Vaginal Misoprostol With Intracervical Foley Catheter in Induction of Labor
- Conditions
- Induction of Labor Affected Fetus / Newborn
- Interventions
- Device: Transcervical Foley catheter
- Registration Number
- NCT03682718
- Lead Sponsor
- Ain Shams University
- Brief Summary
The aim of present study is to compare the safety and efficacy of vaginal misoprostol versus the combination of vaginal misoprostol and intracervical Foley catheter in induction of labor at term pregnancy.
- Detailed Description
Cervical status is a good predictor of the likelihood of vaginal delivery when labor is induced. Any induction method is likely to be effective in a woman with a favorable cervix, whereas no method is highly successful when performed in a woman with a cervix that is unfavorable.
The use of a balloon catheter as induction method was first described in 1862 by Trainer. The goal of the catheter was to ripen the cervix through direct mechanical dilatation of the cervical canal and indirectly by increasing endogenous prostaglandin secretion.
Alternatively, Prostaglandins are one of the key players in cervical ripening by a number of different mechanisms.
The aim of present study is to compare the safety and efficacy of vaginal misoprostol versus the combination of vaginal misoprostol and intracervical Foley catheter in induction of labor at term pregnancy.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 120
Singleton pregnancy Gestational age ≥ 37 weeks (calculated from reliable menstrual dates and/or late first trimester or early second trimester ultrasound) Modified Bishop Score ≥ 5 Valid indication for induction of labor Intact fetal membranes Normal fetal non-stress test cervical dilation less than or equal to 2cm vertex presentation
Any contraindication for vaginal delivery (e.g. placenta Previa, accrete ) Any contraindication for induction of labor (e.g. fetal malpersentation, prior uterine surgery) Active labor Antepartum hemorrhage Eclampsia Patients with hemolysis, elevated liver enzymes and low platelets Suspected chorioamnitis Intrauterine growth retardation Multiple gestation Non-reassuring fetal heart rate Continuous contractions more than 3 times in 10 minutes at onset of induction of labor Intrauterine fetal demise Any contraindication for use of misoprostol (e.g. bronchial asthma, drug allergy, History of glaucoma) Any contraindication for use of Foley catheter (already ripped cervix) Rupture of membranes Not consenting
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description vaginal misoprostol and intracervical Foley catheter Transcervical Foley catheter participants will receive misoprostol by the same dose and method. Transcervical Foley catheter (size 16F, with 30ml balloon capacity) will be passed. The catheter will deflated, removed and cervix re-assessed if no spontaneous expulsion occurred at 12 hours post- insertion. A new catheter will be passed for another 12 hours, if the Bishop score is less than 8 this will be considered as failure of induction. vaginal misoprostol and intracervical Foley catheter Misoprostol participants will receive misoprostol by the same dose and method. Transcervical Foley catheter (size 16F, with 30ml balloon capacity) will be passed. The catheter will deflated, removed and cervix re-assessed if no spontaneous expulsion occurred at 12 hours post- insertion. A new catheter will be passed for another 12 hours, if the Bishop score is less than 8 this will be considered as failure of induction. vaginal misoprostol Misoprostol Misoprostol group; participants will receive 50 μg intravaginal in the posterior vaginal fornix, 25 μg will be given every 4 hours for another two doses, if a satisfactory Bishop score of 8 not reached, patient will take an overnight rest and she will continue induction by the same doses on the next day-provided that there is no ROMs- (this is according to Ain Shams University Protocol) The maximum dose of Misoprostol is 200 μg. Oxytocin infusion will not started until 6 hours after the last dose or if there is no adequate contractions obtained.
- Primary Outcome Measures
Name Time Method induction delivery time 48 hours time elapsed from start of induction till delivery of the baby
- Secondary Outcome Measures
Name Time Method Mode of delivery 48 hours mode od delivery either vaginal or Caesarian Section
induction active stage time 24 hours time elapsed from induction of labor till reaching 6 cm cervical dialtation
Tachysystole 48 hours Tachysystole as 5 or more contraction in 10 minutes for two consecutive 10 minutes without FHR abnormalities.
hypersystole 48 hours one uterine contraction with duration of more than 90 sec.
misoprstol dose 24 hours total misoprstol needed in each group
Maternal Pyrexia 48 hours fever (Temp \> 37.8 ) any time during labor
Trial Locations
- Locations (1)
Ahmed Abass
🇪🇬Cairo, Egypt