Evaluating contraceptive choice through the method-mix approach. An Indian Council of Medical Research (ICMR) task force study

The method-mix approach was used to evaluate informed contraceptive choices in the present study. A total of 8,077 potential clients were given a balanced presentation of all available contraceptive methods in the national program, ie, the CuT 200 intrauterine device (IUD), low-dose combined oral pills (OC), condom, and sterilization (female/male) along with a new method, Norplant(R).(1) The majority of women opted for spacing methods; among them, the IUD was preferred by about 60% of clients, followed by condoms (9%), OC (6%), and Norplant (5%). Sterilization, mainly female, was accepted by about 17% of the women making an informed choice.The economic status of couples did not influence the contraceptive choices, as all the methods were offered free of cost in the present study, which is the current practice in the national program. Illiterate women more often accepted sterilization (about 25%) than did literate women (15%). This is because illiterate women had more children; about 30% of illiterate women had three or more children, as opposed to 16.2% of literate women. However, literacy status did not influence the choice of any specific spacing method. The study also revealed that, by encouraging potential clients to make an informed choice, they could override the provider's bias while accepting a particular type of spacing method. This is evident from the observation that Norplant was the first choice of the provider for 35% of the women, whereas only 5% of women preferred and accepted Norplant. The present study stresses an urgent need to promote the practice of informed choices in the national program with a variety of contraceptive options-especially, spacing methods for improving contraceptive prevalence and reproductive health in the country.     

改良型银夹提高输卵管绝育术成功率的研究

目的:探讨改良型银夹在绝育术中的绝育效果,提高银夹法结扎术的成功率。方法:在YZ-Ⅱ型银夹的基础上通过加宽加长加厚原银夹,改进其防滑关锁装置;比较改良的YZ-Ⅱ输卵管银夹与原夹的绝育效果。结果:1052例中采用改良夹340例,原夹712例,绝育3年后寿命表复孕率分别为0·00%和0·70%。结论:改良型银夹明显提高了银夹绝育术的成功率,尤其适用于输卵管血管增粗者,值得临床推广。     

The safety of field tubal sterilization: A cohort study

A cohort study on female sterilization has been carried out to compare the safety of field-based procedures with hospital-based procedures. A total of 217 women were recruited, consisting of 103 field-based and 114 hospital-based acceptors. Married and healthy women 20–45 years of age, having at least two living children, not obese, no history of major abdominal surgery, no signs of acute pelvic inflammatory disease, and no contraindication to ketamin were included in the study. Women with severe pelvic adhesions encountered during surgery were excluded from the study.The ambulatory procedure was used for all acceptors except those who were sterilized in hospital immediately after delivery. They were asked to come to the Sarjito Hospital (hospital-based) or Puskesmas (primary health care center or field-based), after fasting the night before. Ketamin, 50–100 mg, was used intravenously for general anesthesia. Minilaparotomy followed by the Pomeroy method was used for standard female tubal sterilization. Tetracycline, 3×500 mg was given for five days prophylactically. Follow-up was carried out one and six weeks after the day of operation. Data were processed with an IBM-compatible PC, using version 3.0 SPSS program. Studentst-test, chi-square test and relative risk (95% confidence limit (CL)) were used for statistical analysis.Both groups were comparable in terms of age, parity, body weight, and body height. The duration of operation in the field was somewhat longer than that in the hospital, i.e. 24.58 vs 21.14 minutes. No major surgical complication was encountered in this study, but one woman had superficial bleeding (from the site of incision) and one suffered from nausea and vomiting as a complication of the anesthesia. The rate of incision infection during one week was 5.82% in the field, compared with 3.51% in the hospital (RR 1.66, 95% CL 0.22–12.69). The rate of mild pelvic inflammatory disease was 2.91% in the field, compared with 1.75% in the hospital (RR 1.66, 95% CL 0.00–8.94). There were no significant complaints at the six-week follow-up except one case of wound infection resulting from hospital sterilization. This case was treated by topical antibiotics. The study concluded that field-based sterilization is as safe as that in hospital.

