxygen and mechanical ventilation
Weight, length, HC at birth and hospital discharge

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35
Q

What were the secondary outcomes of the ACTORDS trial?

A

Clinical chorioamnionitis requiring intrapartum antibiotics
Maternal postpartum pyrexia 38 degrees +
Maternal side effects
Other measures of neonatal morbidity

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36
Q

What were the main findings of the ACTORDS trial?

A

Statistically significant reduction in RDS in the steroid group - 33 vs 41%, RR 0.82, NNT 14
Statistically significant less severe lung disease in the RDS group - 12 vs 20%, RR 0.6, NNT 14
Statistically significant less oxygen and mechanical ventilation

No difference in mean weight, length and HC at birth and discharge
No difference in secondary outcomes (chorio, other neonatal morbidity)

More women in steroid group had CS

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37
Q

What was the conclusion of the ACTORDS trial?

A

Repeat doses of corticosteroids reduced short term neonatal morbidity up to 32 weeks gestation without an increase in infection or negative impacts on fetal growth

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38
Q

ACTORDS trial strengths

A

Large numbers (1000)
Low loss to follow-up
Double blinded
RCT

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39
Q

ACTORDS trial limitations

A

No long term follow-up data
Significant heterogeneity - wide range of gestational ages
A meta-analysis after this study did not show a reduction in RDS

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40
Q

What is the aim of the ACHOIS trial (NEJM 2005)?

A

To determine whether treatment of GDM reduces the risk of perinatal complications

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41
Q

What sort of study was the ACHOIS trial?

A

Multi-centre, randomised control trial

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42
Q

What was the inclusion criteria of the ACHOIS trial?

A

Singleton/twin pregnancy 16-30/40 + one or more risk factors for GDM or positive polycose test
AND
Had impaired glucose tolerance on OGTT at 24-34/40
<7.8 1h, 7.8-11 2h)

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43
Q

What was the intervention and comparison in the ACHOIS trial?

A

Intervention - dietary advice, glucose monitoring +/- insulin
Comparison - routine care (not advised of insulin resistance)

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44
Q

What were the primary outcomes of the ACHOIS trial?

A

Fetal
- Composite of serious complications (death, SD, fracture, nerve palsy)
- Admission to NNU
- Jaundice requiring phototherapy
Maternal
- Need for IOL
- Need for CS
- Health status on survey

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45
Q

What was one important secondary outcome of the ACHOIS trial?

A

Birth weight

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46
Q

What were the main findings of the ACHOIS study?

A
  • Statistically significant decrease serious neonatal complications in the treatment group - 1 vs 4%, RR 0.33, NNT 34
    -Statistically significant increase in NNU admission (RR 1.13), IOL (RR 1.36)
  • Statistically significant improvement in maternal mental health
  • Statistically significant reduction in macrosomia (RR 0.47)
  • No difference in CS, jaundice, shoulder dystocia
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47
Q

What was the main conclusion of the ACHOIS study?

A

Treatment of gestation diabetes reduces serious perinatal morbidity and may improve maternal mental health

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48
Q

ACHOIS study strengths

A

RCT
Large numbers (1000)

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49
Q

ACHOIS study weaknesses

A

No criteria for “routine care”
Possibility for confounding factors

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50
Q

What was the aim of the AJOG 2003 Progesterone Trial - Prophylactic administration of progesterone by vaginal suppository to reduce the incidence of spontaneous preterm birth in women at increased risk: A randomised placebo-controlled double-blind study

A

To evaluate the effect of prophylactic vaginal progesterone in decreasing preterm birth rate in a high risk population

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51
Q

What is the inclusion criteria for the AJOG 2003 Progesterone PTB trial?

A

Pregnant women at high risk for preterm delivery - at least one prior spontaneous PTB, prophylactic cervical cerclage and uterine malformation.

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52
Q

What was the intervention and comparison in the AJOG 2003 Progesterone PTB trial?

A

Intervention - 100mg progesterone suppository PV OD from 24-34/40
Comparison - identical placebo control

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53
Q

What were the primary outcomes of the AJOG 2003 Progesterone PTB trial?

