Overview

Outpatient Induction of Labour Using Intracervical Foley Catheter

Status:
Not yet recruiting
Trial end date:
2024-06-30
Target enrollment:
0
Participant gender:
All
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)
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hospital Kemaman
Criteria
Inclusion Criteria:

(i) Age > 18 year old (ii) Singleton pregnancy (iii) Cephalic presentation (iv) Multiparous
women in their 2nd to 5th pregnancy (Para 1 to 4) (v) Gestational age between 37+0 and 41+0
weeks. (vi) No previous uterine surgery (lower segment caesarean section, upper segment
caesarean section, myomectomy (vii) Resides within 30 minutes drive from Hospital Kemaman
(viii) Has access to a telephone (ix) Has reliable transportation (i.e. able to get to the
hospital immediately without the need of ambulance) (x) Acceptance of participation by the
signing of a written consent.

Exclusion Criteria:

(i) Pregnancy with non-cephalic presentation (ii) Prior cesarean delivery (iii) Gestational
hypertension or preeclampsia on 2 or more medications (iv) Diabetes in pregnancy on high
dose medication(s); insulin of more than 60 units per day or combination of insulin and
oral hypoglyceamic agent (v) Low lying placenta or placenta praevia (vi) Rupture of
membrane (vii) Primiparae and grandmultiparae (para 5 or more) (viii) Multiple pregnancy
(ix) Fetal death (x) Fetal anomalies: defined as the presence of a major fetal anomaly of
any organ system (xi) Fetal growth restriction: defined as an ultrasound derived estimated
fetal weight less than the 10th percentile for gestational age (xii) Suspected macrosomia:
defined as an ultrasound derived estimated fetal weight of more than 90th centile for
gestational age (xiii) Oligohydramnios: ultrasound measured amniotic fluid index less than
the 10th percentile for gestational age (xiv) Polyhydramnios: defined as an AFI of 24 cm or
greater or a single deepest vertical pocket of 8 cm or greater (xv) Latex allergy (xvi)
Contraindication to induction of labor (xvii) Evidence of active phase of labor (xviii)
Inability to give consent