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RANZCOG exam prep > Landmark Trials > Flashcards

Landmark Trials Flashcards

1
Q

Results of RCT planned CS vs VB for twins

A

No evidence that planned CS improved perinatal outcomes

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2
Q

What is the TRUFFLE trial?

A

Two year neurodevelopmental and intermediate perinatal outcomes in infants with very preterm FGR

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3
Q

TRUFFLE Trial - type of study

A

Prospective multi centre unblinded randomised study

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4
Q

Number of participants in the TRUFFLE trial

A

503

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5
Q

What is the MAGPIE trial?

A

Do women with PET, and their babies, benefit from MgSO4?

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6
Q

Results of MAGPIE trial

A

Significantly fewer eclamptic seizures with MgSO4, NNT 91

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7
Q

Results of Cochrane review of magnesium sulfate for women at risk of PTB for neuroprotection

A

Decreased cerebral palsy - RR 0.68, NNT 63 (NNT 29 if <28wks)
Decreased gross motor dysfunction - RR 0.61

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8
Q

What is the CLASP trial?

A

Randomised trial of low dose aspirin for the prevention of preeclampsia among 9364 pregnant women

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9
Q

Intervention for CLASP trial?

A

60mg aspirin or placebo from 12 weeks or from randomisation

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10
Q

Full name of PPROMT Trial

A

Immediate delivery compared with the expectant management after PROM close to term

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11
Q

Primary outcome of PPROMPT trial

A

Neonatal sepsis

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12
Q

Results of PPROMPT Trial

A

No difference in neonatal sepsis (2% vs 3%)
Increased RDS and NICU admission in IOL group
Increased CS rate in IOL group
Increased APH and maternal fever with expectant group

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13
Q

How many women were included in the WHI RCT: Effects of conjugated equine estrogen in postmenopausal women with hysterectomy (2004)

A

10,700

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14
Q

Inclusion criteria for the WHI RCT: Effects of conjugated equine estrogen in PM women with hysterectomy

A

PM women age 50-79 with previous hysterectomy

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15
Q

What was the primary outcome for WHI RCT: Effects of conjugated equine estrogen in PM women with hysterectomy?

A

CHD - MI or CHD death
Secondary outcomes: Stroke, VTE, cancer and fractures

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16
Q

Results of WHI RCT: Effects of conjugated equine estrogen in PM women with hysterectomy

A

Trial stopped early
Increased risk of stroke and VTE
Decreased breast Ca risk in treatment group
Decreased fractures in treatment in treatment group

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17
Q

Provision of no cost LARCs and teenage pregnancy, Secura et al 2014

Type of study?

A

Prospective cohort study, followed for 2-3 years

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18
Q

Provision of no cost long acting contraception and teenage pregnancy

Inclusion criteria

A

1404 of the adolescents enrolled in the CHOICE study, aged between 14-19 years

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19
Q

Who published the Provision of no cost LARCs and teenage pregnancy study?
When?

A

Secura et al, 2014

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20
Q

Ovarian conservation at time of hysterectomy for benign disease, 2005

Type of study

A

Retrospective case control study using Markov decision making modelling

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21
Q

Ovarian conservation at time of hysterectomy for benign disease, 2005

Primary outcome

A

Mortality / long term survival
Breast and ovarian cancer

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22
Q

Ovarian conservation at time of hysterectomy for benign disease, 2005

Results

A

Ovarian conservation to age 65 benefits long term survival
- at no age is there a clear benefit for opohorectomy for survival

BSO: Increases all cause mortality, decreased breast and ovarian cancer

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23
Q

A Comparison of Medical Management with Misoprostol and Surgical Management for Early Pregnancy Loss, 2005

Type of study

A

RCT
652 women (randomised 3:1 to miso)

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24
Q

A Comparison of Medical Management with Misoprostol and Surgical Management for Early Pregnancy Loss, 2005

Inclusion criteria

A

Missed or incomplete miscarriage

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25
Q

A Comparison of Medical Management with Misoprostol and Surgical Management for Early pregnancy loss, 2005

Primary outcome

A

No need or evacuation within 30 days

Secondary outcomes: Hb drop, unplanned trip to hospital, haemorrhage

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26
Q

Results of A Comparison of medical management with misoprostol and surgical management for early pregnancy loss

