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Updated WHO recommendation on tranexamic acid for the treatment of postpartum haemorrhage. Highlights and key messages from the World Health Organization's 2017 Global Recommendation.
Geneva, Switzerland, WHO, 2017 Oct. 5 p. (WHO/RHR/17.21)This summary brief highlights key messages from the updated World Health Organization’s recommendation on Tranexamic acid (TXA) for the treatment of postpartum haemorrhage (PPH), including policy and program implications for translating the TXA recommendation into action at the country level. In 2012, WHO published recommendations for the prevention and treatment of postpartum haemorrhage, including a recommendation on the use of tranexamic acid (TXA) for treatment of PPH. The 2017 updated WHO Recommendation on TXA is based on new evidence on use of TXA for treatment of PPH. Key messages include: 1) The World Health Organization (WHO) recommends early use of intravenous tranexamic acid (TXA) within 3 hours of birth in addition to standard care for women with clinically diagnosed postpartum haemorrhage (PPH) following vaginal birth or caesarean section; 2) Administration of TXA should be considered as part of the standard PPH treatment package and be administered as soon as possible after onset of bleeding and within 3 hours of birth. TXA for PPH treatment should not be initiated more than 3 hours after birth; 3) TXA should be used in all cases of PPH, regardless of whether the bleeding is due to genital tract trauma or other causes; 4) TXA should be administered at a fixed dose of 1 g in 10 mL (100 mg/mL) IV at 1 mL per minute (i.e., administered over 10 minutes), with a second dose of 1 g IV if bleeding continues after 30 minutes; and 5) TXA should be administered via an IV route only for treatment of PPH. Research on other routes of TXA administration is a priority.This summary brief is intended for policy-makers, programme managers, educators and providers.
Managing complications in pregnancy and childbirth (MCPC): A guide for midwives and doctors. Highlights from the World Health Organization’s 2017 Second Edition.
[Geneva, Switzerland], WHO, 2017 May. 8 p. (WHO/MCA/17.02; USAID Cooperative Agreement No. AID-OAA-A-14-00028)Since it was first published in 2000, the World Health Organization’s (WHO’s) Managing Complications in Pregnancy and Childbirth (MCPC) manual has been used widely around the world to guide the care of women and newborns who have complications during pregnancy, childbirth and the immediate postnatal period. The MCPC manual targets midwives and doctors working in district-level hospitals. Selected chapters from the first edition of the MCPC were revised in 2016 based on new WHO recommendations, and the second edition of the MCPC manual is now available. This brief reviews the revision process and summarizes updated clinical guidelines for a subset of revised chapters, including: emotional and psychological support; hypertensive disorders of pregnancy; bleeding in early pregnancy and after childbirth; and prevention and management of infection in pregnancy and childbirth. (Excerpt)
Guideline: Delayed umbilical cord clamping for improved maternal and infant health and nutrition outcomes.
Geneva, Switzerland, WHO, 2014.  p.This guideline is a derivative product from existing World Health Organization (WHO) recommendations on umbilical cord clamping for improving maternal and infant outcomes. The optimal timing of umbilical cord clamping has been debated in the scientific literature for at least a century, and the timing of cord clamping continues to vary according to clinical policy and practice. “Early” cord clamping is generally carried out in the first 60 seconds after birth (most commonly in the first 15-30 seconds), whereas “delayed” (also referred to as “late”) cord clamping is generally carried out more than 1 min after the birth or when the umbilical cord pulsation has ceased. For the mother, delayed cord clamping is one of the actions included in a package for reduction of the risk of postpartum haemorrhage. Member States have requested guidance from WHO on the effects of delayed cord clamping for improving maternal and infant nutrition and health, as a public health strategy in support of their efforts to achieve the Millennium Development Goals, in particular, reduction of child mortality (MDG 4) and improvement of maternal health (MDG 5), as well as the global targets set in the Comprehensive implementation plan on maternal, infant and young child nutrition. The guideline is intended for a wide audience, including policy-makers; their expert advisers; technical and programme staff at organizations involved in the design, implementation and scaling-up of nutrition actions for public health; and health staff providing care to mothers and their infants. (Excerpt)
Geneva, Switzerland, WHO, 2012. 41 p.Postpartum haemorrhage (PPH) is a major cause of mortality, morbidity and long term disability related to pregnancy and childbirth. Effective interventions to prevent and treat PPH exist and can largely reduce the burden of this life-threatening condition. Given the availability of new scientific evidence related to the prevention and treatment of PPH, this document updates previous WHO recommendations and adds new recommendations for the prevention and treatment of PPH. The primary goal of this guideline is to provide a foundation for the implementation of interventions shown to have been effective in reducing the burden of PPH. Health professionals responsible for developing national and local health policies constitute the main target audience of this document. Obstetricians, midwives, general medical practitioners, health care managers and public health policy-makers, particularly in under-resourced settings are also targeted. This document establishes general principles of PPH care and it is intended to inform the development of clinical protocols and health policies related to PPH.
