An interventional study of Oral misoprostol solution (OMS) in Induction of Labor, sponsored by Christian Medical College and Hospital, Ludhiana, India. Completed at 1 site in India. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-18.
Sponsored by Christian Medical College and Hospital, Ludhiana, India · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Titrated oral misoprostol solution
Drug: Oral misoprostol solution (OMS)
Static oral misoprostol solution
Drug: Oral misoprostol solution (OMS)
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 1. hour= 20ml 2. hour= 30ml 3. hour= 30ml 4. hour= 30ml 5. 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.
Interval between induction and delivery
The time taken from induction of labor to delivery measured as 1) \<12 hours 2) 12-24 hours 3) 24-48 hours 4) \>48 hours
Time frame: From first dose of oral misoprostol solution (titrated/static) to childbirth; upto 5 days
Mean change in modified Bishop's score
Measured as difference between modified bishop's score before induction of labor and at amniotomy/stopping of oral misoprostol solution regimen; minimum 0f 1 to maximum of 7.
Time frame: From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days
Number of misoprostol doses
Measured as 1-2; 3-4; 5-6; 7-8; \>9
Time frame: From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days
Time taken to give required doses
Measured as 1-4 hours; 5-8 hours; 9-12 hours; 13-16 hours; 17-20 hours; 21-24 hours
Time frame: From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days
Total misoprostol dosage
Measured as \</=75mcg; 76-150mcg; 151-225mcg; 226-300mcg; \>301 mcg
Time frame: From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days
Mode of delivery
In terms of Vaginal delivery/LSCS
Time frame: Upto 5 days from first dose of oral misoprostol solution
Indication for LSCS
Divided into either of the following: 1. SECONDARY ARREST OF DILATATION 2. MSAF IN EARLY LABOR 3. CTG CATEGORY III 4. FAILED INDUCTION 5. CEPHALOPELVIC DISPROPORTION 6. CORD PROLAPSE 7. DEEP TRANSVERSE ARREST 8. ARREST OF DESCENT OF HEAD
Time frame: Upto 5 days from first dose of oral misoprostol solution
Oxytocin augmentation
Required/Not required
Time frame: From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days
Maternal morbidity
In terms of incidence of either of the following: 1. Incidence of tachysystole 2. Fever- intrapartum and postpartum 3. Puerperal sepsis 4. Uterine rupture
Time frame: From first dose of oral misoprostol solution to dischage from hospital; upto 7 days
Neonatal parameters
Measured in terms of incidence of either of the following: 1. Incidence of meconium-stained liquor 2. APGAR scores at 1,5 min 3. NICU stay
Time frame: From childbirth to discharge of the baby; upto 1 month
Plan to share: Yes — IPD that underlie the results reported in the study, after deidentification (text, tables, figures and appendices) will be shared in the excel sheet format.
Supporting information: Study protocol, Sap, Icf
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Christian Medical College and Hospital, Ludhiana, India