Three-year observational study of immediate post-abortion insertion versus menstrual insertion of etonogestrel contraceptive implant

Objective This study aimed to estimate the difference in vaginal bleeding pattern, discontinuation rate, and satisfaction between immediate after abortion and menstrual insertions of etonogestrel contraceptive implants. Study design Between May 2013 and November 2015, 66 women were recruited in the abortion group who selected etonogestrel implants as their contraceptive immediately after induced abortion. 84 women who underwent the placement of the etonogestrel implant during their menstrual period were enrolled as the menstrual group. The two groups participated in 3-year follow-up outpatient visits at 1, 6, 12, 24, and 36 months after implantation. The vaginal bleeding pattern, discontinuation rate, satisfaction rate were recorded and compared. Results No woman had pregnancy over the study period of 3 years. The incidence of amenorrhea/infrequent bleeding did not differ between the two groups after 12, 24, and 36 months of implantation (53.0% vs. 58.4%, 47.8% vs. 51.6%, and 48.6% vs. 55.6%, respectively). In the abortion group, the incidences of frequent/prolonged bleeding were 15.1%, 32.6%, and 27.0% after 12, 24, and 36 months of implantation, respectively, while the other group showed 27.3%, 25.8%, and 20.4%, respectively. After 12 and 24 months, the continuation use rates were 69.7% and 56.1% in the abortion group and 73.8% and 64.2% in the menstrual group. The 12-month satisfaction rate between abortion group and menstrual group was 69.6% versus 72.6%. Statistical analyses show that there was no difference in vaginal bleeding pattern, discontinuation rate or satisfaction between the two groups. Conclusions Immediately post-abortion may be also a favorable time to undergo etonogestrel implantation.

Pharmacokinetics of Factor VIII Level in Patients Hemophilia A in Relation to Clinical and Radiological Outcomes

Background The benefit of pharmacokinetics (PK) -guided dosing is that both prophylactic and “on demand” dosing will be based on actual FVIII trough and peak levels instead of current FVIII estimates based on body weight and in-vivo recovery based dosing. Knowledge will increase with regards the relationship between FVIII level and bleeding in individual patients. The dose and frequency of factor VIII for patients on prophylaxis should only be reduced if clinically justified and impact should be monitored with regard to bleeding events, bleeding pattern and joint status. Objective To assess the trough and peak level of factor VIII in patients with hemophilia A on low dose prophylaxis and its impact on the clinical and radiological joint status. Patients and Methods A cross sectional study was performed in Ain-Shams University, Pediatrics Hospital, Hemophilia Clinic. It included 25 children and adolescents with hemophilia A on prophylactic factor VIII during the period from September 2018 to August 2019. Factor VIII used was recombinant 3rd generation with a dose of 45 IU/Kg/week rounded to the nearest 500IU. Trough level of factor VIII was done before prophylactic dose and peak level was done one hour postinfusion through chromogenic assay using STAGO-Immuno-Def VIII reagent. Clinical joint score and Functional Independence Score of Hemophilia (FISH) were done. Radiological joint scores were done using conventional x-ray, ultrasound and MRI. Cut-off level of trough levels was studied at 1% and 1%-5% of factor VIII. Results Patients were classified into 3 groups,4 patients (21.1%) had trough level <1%, 13 patients (68.4%) had trough level between 1%-5%, 2 patients (10.5%) had trough level > 5%. No significant difference between trough level of factor VIII and clinical joint scores and FISH scores of patients. Median score of the worst joint of patients with trough level >5% was 5 in comparison to 8 and 7 in patients with trough level 1%-5% and <1% respectively. Mean FISH of patients with trough level >5% was 9.50 ± 2.12 in comparison to 12.92 ± 5.41 and 11.00 ± 3.56 for patients with troughs 1%-5% and <1% that was respectively. Comparison between groups with different trough level of factor VIII according to X-ray scores of patients showed no significant difference Conclusion Low trough levels alone did not warrant intensification of the prophylaxis regimen; rather, the dose and dosing frequency should be adjusted based on individual’s bleeding pattern and many other factors as shown in our study the insignificant relation between trough levels of factor VIII and clinical and radiological outcomes.. More frequent factor VIII monitoring and incorporation into population based PK are warranted.