A

Preterm birth
Uterine contractions

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54
Q

What were the main results of the AJOG 2003 Progesterone PTB trial?

A

Statistically significant reduction in preterm birth <37/40 in the progesterone group - 13.8% vs 28.5% (50% reduction)

Statistically significant reduction in preterm birth <34/40 in the progesterone group - 2.8% vs 18.6% (73% reduction)

Uterine contractions more frequently found in the placebo group that the progesterone group - 54.3% vs 23.6%

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55
Q

What was the conclusion of the 2003 AJOG Progesterone PTB trial?

A

Prophylactic progesterone reduced the frequency of uterine contractions and the rate of preterm delivery in women at high risk for prematurity

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56
Q

2003 AJOG Progesterone PTB trial - strengths

A

Double blinded

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57
Q

2003 AJOG Progesterone PTB trial - weaknesses

A

Low numbers (142 women), 32 total preterm births
Mechanism of action not well understood
Only commenced progesterone at 24/40

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58
Q

What was the aim of the 2009 Cochrane study: Magnesium sulfate for women at risk of PTB for neuroprotection of the fetus?

A

To assess the effects of MgSO4 as a neuroprotective agent when given to women considered at risk of preterm birth

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59
Q

What type of study was the 2009 Cochrane MgSO4 for Neuroprotection?

A

Cochrane systematic review of 5 RCTs

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60
Q

What was the inclusion criteria for the 2009 Cochrane MgSO4 for neuroprotection study?

A

RCTs of MgSO4 in women likely to give birth <37/40.
- 4x studies were for neuroprotective effect <34/40
- 1x study (MAGPIE) was for PET (<37/40)

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61
Q

What were the primary outcomes of the 2009 Cochrane MgSO4 for neuroprotection study?

A

Fetal/infant/child
- Perinatal mortality
- Major neurological disability
- Paediatric mortality + major neurological disability

Maternal
- Serious adverse cardio/resp outcome
- Adverse effects severe enough to stop treatment

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62
Q

What were the secondary outcomes of the 2009 Cochrane MgSO4 for neuroprotection study?

A

Other neonatal serious morbidity

Childhood growth and educational achievements

Other maternal morbidity

Use of health services

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63
Q

What were the main findings of the 2009 Cochrane MgSO4 for neuroprotection study?

A

Statistically significant reduction in cerebral palsy 3% vs 5%, RR 0.68, NNT 63

Statistically significant reduction in gross motor dysfunction RR 0.61

No difference in paediatric mortality or other neurological outcomes

Higher rates of maternal side effects in MgSO4 group

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64
Q

2009 Cochrane MgSO4 for neuroprotection study - strengths

A

Level 1 evidence
- Low chance of bias
Large overall numbers (6000)

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65
Q

2009 Cochrane MgSO4 for neuroprotection study - weaknesses

A

Did not evaluate long term outcomes beyond 2 years of life (and only 2 studies evaluated to up to 2 years of life)

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66
Q

What was the conclusion of the 2009 Cochrane MgSO4 for neuroprotection study?

A

The neuroprotective role for antenatal MgSO4 given to women at risk of PTB is now established.

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67
Q

What was the aim of the 2007 NEJM study - Progesterone and the risk of PTB among women with a short cervix?

A

To evaluate the effect of vaginal progesterone on the incidence of spontaneous early preterm delivery in asymptomatic women found at routine mid-trimester screening to have a short cervix

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68
Q

What type of study was the 2007 NEJM progesterone for short cervix study?

A

Multicentre (5), double blinded, RCT

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69
Q

What was the inclusion criteria of the 2007 NEJM progesterone for short cervix study?

A

Asymptomatic singleton/twin pregnancies 20-25/40 with cervical length <15mm on midtrimester TVUSS

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70
Q

What were the intervention and comparison in the 2007 NEJM progesterone for short cervix study?

A

Intervention - 200mcg utrogestan PV nocte from 24/40 to 33+6/40
Comparison - identical placebo

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71
Q

What was the primary outcome of the 2007 NEJM progesterone for short cervix study?

A

Spontaneous PTB <34/40

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72
Q

What were the secondary outcomes of the 2007 NEJM progesterone for short cervix study?

A

Birth weight
Perinatal mortality
Major neonatal adverse outcomes before discharge
Need for NICU care

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73
Q

What were the main findings of the 2007 NEJM progesterone for short cervix study?

A

Statistically significant less PTB <34/40 in progesterone group - 19% vs 34%, RR 0.56 (not statistically significant in twins)

Non-significant reduction in neonatal mortality

No serious adverse effects

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74
Q

What was the conclusion of the 2007 NEJM progesterone for short cervix study?

A

In women with a short cervix, treatment with progesterone reduces the rates of spontaneous PTB

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75
Q

2007 NEJM progesterone for short cervix study - strengths

A

Placebo controlled RCT
Double blinded
Low risk of bias
Large numbers (25000 screened, 413 included)

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76
Q

2007 NEJM progesterone for short cervix study - weaknesses

A

Self opt-in for TVUSS (82% of eligible population)
No data on effect on longer cervix i.e. 16-25mm

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77
Q

What was the aim of the 2018 NEJM ARRIVE trial?

A

To test the hypothesis that elective IOL at 39/40 results in less perinatal death or severe neonatal complications than expectant management in low-risk nulliparous women

78
Q

What type of study was the 2018 NEJM ARRIVE trial?

A

Multi-centre USA RCT

79
Q

What was the ARRIVE trial inclusion criteria?

A

Low risk nulliparous women who were 34+0-38+6 with a live cephalic singleton and no contraindication to vaginal birth

80
Q

What were the intervention and comparison in the ARRIVE trial?

A

Intervention - IOL 39+0-39+4
Comparison - no elective delivery <40+5 and delivery initiated no later than 42+2

81
Q

What were the primary outcomes of the ARRIVE trial?

A

Composite of perinatal death or severe neonatal complications

Caesarean section

82
Q

What were the secondary outcomes of the ARRIVE trial?

A

Neonatal - other neonatal complications, birth weight, hospital stay etc.

Maternal - perinatal morbidity, instrumental birth etc

83
Q

What were the main findings of the ARRIVE trial?

A

No statistically significant difference in composite perinatal death/severe neonatal outcome - RR 0.8 (CI 0.64-1.0 - contains null), however suggestive of no adverse perinatal outcome

Statistically significant reduction in CS rates - 18.6% vs 22.2%, RR 0.84

Statistically significant reduction in development of maternal hypertensive disorders RR 0.64

84
Q

What was the conclusion of the ARRIVE trial?

A

IOL at 39/40 in low risk nulliparous women resulted in a lower frequency of CS delivery and likely associated with no adverse perinatal outcome

85
Q

ARRIVE trial - strengths

A

RCT
Large numbers (6000)
Objective outcomes

86
Q

ARRIVE trial - weaknesses

A

Does not reflect current NZ maternity practice (largely midwifery led)
Different ethnic mix than Aus/NZ
IOL methods not specified
No long term data
Selection bias - 16,000 women declined to participate

87
Q

What was the aim of the Antenatal Betamethasone for Women at Risk of Later Preterm Delivery (ALPS) trial NEJM 2016?

A

To assess whether AN betamethasone in women likely to deliver in the later preterm period would decrease respiratory and other neonatal complications

88
Q

What was the ALPS study type?

A

Multi-centre (17 USA), double-blinded, placebo-controlled RCT

89
Q

What was the ALPS inclusion criteria?

A

Women with a singleton pregnancy 34+0-36+5 at high risk of delivery in the late preterm period (up to 36+6)

90
Q

What were the ALPS trial intervention and comparison?

A

Intervention - course of 2x IM injections of 12mg betamethasone 24h apart
Comparison - matching placebo

91
Q

What was the ALPS trial primary outcome?

A

Composite end point for the need for respiratory support within 72h of birth

92
Q

What were the ALPS trial secondary outcomes?

A

Neonatal morbidity - Severe respiratory complications, hypothermia, hypoglycaemia, feeding difficulty, IVH, sepsis, NEC etc.

Maternal chorio, endometritis, delivery before steroids completed, length of hospitalisation

93
Q

What were the main findings of the ALPS trial?

