Richtlijn Sterilisatie van de vrouw - NVOG

ReferentieType studieKenmerken(studie/patiënten)Interventie (I)Uitkomstmaten enfollow-up duurResultatenBeoordelingkwaliteit studiewere not, inthe investigator’s opinion, suitable candidatesfor the EssureTMd evice placementprocedure due to inability to comply with theprotocol requirements: (iii) had knownanatomic abnormalities possibly preventingtubal cannulation; (iv) had cervical or uterineneoplasiaor its precursors; (v) had untreated acutecervicitisor a history of acute pelvic inflammatorydisease: (vi) had unexplained abnormaluterine bleeding: (vii) had a history of chronicpelvic pain, severe dysmenorrhoea or severedyspareunia; (viii) had previously undergoneFallopian tube surgery; (ix) had anyunresolved tubal, ovarian or endometrialpathology; and (x) were allergic to contrastmedia.Average age: 35 yHSG (N = 114)Two perforationsUnacceptable position: N = 4 (3.6%).From women with bilateral placement, 2 had small leakage, HSG at 6moths revealed complete occlusion.Of the 130 women undergoing a placement attempt, nine (7%)experienced an adverse event in the study; six (4.6%) were ultimatelyunable to rely on the devices.follow-up*: ? not reportedIdentification ofconfounders andcorrection in analysis: -Financial support:Author is Clinical Professor andPrincipalInvestigator (Australia) EssureTYpbcDiaries:3 mnths (N = 111), 81 maintained a diary for up to six months. 102(89%) reported no pain or unusual symptoms. Small numbersexperienced dysmenorrhoea, spotting etc.Kerin 2003Prospectivecohort studyN=enrolled:269, deviceplacementwasattempted in227NoncomparativeInclusion criteria:Age 23 - 45 yearsRegular mensesDemonstrated prior fertility (> one live birth)Able and willing to use alternativecontraceptive method (barrier or oral)for first 3 months following device placementWilling to keep coital and menstrual log for 6months following device placementAvailable for all study follow-up visitsComprehension of study participation risksand benefitsExclusion criteria:Uncertainty as to desire for permanent birthcontrolThe hysteroscopic sterilizationprocedure was performed inboth thefollicular and luteal phase of themenstrual cycle. Pre-operativeanalgesia, if given, consisted of anon-steroidal anti-in¯ammatorydrug given 30±60 min prior tothe procedure. Women receiveda paracervical block only, or insome cases, withintravenous sedation. Generalanaesthesia was rarely used.(i) the safety of the micro-insertplacement; (ii) tolerance of andrecovery from the placementprocedure; (iii) patient experienceduring the 3 years after placement; (iv)evaluation of tubal occlusion; and (v)effectiveness at preventing pregnancy.Outcome data were measured asdescribed in Kerin 2000. Extrareported outcome = dyspareuniaAs well follow ups at 6 months, 12 and 18 months are described, withsevere loss to follow up.These women have accumulated 1894 womenmonths of effectiveness(time relying on the device forcontraception). As of 30 June 2001 there have been no pregnanciesreported in the study. This represents aneffectiveness rate of 99.4% (95% CI 97.7% to 100%).Successful bilateral placement:88% (CI 83±92%) of women (n = 200)Correct device placement was confirmed in 97% of cases at 3 months.Of the 200 women with initial bilateral placement, 198 hadPatient satisfaction:The majority reported that intraprocedural pain was less than or equalto that expected, and 96% rated tolerance of the deviceplacement procedure as good to excellent.Pain: Women with bilateral and unilateral placement (n = 206): 153(76%) reported pain following the procedure. Pain resolved within 1 dayin 59% of thesen within 3 days in 88% and within 1 week in 99%.Post procedure bleeding in 171/206 women (83%). Resolved within 21day in 27%, 3 days in 64% and 1 weel in 96%.Over 24 months follow-up, 98% of study participants rated theirtolerance of the micro-insert as very good to excellent.Study groups clearly defined: +Selectionbias*: not applicabeAdequate assesment of exposure *:+Adequate assesment of outcomes*:+Assesor of the effect adequatelyblinded*: -Sufficient length of follow-up*: +Selective loss to83