A

84% success rates with Misoprostol vs 97% with Evacuation
- lower success for medical with anembryonic pregnancy
- no difference in haemorrhage or infection
- 5% misoprostol vs 1% evacuation had Hb drop of >30

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27
Q

Conclusion of A Comparison of Medical Management with Misoprostol vs Surgical Management for Early Pregnancy Loss

A

Complications from misoprostol: Rate <1:70
83% would recommend it

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28
Q

Primary Outcome of the ALIFE trial

A

Rate of live birth

Secondary outcome = Gestation at delivery

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29
Q

Results of the ALIFE trial

A

No difference in primary outcome

Those on LMWH + Aspirin delivered ~1 week earlier

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30
Q

ALIFE Trial

Full name of trial

A

Aspirin + Low Molecular Weight Heparin or Aspirin Alone in Women with Recurrent Miscarriage

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31
Q

ALIFE Trial - type of study

A

Multicentre, double blinded, placebo controlled RCT
364 women (84% became pregnant)

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32
Q

ALIFE Trial - Inclusion criteria

A

2 or more unexplained miscarriages >20/40

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33
Q

ALIFE Trial - intervention

A

3 arms:
- 80mg Aspirin + LMWH from 6/40
- 80mg only
- Placebo

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34
Q

SPIN Study - Full name of study

A

Scottish Pregnancy Intervention Study:
RCT of LMWH + Low Dose Aspirin in Women with Recurrent Miscarriage

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35
Q

SPIN Study - Type of study

A

Multicentred ?double-blinded RCT
294 women

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36
Q

SPIN Study - Inclusion criteria

A

2x consecutive pregnancy losses (most recent pregnancies) <24/40
Presenting for antenatal care <7/40SP

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37
Q

SPIN Study

Intervention

A

75mg Aspirin + 40mg LMWH + Intensive monitoring
Vs
Intensive monitoring

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38
Q

WHI RCT: Risks and Benefits of Oestrogen + Progestin in Healthy Post-menopausal Women, Principal Results, 2002

Type of study

A

Multicentre, placebo controlled, RCT
16,600 women

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39
Q

WHI RCT: Risks and Benefits of Oestrogen + Progestin in Healthy Post-menopausal Women, Principal Results, 2002

Inclusion criteria

A

PM women aged 50-79 with intact uterus

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40
Q

WHI RCT: Risks and Benefits of Oestrogen and Progestin in Healthy PM women, Principal results 2002

Intervention

A

Conjugated equine oestrogen 0.625mg/d + Provera 2.5mg/d
vs
Placebo

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41
Q

WHI RCT: Risks and Benefits of Oestrogen + Progestin in Healthy PM Women, Principal Results, 2002

Primary Outcomes

A

Coronary heart disease - acute MI or death due to CHD

Secondary outcomes = Stroke, VTE, Cancer, Fractures

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42
Q

WHI RCT: Risks and Benefits of Oestrogen + Progestin in Healthy PM Women, Principal Results, 2002

Results

A

Trial stopped early

Increased CHD
VTE risk doubled
Increased invasive breast Ca

Decrease in colorectal cancer and hip fractures

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43
Q

Limitations of WHI RCT?

A

Average age 63
Not appropriately assessed for baseline risk - high rates of obesity, HTN, smoking
Only 1 dose/route of HRT
High rates of crossover and discontinuation

44
Q

PLCO Study - Full name

A

Effect of Screening on Ovarian Cancer Mortality
- The Prostate, Lung, Colorectal and Ovarian (PLCO) Screening RCT

45
Q

PLCO Study
- When was it published?

A

2011

46
Q

PLCO Study - type of study

A

Large multicentre RCT
34000 in each arm

47
Q

PLCO Study

Inclusion criteria

A

55-74 years old, no previous dx of lung, colorectal or ovarian cancer

48
Q

PLCO Study - Intervention

A

Annual Ca125 + TV Pelvic USS

49
Q

PLCO - Primary Outcome

A

Ovarian cancer specific mortalitySP

50
Q

SPIN Study - Primary outcome

A

Loss of index pregnancy

51
Q

Results of SPIN Study

A

No difference in primary outcome
No complications of treatment

52
Q

LACE Trial - Full name of trial

A

Effect of TAH vs TLH on Disease Free Survival Among Women with Stage 1 Endometrial Cancer

53
Q

LACE Trial - Type of trial

A

International, multicentre RCT

54
Q

What was the primary outcome of the LACE Trial?

