Medical Induction of Labor Affecting Fetus
Conditions
Keywords
Induction of Labor, Misoprostol
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.
Interventions
DRUGMisotac® Sigma Pharmaceutical Industries
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.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Induction delivery interval i.e. Time from start of medication till delivery | 24 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time from start of labor augmentation by either misoprostol or Syntocinon (oxytocin) to active phase of labor | 12 hours | — |
| Duration of 1st,2nd and 3rd stages of labor | 24 hours | — |
| Patients delivered vaginally within the first 24 hours | 24 hours | — |
| 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 |
| Maternal complications | 24 hours | uterine hyperstimulation, postpartum hemorrhage, uterine rupture, sepsis, shivering, headache, nausea, vomiting, and retained placenta. |
Countries
Egypt
Outcome results
None listed