Archives of Gynecology and Obstetrics. 2007 Dec; 276(6):583-589.The objective was to evaluate quality of life (QOL) and identify its associated factors in a cohort of women with gynecologic cancer. A cross-sectional study was conducted, including 103 women with cervical or endometrial cancer, aged between 18 and 75 years who were receiving their entire treatment at the institution where the investigation was carried out. QOL was measured by the World Health Organization's QOL instrument-abbreviated version (WHOQOL-BREF). Clinical and sociodemographic characteristics, in addition to prevalence of cancer-related symptoms prior to radiotherapy were investigated. Bivariate analysis was performed, applying the Mann-Whitney test. Multivariate analysis was used to identify factors associated with QOL. The mean age of the participants was 56.8 plus or minus 11.6 years. The study included 67 (65%) women with cervical cancer and 36 (35%) women with endometrial cancer. Most participants were at an advanced stage (63.1%). The most common complaints were pain (49.5%) and vaginal bleeding (36.9%). The prevalence of anemia was 22.3%. On multivariate analysis, it was observed that anemia (P = 0.006) and nausea and/or vomiting (P = 0.010) determined impairment in physical domain. Pain negatively influenced physical domain (P = 0.001), overall QOL (P = 0.024), and general health (P = 0.013), while the history of surgery positively affected general health (P = 0.001). Cancer-related symptoms were factors that most interfered with QOL in women with gynecologic cancer. Therefore, more attention should be focused on identifying these symptoms, adopting measures to minimize their repercussions on QOL. (author's)
BJOG: An International Journal of Obstetrics and Gynaecology. 2005 Sep; 112:1221-1228.Objective To determine the prevalence of uterine rupture worldwide. Design Systematic review of all available data since 1990. Setting Community- based and facility-based reports from urban and rural studies worldwide. Sample Eighty-three reports of uterine rupture rates are included in the systematic review. Most are facility based using cross-sectional study designs. Methods Following a pre-defined protocol an extensive search was conducted of 10 electronic databases as well as other sources. Articles were evaluated according to specified inclusion criteria. Uterine rupture data were collected along with information on the quality of reporting including definitions and identification of cases. Data were entered into a database and tabulated using SAS software. Main outcome measures Prevalence of uterine rupture by country, period, study design, setting, participants, facility type and data source. Results Prevalence figures for uterine rupture were available for 86 groups of women. For unselected pregnant women, the prevalence of uterine rupture reported was considerably lower for community-based (median 0.053, range 0.016-0.30%) than for facility-based studies (0.31, 0.012-2.9%). The prevalence tended to be lower for countries defined by the United Nations as developed than the less or least developed countries. For women with previous caesarean section, the prevalence of uterine rupture reported was in the region of 1%. Only one report gave a prevalence for women without previous caesarean section, from a developed country, and this was extremely low (0.006%). Conclusion In less and least developed countries, uterine rupture is more prevalent than in developed countries. In developed countries most uterine ruptures follow caesarean section. Future research on the prevalence of uterine rupture should differentiate between uterine rupture with and without previous caesarean section. (author's)
Clinical diagnosis and assessment of severity of confirmed dengue infections in Vietnamese children: is the World Health Organization classification system helpful?
American Journal of Tropical Medicine and Hygiene. 2004; 70(2):172-179.Classification of dengue using the current World Health Organization (WHO) system is not straightforward. In a large prospective study of pediatric dengue, no clinical or basic laboratory parameters clearly differentiated between children with and without dengue, although petechiae and hepatomegaly were independently associated with the diagnosis. Among the 712 dengue-infected children there was considerable overlap in the major clinical features. Mucosal bleeding was observed with equal frequency in those with dengue fever and dengue hemorrhagic fever (DHF), and petechiae, thrombocytopenia, and the tourniquet test differentiated poorly between the two diagnostic categories. Fifty-seven (18%) of 310 with shock did not fulfill all four criteria considered necessary for a diagnosis of DHF by the WHO, but use of the WHO provisional classification scheme resulted in considerable over-inflation of the DHF figures. If two separate entities truly exist rather than a continuous spectrum of disease, it is essential that some measure of capillary leak is included in any classification system, with less emphasis on bleeding and a specific platelet count. (author's)
Global Blood Safety Initiative. Use of plasma substitutes and plasma in developing countries, Geneva, 20-22 March 1989.