A

Statistically significant reduction in the need for respiratory support within 72h in steroid group - 11.6% vs 14.4%, RR 0.80, NNT 35

Statistically significant reduction in severe respiratory complications in the steroid group - 7.9% vs 12.1%, RR 0.66, NNT 25

but…

Statistically significant increased rate of neonatal hypoglycaemia in the steroid group - 24% vs 15%, RR 1.6

94
Q

ALPS trial - strengths

A

RCT
Double blinding
Clear enrollment criteria
Large numbers (2800)
Small numbers lost to follow-up

95
Q

ALPS trial - weaknesses

A

Looked at short term outcomes only
?applicable to Aus/NZ population

96
Q

ALPS trial conclusion?

A

Antenatal betamethasone in women at risk of late preterm delivery significantly decreased the rate of respiratory complications in newborns, but increased the rate of neonatal hypoglycaemia

97
Q

What was the aim of the Planned caesarean section vs planned vaginal birth for breech presentation at term trial? (Term Breech Trial - Lancet 2000)

A

To determine whether planned caesarean section was safer than planned vaginal birth for selected fetuses in breech presentation at term

98
Q

What sort of study was the Term Breech Trial?

A

Multi-centre (121), multi-country (26), RCT

99
Q

What was the inclusion criteria in the Term Breech Trial?

A

Singleton live frank (extended) or complete (flexed) breech presentation at >/= 37/40

100
Q

What was the intervention and comparison in the Term Breech Trial?

A

Intervention - planned CS at 38+/40

Comparison - planned spontaneous vaginal birth unless indication for IOL or CS developed.

101
Q

What were the primary outcomes of the Term breech trial?

A

Perinatal mortality <28d

Serious neonatal morbidity e.g birth trauma, seizures <24h, Apgar <4 at 5min etc

102
Q

What was the secondary outcome of the Term Breech trial?

A

Maternal mortality or serious maternal morbidity within 6 weeks postpartum e.g.PPH, hysterectomy, infection, PE

103
Q

What were the main findings of the Term Breech trial?

A

Statistically significant reduction in perinatal mortality in CS group 0.3% vs 1.3%, RR 0.23, NNT 100
- RR 0.07, NNT 7 in countries with low perinatal mortality rate

Statistically significant reduction in perinatal morbidity in CS group 1.4% vs 3.8%, RR 0.36, NNT 14 (not significant in high perinatal mortality rate countries)

No difference in maternal mortality or morbidity

104
Q

Term Breech Trial - Strengths

A

Multi-country - generalisability
RCT
Large numbers (2000)
Deliveries in usual manner for the individual units giving real world outcomes
Clearly defined inclusion and exclusion criteria
Decision to treat analysis

105
Q

Term Breech Trial - Weaknesses

A

Recruitment stopped after interim analysis showed differing rate in primary outcome
9% protocol violations and varied standard of care
2 babies included in the vaginal analysis likely dead prior to randomisation
21 breech vaginal births performed by non-experts
12 vaginal breechs were footling or uncertain presentation
30% of vaginal breech births had no USS available
More LGA babies in vaginal breech group
8/13 deaths unlikely due to mode of birth
Intention to treat analysis mean only 50% of vaginal birth group actually had a vaginal birth

106
Q

What was the aim of the Induction of labour compared with expectant management for prelabor rupture of membranes at term study (TERM PROM trial NEJM 1996)?

A

To determine if IOL for women with term PROM is better than awaiting spontaneous labour and whether oxytocin or vaginal prostin was preferable IOL method.

107
Q

What type of study was the TERM PROM trial?

A

Multi-centre (72), multi-country (6), RCT

108
Q

What was the interventions and comparisons in the TERM PROM trial?

A

Interventions:
- Immediate oxytocin IOL
- Immediate Prostin IOL

Comparisons:
- Expectant management with oxytocin IOL at 4 days or if complications
- Expectant management with Prostin IOL at 4 days or if complications

109
Q

What was the inclusion criteria in the TERM PROM trial?

A

Rupture of membranes >/= 37/40 live cephalic singleton

110
Q

What was the primary and secondary outcomes in the TERM PROM trial?

