Richtlijn Sterilisatie van de vrouw - NVOG

ReferenceType studyCharacteristicsIntervention (I)Outcomemeasured andfollow upResultsQualityassessmentKerin 2001ProspectivecohortstudyN= 167,130underwentplacementatemptsInclusion criteria: (i)sought permanent birth control; (ii) werebetween the ages of 21 and 43; (iii) haddemonstrated prior fertility (at least onechild); (iv) were able and willing to use abarrier or oral method of contraception forthe first three months followingEssureTMde vice placement; (v) werewilling to keep a coital and menstrual logfor six months following device placement;(vi) had regular menses, (vii) were availablefor all follow-up study visits; and (viii)could understand the risks and benefits ofstudy participation.Exclusion criteria: (i) were unsureabout their desire to end their fertility; (ii)were not, inthe investigator’s opinion, suitablecandidates for the EssureTMd eviceplacement procedure due to inability tocomply with the protocol requirements:(iii) had known anatomic abnormalitiespossibly preventing tubal cannulation; (iv)had cervical or uterine neoplasiaor its precursors; (v) had untreated acutecervicitisor a history of acute pelvic inflammatorydisease: (vi) had unexplained abnormaluterine bleeding: (vii) had a history ofchronic pelvic pain, severe dysmenorrhoeaor severe dyspareunia; (viii) had previouslyundergone Fallopian tube surgery; (ix) hadany unresolved tubal, ovarian orendometrial pathology; and (x) wereallergic to contrast media.Average age: 35 yEssureTMpbc microinsertswereinserted intothe proximalportion ofthe Fallopiantubes underhysteroscopicvisualisationwithintravenoussedation orparacervicalblock.one weekafter device placement(questionnaire):Occurrencebleeding, discomfortor other symptomsexperienced followingthe procedure andperceptions of theplacement procedure.(daily diaries for sixmonths):untoward symptomsHSG three monthsafter placement:positioning andretention (stable?) andextend of fallopiantube occlusionHSG (N = 114)Unacceptable position: N = 4 (3.6%).From women with bilateral placement, 2 had small leakage, HSG at 6 mothsrevealed complete occlusion.Of the 130 women undergoing a placement attempt, nine (7%) experienced anadverse event in the study; six (4.6%) were ultimately unable to rely on thedevices.Diaries:3 mnths (N = 111), 81 maintained a diary for up to six months. 102 (89%)reported no pain or unusual symptoms. Small numbers experienceddysmenorrhoea, spotting etc.As well follow ups at 6 months, 12 and 18 months are described, with severeloss to follow up.These women have accumulated 1894 womenmonths of effectiveness (timerelying on the device forcontraception). As of 30 June 2001 there have been no pregnancies reported inthe study. This represents aneffectiveness rate of 99.4% (95% CI 97.7% to 100%).NB NON-COMPRATIVEStudy groups clearly defined: +Selectionbias*: nvtAdequate assesment of exposure *: +Adequate assesment of outcomes*: +Assesor of the effect adequately blinded*: -Sufficient length of follow-up*: +Selective loss tofollow-up*: ? not reportedIdentification ofconfounders andcorrection in analysis: -Financial support:Author is Clinical Professor and PrincipalInvestigator (Australia) EssureTY pbc106