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Resumen Se realizó un estudio cohorte de la esterilización femenina a fin de comparer la seguridad de las técnicas empleadas en el terreno con los procedimientos en el medio hospitalario. El citado estudio se efectuó con 217 mujeres en total, de las cuales 103 receptoras provenían del terreno y 114 del hospital. Las que participaron en el estudio eran mujeres casadas, en buen estado de salud, de 20 a 45 años de edad, con al menos 2 hijos vivos, no obesas, sin haber sido sometidas a cirugia abdominal mayor, sin signos de afección pélvica inflamatoria aguda y sin contraindicación respecto de la cetamina. La mujeres que presentaban adherencias pélvicas severas como resultado de intervenciones quirúrgicas fueron excluidas del estudio.Le técnica ambulatoria fue empleada en todas las mujeres receptoras, salvo en aquéllas que habían sido esterilizadas en el hospital immediatamente después de un parto. Se les solicitó que concurrieran al hospital Sarjito (hospital de base) o a Puskesmas (centro de atención primaria de la salud o centro de base) en ayuas desde la noche anterior. La cetamina les fue administrada por vía intravenosa como anestesia general, en dosis de 50 a 100 mg. Se les practicó una minilaparotomía según el método de Pomeroy para efectuar una esterilización tubaria femenina corriente. Se les administró una dosis de 500 mg de tetraciclina 3 veces durante 5 días como profiláctico. El seguimiento se realizó una y seis semanas después de la intervención. El tratamiento de datos se efectuó en un ordenador personal compatible IBM utilizando la versión 3.0 del programa SPSS. Para el análisis estadístico se utilizó el test T, el test chi-cuadrado y de riesgo relativo (límite de confianza del 95%).Los dos grupos eran comparables en cuanto a edad, paridad, peso corporal y estatura. La intervención en el terreno duró un poco más que en el hospital, 24.58 contra 21.14 minutos. No hubo ninguna complicación quirúrgica importante, salvo un caso de hemorragia superficial (en la incisión) y un caso de náusea y vómitos, como resultado de la anestesia. Durante una semana la proporción de infección a nivel de la incisión fue del 5.82% en el terreno, en comparación con el 3.1% en el hospital (RR 1.66, 95% CL 0.22–12.69). La proporción de inflamación pélvica leve fue del 2.91% en el terreno, en comparación con el 1.75% en el hospital (RR 1.66, 95% CL 0.00–8.94). No se registró ninguna queja grave en el curso de las seis semanas de seguimiento, salvo un caso de infección de la herida atribuible a la esterilización realizada en el hospital. Este caso fue tratado con antibióticos de aplicación local. El estudio permitió llegar a la conclusión de que la esterilización realizada en el terreno es tan segura como la realizada en el hospital.

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Resumé Une étude cohorte sur la stérilisation féminine a été réalisée afin de comparer la sécurité des techniques employées sur le terrain avec les procédés en milieu hospitalier. Un total de 217 femmes a été retenu, dont 103 receptives venant du terrain et 114 rattachées à l'hôpital. Celles qui participaient à cette étude étaient des femmes mariées, en bonne santé, âgées de 20 à 45 ans, ayant au moins deux enfants vivants, non obèses, sans passé de chirurgie abdominale majeure, sans signes d'affection pelvienne inflammatoire aigüe et sans contre-indication à la cétamine. Les femmes présentant de sévères adhérences pelviennes résultant d'interventions chirurgicales ont été exclues de létude.La technique ambulatoire a été employée sur toutes les femmes consentantes, sauf pour celles qui ont eté stérilisées à l'hôpital immédiatement après un accouchement. Il leur a été demandé de venir à l'hôpital Sarjito (hôpital de base) ou à Puskemas (centre de santé primaire ou centre de base) à jeun depuis la veille au soir. La cétamine leur a été administrée par voie intraveineuse pour une anesthésie générale, à raison de 50 à 100 mg. Une minilaparotomie selon la méthode de Pomeroy a été pratiquée pour effecteur une stérilisation tubaire féminine ordinaire. Une dose de 3 fois 500 mg de tétracycline leur a été administrée pendant 5 jours à titre prophylactique. Le suivi a été réalisé une et six semaines après l'intervention. Les données ont été traitées sur un ordinateur personnel compatible IBM utilisant la version 3.0 du programme SPSS. On a employé pour l'analyse statistique l'épreuve du chi carré et du risque relatif (limite de fiabilité de 95%).Les deux groupes étaient comparables pour ce qui concerne l'âge, la parité, le poids corporel et la taille. L'opération sur le terrain a duré un peu plus longtemps qu'à l'hôpital, 24.58 contre 21.14 minutes. Aucune complication chirurgicale majeure n'est survenue, sauf un cas d'hémorragie superficielle (à l'incision) et un cas de nausées et de vomissements, résultant de l'anesthésie. Durant une semaine le taux d'infection au niveau de l'incision a été de 5.82% sur le terrain, comparé à 3.1% à l'hôpital (RR 1.66, 95% CL 0.22–12.69). Le taux d'inflammation pelvienne a été de 2.1% sur le terrain, comparé à 1.5% à l'hôpital (RR 1.6, 95% CL 0.0–8.94). Aucune plainte grave n'a été enregistrée au cours des six semaines de suivi, sauf dans un cas d'infection de la plaie imputable à la stérilisation effectuée l'hôpital. Ce cas a été traité aux antibiotiques en application locale. L'étude a permis de conclure que la stérilisation pratiquée sur le terrain était aussi sûre que celle pratiquée à l'hôpital.

