Journal of the Royal Society of Medicine Volume 85 April 1992 On examination there was a 4-5 cm long ulcer at the anorectal margin confirmed histologically as squamous carcinoma. Haemoglobin 13.4 g/dl; WCC 5.2x 103/4d; platelets 96 x103/4l; ESR 55 mm/h; GGT 56 u/l. Ultrasound of abdomen and CT of abdomen and pelvis were normal. Local radiotherapy resulted in complete resolution. On the 11 July 1990 he was admitted elsewhere with a dry cough and dyspnoea. He was pyrexic and tachypnoeic with basal rhonchi on auscultation. Haemoglobin 9.3 gIdl with normal indices; ESR 130 mm/h; WCC 5.8x103l4d; paO2 65 mmHg; ALP 212 u/l, GGT 137 u/l. Legionella titres were normal. Chest X-ray showed wide spread consolidation. Despite intravenous cefotaxime and erythromycin he died on the 19 July 1990. Pneumocystis carinii pneumonia was diagnosed at postmortem and antibodies to HIV-1 were positive in stored serum. Discussion With the increased prevalence of lHl in the population there will be a corresponding increased incidence of HIV in groups traditionally regarded as 'low risk'. Preconceptions of 'risk groups' may result in misdiagnosis, omission of antiviral and prophylactic therapy and inappropriate treatment of opportunistic infections. Given the age-related increase in disease progression and shorter survival5, this has serious implications for the elderly.
241
Management is often complicated by other medical problems, the age-related increase in infections such as influenza, bacterial pneumonia and tuberculosis, and adverse drug reactions. For younger patients care is often provided by parents, in older patients family support is often difficult to secure. AIDS affects all age groups and perceptions of risk can be misleading. References 1 AIDS/IEV. CDSC Quarterly Surveillance Tables, November 1990 2 Walsh DA. Lengthy incubation for homosexual transmission of acquired immunodeficiency syndrome in a 79 year old man. Postgrad Med J 1989;65:959 3 Kendig NE, Adler WH. The implications of the acquired immunodeficiency syndrome for gerontology research and geriatric medicine. J Gerontol 1990;45:M77-81 4 Moss RJ, Miles SH. AIDS and the geriatrician. JAm Geriatr Soc 1987;35:460-4 5 Moss AR, Baccheti P, Osmond D, et aL Seropositivity for HIV and the development of AIDS or AIDS related condition: three year follow-up of the San Francisco General Hospital cohort. BMJ 1988;296:745-50
(Accepted 11 April 1991)
Monitoring of triplet pregnancy during labour
S Oates MB ChB MRCOG F Hamer MB BS Department of Obstetrics & Gynaecology, St Mary's Hospital, Whitworth Park, Manchester M13 OJD
......._;...j
4._ Keywords: triplets; vaginal delivery; fetal monitoring
As a result of the success of assisted reproduction techniques, multiple births are more common. While the incidence of twins has not significantly altered, that of triplets has risen from 0.11 per thousand deliveries to 0.24 since 19861. With the introduction of twin channel ultrasound monitors it is now possible to monitor at least three fetuses in labour, so that vaginal delivery can be safely achieved.
Figure 1.
Three separate fetal heart
readings
Figure 1. Three separate fetal heart readings
Case report A 23-year-old primigravida booked at 11 weeks, following clomiphene treatment for infertility. A triplet pregnancy was diagnosed on ultrasound scan. She attended antenatal clinic regularly. At 27 weeks she was transferred to our hospital in suspected pre-term labour where she remained until
During the second stage of labour only intermittent recordings were possible due to changing maternal and fetal positions. Three healthy infants were delivered in good condition following lift out forceps deliveries for failure to progress and maternal exhaustion. The first was male weighing 2.34 kg, the second female at 2.23 kg and the third a male weighing 1.90 kg. Mother and babies made good progress, only the smallest requiring phototherapy, and were discharged home on the 12th day.
delivery. The rest of her antenatal course was uneventful. At 35 + weeks due to increasing breathlessness, marked peripheral oedema and generalized immobility, induction of labour was performed. All three fetuses presented cephalically and had grown at just below the 10th centile by serial ultrasound measurements. An epidural was sited at maternal request. Continuous fetal monitoring was possible throughout the first stage by applying a fetal scalp electrode to triplet 1 on a separate monitor, and monitoring the other two triplets using the Meridian 800 Twin monitor (Oxford-Sonicaid) via ultrasound transducers using different ultrasound frequencies (see Figure 1). The first stage of labour progressed normally.
