A Pilot Study of Priming Before Induction Termination of Pregnancy
Condition: Abortion, Induced; Abortion, Second Trimester
Study type: Interventional

Summary: 
      Induction termination of pregnancy (second trimester abortion) has a median time of 14 hours
      from the start of medication (misoprostol) to expulsion of the fetus. The objective of this
      study is to evaluate a method of 'priming' on the length of induction termination of
      pregnancy. "Priming" refers to the use of medication to ready the cervix and uterus so that
      the uterus is more sensitive to medication and contracts more effectively, and also refers to
      softening of the cervix so that there is less resistance to dilation. Priming is used
      extensively before induction of labor for term pregnancy and is also used extensively before
      surgical abortion in second trimester. We would like to add priming the evening before
      induction to the usual treatment and evaluate whether the length of the induction process is
      shortened. Women are admitted to the hospital in the morning to start misoprostol medication,
      and unless expulsion occurs within 8-10 hours, need to stay overnight.

      The study design is to give the priming dose 12 hours before admission. The outcome of
      interest is the induction time from the first dose on misoprostol in the hospital to
      expulsion of the fetus.

      This study aims to assess whether the use of misoprostol as a priming agent would be
      beneficial with women who undergo induction termination of pregnancy.
    

Detailed description: 
      This is a prospective series. All women enrolled will receive the same treatment. 10 women
      without prior births and 10 women with prior births will be enrolled. The study design is to
      give the priming dose 12 hours before admission.

      The outcome of interest is the induction time from the first dose on misoprostol in the
      hospital to expulsion of the fetus.

      Inclusion criteria: Women who have requested induction abortion and completed the counseling
      and consent process for abortion. Women 18 years of age or over. Capable of giving informed
      consent. Speak English or Spanish Pregnancy 18-23 weeks. No contraindication to misoprostol
      abortion

      Exclusion criteria: Unable to understand and give informed consent. Pregnancy less than 18
      weeks or over 23 weeks on the day of enrollment. Ruptured membranes or signs of infection
      (temperature over 100.6 F,WBC >15K) Fetal demise Multi-fetal pregnancy Contraindication to
      any of the agents used for misoprostol induction abortion

      After women have started the abortion process (completed counseling and consent for abortion,
      and completed the fetocidal digoxin injection), they will be approached by one of the
      investigators. The procedures and the consent process will be explained. If they consent,
      they will be given an envelope which contains 50 mcg of misoprostol (1/2 of a 100 mcg
      tablet). They will be instructed to place the tablet buccally and hold it in place for 30
      minutes, after which it can be swallowed, between 8 and 9 pm that evening.

      They will return at 7 am the next morning; the actual induction process starts between 8 and
      10 am depending on the bed situation. The reminder of the care is identical to women not in
      the study and consists of misoprostol 400 every 6 hours. The only step that will be from the
      current induction process is the administration of the priming dose the night before.

      The duration of participation for individuals is up to 48 hours. The study overall will take
      one year.

      Analytic plan:

      This is a pilot study to estimate the effect on induction times, and to monitor for any
      adverse events. This pilot will be the basis of further study.

      When the sample size is 19, a two-sided 95.0% confidence interval for a single mean will have
      an interval that extends no more than 1.5 from the observed mean, assuming that the true
      standard deviation is 3.25 and that the confidence interval is based on the t statistic. The
      "typical" mean is 14 hours and the 95% confidence interval around 12.5 hours is 11hours to 14
      hours.

      The primary outcome is the induction time, the time from start of induction until fetal
      expulsion. As there are about 80 induction procedures per year, and past studies have
      enrolled 50-60% of eligible women, it will take approximately 6 months to complete
      enrollment.

      The length of induction will be described and the mean will be contrasted to a typical value
      (14 hours) . Minor events such as nausea will be tabulated. There will be a sub-analysis of
      outcome by parity (women without prior births compared to women with prior births). This
      study is not powered to show differences between these two groups but this information wil be
      helpful in planning future studies.
    

Intervention name(s): Addition of misoprostol 25 mcg 12 hours before induction
Intervention type(s): Drug
Intervention description(s): Misoprostol given buccally the night before induction
Intervention MeSH terms: Misoprostol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: induction; abortion; injection, intra-amniotic; misoprostol