Brainscape's Knowledge GenomeTM


Top Flashcards (Certified)
All Flashcards

RANZCOG exam prep > Landmark Trials > Flashcards

Landmark Trials Flashcards

(106 cards)

Start Studying
1
Q

Results of RCT planned CS vs VB for twins

A

No evidence that planned CS improved perinatal outcomes

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

What is the TRUFFLE trial?

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

TRUFFLE Trial - type of study

A

Prospective multi centre unblinded randomised study

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

Number of participants in the TRUFFLE trial

A

503

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

What is the MAGPIE trial?

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

Results of MAGPIE trial

A

Significantly fewer eclamptic seizures with MgSO4, NNT 91

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

What is the CLASP trial?

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

Intervention for CLASP trial?

A

60mg aspirin or placebo from 12 weeks or from randomisation

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

Full name of PPROMT Trial

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

Primary outcome of PPROMPT trial

A

Neonatal sepsis

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

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

A

Secura et al, 2014

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

Ovarian conservation at time of hysterectomy for benign disease, 2005

Primary outcome

A

Mortality / long term survival
Breast and ovarian cancer

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

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

Inclusion criteria

A

Missed or incomplete miscarriage

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
25
A Comparison of Medical Management with Misoprostol and Surgical Management for Early pregnancy loss, 2005 Primary outcome
No need or evacuation within 30 days Secondary outcomes: Hb drop, unplanned trip to hospital, haemorrhage
26
Results of A Comparison of medical management with misoprostol and surgical management for early pregnancy loss
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
27
Conclusion of A Comparison of Medical Management with Misoprostol vs Surgical Management for Early Pregnancy Loss
Complications from misoprostol: Rate <1:70 83% would recommend it
28
Primary Outcome of the ALIFE trial
Rate of live birth Secondary outcome = Gestation at delivery
29
Results of the ALIFE trial
No difference in primary outcome Those on LMWH + Aspirin delivered ~1 week earlier
30
ALIFE Trial Full name of trial
Aspirin + Low Molecular Weight Heparin or Aspirin Alone in Women with Recurrent Miscarriage
31
ALIFE Trial - type of study
Multicentre, double blinded, placebo controlled RCT 364 women (84% became pregnant)
32
ALIFE Trial - Inclusion criteria
2 or more unexplained miscarriages >20/40
33
ALIFE Trial - intervention
3 arms: - 80mg Aspirin + LMWH from 6/40 - 80mg only - Placebo
34
SPIN Study - Full name of study
Scottish Pregnancy Intervention Study: RCT of LMWH + Low Dose Aspirin in Women with Recurrent Miscarriage
35
SPIN Study - Type of study
Multicentred ?double-blinded RCT 294 women
36
SPIN Study - Inclusion criteria
2x consecutive pregnancy losses (most recent pregnancies) <24/40 Presenting for antenatal care <7/40SP
37
SPIN Study Intervention
75mg Aspirin + 40mg LMWH + Intensive monitoring Vs Intensive monitoring
38
WHI RCT: Risks and Benefits of Oestrogen + Progestin in Healthy Post-menopausal Women, Principal Results, 2002 Type of study
Multicentre, placebo controlled, RCT 16,600 women
39
WHI RCT: Risks and Benefits of Oestrogen + Progestin in Healthy Post-menopausal Women, Principal Results, 2002 Inclusion criteria
PM women aged 50-79 with intact uterus
40
WHI RCT: Risks and Benefits of Oestrogen and Progestin in Healthy PM women, Principal results 2002 Intervention
Conjugated equine oestrogen 0.625mg/d + Provera 2.5mg/d vs Placebo
41
WHI RCT: Risks and Benefits of Oestrogen + Progestin in Healthy PM Women, Principal Results, 2002 Primary Outcomes
Coronary heart disease - acute MI or death due to CHD Secondary outcomes = Stroke, VTE, Cancer, Fractures
42
WHI RCT: Risks and Benefits of Oestrogen + Progestin in Healthy PM Women, Principal Results, 2002 Results
Trial stopped early Increased CHD VTE risk doubled Increased invasive breast Ca Decrease in colorectal cancer and hip fractures
43
Limitations of WHI RCT?
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
PLCO Study - Full name
Effect of Screening on Ovarian Cancer Mortality - The Prostate, Lung, Colorectal and Ovarian (PLCO) Screening RCT
45
PLCO Study - When was it published?
2011
46
PLCO Study - type of study
Large multicentre RCT 34000 in each arm
47
PLCO Study Inclusion criteria
55-74 years old, no previous dx of lung, colorectal or ovarian cancer
48
PLCO Study - Intervention
Annual Ca125 + TV Pelvic USS
49
PLCO - Primary Outcome
Ovarian cancer specific mortalitySP
50
SPIN Study - Primary outcome
Loss of index pregnancy
51
Results of SPIN Study
No difference in primary outcome No complications of treatment
52
LACE Trial - Full name of trial
Effect of TAH vs TLH on Disease Free Survival Among Women with Stage 1 Endometrial Cancer
53
LACE Trial - Type of trial
International, multicentre RCT
54
What was the primary outcome of the LACE Trial?
Disease free survival Secondary outcomes: Recurrent endometrial cancer and overall survival
55
LACE Trial Results?
No difference in primary outcome No difference in overall survival, surgical risks or QoL
56
Limitations of the LACE Trial
11% lost to follow up, skill of surgeons
57
PLCO Study - Secondary outcomes
Ovarian cancer incidence, cancer stage, survival, all cause mortality, harms of screening
58
Results of PLCO Study
No difference in primary outcomes No difference in all cause mortality Increased rates of oophorectomy in screened group - high number of false positives
59
Strengths and Limitations of the PLCO Study