The diagnostic value of squirting rectal bleeding: The first description of such bleeding pattern

Background and objective: Rectal bleeding is a common symptom that has many patterns, but none of them are accurately diagnostic. One newly noticed pattern can be diagnostic, namely, the squirting pattern, for which this study was conducted. Methods: The study was conducted between Jan 2013 and Jun 2018, including 132 patients who presented with a squirting pattern of rectal bleeding, which is thought to be due to hemorrhoids. All these patients underwent clinical evaluation and anoscopy, and the majority (n=94) underwent colonoscopy. Results: At the time of clinical examination, 23 patients showed actively bleeding hemorrhoids. Fifteen patients were not convinced to undergo colonoscopy. The rest (n=94) who had no visible active bleeding at the time of examination underwent a colonoscopy to exclude other possible rectal or colonic pathology. All the 94 colonoscopies were negative for other bleeding sources. Two patients showed single benign non bleeding polyps, which were excised and biopsied. Conclusion: This study highlights a pattern of rectal bleeding that is not described before and proved it is a reliable diagnostic pattern for hemorrhoids. It also showed that colonoscopy is not needed in patients below 40 years complaining of squirting rectal bleeding unless indicated for some other reason. This decision is to be made very carefully. Keywords: Squirting rectal bleeding; Hemorrhoids; Colonoscopy.

Digital Medical Device Companion (MyIUS) for New Users of Intrauterine Systems: App Development Study

Background Women choosing a levonorgestrel-releasing intrauterine system may experience changes in their menstrual bleeding pattern during the first months following placement. Objective Although health care professionals (HCPs) can provide counseling, no method of providing individualized information on the expected bleeding pattern or continued support is currently available for women experiencing postplacement bleeding changes. We aim to develop a mobile phone–based medical app (MyIUS) to meet this need and provide a digital companion to women after the placement of the intrauterine system. Methods The MyIUS app is classified as a medical device and uses an artificial intelligence–based bleeding pattern prediction algorithm to estimate a woman’s future bleeding pattern in terms of intensity and regularity. We developed the app with the help of a multidisciplinary team by using a robust and high-quality design process in the context of a constantly evolving regulatory landscape. The development framework consisted of a phased approach including ideation, feasibility and concept finalization, product development, and product deployment or localization stages. Results The MyIUS app was considered useful by HCPs and easy to use by women who were consulted during the development process. Following the launch of the sustainable app in selected pilot countries, performance metrics will be gathered to facilitate further technical and feature updates and enhancements. A real-world performance study will also be conducted to allow us to upgrade the app in accordance with the new European Commission Medical Device legislation and to validate the bleeding pattern prediction algorithm in a real-world setting. Conclusions By providing a meaningful estimation of bleeding patterns and allowing an individualized approach to counseling and discussions about contraceptive method choice, the MyIUS app offers a useful tool that may benefit both women and HCPs. Further work is needed to validate the performance of the prediction algorithm and MyIUS app in a real-world setting.

Early Removal of the Etonogestrel Contraceptive Implant and Associated Factors Among Users at the Urban Family Planning Clinic in Siriraj Hospital, Bangkok, Thailand

