Short-term complications after surgically induced abortions: a register-based study of 56 117 abortions

BACKGROUND: Performing an induced abortion is a rather simple medical procedure which is frequently done and side-effects will have public health implications unless they are very rare. We estimated the incidence of side-effects detected during the stay at the hospital and 2 weeks after the discharge. We only include side-effects reported by clinics or hospitals. METHODS: Altogether 56 117 induced abortions performed by public hospitals in Denmark from 1980 to 1994 were analyzed in this study. The study combined results from the mandatory reporting of side-effects to the National Induced Abortion Registry and all diagnoses reported to the Hospital Discharge Registry. RESULTS: Side-effects in the form of bleeding, infections or re-evacuation were recorded for about 5%. We found more side-effects in teenage women and for abortions performed late in pregnancy. We found nothing to indicate that the frequency of side-effects following an abortion changed over time. CONCLUSIONS: About 5% have side-effects registered by hospitals following an induced abortion. The long-term consequences of this are not known.     

Pain therapy in patients with gynecologic tumors. Analysis of ambulatory pain management]

In a retrospective study efficacy and side-effects of long-term pain management of 58 patients with gynaecological cancer were analysed. Pathophysiological changes of the underlying tumor determined the choice of pain therapy. In more than 90% sufficient analgesia was obtained with tolerable side-effects. When patients became unable to swallow oral medication or showed intolerable side-effects, continuous subcutaneous or epidural opioid administration by means of lightweight disposable infusors proofed to be an efficient alternative in pain therapy.     

Use of prostaglandin, hypertonic saline and oxytocin for second-trimester abortion.

The management of second-trimester abortion is still not satisfactory with respect to safety and side-effects; it is considered to be in a state of evolution. The goal of this investigation has been to combine, in reduced quantity, prostaglandin and hypertonic saline in order to minimize the complications and side-effects associated with the separate administration of each component. This study documents the results of a random sample of 385 abortions performed in the second trimester, induced by intra-amniotic instillation of prostaglandin (20 mg) and NaCl 5 and 10 g in different volumes and concentrations augmented with oxytocin. In a series of 20 patients, the coagulation profile is presented and the clinical characteristics of 4 groups are compared. This study demonstrated no coagulation defects. The gastrointestinal side-effects were reduced. In spite of the reduced dosage of each component, the instillation abortion interval still remained 17.08 h on the average. Incomplete abortion ranged from 32% to 48.78%. The data presented in this report suggests that combination of prostaglandin, hypertonic saline and oxytocin is feasible for midtrimester abortion.     

Safety aspects and side-effects of ExEm-gel and foam for uterine cavity distension and tubal patency testing

A state-of-the-art overview of the safety and side-effects of ExEm-gel for uterine cavity distension and ExEm-foam for tubal patency testing is presented. A literature search was carried out using PubMed, textbooks, pharmaceutical databases and reports of toxicity tests. Information on clinical use in humans and experiments in animal models was collected and grouped according to the following components: glycerol, hydroxyethyl cellulose and purified water; subjects included toxicity test, influence on sperm cells, oocytes, blastocyst development, uterine cavity distension, tubal patency testing, pain and obstetric applications. No unknown side-effects of gel or foam, or unexpected concerns about safety, were reported. More information than expected was available on the absence of effects of the components on various human tissues. Although it is difficult to prove that the search is complete, and it is possible that side-effects remain unreported, the combination of glycerol, hydroxyethyl cellulose and purified water is considered to be safe for intrauterine application and tubal patency testing, indicating an optimal risk–benefit ratio in clinical use. The safest strategy, however, is to restrict clinical examinations with gel and foam to the pre-ovulatory phase of the menstrual cycle.     

A randomised trial of two regimens of vaginal misoprostol to manage termination of pregnancy of up to 16 weeks

OBJECTIVE: The purpose of this study was to compare the efficacy and side-effects of two regimens of vaginal misoprostol for pregnancy termination of up to 16 weeks. METHODS: A randomised clinical trial of medical pregnancy termination of up to 16 weeks was conducted. A hundred pregnant women requesting legal termination of pregnancy were randomised into two groups to receive either 200 microg (50 women) or 400 microg (50 women)--vaginal misoprostol every six hours up to four doses. Outcome of abortion and side-effects were assessed. RESULTS: The groups were similar in maternal age, gestational age, parity and indication for pregnancy termination. There were no statistically significant differences between the two groups in abortion (P = 0.084) and mean induction to abortion time (P = 0.35). However, the side-effects in the 400 microg group were significantly higher than in the 200 microg group (P = 0.000). Conclusion: In pregnancy termination of up to 16 weeks, 200 microg vaginal misoprostol every six hours up to four doses was as effective as 400 microg, but side-effects were more common in 400 microg regimen.     