Discussion The management of delivery in a triplet pregnancy is debatable, some authors2 advocating delivery by caesarean section, while others45 feel that vaginal delivery may be just as appropriate. Most triplet pregnancies end prematurely, 76% being delivered before 36 weeks gestation'. Ron-El et aW5 in a series of 19 sets of triplets, reported a perinatal mortality rate of 123/1000 in vaginally delivered triplets, as opposed to 62/1000 in those delivered by caesarean section. The mean gestational age of those delivered by caesarean section was 2.2 weeks more advanced than the vaginally delivered group. Loucoupoulos and Jewelewicz6 reported similar findings.
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Journal of the Royal Society of Medicine Volume 85 April 1992
The most common presentation of the first triplet is vertex Presentation of the second and third triplet is more variable. Michelwitz et al.7 reported a very high incidence of malpresentation and concluded that delivery by caesarean section was indicated. Several studies7'8 report increasing perinatal mortality for the second and third triplets. In the largest review available, of 367 triplet pregnancies, Deale and Cronje9 support this finding but noted there was a significant reduction when the second and third infants were delivered by caesarean section. However Itzovic8 found birth order directly related to perinatal outcome in vaginally delivered triplets only before 35 weeks, and concluded it was reasonable to allow vaginal delivery of uncomplicated triplets after 34 weeks. Daw' found breech presentation to be associated with a poorer neonatal outcome independent of birth order, whereas Holcberg et al.W0 failed to confirm this. In none of the reported series is any mention made of electronic fetal monitoring in labour, indeed we could find no data on this for triplet pregnancy, although Perol et al." and Read and Miller"2 discuss monitoring of twins. With twins it is now standard practice to monitor electronically the fetal heart rates by applying a scalp electrode to the leading twin and using an ultrasound transducer for the second. For triplets with the use of twin channel ultrasound monitors using different frequencies, the second and third fetuses can be successfully monitored although considerable efforts are required by the attendants to ensure three different readings are obtained. We consider that now continuous fetal monitoring in triplet
(73.5%').
labour is feasible, vaginal delivery is advocated, reserving caesarean section for when fetal problems arise. References 1 Obstetric data. Three, four and more. London: HMSO, 1990 2 Daw E. Triplet pregnancy. Br J Obstet Gynaecol 1978;85:505-9 3 Pons JC, Mayenga JM, Plu G, Forman RG, Papiernik E. Management of triplet pregnancy. Acta Genet Med Gemellol 1988;37:99-103 4 Thiery M, Kermans G, Derom R. Triplet and higher order births: what is the optimal delivery route? Acta Genet Medica Gemellol 1988;37:89-98 5 Ron-El R, Capsi E, Schreyer P, et al. Triplet and quadruplet pregnancies and management. Obstet Gynecol 1981;57:458-63 6 Loucopoulos A, Jewelewicz R. Management of multifetal pregnancies: 16 years' experience at the Sloane Hospital for Women. Am J Obstet Gynecol 1982;143:902-5 7 Michelwitz H, Kennedy J, Kawada C, Kennison R. Triplet pregnancies. J Reprod Med 1981;26:243-6 8 Itzkowic D. A survey of 59 triplet pregnancies. Br J Obstet Gynaecol 1979;86:22-8 9 Deale C, Cronje H. A review of 367 triplet pregnancies. S Afr Med J 1984;66:92-4 10 Holcberg G, Biale Y, Leventhal H, Insler V. Outcome of pregnancy in 31 triplet gestations. Obstet Gynecol 1982;59:472-6 11 Pernoll M, Carnes R. Electronic fetal monitoring of twin gestations. Am J Obstet Gynecol 1973;116:583-4 12 Read J, Miller F. Technique of simultaneous direct intrauterine pressure recording for electronic monitoring of twin pregnancy. Am J Obstet Gynecol 1977;129:228-9
(Accepted 11 April 1991)
Meeting report
The complexity of clinical drug trials has increased enormously over the past decade, with a concomitant burgeoning increase in the amount of documentation required. In the main, this has resulted from the statutory requirements of the regulatory authorities, particularly in the USA. Inevitably, much of the burden of this extra effort has been taken over by specialist contract companies or by the pharmaceutical sponsors. However, when it comes to publishing the results of clinical trials, what is the relative involvement of these organizations and of the investigators themselves? The Forum considered these problems, with an emphasis on the professional point of view.
