Vaginal Misoprostol and Foley Catheter for Induction of Labor

Zagazig University160 enrolled

Overview

to compare between sequential and concurrent use of vaginal misopristol plus foleys catheter for induction of labor

two groups of patients who are eligible for labor induction were randomized to either sequential use of vaginal misopristol plus foleys catheter or concurrent use of vaginal misopristol plus foleys catheter.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

160

Conditions

Induction of Labor Affected Fetus / Newborn

Interventions

MisoprostolDRUG

vaginal Misoprostol Plus Foley Catheter

Foley CatheterDEVICE

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Indication for labour induction Term pregnancy with alive fetus Bishop score less than five Exclusion Criteria: * Age less than 18 years Previous uterine scar Nonvertex presentation Non-reassuring fetal status Fetal anomalies Fetal growth restriction Genital bleeding Tumors, malformations and/or ulcers of vulva, perineum or vagina

Locations (1)

Zagazig University

Zagazig, Egypt

Outcomes

Primary Outcomes

induction delivery interval (time from starting induction to delivery)

safety issue

Time frame: 48hours

Secondary Outcomes

Need of oxytocin for augmentation of labour

safety issue

Time frame: 48h

Number of doses needed to bring on labour

safety issue

Time frame: 48h

Failed induction (failure to elicit contraction after 72 hours)

safety issue

Time frame: 72h

Hyperstimulation syndrome

safety issue

Time frame: 24h

Cesarean section

safety issue

Time frame: 72h

Severe neonatal morbidity or perinatal death

safety issue

Time frame: 28 days

Serious maternal morbidity or maternal death

safety issue

Time frame: 42 days

Data from ClinicalTrials.gov

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