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This paper is based on a presentation given at the Seventh International Meeting of the Society for the Advancement of Contraception, which was held in Singapore on 4–11 November, 1990.     

Technical failures in female sterilization using the tubal ring: a case-control analysis

To delineate characteristics of women predisposing to sterilization technical failures, we performed an analysis of 20 technical failures that occurred during tubal ring procedures and 80 control ring procedures matched on planned surgical approach and study site. None of the women had recently been pregnant (interval procedures). The odds ratios (ORs) were elevated for women wearing an IUD in the three months prior to sterilization (OR = 5.0, 90% confidence interval [CI] 2.2, 11.2) and for women with a history of spontaneous abortion (OR = 4.3, 90% CI 1.8, 9.8). A history of pelvic inflammatory disease (PID) and/or current evidence of PID was strongly associated with technical failure (X2 = 25.0, p less than 0.001). The combined effect of any two of these three factors increased the risk synergistically. We examined these factors prospectively and confirmed the elevated risks (relative risk [RR] = 5.0, 5.5 and 22.7 for recent IUD wearing, spontaneous abortion history and history/evidence of PID, respectively). The prospective analysis also found that previous abdominal surgery is associated with technical failure (RR = 6.7).     

Randomized trial to compare perioperative outcomes of Filshie clip vs. Pomeroy technique for postpartum and intraoperative cesarean tubal sterilization: a pilot study

OBJECTIVE: To compare, by conducting a randomized trial, Filshie clip and Pomeroy techniques for postpartum and intrapartum cesarean sterilizations in a United States teaching hospital with respect to surgeon preference and perioperative outcomes. METHOD: Thirty-two obstetric patients consented for sterilization were randomized to Pomeroy technique or Filshie clip placement. Following the surgical procedure, surgeons and operating room technicians completed a survey regarding their experience with the procedures and preference. Patient demographic data, time for procedure and follow-up visits were obtained by chart review. RESULTS: For most postpartum sterilizations, the mean duration of the procedure was almost 7 min faster for the Filshie clip technique (p = 0.08); perioperative outcomes were equivalent (p = 0.05). Application of the Filshie clip was rated easier than Pomeroy suture application and, overall, the Filshie clip sterilization procedure was rated less difficult (p = 0.03). Seventy percent of surgeons preferred the Filshie clip technique and would choose it if only one postpartum sterilization method was available. CONCLUSION: For obstetric sterilization, surgeons preferred the Filshie clip over the Pomeroy technique. In addition, operating time was shorter for the Filshie clip. This pilot study suggests that use of the Filshie clip technique has the potential to establish a new standard of care for postpartum and intrapartum cesarean sterilization.     

Randomized comparative study of culdoscopy and minilaparotomy for surgical contraception in women: Task force on female sterilization special programme of research, development and research training in human reproduction

Informed, healthy, volunteering women seeking interval sterilization were randomly allocated either to culdoscopy or to minilaparotomy. Data concerning the operation and follow-up to six weeks post-operation were analyzed for 199 women in the culdoscopy group and 196 in the minilaparotomy group.Major complications, both at operation and subsequently, occurred only in the vaginal procedure group (3%). Minor complications occurred in 3.6% of women in the minilaparotomy group, the majority of these involving the abdominal wound. In the women operated vaginally, minor complications occurred in 1.5%. Failure to perform the intended procedure on the fallopian tubes occurred in 10.6% of culdoscopy cases and 0.5% of minilaparotomy cases. It is concluded that the vaginal approach cannot be recommended except for surgeons experienced in vaginal surgery.     