the patient can retain. Comprehension and language must be considered but many mentally ill patients are nevertheless capable of giving informed consent. Placebo and double-blind procedures must be explained and control treatment, even when relatively ineffective, is always preferred to placebo. In multi-centre trials, the co-ordinator should not be an employee of the company organizing the trial and the protocol must always be submitted to each individual local Ethical Committee. Professor Brandon felt that such trials would be better organized by the Royal Colleges, research groups or even individual researchers, rather than the sponsors themselves. No constraints concerning publication should be placed on the investigator and insistence on prior permission, even in the case of the Department of Health, is to be deprecated. Premature publication via the media must be inhibited, as should 'trial by TV' as in the case of a recent programme concerning an antidepressant.
Responsibility for publication cannot be separated from the ethical responsibility of the investigator in conducting the trial in the first place. Professor Sydney Brandon (University of Leicester) emphasized that, according to the Declaration of Helsinki, the wellbeing ofthe subject is paramount and doctors should refuse to take part, or should withdraw from, trials where this is threatened. The 'cost-benefit analysis' must be in the patient's favour and informed consent should include printed information that
Responsible sponsorship was the subject of the next speaker, Professor Desmond Julian (British Heart Foundation, London) who commented that clinical investigators and pharmaceutical companies needed each other and that, for the most part, the relationship was a satisfactory one. However, other factors may intrude, in particular financial considerations. Investigators do not always have adequate resources and it is appropriate that companies should only support those who do and should closely monitor the
Clinical trial results: whose responsibility? Keywords: clinical trials; publication; multi-centre studies; statistics; sponsorship
Report of meeting of Forum on Clinical Pharmacology & Therapeutics, 18 March 1991
0141-0768/92/ 040242-03/$02.00/0 © 1992 The Royal Society of Medicine
241
Management is often complicated by other medical problems, the age-related increase in infections such as influenza, bacterial pneumonia and tuberculosis, and adverse drug reactions. For younger patients care is often provided by parents, in older patients family support is often difficult to secure. AIDS affects all age groups and perceptions of risk can be misleading. References 1 AIDS/IEV. CDSC Quarterly Surveillance Tables, November 1990 2 Walsh DA. Lengthy incubation for homosexual transmission of acquired immunodeficiency syndrome in a 79 year old man. Postgrad Med J 1989;65:959 3 Kendig NE, Adler WH. The implications of the acquired immunodeficiency syndrome for gerontology research and geriatric medicine. J Gerontol 1990;45:M77-81 4 Moss RJ, Miles SH. AIDS and the geriatrician. JAm Geriatr Soc 1987;35:460-4 5 Moss AR, Baccheti P, Osmond D, et aL Seropositivity for HIV and the development of AIDS or AIDS related condition: three year follow-up of the San Francisco General Hospital cohort. BMJ 1988;296:745-50
(Accepted 11 April 1991)
Monitoring of triplet pregnancy during labour
S Oates MB ChB MRCOG F Hamer MB BS Department of Obstetrics & Gynaecology, St Mary's Hospital, Whitworth Park, Manchester M13 OJD
......._;...j
4._ Keywords: triplets; vaginal delivery; fetal monitoring
As a result of the success of assisted reproduction techniques, multiple births are more common. While the incidence of twins has not significantly altered, that of triplets has risen from 0.11 per thousand deliveries to 0.24 since 19861. With the introduction of twin channel ultrasound monitors it is now possible to monitor at least three fetuses in labour, so that vaginal delivery can be safely achieved.