Objective: To study the rate and reasons for the early removal of etonogestrel contraceptive implants and associated factors at the family planning clinic in Siriraj Hospital. Materials and Methods: This retrospective cohort study was conducted between May 2015 and December 2019 and contained 1,030 women who received the etonogestrel contraceptive implant. The medical records of demographic characteristics and clinical factors i.e., implant insertion date, implant removal date, reason for implant removal, contraceptive use before implant insertion and after implant removal, documented bleeding pattern and acceptability, were identified. Results: The mean age of participants was 28.6 ± 6.9 years. About 21% of women (218/1030) prematurely discontinued their etonogestrel implant. A desire to become pregnant was the most common reason for early removal of the etonogestrel implant (32%). Meanwhile, the most common side-effect contributing to early removal was unscheduled bleeding. The associated variables of early etonogestrel implant removal were low BMI (p-value = 0.021) and unacceptability of bleeding pattern at one year (p-value < 0.001) and two years (p-value < 0.001) after insertion. Conclusion: Early etonogestrel implant discontinuation rate was remarkable and the main reasons for it include a desire to become pregnant and bleeding side effects. Moreover, a lower BMI and unacceptability of bleeding problems also increased the likelihood of early removal of this contraceptive method.

Levonorgestrel intrauterine system in menorrhagia-an effective and acceptable alternative

Background: To study the efficacy, performance and acceptability of levonorgestrel intrauterine device (LNG-IUS) in treatment of women with menorrhagia.Methods: This was a descriptive, prospective and observational study conducted over a period of January 2015 to September 2020. Seventy-five (75) women presented with heavy menstrual bleeding having no contraindication for device underwent LNG-IUS insertion after consent. Menstrual pattern, pictorial blood loss assessment chart score (PBAC), rate of acceptability and satisfaction were recorded at 3 months, 6 months, 1, 2 and 3 years after insertion of LNG-IUS.Results: The most common bleeding pattern at 3 month post-insertion was inter-menstrual spotting followed by infrequent menses, oligomenorrhea and amenorrhea. LNG-IUS caused 45.19% reduction in menstrual blood loss (MBL) at 3 months, 81.48% at 1 year, 91.85% at 2 years and 97% at 3 years. Hemoglobin levels improved from mean baseline 8.9 mg/l to 12.8 mg/l at 3 years. Majority of women were satisfied with this minimally-invasive treatment with continuation rate of 94.66%. No major side-effects were noted.Conclusions: LNG-IUS is an excellent minimal invasive, highly effective in controlling blood loss and well-tolerated alternative for women with menorrhagia. Its fertility-sparing property makes it an emerging option for young women.

Management of a case of Primary infertility with PCOD and tubal blockage with Apamarga Kshaar Tail Uttarbasti ,Varunaadi Kashaya and Shatpushpa Churna A Case Study

PCOD & Tubal Blockage are one of the commonest cause of infertility in female patients . Women unable to procreate progeny is considered as Vandhya in Ayurveda. PCOD & TUBAL BLOCKAGE are taken as KSHETRA and BEEJA dushti among four essential factors needed for conception. Both for tubal blockage and PCOD the responsible doshas are VATA and KAPHA. In this case both sanashaman and sanshodhan chikitsa was done. The drugs selected were: Apamarga kshar tail for uttarbasti for three consecutive cycles , Varunaadi Kashaya, Shatpushpa churna orally for 6 months. USG and HSG were used as confirmatory diagnostic tools. 3 Effect of drug on menstrual bleeding pattern was seen for 2nd month of treatment and patient conceived after 7 months of treatment.

Management of a case of Primary infertility with PCOD and tubal blockage with Apamarga Kshaar Tail Uttarbasti ,Varunaadi Kashaya and Shatpushpa Churna A Case Study

PCOD & Tubal Blockage are one of the commonest cause of infertility in female patients . Women unable to procreate progeny is considered as Vandhya in Ayurveda. PCOD & TUBAL BLOCKAGE are taken as KSHETRA and BEEJA dushti among four essential factors needed for conception. Both for tubal blockage and PCOD the responsible doshas are VATA and KAPHA. In this case both sanashaman and sanshodhan chikitsa was done. The drugs selected were: Apamarga kshar tail for uttarbasti for three consecutive cycles , Varunaadi Kashaya, Shatpushpa churna orally for 6 months. USG and HSG were used as confirmatory diagnostic tools. 3 Effect of drug on menstrual bleeding pattern was seen for 2nd month of treatment and patient conceived after 7 months of treatment.