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NCT05622968
Outpatient Induction of Labour Using Intracervical Foley Catheter
Conditions: Pregnancy Related, Induction of Labor Affected Fetus / Newborn
Sex: All
Ages: 18 Years – 50 Years
Phase: NA
Enrollment: 288
Sponsor: Hospital Kemaman
Location: Malaysia
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)
Eligibility Criteria
Inclusion Criteria:Age > 18 year oldSingleton pregnancyCephalic presentationMultiparous 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, myomectomyResides within 30 minutes drive from Hospital KemamanHas access to a telephoneHas 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 presentationPrior cesarean deliveryGestational hypertension or preeclampsia on 2 or more medicationsDiabetes in pregnancy on high dose medication(s); insulin of more than 60 units per day or combination of insulin and oral hypoglycemic agentLow lying placenta or placenta praeviaRupture of amniotic membranePrimiparae and grandmultiparae (para 5 or more)Multiple pregnancyFetal deathFetal anomalies: defined as the presence of a major fetal anomaly of any organ systemFetal growth restriction: defined as an ultrasound derived estimated fetal weight less than the 10th percentile for gestational ageSuspected macrosomia: defined as an ultrasound derived estimated fetal weight of more than 90th centile for gestational ageOligohydramnios: ultrasound measured amniotic fluid index (AFI) less than the 10th percentile for gestational agePolyhydramnios: defined as an AFI of 24 cm or greater or a single deepest vertical pocket of 8 cm or greaterLatex allergyContraindication to induction of laborEvidence of active phase of labor
Source: ClinicalTrials.gov (NCT05622968). StuddyBuddy aggregates publicly available trial information.