Clinical trial NCT03682718: Vaginal Misoprostol With Intracervical Foley Catheter in Induction of Labor
Official title: Vaginal Misoprostol With Intracervical Foley Catheter Versus Vaginal Misoprostol Alone in Induction of Labor at Term Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Induction of Labor Affected Fetus / Newborn
Keywords: misoprostol , intracervical Foley catheter , induction of labor , term pregnancy.
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: induction delivery time
timeFrame: 48 hours
Secondary outcomes:
measure: misoprstol dose
timeFrame: 24 hours
measure: induction active stage time
timeFrame: 24 hours
measure: Mode of delivery
timeFrame: 48 hours
measure: Maternal Pyrexia
timeFrame: 48 hours
measure: hypersystole
timeFrame: 48 hours
measure: Tachysystole
timeFrame: 48 hours
Other outcomes:
measure: Neonatal Apgar score
timeFrame: 1 min after delivery
measure: Neonatal Apgar score
timeFrame: 5 min after delivery
measure: Neonatal birth weight
timeFrame: 10 min after delivery
measure: neonatal ICU admission
timeFrame: 2 hours after delivery
Locations:
city: Cairo
country: Egypt
facility: Ahmed Abass
Study officials:
References: