Outpatient Induction of Labour Using Intracervical Foley Catheter (NCT05622968) | Clinical Trial Compass
TerminatedNot Applicable
Outpatient Induction of Labour Using Intracervical Foley Catheter
Stopped: Poor recruitment
Malaysia88 participantsStarted 2023-01-01
Plain-language summary
Prospective quasi-experimental study between a study population who will receive outpatient induction of labour using intracervical Foley catheter, followed by the inpatient induction using intravaginal prostaglandin and a control group of women with similar characteristics undergoing inpatient labour induction with intravaginal prostaglandin (standard management)
Who can participate
Age range18 Years – 50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \> 18 year old
* Singleton pregnancy
* Cephalic presentation
* Multiparous women in their 2nd to 5th pregnancy (Para 1 to 4)
* Gestational age between 37+0 and 41+0 weeks.
* No previous uterine surgery (lower segment caesarean section, upper segment caesarean section, myomectomy
* Resides within 30 minutes drive from Hospital Kemaman
* Has access to a telephone
* Has reliable transportation (i.e. able to get to the hospital immediately without the need of ambulance)
* Acceptance of participation by the signing of a written consent.
Exclusion Criteria:
* Pregnancy with non-cephalic presentation
* Prior cesarean delivery
* Gestational hypertension or preeclampsia on 2 or more medications
* Diabetes in pregnancy on high dose medication(s); insulin of more than 60 units per day or combination of insulin and oral hypoglycemic agent
* Low lying placenta or placenta praevia
* Rupture of amniotic membrane
* Primiparae and grandmultiparae (para 5 or more)
* Multiple pregnancy
* Fetal death
* Fetal anomalies: defined as the presence of a major fetal anomaly of any organ system
* Fetal growth restriction: defined as an ultrasound derived estimated fetal weight less than the 10th percentile for gestational age
* Suspected macrosomia: defined as an ultrasound derived estimated fetal weight of more than 90th centile for gestational age
* Oligohydramnios: ultrasound measured amniotic fluid index (AFI) less than the 10th percentile for gestational age
* Polyhydra…
What they're measuring
1
Induction of labour-delivery interval
Timeframe: Induction of labour (intravaginal prostaglandin) to delivery