To test the safety and efficacy of titrated oral misoprostol compared to vaginal dinoprostone for labor induction.
* 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
The solution will be orally administrated every two hours (maximum 12 hours) until adequate uterine contractions obtained (3 per 10 minutes each lasting 40-60 seconds) and then stopped. The initial dose of 20 ml (20 ug) 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. If the uterine contractions are judged to be adequate, the next dose of misoprostol will be omitted.
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.
New Maternity Hospital - Ain Shams university
Cairo, Cairo Governorate, Egypt
RECRUITINGInduction delivery interval i.e. Time from start of medication till delivery
Time frame: 24 hours
Patients delivered vaginally within the first 24 hours
Time frame: 24 hours
Time from start of labor augmentation by either misoprostol or Syntocinon (oxytocin) to active phase of labor
Time frame: 12 hours
Duration of 1st,2nd and 3rd stages of labor
Time frame: 24 hours
Maternal complications
uterine hyperstimulation, postpartum hemorrhage, uterine rupture, sepsis, shivering, headache, nausea, vomiting, and retained placenta.
Time frame: 24 hours
Mode of delivery
Vaginal , instrumental or Cesarean section
Time frame: 24 hours
Neonatal outcome
Apgar score at 1 and 5 minutes and Neonatal Intensive Care Unit admission
Time frame: 24 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.