Home » Trials » SLCTR/2021/023


Sending home versus staying in the hospital for induction of labour using a Foley catheter at term: a non-inferiority randomised controlled trial (HOME Trial)

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SLCTR Registration Number

SLCTR/2021/023


Date of Registration

04 Aug 2021

The date of last modification

Aug 04, 2021



Application Summary


Scientific Title of Trial

Sending home versus staying in the hospital for induction of labour using a Foley catheter at term: a non-inferiority randomised controlled trial (HOME Trial)


Public Title of Trial

Comparison of efficacy and safety outcomes in mother and neonate following, sending home versus keeping in the hospital after induction of labour with Foley catheter


Disease or Health Condition(s) Studied

Pregnancy


Scientific Acronym

HOME


Public Acronym

None


Brief title

None


Universal Trial Number

U1111-1266-9326


Any other number(s) assigned to the trial and issuing authority

P/145/12/2020 (Ethics Review Committee of the Faculty of Medicine, University of Kelaniya)


Trial Details


What is the research question being addressed?

What are the efficacy and safety outcomes on the mother and fetus, when a transcervical Foley catheter is used for 48 hours in the induction of labor, as an outpatient procedure compared to an inpatient procedure?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Active


Assignment

Parallel


Purpose

Other


Study Phase

Not Applicable


Intervention(s) planned

Study settings: Six Teaching Hospitals in Sri Lanka- Teaching Hospital, Mahamodara, Galle, North Colombo Teaching Hospital, Teaching Hospital, Anuradhapura, Teaching Hospital, Batticaloa, Castle Street Hospital for Women, Colombo and De Soysa Hospital for Women, Colombo.

Randomization

a. Method of randomization into study arms - Variable block randomisation b. Unit of randomization- Each eligible woman for induction of labour. c. Method of sequence generation- Randomisation sequence will be prepared by an independent statistician and maintained centrally by the central coordinating center (central telephone randomisation by the research nurse/doctor from De Soysa Hospital for Women, Colombo). Allocation ratio - 1:1. d. Method of allocation concealment- Central telephone randomisation.

Intervention

Eligible women will be identified at their last antenatal clinic visit and low-risk women at 40 weeks +3 days of gestation and/or any other low-risk women requiring induction of labour after 37 weeks of gestation will be admitted to the hospital. After admission, patient information sheets will be provided and informed written consent will be taken from all eligible women.

Thereafter, a vaginal examination will take place. For women who have a Bishop score <6, a sterile vaginal speculum examination will be performed in the dorsal position by a postgraduate resident or a senior medical officer (at least one year experience) and a 16Fr standard latex transcervical Foley catheter will be inserted under aseptic conditions after cleaning with povidone-iodine. The catheter will be inflated with 60mL sterile water. The urinary channel of the Foley catheter will be closed off with a sterile cap. The catheter will be taped into the inner aspect of the thigh to allow her to move comfortably and after applying gentle traction against the internal cervical os.

After catheter insertion, they will be observed for 30-minutes of bed rest, while fetal condition and uterine activity are monitored. A post-procedure 20-minute cardiotocogram will be offered one hour after insertion and if the cardiotocogram is normal, women will be randomised into two arms; home and hospital settings.

Control
Induction of labour with Foley catheter for 48 hours while as an inpatient. This is the accepted standard method for induction of labour with mechanical methods.

Blinding - No blinding


Inclusion criteria

•Women with live singleton pregnancies with a cephalic presentation •Women with >37 weeks +0 days to 42 weeks +0 days gestation, with intact membranes requiring IOL •Women living within 20km or less (40-minute drive or less) from the hospital, having a telephone, and someone to provide transport to the hospital in an emergency


Exclusion criteria

• Women with high-risk pregnancies (heart disease, hypertension, hyper-glycaemia on metformin or insulin therapy, fetal growth restriction) • Less than 18 years of age • Major congenital anomaly as per routine anomaly scan • Previous caesarean delivery • Modified Bishop Score (MBS) > 6 • Evidence of regular uterine contractions • Known hypersensitivity for any of the products for induction/ latex • Any contraindications to vaginal birth, i.e. Placenta praevia • Evidence of any vaginal or cervical infection



Primary outcome(s)

1.