A

Disease free survival

Secondary outcomes: Recurrent endometrial cancer and overall survival

55
Q

LACE Trial

Results?

A

No difference in primary outcome
No difference in overall survival, surgical risks or QoL

56
Q

Limitations of the LACE Trial

A

11% lost to follow up, skill of surgeons

57
Q

PLCO Study - Secondary outcomes

A

Ovarian cancer incidence, cancer stage, survival, all cause mortality, harms of screening

58
Q

Results of PLCO Study

A

No difference in primary outcomes

No difference in all cause mortality
Increased rates of oophorectomy in screened group - high number of false positives

59
Q

Strengths and Limitations of the PLCO Study

A

Strengths: Multicentre, randomised

Limitations: 13% non-compliant with screening, some in control group received screening outside of trial

60
Q

Conclusion of PLCO Study

A

Screening intervention not effective at reducing cause specific mortality
Screening increased invasive procedures and associated harms

61
Q

Million Women Study - What is the full name of the study?

A

Breast cancer and HRT in the Million WOmen Study

62
Q

Million women study - type of trial

A

Cohort study
- age 50-64 years

63
Q

Million women study - inclusion criteria

A

Age 50-64
Recruited at time of triennial breast screening

64
Q

Million women study - primary outcome

A

First diagnosis of invasive breast cancer and attributable deaths

65
Q

Million women study - results

A

Increased risk of breast cancer in current users (RR 1.66) not in past users.
No increased risk if stopped >5yrs.
RR for estrogen only = 1.3
RR for E+P = 2.0

+5 per 1000 oestrogen only if used >10yrs
+19 per 1000 combined if used >10yrs

66
Q

Strengths and Limitations of the Million Women Trial

A

Strengths = Large
Limitations = Poor selection as recruited at screening (likely higher health literacy, SES etc), assumptions made about menopausal status

67
Q

When was the MAGPIE Trial published?

A

2002

68
Q

What is the full name of the MAGPIE trial?

A

Do women with pre-eclampsia, and their babies, benefit from MgSO4?

69
Q

MAGPIE - Type of trial

A

International multicentre, placebo controlled, double blinded RCT
Included over 10,000 women

70
Q

What was the conclusion of the TRUFFLE Trial?

A

Timing of delivery based on late DV changes (absent a-wave) MAY improve neurodevelopment at 2 years

71
Q

Strengths and limitations of the TRUFFLE Trial?

A

Strengths: Randomised, multicentre
Limitations: Unblinded
Delivery sometimes required for maternal reasons or based on obvious CTG changes (not STV)Pr

72
Q

Progesterone and the risk of preterm birth among women with a short cervix, 2007

Type of study?

A

Multicentre, double blinded, placebo controlled RCT
250 patients in study (but over 24000 screened)

73
Q

Progesterone and the risk of preterm birth among women with a short cervix, 2007

Inclusion criteria

A

Cervix =/< 15mm on mid-trimester USS 20-25/40, irrespective of previous history

74
Q

Primary outcome for Fonseca et al study published in 2007

A

Preterm birth <34/40
(progesterone and the risk of pre-term birth among women with a short cervix)

75
Q

Progesterone and the risk of preterm birth among women with a short cervix, 2007

Results

A

Reduction in PTB <34/40
19% vs 34% (RR 0.56)

76
Q

Strengths and limitations of Progesterone for Short cervix trial in 2007?

A

Strengths - randomised, double blinded and placebo controlled –> low risk of bias.
Sufficiently powered

Limitations: Small, different dose of progesterone used compared to previous RCT (200mg vs 100mg)

77
Q

When was the TERM PROM trial published?

A

1996

78
Q

TERM PROM, 1996
Full name

A

Induction of labour compared with expectant management for prelabour rupture of membranes at term

79
Q

TERM PROM - interventions

A

4 arms
Immediate IOL with either synto or PG
Expectant mgt with IOL at 4 days or when indication arose
- either synto or PG

80
Q

TERM PROM - inclusion criteria

A

PROM >37 weeks with cephalic singletone
- excluded if in active labour, or contraindication to any treatment (e.g chorio or meconium liquor)

81
Q

ACHOIS Trial - Primary outcome

A

Infants: Death, shoulder dystocia, fracture, nerve palsy, NICU admission and jaundice