Women's acceptance of an injectable progestin-only contraceptive in a free-choice environment in Turkey

A progestin-only injectable contraceptive has been integrated into the method mix at a well-woman clinic in Turkey. During the period from 1st December 1996 to 1st December 1997, among 3545 new method acceptors at the clinic, 254 women decided to use the injectable, giving an initial acceptance rate of 7%. Continuation rates, however, were quite low: 43.7% at 6 months and only 18.5% at 12 months. Though all the side-effects were mentioned during the counselling sessions, side-effects such as amenorrhea and spotting might have been underestimated by the potential users of this method, which was new in the country. A more detailed counselling with a strong emphasis on frequent side-effects might lower the initial acceptance rate, but can help to increase the continuation rates.     

Women's acceptance of an injectable progestin-only contraceptive in a free-choice environment in Turkey.

A progestin-only injectable contraceptive has been integrated into the method mix at a well-woman clinic in Turkey. During the period from 1st December 1996 to 1st December 1997, among 3545 new method acceptors at the clinic, 254 women decided to use the injectable, giving an initial acceptance rate of 7%. Continuation rates, however, were quite low: 43.7% at 6 months and only 18.5% at 12 months. Though all the side-effects were mentioned during the counselling sessions, side-effects such as amenorrhea and spotting might have been underestimated by the potential users of this method, which was new in the country. A more detailed counselling with a strong emphasis on frequent side-effects might lower the initial acceptance rate, but can help to increase the continuation rates.     

复倍松减轻天花粉副反应的临床观察

本文对天花粉引产加用地塞米松１２３例、复倍松１１７例进行比较性研究。地塞米松给药方法如文献［１］所述，复倍松组在用天花粉前０．５ｈ肌注３安瓿复倍松，平均体温前者为３７．６１±０．５０℃、后者为３７．５９±０．４６℃。复倍松一次给３安瓿，体温和副反应与地写米松相似，两者无显著性差异，但具体数值复倍松组体温较地塞米松组低，其他副反应亦较地塞米松组发生率低。复倍松与地塞米松一样不影响引产效果，能减轻副反应，又能提高其安全系数，并减少注射次数，值得推广应用。     

吉妮固定式宫内节育器应用效果的研究

目的 :研究吉妮固定式宫内节育器 (GyneFixIUD)的效果。方法 :对 10 7例放置GyneFixIUD和 80例放置含铜 375IUD的妇女进行 1年的临床观察和对照研究。结果 :(1)Gyne组在去除放置技术或子宫过软所致的脱落因素后 ,脱落率显著低于含铜组 (P <0 .0 5) ;(2 )在放置IUD后 3个月和 6个月时 ,副作用有淋漓出血 ,经量过多和白带增多等 ,Gyne组明显低于含铜组 ,差异有显著性 (P <0 .0 1,P <0 .0 5,P <0 .0 1)。结论 :GyneFixIUD的临床使用效果好于含铜 375IUD ,脱落率和副作用低于含铜 375IUD     

Medical management of fibroids

The ideal medical therapy for fibroids is, arguably, a tablet that is taken by mouth, once a day or, even better, once a week, with minimal, if any, side-effects, that induces fibroid regression and thus a resolution of symptoms rapidly, but without affecting fertility. Such a magic bullet does not yet exist, and there are no indications that one is on the horizon. Driven by the observation that fibroid growth is hormone dependent, current medical treatments mainly involve hormonal manipulations. Gonadotrophin-releasing hormone analogues (GnRHa) have been the most widely used, and while they do cause fibroid regression, they can only be used in the short term, as temporizing measures in the perimenopausal woman, or pre-operatively to reduce fibroid size, influence the type of surgery, restore haemoglobin levels and apparently reduce blood loss at operation. They are notorious for rebound growth of the fibroids upon cessation of therapy, and have major side-effects. GnRH antagonists avoid the initial flare effect seen with GnRHa therapy, but otherwise do not appear to have any additional advantages over GnRHa. Selective oestrogen receptor modulators, such as raloxifene, have been shown to induce fibroid regression effectively in post-, but not pre-, menopausal women; even in the former group, experience with these drugs is limited, and they are associated with significant side-effects. Aromatase inhibitors only appear to be effective in postmenopausal women, have potentially significant long-term side-effects, and experience with their use is also limited. There are suggestions that the levonorgestrel intra-uterine system can cause dramatic reduction in menstrual flow in women with fibroids, but to date there have been no RCTs of its use in these women, in whom rates of expulsion of the device appear to be high. The progesterone antagonists mifepristone and asoprisnil have shown significant promise and warrant further research, as they appear to show efficacy in inducing fibroid regression without major side-effects. However, they and the other hormonal therapies that alter oestrogen and progesterone production or function significantly (danazol, gestrinone) are not compatible with reproduction. Therefore, the quest for the ideal medical therapy for fibroid disease continues, and increasing understanding of fibroid biology is ushering in non-hormonal therapies, although all are confined to laboratory experimentation at present. In the meantime, surgical and radiological approaches remain the mainstay effective therapies.     