Figure 1.
Three separate fetal heart
readings
Figure 1. Three separate fetal heart readings
Case report A 23-year-old primigravida booked at 11 weeks, following clomiphene treatment for infertility. A triplet pregnancy was diagnosed on ultrasound scan. She attended antenatal clinic regularly. At 27 weeks she was transferred to our hospital in suspected pre-term labour where she remained until
During the second stage of labour only intermittent recordings were possible due to changing maternal and fetal positions. Three healthy infants were delivered in good condition following lift out forceps deliveries for failure to progress and maternal exhaustion. The first was male weighing 2.34 kg, the second female at 2.23 kg and the third a male weighing 1.90 kg. Mother and babies made good progress, only the smallest requiring phototherapy, and were discharged home on the 12th day.
delivery. The rest of her antenatal course was uneventful. At 35 + weeks due to increasing breathlessness, marked peripheral oedema and generalized immobility, induction of labour was performed. All three fetuses presented cephalically and had grown at just below the 10th centile by serial ultrasound measurements. An epidural was sited at maternal request. Continuous fetal monitoring was possible throughout the first stage by applying a fetal scalp electrode to triplet 1 on a separate monitor, and monitoring the other two triplets using the Meridian 800 Twin monitor (Oxford-Sonicaid) via ultrasound transducers using different ultrasound frequencies (see Figure 1). The first stage of labour progressed normally.
Discussion The management of delivery in a triplet pregnancy is debatable, some authors2 advocating delivery by caesarean section, while others45 feel that vaginal delivery may be just as appropriate. Most triplet pregnancies end prematurely, 76% being delivered before 36 weeks gestation'. Ron-El et aW5 in a series of 19 sets of triplets, reported a perinatal mortality rate of 123/1000 in vaginally delivered triplets, as opposed to 62/1000 in those delivered by caesarean section. The mean gestational age of those delivered by caesarean section was 2.2 weeks more advanced than the vaginally delivered group. Loucoupoulos and Jewelewicz6 reported similar findings.
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Journal of the Royal Society of Medicine Volume 85 April 1992
The most common presentation of the first triplet is vertex Presentation of the second and third triplet is more variable. Michelwitz et al.7 reported a very high incidence of malpresentation and concluded that delivery by caesarean section was indicated. Several studies7'8 report increasing perinatal mortality for the second and third triplets. In the largest review available, of 367 triplet pregnancies, Deale and Cronje9 support this finding but noted there was a significant reduction when the second and third infants were delivered by caesarean section. However Itzovic8 found birth order directly related to perinatal outcome in vaginally delivered triplets only before 35 weeks, and concluded it was reasonable to allow vaginal delivery of uncomplicated triplets after 34 weeks. Daw' found breech presentation to be associated with a poorer neonatal outcome independent of birth order, whereas Holcberg et al.W0 failed to confirm this. In none of the reported series is any mention made of electronic fetal monitoring in labour, indeed we could find no data on this for triplet pregnancy, although Perol et al." and Read and Miller"2 discuss monitoring of twins. With twins it is now standard practice to monitor electronically the fetal heart rates by applying a scalp electrode to the leading twin and using an ultrasound transducer for the second. For triplets with the use of twin channel ultrasound monitors using different frequencies, the second and third fetuses can be successfully monitored although considerable efforts are required by the attendants to ensure three different readings are obtained. We consider that now continuous fetal monitoring in triplet
(73.5%').
