None listed
Conditions
Brief summary
The main objective of the proposed research project is to determine the best protocol to induce labor. A randomized clinical trial will be done to compare two protocols of titrated oral misoprostol and vaginal dinoprostone. This study will have major clinical impact on a very important and frequent clinical situation. This study will have major clinical impact on a very important and frequent clinical situation. Testing the efficacy of titrated oral Misoprostol to achieve induction of labor with lower side effects by giving Misoprostol in lower doses and increased frequency.
Interventions
20 mcg (20 ml) of the solution of misoprostol, as prescribed by the physician, is given to the patient orally every hour for 2 hours. If no uterine activity is present, increase the misoprostol dose by 10 mcg (10 ml) i.e. 30 mcg (30) and continue this dose every hour for 3 hours. Active labor is defined as regular uterine contractions occurring every 3-5 minutes and lasting 60 seconds or more. If the patient is not in active labor, 2 hours of observation without any dose was given. If still not
20 mcg (20 ml) of the solution of misoprostol, as prescribed by the physician, is given to the patient orally every hour for 2 hours. If no uterine activity is present, increase the misoprostol dose by 10 mcg (10 ml) i.e. 30 mcg (30) and continue this dose every hour for 3 hours. Active labor is defined as regular uterine contractions occurring every 3-5 minutes and lasting 60 seconds or more. If the patient is not in active labor, 2 hours of observation without any dose was given. If still not in labor, increase the dose by 10 mcg (10 ml) i.e. 40 mcg (40 ml) for one hour. This is followed by 2 hours of observation. If still not in active labor the dose is increased by 10 mcg (10 ml) i.e. 50 mcg (50 ml) for one hour and finally increased by 10 mcg (10 ml) i.e. 60 mcg (60 ml) hourly for four hours, oxytocin should be started as per hospital's protocol. Oxytocin should be started no sooner than 2 hours after the last misoprostol dose. Once active labor is established, misoprostol is stopped.
Sponsors
King Abdulaziz University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Singleton pregnancy for induction of labor. 2. Consent is taken. 3. No contraindication to use either drugs. 4. Bishop score <6.
Exclusion criteria
1. <34 wks gestation. 2. Severe PIH (abnormal LFT’s, protein>1g/day, BPgreater than or equal to 160/100). 3. Previous C/S or other uterine surgery. 4. Twins. 5. Para (number of previous deliveries) four. 6. Uterine contractions.
Outcome results
None listed