A

Primary - Neonatal infection

Secondary - CS, other measures of maternal/fetal/neonatal health, women’s evaluation of care

111
Q

What were the main findings of the TERM PROM trial?

A

No statistically significant difference in neonatal infection and CS rates in all groups.

Clinical chorioamnionitis and postpartum fever less likely to occur in oxytocin IOL group than in expectant oxytocin group - 4% vs 8.6%

Quicker labour with oxytocin vs prostaglandins

Intervention viewed more positively in women

112
Q

TERM PROM trial - Strengths

A

RCT
Multi-country - generalisable
Large numbers (5000)

113
Q

TERM PROM trial - Weaknesses

A

Need larger study to detect effect on perinatal mortality (4 deaths total)
Did not control for parity, cervical ripeness, oxytocin augmentation in labour
Did not look at shorter expectant management time i.e. 24-48h
Expectant management group had more VEs - ?explains chorio result

114
Q

What was the conclusion of the TERM PROM study?

A

IOL for PROM with oxytocin does not reduce neonatal infection or CS rate, but does reduce chorioamnionitis rates

115
Q

What type of study was the Broad-spectrum antibiotics for preterm, prelabour rupture of fetal membranes: the ORACLE I randomised trial? (Lancet 2001)

A

Multicentre (161), double-blinded, placebo-controlled RCT

116
Q

What was the aim of the ORACLE I trial?

A

To more definitively determine whether antibiotics for PPROM benefit the neonate.
To determine the best antibiotic choice.

117
Q

What was the inclusion criteria in ORACLE I?

A

PPROM <37/40, no evidence of infection and unclear need for abx.

118
Q

What were the interventions in ORACLE I?

A

Interventions:
- Erythromycin 250mg + placebo
- Co-amoxyclav 325mg + placebo
- Erythromycin + co-amoxyclav
- Double placebo

All PO QID x 10/7

119
Q

What were the primary outcomes in ORACLE I?

A

Fetal/neonatal - Composite primary outcome of perinatal mortality or major adverse outcome prior to discharge (i.e. chronic lung disease) or major cerebral abnormality on USS

*lots of difference secondary outcomes

120
Q

What were the main findings of ORACLE I?

A

Significantly significant decrease in primary outcomes in singletons (not twins) in the erythromycin only group- 11 vs 14%, with significantly less major cerebral anomalies 3 vs 5%

Significantly more prolongation of pregnancy to 48h in erythromycin group

Both co-amoxyclav groups had prolonged pregnancy, but significantly increased rates or NEC 4 vs 2.5%

121
Q

What were the conclusions of the ORACLE I trial?

A

Erythromycin for PPROM associated with a range of health benefits for the neonate. Co-amoxiclav can not be routinely recommended due to association with NEC.

122
Q

ORACLE I - strengths

A

Multi-centre RCT with large numbers (4800)
- Low risk of bias
Provided specific antibiotic and dosing regimen

123
Q

ORACLE I - weaknesses

A

No long term data, but has follow-up trial
UK population - not generalisable to all

124
Q

What was the aim of the ORACLE I 7y follow-up trial?

A

To determine the long-term effects on children of the antibiotic regimens/placebo given during the ORACLE I trial

125
Q

What type of study was the Childhood outcomes after prescription of antibiotics to pregnant women with PPROM - a 7y follow-up of teh ORACLE I trial?

A

Cohort study

126
Q

What was the inclusion criteria for the ORACLE I 7y follow-up study?

A

Children of mothers previously enrolled in ORACLE I trial living in the UK

127
Q

How was information collected for the ORACLE I 7y follow-up study?

A

Parent-completion postal questionnaire

128
Q

What was the primary outcome in the ORACLE I 7y follow-up study?

A

Functional impairment (mild/mod/severe - vision, hearing, speech, ambulation, dexterity, emotion, cognition)

129
Q

What were the main findings of the ORACLE I 7y follow-up study?

A

No difference in functional impairment, behavioural difficulties, developmental cognitive milestones, diabetes in any group.