[Unpublished] 1989. , 5 p. (WHO/GPA/INF/89.17; WHO/LAB/89.9)Health care practitioners should treat hypovolemia with plasma substitutes rather than plasma since it carries the risk of transmitting infections. They can use plasma to manage hemostasis and sometimes acute plasma protein loss, however. Crystalloid, a plasma substitute, spread swiftly from the capillaries into the interstitial fluid space. Therefore health care practitioners must administer 3 volumes of crystalloid for each volume of blood or plasma lost. This phenomenon may bring about tissue edema which is unacceptable for high risk patients. Another set of substitutes are synthetic colloids which serve to retain circulatory water and volume. They include gelatin solutions, dextran 70, and hydroxyethyl starch (HES). The gelatins function as osmotic diuretics and therefore must be supplemented with 1-2 liters of crystalloid solutions. Dextran and HES draw fluid into the intravascular areas from the surrounding extravascular spaces. Depending on the synthetic colloid, side effects consist of circulatory overload, anaphylactoid reactions, red cell aggregation, platelet and factor VIII interference, and hemostatic interference. Albumin and plasma protein fraction make up the 3rd set of substitutes. Since sophisticated manufacturing techniques and strict quality control are required, they are costly for developing countries to import. They must be pasteurized to inactivate HIV, hepatitis, and other viruses. wpossible side effects are circulatory overload, hypotension, and anaphylactoid reactions. WHO has identified >10 guidelines for managing bleeding, e.g. starting an IV if the pulse rate climbs to >100/minute or systolic blood pressure falls to <90 mm Hg. It also has addressed the need for training for nonphysicians who use plasma substitutes.
Geneva, World Health Organization, 1966. (Technical Report Series NO. 332).The value and possible hazards of IUDs are discussed. Grafenberg developed a metal ring IUD in 1928. There was initial enthusiasm about the device, but it became discredited and interest was not revived in the method until 1959. Today, various shapes, sizes, and materials are employed in making IUD'S. No single cause or mechanism of action of an IUD has so far come to light. In sub-human primates the IUD causes accelerated passage of ova through the tube and the rest of the reproductive tract appears to be the major, but not necessarily the only, mechanism, of action. In ruminants, the contraceptive action of the IUD is exerted, at least in part, at the ovarian level. In rats, mice, rabbits, and ferrets, the main effect of the IUD is suppression of the implantation. It is concluded that the action of the IUDs in the human species is exerted before the stage of implantation. The most effective devices are associated with an incidence of 1.8 to 2.9 pregnancies per 100 insertions during the first year of use. The frequency of spontaneous expulsion ranges from about 5% to over 20% depending on the type of device. About one half of all expulsions occur in the first 3 months and comparatively few after the first year. The incidence of removal for medical reasons ranges from approximately 10% to 25% of first insertions during the first year. The method can be used successfully by almost 3 out of every 4 women who adopt it. Side effect and complications include bleeding and pain and less frequently pelvic inflammatory disease and perforation. The only absolute contraindications to the use of IUDs are: (1) active pelvic inflammatory disease, and (2) pregnancy, proven or suspected. Research needs are noted.
WHO multicentre randomised trial of misoprostol in the management of the third stage of labour. [Estudio clínico multicéntrico aleatorizado de la OMS sobre misoprostol en el manejo del alumbramiento]
Lancet. 2001 Sep 1; 358(9283):689-95.Postpartum hemorrhage is a leading cause of maternal morbidity and mortality. Active management of the third stage of labor, including use of uterotonic agent, has been shown to reduce blood loss. Misoprostol (a prostaglandin E1 analogue) has been suggested for this purpose because it has strong uterotonic effects, can be given orally, is inexpensive, and does not need refrigeration for storage. The authors did a multicenter, double- blind, randomized controlled trial to determine whether oral misoprostol is as effective as oxytocin during the third stage of labor. In hospitals in Argentina, China, Egypt, Ireland, Nigeria, South Africa, Switzerland, Thailand, and Vietnam, the authors randomly assigned women about to deliver vaginally to receive 600 mcg misoprostol orally or 10 IU oxytocin intravenously or intramuscularly, according to routine practice, plus corresponding identical placebos. The medications were administered immediately after delivery as part of the active management of the third stage of labor. The primary outcomes were measured postpartum blood loss of 1000 ml or more, and the use of additional uterotonics without an unacceptable level of side-effects. The authors chose an upper limit of a 35% increase in the risk of blood loss of 1000 ml or more as the margin of clinical equivalence, which was assessed by the confidence interval of the relative risk. Analysis was by intention to treat. 9264 women were assigned misoprostol and 9266 oxytocin. 37 women in the misoprostol group and 34 in the oxytocin group had emergency caesarean sections and were excluded. 366 (4%) of women on misoprostol had a measured blood loss of 1000 ml or more, compared with 263 (3%) of those on oxytocin (relative risk 1.39 [95% confidence interval 1.19-1.63], p < 0.0001). 1398 (15%) women in the misoprostol group and 1002 (11%) in the oxytocin group required additional uterotonics (1.40 [1.29-1.51], p < 0.0001). Misoprostol use was also associated with a significantly higher incidence of shivering (3.48 [3.15- 3.84]) and raised body temperature (7.17 [5.67-9.07]) in the first hour after delivery. 10 IU oxytocin (intravenous or intramuscular) is preferable to 600 mcg oral misoprostol in the active management of the third stage of labor in hospital settings where active management is the norm. (author's)
The World Health Organization multinational study of breast-feeding and lactational amenorrhea. IV. Postpartum bleeding and lochia in breast-feeding women.
