Induction of labour with a foley catheter in pregnant women with previous successful vaginal birth in outpatient vs inpatient settings

Outpatient vs inpatient Foley catheter induction of labour in multiparous women: a randomised trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13534944

Enrollment

159

Registered

2019-01-11

Start date

2019-02-18

Completion date

Unknown

Last updated

2021-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnant women who have previously successfully given birth vaginally and require induction of labor for specific reasons Pregnancy and Childbirth

Interventions

Randomisation will only be carried out once the catheter is in-situ and post foley catheter insertion CTG is normal. Randomisation is by the opening of sealed opaque and numbered envelope with lowest

pain or severe discomfort

decreased fetal movements

painful contractility (>2contractions/10 min) and fever (T > 380C). They will be asked to come back the next day morning at 8am for removal of foley catheter. Patients in the inpatien

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Aged 18 years and above 2. Gestational age of > 37 weeks at enrolment 3. Scheduled induction of labour 4. Viable pregnancy 5. Cephalic presentation 6. Singleton pregnancy 7. Unfavourable cervix (Bishop Score = 5) 8. Intact membranes 9. Reassuring pre induction fetal cardiotocography (CTG) Added 18/06/2019: 10. Must have their own transport and live within 30km of the hospital

Exclusion criteria

Exclusion criteria: 1. Allergic to latex 2. Nulliparous 3. Previous uterine scar (caesarean/myomectomy)

Design outcomes

Primary

Measure	Time frame
1. Maternal satisfaction with their care will be measured using the visual numerical rating scale (from 0-10) after delivery. 2. The percentage of women delivering during “working hours” (8am to 5pm).	—

Secondary

Measure	Time frame
Maternal outcomes will be determined using data retrieved from patients' case notes after delivery: 1. Intervention to delivery interval 2. Membrane rupture to delivery interval 3. Mechanism of membrane rupture 4. Oxytocin augmentation 5. Use of additional method(s) for cervical ripening 6. Use of regional analgesia in labour 7. Mode of delivery 8. Estimated blood loss 9. Fever single or more readings of temperature =38oC (intrapartum and day 1 postpartum), diagnosis of chorioamnionitis or endometritis 10. Duration of hospital stay 11. Date and time of catheter evacuated/expulsed Neonatal outcomes will be determined using data retrieved from patients' case notes after delivery: 1. The physical condition of newborn infants will be measured using the Apgar score at 1 and 5 minutes. 2. Arterial cord pH 3. Birth weight 4. Neonatal admission	—

Measure

Time frame

Maternal outcomes will be determined using data retrieved from patients' case notes after delivery: 1. Intervention to delivery interval 2. Membrane rupture to delivery interval 3. Mechanism of membrane rupture 4. Oxytocin augmentation 5. Use of additional method(s) for cervical ripening 6. Use of regional analgesia in labour 7. Mode of delivery 8. Estimated blood loss 9. Fever single or more readings of temperature =38oC (intrapartum and day 1 postpartum), diagnosis of chorioamnionitis or endometritis 10. Duration of hospital stay 11. Date and time of catheter evacuated/expulsed Neonatal outcomes will be determined using data retrieved from patients' case notes after delivery: 1. The physical condition of newborn infants will be measured using the Apgar score at 1 and 5 minutes. 2. Arterial cord pH 3. Birth weight 4. Neonatal admission

—

Countries

Malaysia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 14, 2026