Some evidence of reduction in respiratory problems in erythromycin group

Increase in total bowel problems in co-amoxyclav group

130
Q

ORACLE I 7y follow-up study conclusion?

A

The prescription of antibiotics for women with PPROM seems to have little effect on the health of children at 7 years of age

131
Q

ORACLE I 7y follow-up study - strengths

A

75% follow-up and high response rate
Used standardised questionaire to determine functional impairment

132
Q

ORACLE I 7y follow-up study - weaknesses

A

Risk of bias from parents underreporting or inaccurately reporting responses
Disadvantaged groups over represented in non-responders

133
Q

What was the aim of the HYPITAT study?

A

To assess whether IOL in women with GHTN or mild PET reduces poor maternal outcome compared with expectant monitoring

134
Q

What sort of study was the Induction of labour vs expectant monitoring for gestational HTN or mild PET after 36/40 (HYPITAT Lancet 2009)?

A

Multi-centre (38), unblinded RCT

135
Q

What was the inclusion criteria in the HYPITAT study?

A

Singleton cephalic 36+0 - 41+0 with GHTN (2x DBP >95 6h apart) or mild PET (2x DBP >90 6h apart + proteinuria)

Excluded severe HTN > 170/110 and other complications

136
Q

What was the intervention and comparison in the HYPITAT study?

A

Intervention - IOL within 24h of randomisation (Bishops score >6 - AROM +/- synto, Bishops score 6 or less - cervical ripening)

Comparison - expectant management (BP, urinalysis, CTGs, USS) until spontaneous labour - IOL if severe range BPs or other complicating features

137
Q

What were the primary outcomes of the HYPITAT trial?

A

Composite measure of poor maternal outcome
- mortality, morbidity (HELLP, eclampsia, pulm. oedema, VTE, abruption)
- progression to severe disease
- major PPH >1000mL

138
Q

What were the secondary outcomes of the HYPITAT trial?

A

Mode of birth
Neonatal mortality
Neonatal morbidity

139
Q

What were the main findings of the HYPITAT trial?

A

Significantly significant less composite poor maternal outcome in IOL group - 31% vs 44%, RR 0.71, NNT 8

Less progression to severe disease and less antihypertensive use in IOL group.

No difference in CS rates or neonatal outcomes.

140
Q

What was the conclusion of the HYPITAT trial?

A

IOL associated with improved maternal outcomes in women with GHTN or mild PET, and should be advised for these women beyond 37 weeks.

141
Q

HYPITAT strengths

A

Multi-centre RCT
Large numbers (700)

142
Q

HYPITAT weaknesses

A

Single country (Netherlands) - ?generalisable
Unblinded
Half of the women in expectant management ended up with IOL

143
Q

What type of study was the PPROMT trial?

A

Multi-centre, multi-country (11), unblinded RCT

144
Q

What was the aim of the Immediate delivery compared with expectant management after PPROM close to term (PPROMT) (2016 Lancet)?

A

To establish whether immediate birth in singletons with ROM close to term reduces neonatal infection without increasing other morbidity

145
Q

What was the inclusion criteria in the PPROMT trial?

A

Singleton pregnancies in women >16y with prelabour ROM 34+0-36+6 without signs of infection

146
Q

What was the intervention and comparison in the PPROMT trial?

A

Intervention - immediate IOL
Comparison - expectant management

147
Q

What was the primary outcome in the PPROMT trial?

A

Neonatal sepsis

148
Q

What were the secondary outcomes in the PPROMT trial?

A

Composite neonatal morbidity and mortality e.g. RDS, ventilation, NICU stay, perinatal death

Maternal:
- APH
- Intrapartum fever
- PN abx
- Mode of birth

149
Q

What were the main findings of PRROMT?

A

No significant difference in neonatal sepsis (even if GBS +ve) *note that follow-up study found benefit with immediate delivery if GBS positive

No significant difference in composite neonatal outcome
BUT
- Significant increase in RDS (8 vs 5%, RR 1.6), mechanical ventilation (RR 1.4), NICU stay and CS (RR 1.4) in IOL group

Statistically signicant increase in APH (RR 0.6), maternal fever (RR 0.4) and longer hospital stay in expectant management group

150
Q

What was the conclusion of the PRROMT trial?