Acceptability and side-effects of Implanon in Switzerland: a retrospective study by the Implanon Swiss Study Group.

DESIGN: A multicenter, retrospective study of the single-rod contraceptive implant, Implanon (NV Organon, Oss, The Netherlands), was carried out in Switzerland in 1183 women. METHODS: Assessments included duration of use, bleeding pattern, side-effects and subjective acceptability and satisfaction with the method. RESULTS: A total of 991 women (84%) had at least one follow-up visit and 306 (26%) had two visits with a mean duration between insertion and follow-up of 224 days (7.4 months) and 347 days (11.4 months), respectively. Implanon was removed prematurely in 235 women (24%), primarily because of side-effects (20%) and for family planning reasons (4%). Side-effects leading to discontinuation were mainly bleeding disturbances (45%), acne (12%) and other reasons (15%). The mean duration between insertion and removal for discontinuers was 280 days (9.2 months). Side-effects related to bleeding (visit 1) included infrequent bleeding (28%), amenorrhea (33%), prolonged bleeding (15%), and metromenorrhagia (frequent and heavy bleeding) (16%). Other reported side-effects at visit 1 included dizziness (12%), acne (11%), mood swings (8%) and headache (5%). The incidence of side-effects reported at visit 2 was generally comparable to that at visit 1. CONCLUSIONS: The results of this study show that early discontinuation of implant use is primarily due to bleeding problems. Extensive counseling before implant insertion may help to prevent this. It is also important to develop an easy solution to successfully treating progestogen-induced bleeding disturbances.     

Side-Effects and Complications of Outpatient Hysteroscopy

Summary: Outpatient hysteroscopy and biopsy was performed on 403 occasions. Complications were rare (<1%). Side-effects occurred in 70% of patients but rarely required treatment. Preoperative explanation of the type, severity and frequency of side-effects reduces patient anxiety at the time when side-effects occur.     

Three-cycle fentanyl patch system significantly improves pain control in gynecologic cancer

Pain affects many cancer patients, and in advanced stages of the disease it can significantly affect the quality of their lives. Morphine has long been the 'gold standard' for the treatment of cancer pain. However, its side-effects, particularly sedation and cognitive impairment at high doses, have encouraged the use of 'opioid rotation'. The transdermal fentanyl patch has advantages over oral morphine, with reduced side-effects and increased convenience in practical usage. The side-effects were reduced in patients who changed to the fentanyl patch, but rescue analgesia was often needed because of the decrease of fentanyl release from the patch, especially on the patch replacement day. We have developed a three-cycle fentanyl patch system that provided an appropriate pain control, and this system should be considered for pain relief in cancer patients.     

Prostaglandin inhibitors in preterm labour

Prematurity accounts for the majority of neonatal morbidity and mortality in the developed world. The process of labour resembles inflammation, with prostaglandin and cytokine production both before and during labour. Anti-inflammatory drugs therefore have the potential to prevent preterm delivery. Indomethacin is the only tocolytic drug proven to delay delivery beyond 37 weeks and to reduce the incidence of low birth weight (<2500 g). There are, however, fetal side-effects such as ductal constriction and impaired renal function associated with its use. It is the type 2 isoform of cyclo-oxygenase (COX-2), which is important for the production of prostaglandins within intrauterine tissues and that up-regulation of COX-2 is associated with labour. Although indomethacin is currently the most common non-steroidal anti-inflammatory drug (NSAID) used in the treatment of preterm labour, it was hoped that COX-2-selective drugs, used as tocolytics, would target COX-2 activity and potentially spare COX-1-specific fetal side-effects. Experience with sulindac and nimesulide has been linked with both constriction of the ductus arteriosus and oligohydramnios. It is unclear whether this is due to COX-2-dependent side-effects, or due to accumulation of drug in the fetal circulation leading to levels that would cause COX-1 inhibition. Currently, the use of COX-2-selective drugs should therefore be confined to randomized controlled trials.     

