Titrated Oral Misoprostol Compared to Vaginal Dinoprostone for Induction of Labor
- Conditions
- Medical Induction of Labor Affecting Fetus
- Interventions
- Drug: Misotac® Sigma Pharmaceutical Industries
- Registration Number
- NCT02036437
- Lead Sponsor
- Ain Shams University
- Brief Summary
To test the safety and efficacy of titrated oral misoprostol compared to vaginal dinoprostone for labor induction.
- Detailed Description
* There are many indications for induction of labor in the obstetric practice, of which prolonged gestational age stands as the most common indication. It is well recognized that with an unripe cervix, induction may be difficult and often unsuccessful. The use of an agent to ripen the cervix prior to induction is acceptable in the modern practice.
* Misoprostol, a prostaglandin E1 analogue, is the most interesting alternative to Dinoprostone because of its effectiveness, low cost, and temperature stability. It ripens the cervix by inducing regular uterine contractions. However, it is associated with several adverse effects especially uterine hyperstimulation, which is painful and may result in fetal compromise.
* Testing the efficacy and safety of titrated oral misoprostol versus vaginal dinoprostone may develop a new safe and effective method for labor induction.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 200
- Single vertex presentation.
- Gestational age > 37 weeks calculated from last menstrual period or U/S scanning.
- Bishop score <8 .
- Not in labor.
- Reassuring fetal heart rate (CTG for 20 min on the day of induction).
- Valid indication for Induction of labor.
- Gestational age <37 weeks.
- Patients with rupture of membranes.
- Previous uterine scar.
- Fetal malpresentation.
- Multiple pregnancy.
- Significant antepartum hemorrhage
- Uncontrolled DM.
- Severe Pre-eclampsia or Eclampsia
- If there are contraindications to receive the drugs, e.g. allergy, history of severe asthma,.....etc.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cases Misotac® Sigma Pharmaceutical Industries A dose of 20ug is required obtained by dissolving the 200ug tablet (Misotac® Sigma Pharmaceutical Industries) in 200 ml water (1ug per ml), the solution is shaked well before each administration. The solution will be orally administrated every two hours (max. 12 hrs) until adequate uterine contractions obtained (3 per 10 minutes each lasting 40-60 seconds) and then stopped. The initial dose will be increased to 40 ml (40ug) after two doses if there are no contractions. The timing and strength of contractions will be assessed by abdominal palpation. If the contractions are inadequate, augmentation of the active phase of labor will be attempted by hourly-titrated oral misoprostol (20 ml) +/- amniotomy. Control Dinoprostone 3 mg Dinoprostone 3 mg (Dinoglandin® Alexandria Co. for Pharmaceuticals) will be inserted in the posterior vaginal fornix and repeated after six hours if contractions are inadequate (i.e. two doses maximum). If the contractions become inadequate, augmentation of the active phase of labor will be attempted by Syntocinon (oxytocin) infusion +/- amniotomy.
- Primary Outcome Measures
Name Time Method Induction delivery interval i.e. Time from start of medication till delivery 24 hours
- Secondary Outcome Measures
Name Time Method Patients delivered vaginally within the first 24 hours 24 hours Duration of 1st,2nd and 3rd stages of labor 24 hours Time from start of labor augmentation by either misoprostol or Syntocinon (oxytocin) to active phase of labor 12 hours Maternal complications 24 hours uterine hyperstimulation, postpartum hemorrhage, uterine rupture, sepsis, shivering, headache, nausea, vomiting, and retained placenta.
Mode of delivery 24 hours Vaginal , instrumental or Cesarean section
Neonatal outcome 24 hours Apgar score at 1 and 5 minutes and Neonatal Intensive Care Unit admission
Trial Locations
- Locations (1)
New Maternity Hospital - Ain Shams university
🇪🇬Cairo, Egypt