None listed
Conditions
Brief summary
The research hypothesis is that more women for whom induction of labor is indicated will undergo vaginal delivery within 24 hours with hourly treatment with oral misoprostol compared with 2 hourly treatment.The primary objective is to compare the achievement of vaginal delivery within 24 hours following induction with hourly or 2 hourly oral misoprostol.
Interventions
Hourly titrated oral misoprostol for induction of labor. Solution Preparation
Dissolve 200 mcg of misoprostol in 200 ml of water. The solution now has a misoprostol concentration of 1 mcg/ml.
Dosing
20 mcg (20 ml) of the solution to be given to the patient orally every hour until active labor was achieved or 4 doses given.
If uterine activity is present, but the patient is not in active labor, give the same dose and reassess in one hour.
If no uterine activity is present after 4 doses, in
Hourly titrated oral misoprostol for induction of labor. Solution Preparation Dissolve 200 mcg of misoprostol in 200 ml of water. The solution now has a misoprostol concentration of 1 mcg/ml. Dosing 20 mcg (20 ml) of the solution to be given to the patient orally every hour until active labor was achieved or 4 doses given. If uterine activity is present, but the patient is not in active labor, give the same dose and reassess in one hour. If no uterine activity is present after 4 doses, increase the misoprostol dose to 40 mcg (40 ml) every hour until active labor was achieved or 4 doses given. If uterine activity is present, but the patient is not in active labor, give the same dose and reassess in one hour. If no uterine activity is present after 4 doses of 40 mcg or 40 ml (8 hours from the start), increase the misoprostol dose to 60 mcg (60 ml) every hour until active labor was achieved or 16 doses of 60 mcg given. Maximal total dose is 1200 mcg in 24 hours. Once active labor is established at any dose, discontinue the misoprostol.
Sponsors
Abdulrahim Rouzi.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Singleton live pregnancy for induction of labor. 2. At or more than 34 weeks of gestation 3. Bishop score less than or equal to 6. 4. Intact membranes. 5. Cephalic presentation. 6. Reassuring fetal heart pattern.
Exclusion criteria
1. Hypersensitivity to misoprostol 2. Previous C/S or other uterine surgery. 3. Severe PIH (abnormal LFT’s, protein>1g/day, BP= 160/100). 4. Para 4 and more. 5. Multiple gestation. 6. Uterine contractions. 7. Significant maternal cardiac, renal , or liver disease.
Outcome results
None listed