Phase II clinical trial with Praneem polyherbal tablets for assessment of their efficacy in symptomatic women with abnormal vaginal discharge (an ICMR task force study)

Abnormal vaginal discharge syndrome (AVDS) is a commonly observed gynaecological complaint for which women seek medical attention. The present study was conducted in six Indian Council of Medical Research centres with Praneem polyherbal tablets (PPT), to determine their efficacy in the treatment of symptomatic women with AVDS. Data are given on 141 subjects investigated. In total, 137 women (97%) reported complete (n=62, 44%) and partial (n=75, 53%) relief from symptoms after use of PPT for seven consecutive days. On speculum examination, 71 (74%) women were confirmed to be cured of AVDS. Microbiological tests could only be conducted microscopically for Trichomonas vaginalis, Candida albicans and bacterial vaginosis. It was observed that all women with T. vaginalis had this infection cured by PPT, and the cure rate was 77% for C. albicans and 68% for bacterial vaginosis. Seventy-eight women (55%) reported a transient burning sensation, mostly on the first 2 d of intake of PPT; however, they continued to use the tablets for the prescribed 7 d. This study lays the basis for an extended Phase II/III clinical trial, preferably randomized and comparing a larger number of women to confirm the safety and efficacy of PPT.     

The safety,efficacy and acceptability of task sharing tubal sterilization to midlevel providers: a systematic review

Background

Task sharing is an important strategy for increasing access to modern, effective contraception for women and reducing unmet need for family planning.

Objective

The objective was to identify evidence for the safety, efficacy or acceptability of task sharing tubal sterilization to midlevel providers.

Search strategy

We searched PubMed, Cochrane and Popline for articles in all languages using the following key words: task sharing, tubal sterilization, midlevel providers, task shifting.

Selection criteria

All studies reporting on any measure of safety, efficacy or acceptability of tubal sterilization performed by any cadre of midlevel providers.

Data collection and analysis

Data were independently abstracted by two authors and graded using the United States Preventive Services Task Force rating for evidence quality. Heterogeneity of outcome measures precluded a meta-analysis.

Main results

Nine studies of fair to poor quality reported on safety and acceptability outcomes. Generalizability of findings is limited by inadequate sample size and lack of statistical comparisons. No study reported on long-term efficacy outcomes.

Conclusions

Well-designed clinical trials, of adequate sample size, are urgently needed to establish the safety, efficacy and acceptability of task sharing tubal sterilization to midlevel providers.     

Contraceptive female sterilization in Alabama: a replication of the WHO study.

The prevalence of female sterilization for contraceptive purposes has grown rapidly throughout the world, and is especially high in the United States. Yet the psychosocial impact of female sterilization is incompletely understood. Much of the previous research has been retrospective and has lacked comparison groups of women using other methods. Better designed, prospective studies have been needed, and the World Health Organization's Collaborative Prospective Study of Female Sterilization was conducted to address this need. No evidence was found in the WHO study of a significant impact of tubal ligation compared to other contraceptive methods on mental health, menstruation, or sexual satisfaction. The present study, a replication of the WHO study, compared 323 Alabama women undergoing elective contraceptive sterilization with 318 women using other techniques to control fertility. In general, the results supported the WHO study conclusions. Although sterilization produced a small increase in menstrual distress in Alabama, there were no significant differences between sterilization and comparison women in mental health or sexual satisfaction.     

ICMR task force study on hormonal contraception. Transfer of levonorgestrel (LNG) administered through different drug delivery systems from the maternal circulation into the newborn infant's circulation via breast milk

The transfer of levonorgestrel (LNG) from the maternal plasma via breast milk to the infant was studied in 38 fully lactating and breast-feeding women at 4-6 weeks postpartum, for a duration of 28 days. These volunteers were provided with LNG contraceptive treatment delivered through three, different routes of drug delivery system: (i) intrauterine devices impregnated with LNG (LNG-IUD); (ii) subdermal implant (Norplant (R)-2); and (iii) minipills (LNG 30 micrograms daily). On the first day after either the LNG-IUD (n = 14 women) or Norplant (R)-2 (n = 14 women) insertion, the maternal blood and breast milk samples were collected at 2, 4 and 8 hourly intervals. This was followed by daily collection of these samples as well as infant's blood from days 2 to 4 and thereafter on days 7, 14 and 28. For infant's blood samples from LNG minipill users (n = 10 women), only a single 4-hour sample was collected on the first day and no samples were collected on days 3 and 4. The rest of the schedule for collection of maternal blood and breast milk as well as infant's blood samples were the same in minipill users as for the other two treatment groups. The study revealed a lower LNG percentage transfer from maternal sera to breast milk--11.8 +/- 2, 7 +/- 2 and 8 +/- 1 and relatively higher percentage LNG transfer from breast milk to infant's sera--75 +/- 17, 68 +/- 20 and 32 +/- 3, in LNG-IUD, Norplant (R)-2 and minipill users, respectively. Therefore, LNG contraceptive steroid is transferred into the infant's circulation, the biological significance of which remains to be established.     

