Induction of Labor Affected Fetus / Newborn
Conditions
Keywords
misoprostol , intracervical Foley catheter , induction of labor , term pregnancy.
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.
Interventions
combined methods of induction of labor Floey Catheter with misoprstol
DRUGMisoprostol
Misoprstol inserted vaginally for induction of labor
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| induction delivery time | 48 hours | time elapsed from start of induction till delivery of the baby |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mode of delivery | 48 hours | mode od delivery either vaginal or Caesarian Section |
| Maternal Pyrexia | 48 hours | fever (Temp \> 37.8 ) any time during labor |
| hypersystole | 48 hours | one uterine contraction with duration of more than 90 sec. |
| Tachysystole | 48 hours | Tachysystole as 5 or more contraction in 10 minutes for two consecutive 10 minutes without FHR abnormalities. |
| misoprstol dose | 24 hours | total misoprstol needed in each group |
| induction active stage time | 24 hours | time elapsed from induction of labor till reaching 6 cm cervical dialtation |
Other
| Measure | Time frame | Description |
|---|---|---|
| neonatal ICU admission | 2 hours after delivery | Number of neonates in need for ICU admission |
| Neonatal Apgar score | 1 min after delivery | Neonatal Apgar score |
| Neonatal birth weight | 10 min after delivery | Neonatal birth weight |
Countries
Egypt
Outcome results
None listed