Ingrid Wikström

Self-sampling of the vaginal fluid at home combined with high-risk HPV testing.

Background:Around 65% of women with cervical carcinoma in Sweden have not attended an organised screening. We therefore investigated the value of using self-sampling at home in combination with a test for high-risk human papilloma virus (HPV) to increase participation.Methods:A total of 2829 women 30–58 years old, who had not attended the organised screening for ⩾6 years, were recruited. They were offered self-sampling at home (Qvintip) and recommended to send the collected vaginal fluid to a laboratory for analysis of the presence of high-risk HPV (Hybrid Capture 2 method).Results:A total of 39.1% of the women accepted home sampling. These women disclosed a relatively high prevalence of high-risk HPV, which decreased with age, from 11.1% in women 30–39 years old to 2.9% in women ⩾50 years . Follow-up disclosed histological cervical intraepithelial neoplasm (CIN) 2–3 lesions in 43.2% of the women with a persistent HPV infection, corresponding to 2.0% of the total number of participating women. The sensitivity of a single smear to detect the histological CIN 2–3 lesions were only 52.6%, even if all abnormal smears (atypical squamous cells of unknown significance (ASCUS)–CIN 3)) were included.Conclusion:The use of self-sampling at home in combination with testing for high-risk HPV increases the participation rate of the organised screening and detects almost twice as many women with pre-malignant cell alterations (CIN 2–3) in comparison those with a single cytological smear.

Self-sampling and HPV testing or ordinary Pap-smear in women not regularly attending screening: a randomised study

Background:Most women with cervical cancer have not participated in Pap-smear screening. Self-sampling of vaginal fluid in combination with high-risk HPV testing may be a method to increase the attendance rate.Methods:A total of 4060 women, 39–60 years old, who had not attended the organised Pap-smear screening for 6 years or more were randomised into two equal groups. A study group was offered to self-sample vaginal fluid (Qvintip) at home and/or recommended to attend the Pap-smear screening. The collected fluid after self-sampling was examined for the presence of high-risk HPV (Hybrid Capture 2 method). Controls were only recommended to attend the Pap-smear screening. The end point was a histological identification of CIN2–3.Results:The participation rate was 39% (771 out of 2000) in the self-sampling group and 9% (188 out of 2060) in the conventional cytology (P<0.001). The number of histological CIN2–3 alterations detected was 0.4% (8 out of 2000) among women offered self-sampling of vaginal fluid and 0.07% (3 out of 4060) in women offered Pap-smears. The odds ratio (OR) for offering self-sampling and HPV testing instead of Pap-smear screening for detection of CIN2–3 was OR=5.42 (95% CI: 1.30–31.8).Conclusion:Offering self-sampling of vaginal fluid followed by a high-risk HPV test was considerably more effective for detection of histological CIN2–3 lesions in comparison with offering Pap-test in a midwife reception in women not regularly attending organised screening.

Attitudes to self-sampling of vaginal smear for human papilloma virus analysis among women not attending organized cytological screening

Background. The major problem with the cytological screening is the non‐optimal participation rate among women invited for cervical smear collection. The aim of the present investigation was to examine the attitudes of the non‐responding women to perform self‐sampling of vaginal smear at home as a method to increase the coverage of the screening and to examine the prevalence of high‐risk human papilloma virus (HPV) among the responding women. Methods. From the database of the Department of Cytology, University Hospital of Uppsala 198 women, aged 35‐55 years, who had not attended the organized gynaecological screening for over 6 years were identified. They were sent a letter of information about the study and one week later a self‐sampling device aimed to collect vaginal smear. The vaginal smear of the women responding to the offer of self‐sampling was analysed for high‐risk HPV using Hybrid Capture 2 method or polymerase chain reaction amplification of HPV DNA. All women in the study also received a questionnaire in order to investigate their attitudes towards self‐sampling as an alternative in the organized screening. Results. Of the 198 women 15 women had to be excluded. Fifty‐eight per cent of the women responded and collected vaginal smear at home and among them 7% were positive for high‐risk HPV. The questionnaire revealed no significant difference of age, country of birth and occupation or marital status, on using self‐sampling of vaginal smear at home. The attitudes among responding and non‐responding women differed. The responding women who contributed by sampling vaginal smear were more positive to self‐sampling of vaginal smear (p<0.01). Conclusions. Offering self‐sampling of vaginal smear in women not attending the organized cytological screening increases the coverage and identifies an additional group of women with an increased risk to develop cervical cancer. The attitude towards self‐sampling was mainly positive.