Vaginal delivery rate

[

At the time of hospital discharge

]
2.

Perinatal morbidity and mortality parameters (composite measure)

a. Stillbirth b. Admission to neonatal intensive care unit (NICU- for any period) c. Birth trauma (mechanical causes during childbirth) d. Intrapartum death e. Neonatal mortality f. Neonatal seizures g. Confirmed neonatal infection needing antibiotics h. Hypoxic-ischaemic encephalopathy (HIE) i. Meconium aspiration syndrome (MAS) j. Severe neonatal respiratory morbidity (consists of mechanical ventilation, infantile respiratory distress syndrome (RDS) and pneumothorax)

[

At the time of hospital discharge

]

Secondary outcome(s)

1.

Admission to intensive care unit (ICU)- for any period

[

At the time of hospital discharge

]
2.

Maternal infection (temperature ≥ 38 ºC at any time during induction, labour, and delivery/ use of intravenous antibiotics/ clinically suspected/confirmed infection such as chorioamnionitis or postpartum endometritis)

[

48 hours postpartum

]
3.

Postpartum haemorrhage > 1000mLs

[

48 hours postpartum

]
4.

Uterine rupture

[

48 hours postpartum

]
5.

Hysterectomy for any complications resulting from birth

[

At the time of hospital discharge and six weeks postpartum

]
6.

Damage to internal organs (bladder, bowel, ureters)

[

48 hours postpartum

]
7.

Cardio-respiratory arrest

[

at the time of hospital discharge upto six weeks postpartum

]
8.

Stroke

[

at the time of hospital discharge and six weeks postpartum

]
9.

Pulmonary embolism

[

at the time of hospital discharge and six weeks postpartum

]
10.

Postnatal depression

[

48 hours postpartum

]
11.

Maternal mortality

[

48 hours postpartum

]
12.

Mode of delivery (spontaneous vaginal and operative delivery and caesarean delivery with indications

[

48 hours postpartum

]
13.

Induction to delivery interval

[

48 hours postpartum

]
14.

Length of hospital stay for mother and baby

[

at the time of hospital discharge

]
15.

Women’s satisfaction with their respective outpatient or inpatient approach

[

48 hours postpartum

]
16.

Acceptability of the Foley catheter as an outpatient method to women

[

After six weeks of delivery

]
17.

Acceptability of the Foley catheter as an outpatient method to partners

[

After six weeks of delivery

]
18.

Healthcare cost for the two methods of induction of labour and their cost-effectiveness

[

at the time of hospital discharge and six weeks postpartum

]

Target number/sample size

1096 [548 for each arm]


Countries of recruitment

Sri Lanka


Anticipated start date

2021-09-06


Anticipated end date

2022-08-08


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

Self-funded


Regulatory approvals

Not applicable



State of Ethics Review Approval


Status

Approved


Date of Approval

2021-06-18


Approval number

P/145/12/2020


Details of Ethics Review Committee

Name: Ethics Review Committee of the Faculty of Medicine, University of Kelaniya.
Institutional Address:Ragama, Sri Lanka
Telephone:+94 11 2961267
Email: erckelaniya@gmail.com

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Malitha Patabendige
Consultant Obstetrician and Gynaecologist
Base Hospital Pottuvil, Pottuvil, Sri Lanka

+94777357030

mpatabendige@gmail.com

Contact Person for Public Queries

Malitha Patabendige
Consultant Obstetrician and Gynaecologist
Base Hospital Pottuvil, Pottuvil, Sri Lanka

+94777357030

mpatabendige@gmail.com


Primary study sponsor/organization

Dr. Malitha Patabendige
Consultant Obstetrician and Gynaecologist
Base Hospital Pottuvil, Pottuvil, Sri Lanka
+94777357030

mpatabendige@gmail.com

Secondary study sponsor (If any)







Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

Yes


IPD sharing plan description

All the individual participant data after deidentification (including data dictionaries) will be shared along with the study protocol, data collection tools, and analysis plan immediately following publication and there will be no end date. These will be shared for researchers with a methodologically sound proposal and for an individual participant meta-analysis. Data will be available upon a reasonable request from the corresponding author.


Study protocol available

Yes


Protocol version and date

Version 4, 18 June 2021


Protocol URL


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results