Association of perforation of the appendix with female tubal infertility

Although perforation of the appendix is considered a risk factor for female tubal infertility, the epidemiologic evidence supporting this relation is inconsistent. Risk factors for tubal infertility were compared for 121 women with documented primary tubal infertility attending in vitro fertilization clinics in Toronto, Canada, from July to December 1998 and 490 controls who were pregnant during the same time period. Self-administered questionnaires and review of medical records were used to assess exposures. The authors found that neither history of acute appendicitis nor perforation of the appendix was a statistically significant risk factor for tubal infertility. The crude odds ratio for perforated appendicitis was 3.4 (95% confidence interval (CI): 0.9, 12.9), and the adjusted odds ratio was 1.4 (95% CI: 0.3, 6.2). In addition to increased age and annual income, cigarette smoking (odds ratio (OR) = 2.0, 95% CI: 1.2, 3.2), history of endometriosis (OR = 6.0, 95% CI: 2.8,12.8), and history of pelvic inflammatory disease (OR = 6.0, 95% CI: 2.8, 12.8) were significantly associated with tubal infertility in multivariate analysis. These data do not provide substantial evidence that perforation of the appendix is an important risk factor for female tubal infertility.     

Maternal education, female labour force participation and child mortality: evidence from the Indian census

The objective of this paper is to examine how child mortality changes with different levels of maternal education and to quantify the impact of material education and female labour force participation. Child mortality gradients, according to years of education, are rather steep at the primary education level for both male and female children. In post-primary stages of education incremental gains in mortality reduction are almost non-existent. Child mortality is inversely related to both maternal education and female labour force participation but disaggregated analysis showed that female labour force participation has no impact on child mortality among females with fewer than seven years of education. The relative impact of maternal education on child mortality is three times stronger than that of female labour force participation. Excess female child mortality prevailing in certain parts of India also has an inverse relationship with the length of mothers' education, and female labour force participation. Female labour force participation has a stronger influence on excess female child mortality than on absolute child mortality. The evidence in the paper lends support to Bardhan's hypothesis on excess female child mortality.     

输卵管结扎术后并发子宫内膜异位症68例分析

目的探讨输卵管结扎术和子宫内膜异位症的关系.方法我院近8年来输卵管结扎术后腹腔镜检查确诊为子宫内膜异位症的患者68例,回顾性分析输卵管结扎的方法,结扎后的并发症及其临床表现和术后子宫内膜异位症的分期.结果不同的输卵管结扎方法术后均有可能并发子宫内膜异位症,53%的患者有典型的子宫内膜异位症的临床表现,结扎后出现腹腔瘘的患者有14.7%合并子宫内膜异位症.结论输卵管结扎术后有可能并发子宫内膜异位症的发生,若出现腹痛、痛经和盆腔包块时应及时行腹腔镜检查以帮助诊断和治疗.     

局麻单孔腹腔镜电凝绝育术618例临床效果观察

目的:探讨局麻单孔腹腔镜电凝绝育术(简称电凝绝育术)的有效性、安全性及可接受性。方法:分析618例行电凝绝育术的已婚育龄妇女术时相关指标及术后第1、3、6、12个月随访情况。结果:604例(97.73%)成功行电凝绝育术,6例(0.97%)因盆腔粘连无法暴露一侧输卵管仅行单侧输卵管电凝绝育术,8例(1.29%)因气腹针穿刺失败或因盆腔严重粘连无法暴露输卵管而未进行手术。术后1年妊娠1例(0.16%);613例(99.19%)术中出血<5ml;589例(96.56%)于电凝开始时5～10s诉下腹疼痛,可忍受,10s后无疼痛感;6例(0.97%)合并粘连并影响操作,进行粘连松解;150例(24.39%)镜下发现盆腔异常情况;17例(2.79%)发生非严重手术并发症,均未造成严重后果。平均手术时间19.36min,平均留观时间30.52min。术后第1,3,6,12个月随访时部分观察对象出现不同程度的腹痛、腰痛、劳动力下降、月经改变等情况,经对症处理、心理疏导后恢复正常,满意度达97.83%。结论:单孔腹腔镜电凝绝育术是一种安全、有效、育龄群众易接受的女性绝育方法,值得临床应用。     

补充医疗保险与主体医疗保险的衔接研究

我国城镇职工基本医疗保险是主体医疗保险。补充医疗保险通过各种形式对主体医疗保险起补充作用。在全面推进城镇职工基本医疗保险制度改革的同时,如何采取各种补充医疗保险形式,解决主体医疗保险没有覆盖的范围、项目和