FERTILITY AND STERILITY.. 1999 Sep; 72(3):441-7.The main purpose of this study was to compare the duration of postpartum lochia among 7 groups of breast-feeding women, and in addition, to investigate whether age, parity, birth weight, or the amount of breast-feeding affects this duration. The participants included 4118 breast-feeding women aged 20-37 years living in China, Guatemala, Australia, India, Nigeria, Chile, or Sweden. The duration of lochia, frequency of an end-of-puerperium bleeding episode, and frequency of post-lochia bleeding episodes within 56 days of delivery were measured. This study revealed that the median duration of lochia was 27 days and varied significantly among the centers (range, 22-34 days). In about 11% of the women, lochia lasted >40 days. An end-of-puerperium bleeding episode around the 40th day postpartum was reported by 20.3% of the women. Bleeding within 56 days of delivery (separated from lochia by at least 14 days) occurred in 11.3% of the women and usually was followed by a confirmatory bleeding episode 21-70 days later. This study was able to quantify the average duration of postpartum lochia at 3-5 weeks, with significant variations by population. Lochia durations of >40 days were not unusual. A separate and distinct end-of-puerperium bleeding episode occurred in 1 out of every 4-5 women, although it is unclear how this phenomenon is clinically, socially, or culturally significant.
POPULI. 1992 Nov; 19(5):10-1.In 1989, 1st trimester abortions were made legal in Mongolia. A multiparty government was elected in July 1990 which encouraged of 4 or fewer children per family, it discouraged childbearing under 20 and over 35 years of age, and it encouraged modern contraception. Years of pronatalist policies contributed to maternal mortality rates of up to 420 for 100,000 live births in some regions. The maternal mortality rate plummeted to around 160 deaths for 100,000 live births in 1985-89, and subsequently to around 110/100,000 live births. However, by 1991 the rate rose to around 120/100,000 despite the fact that 9 in 10 deliveries take place in a hospital or health center. More than half of the country's population lives in the vast interior: women often bled to death following childbirth because of transportation problems. Because of previous pronatalist policies, the number of Mongolians more than doubled since 1960 and tripled since the 1930s to an estimated 2.1 million in 1991. 70% of Mongolians are <35 years of age, and this number is growing by about 2.8% per year. Postpartum hemorrhage is the most common cause of death, because half of the pregnant women have some degree of anaemia attributable to iron deficiency and frequent childbirth. The total fertility rate decreased from an average of 7.5 children per women in the 1970s to around 3.8 now the current (United Nations estimate is 4.7). The United Nations Population Fund has provided more than 90,000 intrauterine devices, 1.2 a million condoms, and limited quantities of contraceptive pills in addition to obstetric and gynecological equipment and training. At the same time, nearly half of the country's maternal rest homes have been closed. Some 86% of women work, and more than 7 in 10 doctors are women. The election of 3 women to the national legislature gives women 4% of 76 legislative seats, as compared to 2.4% in the earlier People's Great Hural.
Maternal mortality associated with hypertensive disorders of pregnancy in Africa, Asia, Latin America and the Caribbean.
BRITISH JOURNAL OF OBSTETRICS AND GYNAECOLOGY. 1992 Jul; 99(7):547-53.An epidemiologist analyzed community and hospital-based data obtained from the WHO data base on maternal mortality and morbidity to examine maternal mortality associated with hypertensive disorders of pregnancy (HDP) in Africa, Asia, the Caribbean, and Latin America. Overall estimates of mortality associated with HDP among countries in Africa, Latin America, and the Caribbean did not differ, even though overall maternal mortality was much higher in Africa than in Latin America and the Caribbean. In Asia, however, estimates of both maternal mortality and mortality associated with HDP were quite varied (maternal mortality range = 15-905 and percentage of deaths due to HDP range = 4 = 55%). Qatar had the lowest maternal mortality (15) and the highest percentage of deaths due to HDP (55%). Even though maternal mortality was lowest in southern Africa (90-115 vs. 80-1140), percentage of deaths due to HDP was basically high (10-27%). In West Africa, the same HDP levels ranged from 7% to 18%. Maternal mortality was relatively low in the Caribbean (30-80), but it had a very high percentage of deaths due to HDP (30-73%). In Argentina and Chile, maternal mortality was higher than that of the Caribbean (180 and 110. respectively), yet had a low percentage of deaths due to HDP (10%). These data indicated that overall 10-15% of all maternal deaths were associated with HDP. In those countries with detailed data, 60-100% of these deaths were due to eclampsia. Thus eclampsia caused 10% of all maternal deaths. These results suggested that infection and hemorrhage were responsible for the excess maternal mortality. They also implied that deaths associated with HDP may be the most difficult to prevent in developed and developing countries. Health practitioners do not agree on the optimal management of preeclampsia and eclampsia. Several clinical trials worldwide are now evaluating the various management options.
