Vaginal Misoprostol With Intracervical Foley Catheter in Induction of Labor

Ain Shams University120 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

120

Conditions

Induction of Labor Affected Fetus / Newborn

Interventions

Transcervical Foley catheterDEVICE

combined methods of induction of labor Floey Catheter with misoprstol

MisoprostolDRUG

Misoprstol inserted vaginally for induction of labor

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Ahmed Abass

Cairo, Egypt

Outcomes

Primary Outcomes

induction delivery time

time elapsed from start of induction till delivery of the baby

Time frame: 48 hours

Secondary Outcomes

misoprstol dose

total misoprstol needed in each group

Time frame: 24 hours

induction active stage time

time elapsed from induction of labor till reaching 6 cm cervical dialtation

Time frame: 24 hours

Mode of delivery

mode od delivery either vaginal or Caesarian Section

Time frame: 48 hours

Maternal Pyrexia

fever (Temp \> 37.8 ) any time during labor

Time frame: 48 hours

hypersystole

one uterine contraction with duration of more than 90 sec.

Time frame: 48 hours

Tachysystole

Tachysystole as 5 or more contraction in 10 minutes for two consecutive 10 minutes without FHR abnormalities.

Time frame: 48 hours

Data from ClinicalTrials.gov

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