Gynae Flashcards
WHI: HRT vs Placebo
Large prospective RCT 2002
16000 women 50-79
Two arms: oestrogen + progestin; or placebo
Primary outcome: CHD and invasive breast cancer
Secondary outcome: stroke, PE, DVT, endometrial ca, colorectal ca, hip and vertebral #, and death from other causes
Stopped at 5.2 years —>increased risk breast ca, stroke, chd, and VTE
Decreased risk f colon can, hip and vertebral #
No change in endometrial and lung cancer
WHI: estrogen only vs placebo
2004, 10000 women, hysterectomy
Two arms:
Estrogen
Placebo
Primary outcome: CHD and invasive breast cancer
Secondary: stroke, PE, DVT, colorectal cancer, hip/vertebral # and death from other causes
Followed up for 6.8 yrs on ave No increased risk breast ca or chd Increase risk of VTE and stroke No difference for colon ca Reduced hip and vertebral #
PLCO screening trial
Prospective RCT 1992-2001
78, 232 women age 55-74
Randomized to annual TVUS/Ca125 vs routine care
Median f/u 12.4 years
Results: No difference in mortality among groups
50% risk of surgical complications
UKCTOCS trial of ovarian cancer screening
202,638, 2009
Randomized
Control vs annual TVS
ROCA: normal/intermediate/elevated
7 year follow up
Normal ROCA - annual ca125
Intermediate- ca125 3 month
Elevated - ca125 & TVS
Decreased mortality only if omitted primary peritoneal cancer
Otherwise no stat benefit
Ant repair vs TV mesh for POP
Multicentre, parallel group, RCT
Primary outcome: stage 0-1 POP-Q and abscence of symptoms 12 months post op
389 women Primary outcome better 2x in mesh group Higher rates of complication Higher rates of SUI in mesh group Mesh exposure in 3.2%
Risk of recurrence with anterior prolapse repair
40%
POPPY trial
multicentre, RCT
PFMT vs lifestyle advice
Stages 1-3
Primary outcome:pt reported symptoms at 12 months
447 women
Fewer symptoms in those with PFMT
TVT for SUI
Multicentre, RCT
TVT vs colposuspension
344 with urodynamic SUI
Assessment before ant at 6 months with SF-36 and EQ-5D, one week urinatey diary
No sig diff in cure rates
Bladder injury more common with TVT
Colposuspension more post op complications and longer recovery time
Evaluate study
To compare effects of TLH and TAH and. LVH and VH
Two parallel,, multicentre, randomized trials
1380 women
primary outcome: Rate of major complications
Results:
Laparoscopy:: Higher rate major complications; NNT. To harm 20; more op. Time, less painful, shorter stay in hospital
No difference with VH; NNT. To harm. 333
LACE trial - Effect of TLH vs TAH on disease-free survival among women with Stage I Endometrial cancer; 2017
Objective: ?TLH non-inferior
Multicentre, randomized equivalence trial, 2005-2010
760 women
Primary outcome: disease-free survival (interval between surgery and date of first recurrence, including progression or new primary or death at 4.5yrs after randomization)
Results: equivalent survival rates
NEJM effectiveness of LARC
2012
Prospective cohort study
7486 participants
Aim: reduce unintended pregnancies
Participants had reversible contraception of their choice
Cohorts <21yo or >21
Failure rate OCP, patch and ring 4.55:100; LARC 0.27 (20x higher failure rate)
<21 yo risk of unintended pregnancy twice as high
Limitations: DMPA failure rate probably higher as in study was recorded with perfect use which 40% of women will discontinue in the first year
Non-randomized design
Generalizability -participants high risk for unintended pregnancy so may not reflect whole population
MIST trial 2006
RCT
Identify if difference in infection rate between medical and expectant management with surgical management of first trimester miscarriage
7 units in UK, 1200 women
<13 weeks with early fetal disease or incomplete miscarriage
OUtcome: infection at 14 days and 8 weeks or need for admission or surgical intervention
Higher number of hospital admissions and surgical curettage in medical and expectant groups
No evidence of difference in infection rates by method of management
SPIN study (Scottish pregnancy intervention study) LMWH and aspirin for women with recurrent miscarriage
2010 multicentre RCT
294 women randomized to either LMWH and aspirin or no treatment for women with unexplained recurrent miscarriage
No benefit compared to fetal surveillance
Limitation: included those with 2 miscarriages; ?group with 3 or more may find a benefit
ALIFE trial (aspirin plus heparin or aspirin alone in women with recurrent miscarriage)
NEJM 2010
RT 364 women <6/40, given either aspirin plus heparin, or aspirin, or placebo once viable pregnancy demonstrated
No improvement in live birth rate compared to placebo among women with unexplained recurrent miscarriage
Limitation: included women either attempting conception or pregnant <6/40 - not powered enough to do subgroup analysis
Breast cancer and HRT in the Million women study (2003)
Women age 50-64, cohort study
Provided info about use of HRT, personal details and followed up for cancer incidence
Current users HRT more like to get BCA and die from it
Past users of HRT were not at increased risk of fatal disease
All HRT increased risk including tibolone, but highest increase with combined HRT
RR varied by oestrogen preparation
Oestrogen only: 5 additional breast cancer per 1000
Combined: 19 additional breast cancers per 1000