Geneva, Switzerland, World Health Organization [WHO], Division of Family Health, Maternal Health and Safe Motherhood Programme, 1992. 74 p. (Safe Motherhood; WHO/MSM/92.4)Women in Africa face a lifetime risk of maternal mortality 500 times greater than that of women in developed countries. This lifetime risk is also considerably higher for women in other developing regions compared to that for those in developed countries. Many health professionals believe that antenatal care in developing countries decreases the likelihood of women dying pregnancy and childbearing as well as significant maternal morbidity, yet no one has systematically assessed its potential to actually improve maternal health. The WHO Maternal Health and Safe Motherhood Programme plans to support research to examine antenatal care's potential. It has reviewed the effectiveness of antenatal interventions compared to poor maternal health in developing countries. The review reveals that good quality data are scarce and that health providers have not accurately tested many interventions. For example, the US, UK, and Sweden have all achieved low case fatality rates for eclampsia using a different anticonvulsant therapy for severe preeclampsia (magnesium sulfate; diazepam or other benzodiazepines; and hydralazine with at least chlorpromazine, pethidine, diazepam, and chlormethiazole, respectively), but few trails have compared the different treatments. This review begins with an overall look at antenatal care programs. It then examines interventions of the leading causes of maternal mortality and morbidity (hemorrhage and anemia, hypertensive disorders of pregnancy, obstructed labor, and puerperal sepsis and genitourinary). The most effective interventions are those that deal with chronic conditions rather than acute conditions which arise near delivery. The review concludes with a table of effective antenatal interventions and tables of research questions about potentially effective antenatal interventions against various maternal conditions.
ENTRE NOUS. 1991 Dec; (19):15.About 8 million women use the long acting injectable contraceptive depot-medroxy-progesterone acetate (DMPA) and norethisterone enanthate (NET-EN). These progesterone only injectables are not dependent on sexual activity and are easy to administer. Yet they are not always well accepted since they can interfere with menstrual bleeding and often induce amenorrhea. Researchers find that adding estrogen to DMPA and NET-EN treats these irregularities. They must use esters with limited action to protect the endometrium from constant estrogens, however, which requires monthly injections. Thus bleeding occurs once a month just like the normal menstrual cycle. Clinical trials in China of Injectable No. 1 (250 mg 17-alpha-hydroxyprogesterone caproate and 5 mg estradiol valerate) show that it has few side effects and is acceptable. Other trials in China are evaluating monthly injectables with NET-EN or megestrol acetate. Numerous developing countries often as WHO's Special Programme of Research in Human Reproduction for effective, safe, and fully studied monthly injectables. WHO operates under a 2 part strategy: optimum improvement of HPR 102 (50 m NET-EN and 5 mg estradiol valerate) and Cyclofem (25 mg DMPA and 5 mg estradiol cypionate) resulting in a reduction of the dose of at least 1 of the hormones and results of a study of the efficacy and side effects of these 2 injectables. It hopes the study provides the impetus to introduce them into national family planning programs. It demonstrates that they are indeed efficacious, effect fewer changes in the menstrual cycle than the progesterone only injectables, and are well accepted, even though women must go to a clinic every 27-33 days for an injection. Other studies are determining their effects on lipid and glucose metabolism, coagulation, and fibrinolysis. They are also looking at the time needed for ovulation to return. 1 study shows that menstruation returned in all women by the 3rd cycle.
A randomized comparative study of interval insertion of three intrauterine devices: the copper T 220c, the Nova T and the WHO levonorgestrel 2 ug IUD.
[Unpublished] 1985 May. 5 p. (Project: 82901)The objective is to compare the effectiveness and acceptability of 3 IUDs inserted in 300 health women, aged 24-38. All have had at least 1 full-term delivery. Subjects were randomly allocated to 1 of the 3 IUDS: the Copper T 220C (Tcu 220c), the Nova T, and the World Health Organization levonorgestrel 2 ug IUD. Insertion was done from the 3rd to the 5th day of menstruation between Feb. and Sept. 1984 and followed up at 48 hours, 3, 6, 12, and 24 months after IUD insertion. 12 month data was collected for cumulative rates, based on life table procedures and analyzed with log-rank test. There was no loss to follow up and no insertion failure. All levonorgestrel IUDs have been removed because the levonorgestrel-releasing IUD has a relatively high risk of ectopic pregnancy. The use-related discontinuation rates of Tcu 220c, Nova T, and levonorgestrel IUD during 12 months of use, were 11.1, 2.4, and 12.7, respectively. The difference between Tcu 220c and Nova T were statistically significant (p.<0.01). The continuation rates of Tcu 220c, Nova T, and levonorgestrel during 6 months of use were 94.0, 99.0, and 96.0, respectively. During 12 months of use, they were 88.9, 97.6, and 87.3 respectively. 1 ectopic pregnancy occurred with the levonorgestrel IUD after 7 months of use. No pregnancy occurred in Nova T users. The pregnancy rates of Tcu 220c and levonorgestrel IUD during 12 months of use were 1.0 and 1.3, respectively. Removal rates for bleeding with Tcu 220c and levonorgestrel IUD during 12 months of use were 3.1 and 1.0, respectively. The removal rate for pain with Tcu 220c during 12 months of use was 2.0. The duration of bleeding and spotting with 3 IUDs, 3, 6, 9, and 12 months of use are illustrated. Preliminary results show that the Nova T is superior to Tcu 220c and levonorgestrel IUDs. Expulsion is the main event in both Nova T and Tcu 220c. More attention should be paid to the insertion technique. The duration of bleeding and spotting of levonorgestrel IUD were longer in the last 3 months after insertion, but was shortest at 1 year of use when compared with Tcu 220c and Nova T.