Mothers: IOL, C/S, psych outcomes and QoL

82
Q

ACHOIS Trial - Results

A

Decreased rate of serious perinatal outcomes in treatment group (4% to 1%, NNT 34)
Decreased macrosomia, increased NICU admissions

Maternal: Increased IOL rate, same C/S rate, decreased depression in treatment group

83
Q

Limitations of ACHOIS trial

A

Not blinded
Possible bias due to increased clinician awareness
Groups not homogenous

84
Q

What was the aim of the ARRIVE trial

A

To test whether IOL at 39 weeks would result in lower risk of perinatal death or severe neonatal complication, than expectant management in low risk nulliparous women

85
Q

ARRIVE Trial - type of study

A

Multicentred, parallel group, unmasked RCT
6106 women

86
Q

ARRIVE trial - inclusion criteria

A

Low risk nulliparous women 34-38+6 at time of enrollment
Singleton, cephalic, with no contraindication to NVD

87
Q

Oracle 1 Trial - Full name of study

A

Broad spectrum antibiotics for preterm pre-labour rupture of membranes

88
Q

Oracle 1 Trial - intervention

A

Erythromycin
Augmentin
Both
Neither
For 10 days

89
Q

What were the primary and secondary outcomes of the ARRIVE Trial?

A

Primary outcome: Composite of perinatal death or severe neonatal complications

Secondary outcome = C/S rate

90
Q

ARRIVE Trial - Results

A

No significantly decreased risk of primary outcome (perinatal death or severe neonatal complications)
Significantly reduced rate of C/S in IOL group (18.6% vs 22.2%)

Women reported increased satisfaction and feeling of control in IOL group

91
Q

Strengths and limitations of the ARRIVE trial

A

Strengths - study design, large size

Limitations: Doesn’t reflect how we practice in NZ (LMC vs obs lead)
Different IOL methods
Not blinded

92
Q

WOMAN Trial, 2017 - Name of study

A

Effect of early TXA administration on mortality, hysterectomy and other morbidities in women with PPH

93
Q

WOMEN Trial - type of study

A

International double blinded, placebo controlled RCT
20,000 participants

94
Q

WOMAN trial - inclusion criteria

A

PPH 500ml after VB, or 1000ml after C/S, or EBL enough to cause haemodynamic instability

95
Q

What was the primary outcome in the ORACLE 1 trial

A

Composite of neonatal death, chronic lung disease, and major cerebral abnormality

96
Q

Results of ORACLE I Trial?

A

Erythromycin decreased primary outcome but not statistically significant

Significant prolongation of pregnancy and decreased surfactant and O2 use

Increased NEC with Augmentin

97
Q

HYPITAT Trial, 2009
- Name of study

A

Induction vs Expectant management for gestation HTN or mild PET after 36 weeks

98
Q

HYPITAT Trial, 2009
- Inclusion criteria

A

36-41/40
Singleton cephalic
Gestational HTN with diastolic BP >95 or mild PET with diastolic BP >90 and proteinuria
Excluded severe hypertension 170/110, severe PET, HELLP, pre-existing HTN

99
Q

HYPITAT Trial, 2009,
- Intervention

A

IOL within 24hrs
vs
Expectant mgt with monitoring, if no severe HTN - IOL >41/40

100
Q

ACHOIS Trial, 2005 - Name of trial

A

Effect of treatment of GDM on pregnancy outcomes

101
Q

ACHOIS Trial, 2005 - Intervention

A

Routine ANC
vs
GDM care with education, dietary advice, BSL monitoring and targets, plus insulin as needed

102
Q

HYPITAT Trial - Primary outcome

A

Composite measure of poor maternal outcome (death, morbidity, progression to severe disease)

103
Q

HYPITAT Trial - Results

A

Primary outcome decreased in IOL group (RR 0.71), NNT = 8
–> mainly due to less progress to severe disease

Benefit of IOL not present <37/40

No difference in neonatal outcomes

104
Q

Planned C/S or VB for Twins 2013
- Primary outcomes

A

Composite fetal / neonatal morbidity and mortality
Composite maternal morbidity and mortality

105
Q

HAPO Study - Primary outcomes

A

Birth weight >90th%
C/S
Neonatal hypoglycaemia
Cord c-peptide levels

106
Q

HAPO Study - Results

A

With increase in maternal glucose results = increase in each primary outcome
- Birth weight >90th% and c-peptide levels = Strong association
- C/S and neonatal hypoglycamia = Weaker association

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