Strengths: Multicentre, randomised Limitations: 13% non-compliant with screening, some in control group received screening outside of trial
60
Conclusion of PLCO Study
Screening intervention not effective at reducing cause specific mortality Screening increased invasive procedures and associated harms
61
Million Women Study - What is the full name of the study?
Breast cancer and HRT in the Million WOmen Study
62
Million women study - type of trial
Cohort study - age 50-64 years
63
Million women study - inclusion criteria
Age 50-64 Recruited at time of triennial breast screening
64
Million women study - primary outcome
First diagnosis of invasive breast cancer and attributable deaths
65
Million women study - results
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
Strengths and Limitations of the Million Women Trial
Strengths = Large Limitations = Poor selection as recruited at screening (likely higher health literacy, SES etc), assumptions made about menopausal status
67
When was the MAGPIE Trial published?
2002
68
What is the full name of the MAGPIE trial?
Do women with pre-eclampsia, and their babies, benefit from MgSO4?
69
MAGPIE - Type of trial
International multicentre, placebo controlled, double blinded RCT Included over 10,000 women
70
What was the conclusion of the TRUFFLE Trial?
Timing of delivery based on late DV changes (absent a-wave) MAY improve neurodevelopment at 2 years
71
Strengths and limitations of the TRUFFLE Trial?
Strengths: Randomised, multicentre Limitations: Unblinded Delivery sometimes required for maternal reasons or based on obvious CTG changes (not STV)Pr
72
Progesterone and the risk of preterm birth among women with a short cervix, 2007 Type of study?
Multicentre, double blinded, placebo controlled RCT 250 patients in study (but over 24000 screened)
73
Progesterone and the risk of preterm birth among women with a short cervix, 2007 Inclusion criteria
Cervix =/< 15mm on mid-trimester USS 20-25/40, irrespective of previous history
74
Primary outcome for Fonseca et al study published in 2007
Preterm birth <34/40 (progesterone and the risk of pre-term birth among women with a short cervix)
75
Progesterone and the risk of preterm birth among women with a short cervix, 2007 Results
Reduction in PTB <34/40 19% vs 34% (RR 0.56)
76
Strengths and limitations of Progesterone for Short cervix trial in 2007?
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
When was the TERM PROM trial published?
1996
78
TERM PROM, 1996 Full name
Induction of labour compared with expectant management for prelabour rupture of membranes at term
79
TERM PROM - interventions
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
TERM PROM - inclusion criteria
PROM >37 weeks with cephalic singletone - excluded if in active labour, or contraindication to any treatment (e.g chorio or meconium liquor)
81
ACHOIS Trial - Primary outcome
Infants: Death, shoulder dystocia, fracture, nerve palsy, NICU admission and jaundice Mothers: IOL, C/S, psych outcomes and QoL
82
ACHOIS Trial - Results
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
Limitations of ACHOIS trial
Not blinded Possible bias due to increased clinician awareness Groups not homogenous
84
What was the aim of the ARRIVE trial
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
ARRIVE Trial - type of study
Multicentred, parallel group, unmasked RCT 6106 women
86
ARRIVE trial - inclusion criteria
Low risk nulliparous women 34-38+6 at time of enrollment Singleton, cephalic, with no contraindication to NVD
87
Oracle 1 Trial - Full name of study
Broad spectrum antibiotics for preterm pre-labour rupture of membranes
88
Oracle 1 Trial - intervention
Erythromycin Augmentin Both Neither For 10 days
89
What were the primary and secondary outcomes of the ARRIVE Trial?
Primary outcome: Composite of perinatal death or severe neonatal complications Secondary outcome = C/S rate
90
ARRIVE Trial - Results
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
Strengths and limitations of the ARRIVE trial
Strengths - study design, large size Limitations: Doesn't reflect how we practice in NZ (LMC vs obs lead) Different IOL methods Not blinded
92
WOMAN Trial, 2017 - Name of study
Effect of early TXA administration on mortality, hysterectomy and other morbidities in women with PPH
93
WOMEN Trial - type of study
International double blinded, placebo controlled RCT 20,000 participants
94
WOMAN trial - inclusion criteria
PPH 500ml after VB, or 1000ml after C/S, or EBL enough to cause haemodynamic instability
95
What was the primary outcome in the ORACLE 1 trial
Composite of neonatal death, chronic lung disease, and major cerebral abnormality
96
Results of ORACLE I Trial?
Erythromycin decreased primary outcome but not statistically significant Significant prolongation of pregnancy and decreased surfactant and O2 use Increased NEC with Augmentin
97
HYPITAT Trial, 2009 - Name of study
Induction vs Expectant management for gestation HTN or mild PET after 36 weeks
98
HYPITAT Trial, 2009 - Inclusion criteria
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
HYPITAT Trial, 2009, - Intervention
IOL within 24hrs vs Expectant mgt with monitoring, if no severe HTN - IOL >41/40
100
ACHOIS Trial, 2005 - Name of trial
Effect of treatment of GDM on pregnancy outcomes
101
ACHOIS Trial, 2005 - Intervention
Routine ANC vs GDM care with education, dietary advice, BSL monitoring and targets, plus insulin as needed
102
HYPITAT Trial - Primary outcome
Composite measure of poor maternal outcome (death, morbidity, progression to severe disease)
103
HYPITAT Trial - Results
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
Planned C/S or VB for Twins 2013 - Primary outcomes
Composite fetal / neonatal morbidity and mortality Composite maternal morbidity and mortality
105
HAPO Study - Primary outcomes
Birth weight >90th% C/S Neonatal hypoglycaemia Cord c-peptide levels
106
HAPO Study - Results
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

RANZCOG exam prep (6 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2025 Bold Learning Solutions. Terms and Conditions