Ahmed Abass
Cairo, 11311, Egypt
NCT Number: NCT03682718
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.
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Notify Me18 year–40 year
Female
Interventional
Phase 4
Cairo, 11311, Egypt
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
combined methods of induction of labor Floey Catheter with misoprstol
Misoprstol inserted vaginally for induction of labor
Time frame: 48 hours
time elapsed from start of induction till delivery of the baby
Time frame: 24 hours
total misoprstol needed in each group
Time frame: 24 hours
time elapsed from induction of labor till reaching 6 cm cervical dialtation
Time frame: 48 hours
mode od delivery either vaginal or Caesarian Section
Time frame: 48 hours
fever (Temp > 37.8 ) any time during labor
Time frame: 48 hours
one uterine contraction with duration of more than 90 sec.
Time frame: 48 hours
Tachysystole as 5 or more contraction in 10 minutes for two consecutive 10 minutes without FHR abnormalities.
Time frame: 1 min after delivery
Neonatal Apgar score
Time frame: 5 min after delivery
Neonatal Apgar score
Time frame: 10 min after delivery
Neonatal birth weight
Time frame: 2 hours after delivery
Number of neonates in need for ICU admission
Ain Shams University
Other
Vaginal Misoprostol With Intracervical Foley Catheter Versus Vaginal Misoprostol Alone in Induction of Labor at Term Pregnancy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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