A

In the absence of overt signs of infection or fetal compromise, a policy of expectant management with appropriate surveillance of maternal and fetal wellbeing should be followed in pregnant women who present with PROM close to term

151
Q

PPROMT - strengths

A

RCT
Large numbers (1800)
Multi-country - generalisable
Low level lost to follow-up

152
Q

PPROMT - weaknesses

A

Unblinded
No protocol for monitoring in expectant management

153
Q

What type of study was the WOMAN trial (Lancet 2017)?

A

Multi-country double-blinded placebo-controlled RCT

154
Q

What was the aim of the Effect of early TXA administration on mortality, hysterectomy, and other morbidities in women with PPH ‘WOMAN’ trial (Lancet 2017)?

A

To assess the effects of early TXA on death, hysterectomy and other relevant outcomes in women with PPH

155
Q

What was the inclusion criteria for the WOMAN trial?

A

16y+ with PPH after CS (1000mL) or NVB (500mL) or clinical diagnosis

156
Q

What were the intervention and comparison in the WOMANtrial?

A

Intervention - 1g TXA slow infusion (second dose if bleeding continued after 30min or restarted within 24h)
Comparison - Matching placebo

157
Q

What was the primary outcome of the WOMAN trial?

A

Composite of maternal death from all causes or hysterectomy within 42d of randomisation

158
Q

What were the secondary outcomes in the WOMAN trial?

A

Maternal mortality due to bleeding

Other maternal morbidity e.g. VTE, laparotomy, sepsis

159
Q

What were the main findings of the WOMAN trial?

A

No significant difference primary outcome (all cause death/hysterectomy).

Statistically significant reduction in death from bleeding in the TXA group if given within 3h of birth (1.2% vs 1.7%, RR 0.69)

Statistically significant reduction in laparotomy in TXA group (0.8 vs 1.3%, RR 0.64)

No difference in adverse outcomes e.g. VTE

160
Q

What was the conclusion of the WOMAN trial?

A

TXA reduces death from bleeding in women with PPH with no adverse effects. Should be given ASAP after bleeding onset.

161
Q

WOMAN trial strengths

A

Very large numbers (20,000)
Multi-country (21) - more generalisable
Multi-centre (193)
Double-blinded - low chance of bias
Low loss to follow-up

162
Q

WOMAN trial - weaknesses

A
  • Funded by drug company (conflict of interest)
  • Did not study PO TXA
163
Q

What was the aim of the Antenatal betamethasone and incidence of neonatal respiratory distress after ELCS: pragmatic randomised trial (BMJ 2005)? ASTECS

A

To test whether steroids reduce respiratory distress in babies born by ELCS at term

164
Q

What type of study was the ASTECS study?

A

Multicentre (10), unblinded RCT

165
Q

What was the inclusion criteria for the ASTECS trial?

A

Intervention - 2x IM doses of 12mg betamethasone 24h apart, within 48h before ELCS

Comparison - treatment as usual

166
Q

What were the primary and secondary outcomes of the ASTECS trial?

A

Primary - Admission to NNU with respiratory distress

Secondary - severity of respiratory distress and level of care neded

167
Q

What were the main results of the ASTECS trial?

A

Significantly significant reduction in admission to NNU with respiratory distress in the steroid group - RR 0.46.

No statistically significant difference between rates of TTN and RDS diagnoses

168
Q

What was the conclusion of the ASTECS trial?

A

Antenatal betamethasone and delaying delivery until 39/40 both reduce admissions to NNU after ELCS at term

169
Q

ASTECS - strengths

A

Multicentre RCT
Large numbers (1000)

170
Q

ASTECS - weaknesses

A

Unblinded
Not placebo controlled

171
Q

What was the aim of the randomised trial of planned caesarean or vaginal delivery for twin pregnancy trial (NEJM 2013)?

A

To compare the risk of perinatal death or serious morbidity with ELCS and vaginal birth for twin pregnancies 32+0 to 38+6 if leading twin cephalic

172
Q

What type of study was the Twin Birth Study 2013 NEJM?