OUTLOOK. 1990 Jun; 8(2):7-9.This article summarizes the most recent data on WHO's multicenter clinical trial test of the low dose progestin-releasing vaginal ring as an effective contraceptive for women. The study involved 1005 women aged 19-34 and was carried out from 1980-86 at 19 centers in 13 countries, including 9 developing countries. The overall findings on vaginal ring use included: the ring's effectiveness was comparable to oral contraceptive (OC) effectiveness, pregnancy rates increased with increasing body weight, about 1/2 of the users had discontinued the ring by 1 year, the ring disrupted menstrual bleeding patterns in about 1/2 of all users, and about 1/4 of all users expelled the ring at least once but most continued to use it. The irregular bleeding pattern was the main reason for discontinuation. Part of the reason for having different ring contraceptive effectiveness in different countries could be due to differing average weights of the women. Increasing risk of expulsion was directly related to increasing age by approximately 3% with each year of age. For effective use of 90-day low-dose levonorgestrel-releasing vaginal ring, appropriate clients should have the following: a dislike for inserting and removing vaginal devices, low weight, counselling on potentially irregular bleeding, and counseling on how to deal with an expulsion. (author's modified)
CONTRACEPTION. 1988 Aug; 38(2):129-56.Methods of analyzing vaginal bleeding patterns, both of normally menstruating non-contracepting and contracepting women, are reviewed, and the reference period method is described in greater detail. For women using long-acting hormonal methods, the concept of cycle is no longer appropriate. The reference period method adopts the woman as the unit of analysis, divides her menstrual diary into consecutive periods, and summarizes vaginal bleeding patterns within each period. Data are presented in bar plots showing median length of bleeding, 5th and 95th percentiles, means and standard deviations. Natural, oral contraceptive, and IUD patterns are similar, while 3-monthly injections, vaginal rings and minipill patterns are disrupted patterns with no notion of cyclicity. Dealing with events that overlap reference period boundaries is still a problem, and is still being studied by working groups, in particular at WHO and the University of Exeter. For example, the effects of different definitions have not yet been systematically evaluated, and recommendations have not been tested empirically. The WHO has published a set of data on 4817 women's diaries to stimulate statistical research on this topic.
CONTRACEPTION. 1988 Aug; 38(2):165-79.Researchers recruited 1216 females to study changes in amenorrhea patterns with successive injections of the long acting injectable contraceptive depot-medroxyprogesterone acetate (DMPA). The women received an injection of either 100 mg or 150 mg DMPA on the day of randomization and 3 additional injections at 90 day intervals. 1151 (94.7%) women completed a menstrual diary that could be used, but only diaries of at least 60 days were considered in each reference period (90 days). Of the 99 who received only 1 100mg injection, 23 had amenorrhea. Of the 361 receiving 4 injections, 142 experienced no amenorrhea in any of the injection intervals and 30 had amenorrhea in all 4 intervals. Overall 281 women out of 576 who received 1-4 injections of 100 mg DMPA did not experience amenorrhea at all. For those in the 150 mg sample receiving 1-4 injections, 237 out of 575 women did not have amenorrhea. Analysis of change over time suggested an increase incidence of amenorrhea following the 2nd injection. In terms of the probability of a woman accepting a injection, women who experienced amenorrhea with the 1st injection were less likely to accept a 2nd, especially in the 150 mg DMPA group. Additionally, the trend in amenorrhea pattern demonstrated that a 3rd injection was adversely affected by amenorrhea in the 2nd injection interval in the 150 mg group but not the 100 mg group. Nevertheless, the decision to have a 4th injection appeared adversely affected by amenorrhea in the 3rd injection interval in both groups. The conditional probabilities used in this research can also be applied to examine continuation or survival rates in a follow-up study based on any prognostic factors.
