Techniques to Improve Efficacy of Second Trimester Medical Termination
Condition: Pregnancy
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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
    

Intervention name(s): Misoprostol
Intervention type(s): Drug
Intervention description(s): Comparison of 3 routes of administration of misoprostol for termination of pregnancy 14-24 weeks
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Abortion; Misoprostol; Mifepristone; Pregnancy; Fetus