A

Multi-centre (106), Multi-country (25), RCT

173
Q

What was the inclusion criteria in the Twin Birth Trial?

A

Twin pregnancy (DCDA or MCDA) 32+0 to 38+6, leading cephalic, both twins EFW 1500-4000g on USS within 7d before randomisation

174
Q

What were the interventions in the Twin Birth Trial?

A

Planned caesarean section

Planned vaginal birth

175
Q

What were the primary and secondary outcomes of the Twin birth Trial?

A

Primary - Composite outcome of neonatal mortality or serious morbidity (birth injury, Apgar <4 at 5min, seizures etc)

Secondary outcomes
- Composite outcome of maternal mortality or serious morbidity

175
Q

What were the main findings of the Twin Birth Trial?

A

No significant difference in all outcomes - neonatal or maternal death or serious morbidity

176
Q

Twin Birth Trial - strengths

A

RCT
Multi-country - generalisable
Multi-centre
Large numbers (1398)
Low level lost to follow-up

177
Q

Twin Birth Trial - weaknesses

A

Only generalisable to units where experienced obstetrician available for birth and access to EMCS

178
Q

What was the inclusion criteria of the HAPO study?

A

18y+ without pre-existing diabetes, ART, HIV/Hepatitis, uncertain dates, multiples or non-english speaking

+ OGTT 24-32/40 with fasting <5.8mmol/L and 2h <11.1mmol/L

179
Q

What was the exposure in the HAPO study?

A

Categories of glycaemic index on OGTT

180
Q

What were the primary outcomes of the HAPO study?

A

Birthweight > 90th (LGA)
Primary caesarean section
Neonatal hypoglycaemia
Cord blood C peptide >90th centile

181
Q

What were the secondary outcomes of the HAPO study?

A

PTB <37/40
SD or birth injury
NICU admission
Jaundice
PET

182
Q

What were the main findings in the HAPO study?

A

There is an increasing risk of all primary outcomes (LGA, primary CS, neonatal hypoglycaemia, cord blood C peptide >90th) with increasing glucose category
- Strongest association with LGA and C peptide

Increase in all secondary outcomes (PTB <37/40, SD/birth injury, NICU admission, jaundice, PET) with increasing glucose category

183
Q

What was the conclusion of the HAPO study?

A

Increasing glucose intolerance is associated with increasing risk of LGA, CS, cord C peptide, neonatal hypoglycaemia and other adverse outcomes

184
Q

HAPO study - strengths

A

Large numbers (23,000)
International study - generalisable
Researchers were blinded to the OGTT result

185
Q

HAPO study - weaknesses

A

Not an RCT - increased risk of confounding
Not powered to assess perinatal death
No information on BMI or gestational weight gain

186
Q

What were the primary and secondary outcomes of the Twin birth Trial?

A

Primary - Composite outcome of neonatal mortality or serious morbidity (birth injury, Apgar <4 at 5min, seizures etc)

Secondary outcomes
- Composite outcome of maternal mortality or serious morbidity

187
Q

Twin Birth Trial conclusion

A

In MCDA/DCDA twin pregnancies with leading twin cephalic, planned delivery via CS did not significantly decrease or increase the risk of fetal or maternal death or serious morbidity

187
Q

What was the aim of the Hyperglycaemia and Adverse Pregnancy Outcomes (NEJM 2008) study?

A

To clarify the risks of adverse outcomes associated with various degrees of maternal glucose intolerance less severe than that in overt diabetes mellitus

188
Q

What type of study was the HAPO study?

A

International observational study

189
Q

What were the primary and secondary outcomes of the Twin birth Trial?

A

Primary - Composite outcome of neonatal mortality or serious morbidity (birth injury, Apgar <4 at 5min, seizures etc)

Secondary outcomes
- Composite outcome of maternal mortality or serious morbidity

190
Q

What were the primary and secondary outcomes of the Twin birth Trial?

A

Primary - Composite outcome of neonatal mortality or serious morbidity (birth injury, Apgar <4 at 5min, seizures etc)

Secondary outcomes
- Composite outcome of maternal mortality or serious morbidity

Landmark Trials (2 decks)

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