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Off-label drugs

  1. Top of page
  2. Off-label drugs
  3. Obstetric surveillance
  4. Vaginal hysterectomy
  5. Fetal fibronectin
  6. Fibroids
  7. Deprivation and the menopause

Last year we discussed off-label tocolytics. This month we have twocommentaries on misoprostol, another drug often used controversially outside its licensed indications. Marsden Wagner argues (pp. 266–268) against misoprostol as a cervical ripening agent on the grounds that it has not been properly evaluated, and that other licensed drugs are available, while a group of medical campaigners with links to developing countries, argue (pp. 269–272) that it should be used more widely. Their claim is based largely on cost. Misoprostol is cheaper than alternative prostaglandins, although whether this reflects lack of safety evaluation in pregnancy, or a genuinely lower market price because of a more favourable balance between supply and demand, is debatable. The advocates of off-label misoprostol also emphasise its place in abortion or to control post partum haemorrhage, rather than to induce labour. Despite the lack of a licence, the evidence-base for the former indications is relatively strong.

Obstetric surveillance

  1. Top of page
  2. Off-label drugs
  3. Obstetric surveillance
  4. Vaginal hysterectomy
  5. Fetal fibronectin
  6. Fibroids
  7. Deprivation and the menopause

For 20 years British paediatricians have notified new cases of a panel of topical but rare childhood conditions to a central office each month. Although it has been a dramatically successful research tool, obstetricians have until now relied on ad hoc surveys, such as the BEST one of eclampsia in 1992. We are now following the paediatricians' lead with the launch of the United Kingdom Obstetric Surveillance System (UKOSS) (pp. 263–265).

Vaginal hysterectomy

  1. Top of page
  2. Off-label drugs
  3. Obstetric surveillance
  4. Vaginal hysterectomy
  5. Fetal fibronectin
  6. Fibroids
  7. Deprivation and the menopause

The proportion of hysterectomy operations performed by the vaginal route varies widely between regions and hospitals according to a survey from the Doctor Foster unit at Imperial College (pp. 326–328). The variation, which was not explained by difference in case mix, is likely to come under close scrutiny in future as the NHS moves towards paying hospitals according to a tariff for work undertaken. If, as the authors claim, the vaginal route is really quicker and safer, managers will have to encourage it. Some people doubt the wisdom of allowing this sort of commercial pressure to influence doctors' decisions but at least the new system will create an incentive for hospitals to collect accurate statistics.

On pages 329–333 a group from Kent report a randomised controlled trial of a newish haemostastic device at vaginal hysterectomy. The Ligasure instrument uses controlled pressure and electro-coagulation to occlude the sort of larger vessels which would normally require ligation. The trial confirms that operative time is reduced with the use of the new device, but was too small to estimate relative safety. Audit and case control studies are probably better at evaluating that.

Fetal fibronectin

  1. Top of page
  2. Off-label drugs
  3. Obstetric surveillance
  4. Vaginal hysterectomy
  5. Fetal fibronectin
  6. Fibroids
  7. Deprivation and the menopause

Fetal fibronectin in vaginal secretions is a good predictor of pre-term delivery (pp. 293–298). The authors of the present study revealed the results to patients which would have compromised their estimate of test accuracy if treatment had been given, but which gave them the opportunity to measure the resulting patient anxiety. Patients with a positive result at 24 weeks were more anxious, and justifiably so, since nearly half of them were delivered before 30 weeks. Fortunately few other women, outside research projects, need be made anxious, because we have no effective treatment for high risk of preterm labour.

Fibroids

  1. Top of page
  2. Off-label drugs
  3. Obstetric surveillance
  4. Vaginal hysterectomy
  5. Fetal fibronectin
  6. Fibroids
  7. Deprivation and the menopause

Open myomectomy, the conventional treatment for women with symptomatic fibroids who wish to retain fertility, is a major operation with high morbidity. On pages 340–345 Adam Magos and his colleagues from the Royal Free in London report a randomised trial of the use of three haemostatic tourniquets during the operation, one of which was left in situ. The effect on blood loss and need for transfusion was dramatic, although the difference was largely due to a higher than expected blood loss in the control group. There appeared to be no obvious alteration in ovarian function post operatively, but the results of fertility follow-up are awaited.

Fibroid embolisation also potentially retains fertility. On pages 321–325 the group from Guildford, with perhaps the most experience in the UK, report the outcome for 26 pregnancies in 22 women. The high rate of preterm delivery was also seen in other series, and the high rate of caesarean section may owe as much to the age of the mothers and their previous history as to the embolisation itself.

Deprivation and the menopause

  1. Top of page
  2. Off-label drugs
  3. Obstetric surveillance
  4. Vaginal hysterectomy
  5. Fetal fibronectin
  6. Fibroids
  7. Deprivation and the menopause

Social deprivation in adulthood is associated with early menopause, although the effect may be mediated by smoking. On pages 346–354 Hardy and Kuh use data from the Medical Research Council's National Survey of Health and Development to investigate early-life influences. Such factors as parental divorce and having a father in a manual occupation in childhood are more strongly associated with early menopause than later-life stress, and the association is independent of later-life behavioural factors.