WHO CHRONICLE. 1986; 40(1):31-6.A traditional practice that has attracted considerable attention in the last decade is female circumcision, the adverse effects of which are undeniable. 70 million women are estimated to be circumcised, with several thousand new operations performed each day. It is a custom that continues to be widespread only in Africa north of the equator, though mild forms of female circumcision are reported from some Asian countries. In 1979 a Seminar on Traditional Practices that Affect the Health of Women and Children was held in the Sudan. It was 1 of the 1st interregional and international efforts to exchange information on female circumcision and other traditional practices, to study their implications, and to make specific recommendations on the approach to be taken by the health services. There are 3 main types of female circumcision: circumcision proper is the mildest but also the rarest form and involves the removal only of the clitoral prepuce; excision involves the amputation of the entire clitoris and all or part of the labia minora; and infibulation, also known as Pharaonic circumcision, involves the amputation of the clitoris, the whole of the labia minora, and at least the anterior 2/3 and often the whole of the medial part of the labia majora. Initial circumcision is carried out before a girl reaches puberty. The operation generally is the responsibility of the traditional midwife, who rarely uses even a local anesthetic. She is assisted by a number of women to hold the child down, and these frequently include the child's own relatives. Most of the adverse health consequences are associated with Pharaonic circumcision. Hemorrhage and shock from the acute pain are immediate dangers of the operation, and, because it is usually performed in unhygienic circumstances, the risks of infection and tetanus are considerable. Retention of urine is common. Cases have been reported in which infibulated unmarried girls have developed swollen bellies, owing to obstruction of the menstrual flow. Implantion dermoid cysts are a very common complication. Infections of the vagina, urinary tract, and pelvis occur often. A women who has been infibulated suffers great difficulty and pain during sexual intercourse, which can be excruciating if a neuroma has formed at the point of section of the dorsal nerve of the clitoris. Consummation of marriage often necessitates the opening up of the scar. During childbirth infibulation causes a variety of serious problems including prolonged labor and obstructed delivery, with increased risk of fetal brain damage and fetal loss. A variety of reasons are advanced by its adherents for continuing to support the practice of female circumcision, but the reasons are rationalizations, and none of the reasons bear close scrutiny. The campaigning against female circumcision is reviewed.
In: Zatuchni GL, Goldsmith A, Shelton JD, Sciarra JJ, ed. Long-acting contraceptive delivery systems. Philadelphia, Pa., Harper and Row, 1984. 1-19. (PARFR Series on Fertility Regulation)Depo-Provera (depomedroxy-progesterone acetate, or DMPA) and NORPLANT (the Population Council's registered trade name for subdermal implants) are focused on in this literature review. Over the past 17 years, more than 1 million individual doses of Depo-Provera have been supplied in Thailand. Currently 6,000 women a month use the method. Depo-Provera has proved outstandingly successful in Bangladesh for years. The basic disadvantage of long-acting steroid systems is that return to fertility is slow and unpredictable. Other disadvantages include menstrual distrubances and weight gain. Acceptability of injectable contraceptives has been studied primarily by the World Health Organization (WHO). In 1976, the Task Force on Acceptability of Research and Family Planning explored preferences among 3 routes of contraceptive administration: 1)oral; 2)intravaginal; and 3)injection. The study was conducted in Indonesia, Korea, Pakistan, and Thailand. Although the oral route was generally preferred by most women, many respondents still chose the injectable. A WHO III multicentered trial comparing the use, effectiveness, side effects and bleeding patterns of Depo-Provera and norethisterone enanthate (NET-EN) was terminated after only 1 year because of excessively high pregnancy rates with NET-EN. A total sample of about 250 women in Manila and Alexandria were interviewed. Results indicated that the 2 most important considerations were effectiveness and menstrual bleeding. Depo-Provera did not affect menstruation. Various types of subdermal implants releasing a contraceptive Silastic implant, is placed beneath the skin of the forearm or upper arm and provides 5 or more years' protection against pregnancy. The 6 capsules are not biodegradable and require surgical removal under local anesthesia.
In: Zatuchni GI, Goldsmith A, Shelton JD, Sciarra JJ, ed. Long-acting contraceptive delivery systems. Philadelphia, Pa., Harper and Row, 1984. 621-7. (PARFR Series on Fertility Regulation)Progestasert (Alza Corporation, Palo Alto, California) achieves relatively high rates of contraceptive effectiveness through the release of a sex hormone--progesterone. Currently, it is recommended that Progestaserts be replaces every 12 months and most copper-bearing IUDs, every 3 years. To improve on Progestasert's 1-year replacement interval, Alza Corporation modified the Progestasert by increasing the amount of pregesterone contained in the IUD (from 38 to 52 mg) without changing the average daily release of 65mg. This long-acting progestasert, called the Intrauterine Progesterone Contraceptive System (IPCS), was designed to have a useful life of 3 years before replacement was required. The IPCS is identical in appearance to the Progestasert, and its contraceptive action in the same as that of the Progestasert. The effectiveness of either is through the effects of an intrauterine foreign body and through the effects of the progesterone on the encometrium. The IPCS system was designed to provide maximum contraceptive protection over a 3-year period and to reduce IUD-related bleeding, pain, and expulsion problems. Results from Alza monitored trials of the IPCS in the US and Mexico indicate that the cumulative life-table pregnancy rate increased from 3.6/100 women after 25 to 30 months of use to 10.6/100 women after 30 to 36 months of use. Laboratory evaluations of removed IPCS devices indicates that after 30 months of IPCS use the release rate of progesterone may not be adequate to prevent pregnancy effectively. The World Health Organization (WHO) evaluated the IPCS in 2 multiclinic studies. Postinsertion complications and complaints for the IPCS and T Cu-200 are shown. The include cervical perforation, ectopic pregnancy, pelvic inflammatory disease, dysmenorrhea, bleeding, spotting, and pelvic pain. The IPCS seemingly offers no particular advantages for use in developing countries.
