Comparison of Two Regimens of Misoprostol for Second Trimester Medical Termination of Pregnancy
Condition: Induced Abortion
Study type: Interventional
Phase: Phase 4

Summary: 
      The hypothesis of the study is that the induction abortion interval time will be
      significantly shorter in the group receiving vaginal misoprostol every six hours in
      comparison to the group who are receiving vaginal misoprostol every twelve hours.
    

Detailed description: 
      Objectives:

      Misoprostol, a prostaglandin analogue, is principally used to prevent peptic ulcer disease
      induced by nonsteroidal anti-inflammatory agents .It has been shown to induce second
      trimester abortion .However , the optimal regimen has not been determined .Studies have used
      doses ranging 200- 800 microgram misoprostol at interval ranging from 3-12 hours.1,2,3,4,5 In
      our previous study we have compared intravaginal misoprostol with extra amniotic ethacridine
      lactate for second trimester MTP.6 In this study we have observed that misoprostol is highly
      effective( success rate 95%) for second trimester MTP with minimal side effects .&
      intravaginal misoprostol results in significantly shorter induction abortion interval in
      comparison to extra amniotic ethacridine lactate .Induction abortion interval in this study
      for misoprostol was 15.5 hours and the dosage of misoprostol was 400 microgram vaginally
      every 12 hours with a maximum of 4 doses .Success rate and induction abortion interval are
      the major factors of clinical importance for second trimester MTP . Our aim is to establish a
      dosage schedule of misoprostol which will result in high success rate in mid trimester MTP
      with further shortening of induction abortion interval Our study hypothesis is that using 400
      microgram of vaginal misoprostol at six hour interval will result in significant shortening
      of induction abortion interval in comparison to 400 microgram vaginal misoprostol at 12 hour
      interval.

      Methods - A prospective randomized comparative clinical trial will be conducted over 200
      women.

      Women attending the hospital for mid trimester MTP i.e. 12-20 weeks of pregnancy will be
      taken up for the study. Gestational age will be determined from LMP & per abdominal findings.
      Ultrasonography will be done in selected women where clinical finding is unreliable . All
      women will be examined for vital parameters and routine hematological and urine examination
      will be done. Randomization will be done using a table of random numbers .A written consent
      for inclusion in the study will be taken from all patients who will be included in the study.

      In one group women will receive 400 microgram vaginal misoprostol tablet at interval of 12
      hours with a maximum of four doses.

      In other group women will receive 400 microgram vaginal misoprostol tablet at an interval of
      6 hours with a maximum of four doses.

      Failure of procedure in both groups will be defined as failed expulsion of fetus at 48 hours
      or as the occurrence of systemic adverse signs and symptoms severe enough to preclude the use
      of additional drugs.

      The patient's vital signs will be monitored every four hours and the occurrence of signs and
      symptoms, such as fever, pain, vomiting, and diarrhea will be recorded. After expulsion of
      the fetus and placenta, check curettage will be done in every case. Completeness of abortion
      will be defined as expulsion of both placenta and fetus without operative assistance. The
      induction abortion interval will be defined as time from administration of 1st dose of
      Misoprostol to abortion of fetus. Hemorrhage will be defined as an estimated blood loss
      exceeding 500 ml or need to blood transfusion. Fever will be defined as rise of temperature
      100.4˚ F or more occurring 24 hours or more after pregnancy termination.

      The following parameters will be studied (1) Induction abortion interval (2) Completeness of
      procedure (3) Failure of abortion (4) side effects (5) cost per procedure.

      Statistical analysis will be carried out with Epi Info statistical software.
    

Intervention name(s): Misoprostol; Misoprostol
Intervention type(s): Drug; Drug
Intervention description(s): 400 microgram vaginal misoprostol tablet will be applied every 6 hours with a maximum of 4 doses; 400 microgram vaginal misoprostol tablet will be applied every 12 hours with a maximum of 4 doses
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Medical termination of pregnancy; Induction of abortion; Misoprostol; MTP in second trimester; 400 microgram vaginal misoprostol