Pregnancy Clinical Trial
Official title:
Comparison of 3 Regimens Using Mifepristone and Misoprostol for Second Trimester Pregnancy Interruption.
Interruption of a pregnancy after 14 weeks gestation may be required when the fetus is dead,
severely malformed or in cases of maternal illness. This process is usually conducted
medically in Australia, using the synthetic prostaglandin E1 analogue misoprostol. This
prostaglandin, although not licensed for use in pregnancy termination, is now a common
abortifacient with a large accumulated experience both within Australia and internationally.
Since 1996, misoprostol has been used at King Edward Memorial Hospital as the principal
agent for second trimester pregnancy termination.
Misoprostol may be administered vaginally, orally, sublingually or buccally in the process
of pregnancy termination. Each route of administration has its own advantages and
disadvantages. The most appropriate route of administration, with the shortest duration of
abortion and lowest side-effect profile has not been determined for all circumstances.
The combination of mifepristone and misoprostol is an established and effective method for
second trimester pregnancy termination. Prior studies have demonstrated a significant
reduction in the duration of abortion with misoprostol when mifepristone priming is used. In
November 2007, the TGA (Therapeutic Goods Administration) approved an application by the
Principal Investigator of this planned study for Authorised Prescriber status for use of the
antiprogesterone agent mifepristone. Since January 2008 the combination of mifepristone and
misoprostol has been used at KEMH for first and second trimester pregnancy termination of
pregnancy, predominantly for circumstances of severe fetal abnormality.
There is however limited data on the impact of gestation on the duration of second trimester
termination. Almost all published studies to date have recruited women in the early second
trimester (typically with a median of 16 weeks gestation). However, most terminations of
pregnancy for fetal abnormality (the most frequent reason for pregnancy interruption of a
live fetus at KEMH) occur at 18-24 weeks gestation. The investigators' experience indicates
a significant impact of increasing gestation with prolongation of the duration of pregnancy
termination. In this study the investigators aim to evaluate three misoprostol regimens for
second trimester pregnancy termination following mifepristone priming with the primary
intention to develop a protocol which results in a delivery rate within 24 hours for 95% of
women at gestations <24 weeks.
Secondary aims of this study will be to assess the incidence of maternal side-effects for
each of the three regimens, the placental retention rates and the need for curettage for
retained placental tissue. As the investigators will be using 3 different methods of
misoprostol administration, the investigators will also review women's satisfaction with the
three regimens for pregnancy termination.
Aims:
1. To compare the efficacy of the vaginal and sublingual administration of the synthetic
prostaglandin misoprostol with the currently used vaginal administration route in
second trimester pregnancy termination.
2. To compare the impact of gestation of the duration of abortion within these three
misoprostol regimens.
3. To compare the incidence of maternal side-effects between the three routes of
prostaglandin administration.
4. To compare the incidence of placental retention and need for curettage between the
three groups
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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