TRAUMATIC INJURY IN LARGE-FOR-DATE INFANTS

Abstract. The risk of traumatic injury and low Apgar score was studied in 473 infants with a birth weight of 4500 g or more at term (LFD) and 473 infants with normal weight (NFD, birth weight ± 1 SD of mean for the respective gestational age). The LFD group comprised 3.2% of all infants delivered during a 5‐year period. Traumatic injuries were observed in 8.0% of the LFD versus 0.6% of the N FD group. The injuries in the LFD group were 28 fractured clavicles, four fractured humerus and 12 brachial plexus injuries. Six of the LFD infants had multiple injuries. The injuries in the NFD group were three fractured clavicles. All infants with traumatic injuries were delivered vaginally. Contributory obstetrical factors for traumatic injury were forceps, post‐term pregnancy and vacuum extraction. High birth weight was correlated to a low Apgar score at one minute, as also was post‐term pregnancy.

High prevalence of oncogenic human papilloma virus in women not attending organized cytological screening.

Since the introduction of organized cytological screening in Sweden, most women currently presenting with cervical cancer are those who have not attended the programme and who have no cytological screening history. The aims of this study were: (i) to measure the response rate among women not attending organized cytological screening who were offered a device for self-sampling a vaginal smear at home; (ii) to examine the prevalence of high-risk human papilloma virus (HPV) among women performing self-sampling. Women aged 35-50 years, who had not participated in organized cytological screening for more than 6 years, were offered the opportunity to collect vaginal samples at home using a self-sampling device (Qvintip). The material collected was analysed for high-risk HPV using the Hybrid Capture 2 method. Of 369 women included in the study, 179 (49%) ordered the self-sampling device and 117 (32%) performed self-sampling at home and sent the sample to our laboratory for analysis. The mean prevalence of high-risk HPV was 26% (30/117), 31% (25/80) in women aged 35-42 years and 14% (5/37) in women aged 43-50 years. There was no significant difference in the participation rate with regard to age. The prevalence of high-risk HPV in women not covered by organized screening was considerably higher than in the general population; therefore they may represent a category at high risk of cervical cancer. The study shows that the use of a disposable self-sampling device for HPV testing is a relevant method to increase the participation rate in countries with organized cytological screening.

Prediction of High Birthweight from Maternal Characteristics, Symphysis Fundal Height and Ultrasound Biometry

The possibility to predict a large infant during pregnancy was assessed using data from a prospective cohort study of 537 singleton pregnancies with term deliveries. Maternal characteristics, symphysis fundal height and ultrasound measurements were used in multivariate analyses for the prediction of an infant with a birthweight of > or = 4,500 or > or = 4,000 g. The positive predictive value was 55% for a birthweight > or = 4,000 g when only maternal characteristics were used, and increased slightly when symphysis fundal height was added. The corresponding value for a single ultrasound measurement at 37 gestational weeks was 52%. Using all available clinical data, positive predictive values of 45 and 80% could be achieved for birthweights of > or = 4,500 and > or = 4,000 g, respectively.

Accuracy of HPV testing of vaginal smear obtained with a novel self-sampling device.