[Some facts concerning injectable contraceptives: memorandum of a World Health Organization meeting] Quelques faits concernant les contraceptifs injectables: memorandum sur une reunion de l'OMS.
Bulletin of the World Health Organization. 1982; 60(4):535-48.This memorandum seeks to clarify issues concerning the safety of injectable contraceptives and to recommend areas for further research. Depo-Provera and norethindrone enanthate, 2 long-acting progestagen preparations, offer the important advantages in contraception of high efficacy, prolonged effect, and reversibility. Depo-Provera has been used since 1950 to treat a wide variety of complaints without serious side effects. It is estimated to have been used by about 10 million women for contraception and is currently used by about 1.5 million in 84 countries. Norethindrone enanthate has been much less widely used since its appearance in 1966 and is currently available in 40 countries. The Group on Toxicologic Evaluation, reviewing the results of longterm use of the 2 steroids in mice, rats, and rhesus monkeys, found no reason to modify their earlier position that the 2 substances were sufficiently safe for use in contraceptive programs. The Group also concluded that beagle dogs are inappropriate models for observation of the effects of the 2 steroids in women because of the predisposition of beagles to mammary tumors and acromegaly and because of differences in the specificity of their progesterone receptors. Some of the dosage levels used in the beagle studies were also questioned. Results of a large number of trials on women in numerous countries were reviewed regarding consequences of the different pharmacological properties of the 2 preparations, their effectiveness at different dosage levels, the nature and consequences of bleeding problems, current knowledge concerning their effects on lipid and glucose metabolism and liver function, possible carcinogenic effects, return of fertility, and effects of exposure in utero or through the mother's milk. None of the clinical or epidemiological studies was able to demonstrate life-threatening secondary effects. The most frequent secondary effect is the disturbance of menstrual cycles which is observed in the majority of women and is the most common cause of discontinuation. Although no serious short or longterm effects have been noted, the substances have been in use for a relatively short time. Research should proceed on the effects of longterm use of both steroids on lipid and glucose metabolism, on the appearance of neoplasms, and on the later development of the fetus or nursing child exposed to them. The study group concluded that Depo-Provera and norethindrone enanthate are acceptable methods of fertility regulation.
Multinational comparative clinical trial of long-acting injectable contraceptives: norethisterone enanthate given in two dosage regimens and depot-medroxyprogesterone acetate. A preliminary report.
Contraception. 1982 Jan; 25(1):1-11.A multicenter phase 3 clinical trial compared norethisterone enanthate (NET-EN) given by 2 different treatment regimens and depot-medroxyprogesterone acetate (DMPA). After 18 months of observation, preliminary findings are reported for 790 women who received NET-EN 200 mg every 60 days; for 796 women who recieved NET-EN every 60 days (200 mg) for 6 months, then 200 mg every 84 days, and for 1589 women who received DMPA 150 mg every 90 days. Overall discontinuation rates and discontinuation for bleeding and personal reasons were similar for all 3 groups after 18 months observation (61.8-63.5/100 women). Terminations due to amenorrhea were significantly higher among DMPA users (12.1 and 17.4/100 women at 12 and 18 months) than among both NET-EN groups (6.8-8.2/100 women at 12 months and 10.4-10.9/100 women at 18 months). The only significant difference in pregnancy rates observed among the 3 groups was a higher rate at 18 months among NET-EN (84 days) users (1.6/100 women), than among DMPA users (0.2/100 women). There was no overall significant difference between the 2 NET-EN groups, although between the 6 and 18 month follow-ups when the 2 NET-EN regimens diverged, the NET-EN (84 days) users' pregnancy rates rose significantly, whereas in the NET-EN (60 days) group, the pregnancy rate did not change. Weight gain was significantly higher in those subjects using NET-EN at 60 day intervals than at 84-day intervals. (author's modified)
People. 1981; 8(1):31.The government of bangladesh is about to introduce injectables into its family planning program with a target figure of 600,000 users. The United Nations Fund for Population Activities has already supplied 84,000 doses of Depo-Provera (DMPA) and 15,000 doses of Noristerat (norethisterone oenanthate) for the program, and groups of Family Welfare Visitors have been trained to give the injections. There has been much criticism in the press of the Health Ministry decision to use injectables in the national program. Voluntary agencies are the source of almost all the experience with injectables thus far in Bangladesh. between them they administered some 26,000 doses in 1979. Their reports on the drug have been guardedly confident. Despite the various side-effects, women continue to prefer DMPA to the oral contraceptive or the IUD. The use of injectables, which is associated by many with irregular bleeding, creates special problems in a Muslim society, where a woman who bleeds is considered as "unclean."