Choice of oxytocic preparation for routine use in the management of the third stage of labour: an overview of the evidence from controlled trials

Prophylactic use of oxytocics reduces the risk of postpartum haemorrhage by about 40%. The analysis presented in this paper assesses which oxytocic preparation is associated with the least risk of postpartum haemorrhage and examines the relative effects of different preparations on the length of the third stage, the risk of manual removal of the placenta, blood pressure and other side-effects. A mixture of oxytocin and ergometrine (Syntometrine) appears to be the safest and most effective prophylactic of the alternatives which have been compared, but the quality of the evidence is not satisfactory. There is scope for a randomized comparison of Syntometrine with oxytocin to obtain unbiased and more precise estimates of their relative effects on postpartum haemorrhage, blood pressure and unpleasant side-effects.     

Role of progestins in contraception

Progestins have been used for contraception for more than 30 years. The main goal was to develop a contraceptive method devoid of the metabolic or clinical side-effects associated with the use of estrogens. The development of new contraceptive methods and formulations is time-consuming and requires devotion, belief, and also strong economical basis. As a result of this endeavor new methods have been developed: oral progestins, implants, injectables, intrauterine hormonal systems, and vaginal rings. Progestin-only contraceptives may be preferable in some situations, which have absolute or relative contraindications to estrogen, side-effects to estrogen containing hormonal contraception, lactation, and comfort and feasibility of formulations for long-term use. At present, emergency contraception is also performed with progestin.     

Acceptability and side-effects of Implanon in Switzerland: a retrospective study by the Implanon Swiss Study Group

Design A multicenter, retrospective study of the single-rod contraceptive implant, Implanon^® (NV Organon, Oss, The Netherlands), was carried out in Switzerland in 1183 women. Methods Assessments included duration of use, bleeding pattern, side-effects and subjective acceptability and satisfaction with the method. Results A total of 991 women (84%) had at least one follow-up visit and 306 (26%) had two visits with a mean duration between insertion and follow-up of 224 days (7.4 months) and 347 days (11.4 months), respectively. Implanon was removed prematurely in 235 women (24%), primarily because of side-effects (20%) and for family planning reasons (4%). Side-effects leading to discontinuation were mainly bleeding disturbances (45%), acne (12%) and other reasons (15%). The mean duration between insertion and removal for discontinuers was 280 days (9.2 months). Side-effects related to bleeding (visit 1) included infrequent bleeding (28%), amenorrhea (33%), prolonged bleeding (15%), and metromenorrhagia (frequent and heavy bleeding) (16%). Other reported side-effects at visit 1 included dizziness (12%), acne (11%), mood swings (8%) and headache (5%). The incidence of side-effects reported at visit 2 was generally comparable to that at visit 1. Conclusions The results of this study show that early discontinuation of implant use is primarily due to bleeding problems. Extensive counseling before implant insertion may help to prevent this. It is also important to develop an easy solution to successfully treating progestogen-induced bleeding disturbances.     

Choice of oxytocic preparation for routine use in the management of the third stage of labour: an overview of the evidence from controlled trials

Summary. Prophylactic use of oxytocics reduces the risk of postpartum haemorrhage by about 40%. The analysis presented in this paper assesses which oxytocic preparation is associated with the least risk of postpartum haemorrhage and examines the relative effects of different preparations on the length of the third stage, the risk of manual removal of the placenta, blood pressure and other side-effects. A mixture of oxytocin and ergometrine (Syntometrine) appears to be the safest and most effective prophylactic of the alternatives which have been compared, but the quality of the evidence is not satisfactory. There is scope for a randomized comparison of Syntometrine with oxytocin to obtain unbiased and more precise estimates of their relative effects on postpartum haemorrhage, blood pressure and unpleasant side-effects.     

Prostaglandin E1 treatment in patent ductus arteriosus dependent congenital heart defects

Prostaglandin E1 (PGE1) treatment can be life saving in patients suffering from ductus dependent congenital heart defect. We analyzed the indications and side-effects of PGE1 therapy over a five-year period. The purpose of the study was also to examine whether a change in serum electrolyte levels could be detected. Forty-nine patients were treated with PGE1 during this period. PGE1 treatment was indicated by ductus dependent systemic circulation in 16 cases, ductus dependent pulmonary circulation in 17 cases, transposition of the great arteries in 13 cases and pulmonary hypertension (persistent fetal circulation) in three cases. As early side-effects of the treatment, fever occurred in 27/49 cases while apnoea was observed in 15 patients. In a one-week-old neonate with coarctation of the aorta grade III intraventricular hemorrhage developed. A mild decrease of sodium, potassium and chloride levels and a slight shift of pH levels toward metabolic alkalosis could be detected after one day and one week of PGE1 treatment. Because of these side-effects of PGE1 patients should be monitored in an intensive care unit. According to our observations electrolyte levels may exhibit a slight decrease; however, in the case of a short-term therapy extra salt supplementation is not necessary.