labour is feasible, vaginal delivery is advocated, reserving caesarean section for when fetal problems arise. References 1 Obstetric data. Three, four and more. London: HMSO, 1990 2 Daw E. Triplet pregnancy. Br J Obstet Gynaecol 1978;85:505-9 3 Pons JC, Mayenga JM, Plu G, Forman RG, Papiernik E. Management of triplet pregnancy. Acta Genet Med Gemellol 1988;37:99-103 4 Thiery M, Kermans G, Derom R. Triplet and higher order births: what is the optimal delivery route? Acta Genet Medica Gemellol 1988;37:89-98 5 Ron-El R, Capsi E, Schreyer P, et al. Triplet and quadruplet pregnancies and management. Obstet Gynecol 1981;57:458-63 6 Loucopoulos A, Jewelewicz R. Management of multifetal pregnancies: 16 years' experience at the Sloane Hospital for Women. Am J Obstet Gynecol 1982;143:902-5 7 Michelwitz H, Kennedy J, Kawada C, Kennison R. Triplet pregnancies. J Reprod Med 1981;26:243-6 8 Itzkowic D. A survey of 59 triplet pregnancies. Br J Obstet Gynaecol 1979;86:22-8 9 Deale C, Cronje H. A review of 367 triplet pregnancies. S Afr Med J 1984;66:92-4 10 Holcberg G, Biale Y, Leventhal H, Insler V. Outcome of pregnancy in 31 triplet gestations. Obstet Gynecol 1982;59:472-6 11 Pernoll M, Carnes R. Electronic fetal monitoring of twin gestations. Am J Obstet Gynecol 1973;116:583-4 12 Read J, Miller F. Technique of simultaneous direct intrauterine pressure recording for electronic monitoring of twin pregnancy. Am J Obstet Gynecol 1977;129:228-9
(Accepted 11 April 1991)
Meeting report
The complexity of clinical drug trials has increased enormously over the past decade, with a concomitant burgeoning increase in the amount of documentation required. In the main, this has resulted from the statutory requirements of the regulatory authorities, particularly in the USA. Inevitably, much of the burden of this extra effort has been taken over by specialist contract companies or by the pharmaceutical sponsors. However, when it comes to publishing the results of clinical trials, what is the relative involvement of these organizations and of the investigators themselves? The Forum considered these problems, with an emphasis on the professional point of view.
the patient can retain. Comprehension and language must be considered but many mentally ill patients are nevertheless capable of giving informed consent. Placebo and double-blind procedures must be explained and control treatment, even when relatively ineffective, is always preferred to placebo. In multi-centre trials, the co-ordinator should not be an employee of the company organizing the trial and the protocol must always be submitted to each individual local Ethical Committee. Professor Brandon felt that such trials would be better organized by the Royal Colleges, research groups or even individual researchers, rather than the sponsors themselves. No constraints concerning publication should be placed on the investigator and insistence on prior permission, even in the case of the Department of Health, is to be deprecated. Premature publication via the media must be inhibited, as should 'trial by TV' as in the case of a recent programme concerning an antidepressant.
Responsibility for publication cannot be separated from the ethical responsibility of the investigator in conducting the trial in the first place. Professor Sydney Brandon (University of Leicester) emphasized that, according to the Declaration of Helsinki, the wellbeing ofthe subject is paramount and doctors should refuse to take part, or should withdraw from, trials where this is threatened. The 'cost-benefit analysis' must be in the patient's favour and informed consent should include printed information that
Responsible sponsorship was the subject of the next speaker, Professor Desmond Julian (British Heart Foundation, London) who commented that clinical investigators and pharmaceutical companies needed each other and that, for the most part, the relationship was a satisfactory one. However, other factors may intrude, in particular financial considerations. Investigators do not always have adequate resources and it is appropriate that companies should only support those who do and should closely monitor the
Clinical trial results: whose responsibility? Keywords: clinical trials; publication; multi-centre studies; statistics; sponsorship
Report of meeting of Forum on Clinical Pharmacology & Therapeutics, 18 March 1991
0141-0768/92/ 040242-03/$02.00/0 © 1992 The Royal Society of Medicine