Background. Most of women diagnosed as having cervical cancer have not participated in organized cytological screening. Aim. A study was conducted to evaluate the accuracy of human papilloma virus testing by self‐collected vaginal samples in comparison to regular cytological screening. The agreement of hybrid capture 2 assay and polymerase chain reaction assay for detection of human papilloma virus DNA in self‐collected vaginal samples and clinician‐obtained cervical smears was investigated. Method. Forty‐three women aged 23–58 years admitted for further examination due to previous positive cytology in the organized screening participated in self‐collecting of vaginal samples with a novel self‐sampling device. During the visit a clinician also collected a cervical smear using a cytobrush. The vaginal samples collected with the self‐sampling device were analyzed for high‐risk human papilloma virus with the hybrid capture 2 assay technique and the cervical smears were Pap‐stained, examined cytologically and after that reanalyzed for human papilloma virus DNA using a polymerase chain reaction assay. Result. The vaginal samples were positive for high‐risk human papilloma virus in 37% of the cases using hybrid capture 2 assay. Twelve of the 43 Pap smears showed positive cytology (ASCUS‐CIN 3), of which 4 showed CIN 2–3. When polymerase chain reaction assay was performed, human papilloma virus DNA was detected in 40% of the glass slides. The agreement between cytology and the two human papilloma virus testing techniques was 67–74% (kappa 0.27–0.45) and the agreement between the two human papilloma virus tests was 70% (kappa 0.36). Conclusion. Testing for high‐risk human papilloma virus can identify more women at risk of developing cervical cancer than cytology irrespective of the sampling method. Furthermore, offering a self‐sampling device for collection of vaginal smear seems to be a useful screening tool for cervical cancer among women not responding to an invitation for smear sampling.

Maternal factors associated with high birth weight

Maternal characteristics associated with high birth weight were studied in 473 mothers delivered of singleton infants at term with a birth weight of 4500 g or more. The controls were mothers who gave birth to singleton infants at term, with a normal birth weight ± 1 SD for Swedish newborns. In the multivariate analysis the maximum symphysis‐fundus height measurement and gestational duration were strongly significant (p < 0.001), after correction for other variables, for the probability of being delivered of an infant of high birth weight. Maternal height, weight at beginning of pregnancy, total gestational weight increase and previous live birth of an infant weighing ≥ 4500 g were also important (p < 0.05) for high birth weight. The maternal characteristics included were evaluated in a prognostic model. With symphysis‐fundus height measurement included, the sensitivity increased from 80.3 to 83.3% and specificity from 78.8 to 85.6%, compared with a model where symphysis‐fundus measurement was not available.

Short-time repeat high-risk HPV testing by self-sampling for screening of cervical cancer

Background:Testing for high-risk human papillomavirus (HPV) in primary screening for cervical cancer is considered more sensitive, but less specific, in comparison with Pap-smear cytology. Women with persistent HPV infections have a higher risk of developing cervical intraepithelial neoplasia 2+ (CIN2+) lesions. This study was performed to evaluate the gain in specificity for detection of histologically confirmed CIN2+ lesions achieved by short-time repeat testing for high-risk HPV in women aged 30–65 years, with the primary sample for HPV analysis taken by self-sampling.Methods:A total of 8000 women in Uppsala County, aged 30–65 years, who had not attended organised screening for 6 years or longer, were offered self-sampling of vaginal fluid at home and the samples sent for HPV typing. Of these, 8% (669) were not possible to contact or had performed hysterectomy. Women positive for high-risk HPV in the self-sampling test were invited for a follow-up HPV test and a cervical biopsy on average 3 months after the initial HPV test.Results:In all, 39% (2850/7331) of invited women chose to perform self-sampling of vaginal fluid at home. High-risk HPV infection was found in 6.6% (188) of the women. In all, 89% of the women testing HPV positive performed a follow-up examination, on average 2.7 months, after the first test and 59% of these women were HPV positive in the follow-up test. The prevalence of CIN2+ lesions in women with an initial HPV-positive test was 23% (95% CI 18–30%) and in women with two consecutive HPV-positive tests was 41% (95% CI 31–51%). In women with two positive HPV tests, the prevalence of CIN2+ lesions varied from 49% in women at age 30–39 years to 24% in women at age 50–65 years. Short-time repeat HPV testing increased the specificity for detection of CIN2+ lesions from about 94.2% to 97.8%. The most prevalent HPV types were HPV16 (32%), followed by HPV18/45 (19%) and HPV 33/52/58 (19%).Conclusion:The short-time persistence of high-risk HPV infection in this age group was about 60%. Repeat testing for high-risk HPV using self-sampling of vaginal fluid can be used to increase the specificity in the screening for cervical cancer in women aged 30–65 years.

Low Prevalence of High-risk HPV in Older Women Not Attending Organized Cytological Screening: A Pilot Study

Low prevalence of hight-risk HPV in older women not attending organized cytological screening: A pilot study