Induction of Labor by Oral Misoprostol Solution
Condition: Induction of Labor
Study type: Interventional

Summary: 
      AIM: To evaluate effectiveness and safety of titrated oral misoprostol solution (OMS) in
      comparison with static-dose oral misoprostol solution for induction of labor at term.

      Women with singleton live pregnancy at term without any complications who were admitted in
      labor room for induction of labor were enrolled.

      Study involves allocation of selected women in two groups randomly and use of either titrated
      or static oral misoprostol dose regimen to induce labor. Possible benefits included rapid
      induction of labor with oral drug regimen which is easier to comply as compared to vaginal
      regimens. Women were at risk of all the complications associated with induction of labor like
      labor abnormalities, risk of cesarean section, non reassuring fetal status.
    

Detailed description: 
      This comparative randomized study was conducted in the Department of Obstetrics and
      Gynecology, Christian medical college and hospital, Ludhiana for a period of one year
      beginning from 1st December, 2017 to 30th November, 2018. The study group comprised of all
      antenatal women admitted in labor room at term for induction of labor. Informed consent was
      taken for all selected women. Women were subjected to detailed history taking, a complete
      physical examination including per vaginum examination (to calculate modified bishop's score
      and to rule out cephalopelvic disproportion), investigations and a NST. Gestational age was
      established by the first date of the last menstrual period and confirmed by first trimester
      ultrasound. Presentation was confirmed by palpation and third trimester ultrasound.

      Women after randomization were allocated into two groups. The first group (A) was induced
      with hourly titrated oral misoprostol regimen and the second group (B) received two hourly
      static oral misoprostol regimen. Once labor had started, vital signs were closely monitored
      every 2 hours; fetal heart rate (FHR) and uterine activity every 15 minutes during first
      stage of labor. Per vaginum examination was done 4-hourly or as indicated.

      Primary and secondary outcome measures were noted and analyzed to compare safety and efficacy
      of titrated and oral misoprstol solution.
    

Intervention name(s): Oral misoprostol solution (OMS)
Intervention type(s): Drug
Intervention description(s): Based on the WHO labor induction recommendation, and for the purpose of achieving precise oral misoprostol dosage, one misoprostol tablet (200 mcg) was pulverized and dissolved into 200 ml water.90 Thus 1ml of solution had 1mcg of misoprostol. This misoprostol solution could be preserved at room temperature and remained active for 24 hours.
Hourly titrated oral misoprostol solution was given to group A as described by Wang X et al, 2016 as described below.
0 hour= 20ml
hour= 20ml
hour= 30ml
hour= 30ml
hour= 30ml
hour= 40ml 6.5 hour= 50ml 8.5 hour= 60ml 10.5 hour=60ml
Group B received 25 mcg (25 ml) oral misoprostol solution every 2 hours for a maximum of 12 doses or until the onset of regular uterine activity.
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single center interventional single-blinded randomised controlled trial
Masking: Single (Participant)
Primary purpose: Treatment