NCT05622968

Brief 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)

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 21, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

January 17, 2025

Status Verified

January 1, 2025

Enrollment Period

1.7 years

First QC Date

November 14, 2022

Last Update Submit

January 15, 2025

Conditions

Pregnancy RelatedInduction of Labor Affected Fetus / Newborn

Keywords

outpatient inductionFoley catheter

Outcome Measures

Primary Outcomes (1)

  • Induction of labour-delivery interval

    The mean interval between the start of inpatient cervical ripening and delivery (from the start of cervical ripening with Dinoprostone to the delivery of the baby)

    Induction of labour (intravaginal prostaglandin) to delivery

Secondary Outcomes (13)

  • Success rate of induction of labour within 12 hours

    From the start of inpatient cervical ripening and delivery

  • Success rate of induction of labour within 24 hours

    From the start of inpatient cervical ripening and delivery

  • Delivery outcome

    Induction to delivery

  • Adverse event

    Induction to delivery

  • Labour augmentation

    Induction to delivery

  • +8 more secondary outcomes

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Women who are planned for elective delivery for obstetric indication(s) and undergo outpatient induction of labour using Foley catheter

Device: Foley catheterDrug: Intravaginal prostaglandin E2

Control

PLACEBO COMPARATOR

Women who are planned for elective delivery for obstetric indication(s) and undergo inpatient induction of labour using intravaginal prostaglandin

Drug: Intravaginal prostaglandin E2

Interventions

Foley catheterDEVICE

Insertion of 18G Foley catheter into the cervical canal and inflating the balloon to 60 mls using sterile water

Also known as: urinary catheter
Intervention
Intravaginal prostaglandin E2DRUG

Insertion of intravaginal Dinoprostone

Also known as: Dinoprostone
ControlIntervention

Eligibility Criteria

Age18 Years - 50 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsAll low risk pregnant women with obstetric indication for induction of labour at term
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • Polyhydramnios: defined as an AFI of 24 cm or greater or a single deepest vertical pocket of 8 cm or greater
  • Latex allergy
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Kemaman

Kampong Kemaman, Terengganu, 24000, Malaysia

Location

Related Publications (14)

  • Sharp AN, Stock SJ, Alfirevic Z. Outpatient induction of labour in the UK: a survey of practice. Eur J Obstet Gynecol Reprod Biol. 2016 Sep;204:21-3. doi: 10.1016/j.ejogrb.2016.06.023. Epub 2016 Jul 30.

    PMID: 27513897BACKGROUND

  • Royal College of Obstetricians and Gynaecologists. Evidence-based Clinical Guideline No. 9. Induction of labour

    RESULT

  • ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol. 2009 Aug;114(2 Pt 1):386-397. doi: 10.1097/AOG.0b013e3181b48ef5. No abstract available.

    PMID: 19623003RESULT

  • Leduc D, Biringer A, Lee L, Dy J; CLINICAL PRACTICE OBSTETRICS COMMITTEE; SPECIAL CONTRIBUTORS. Induction of labour. J Obstet Gynaecol Can. 2013 Sep;35(9):840-857. doi: 10.1016/S1701-2163(15)30842-2. English, French.

    PMID: 24099451RESULT

  • Dowswell T, Kelly AJ, Livio S, Norman JE, Alfirevic Z. Different methods for the induction of labour in outpatient settings. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD007701. doi: 10.1002/14651858.CD007701.pub2.

    PMID: 20687092RESULT

  • Vogel JP, Osoti AO, Kelly AJ, Livio S, Norman JE, Alfirevic Z. Pharmacological and mechanical interventions for labour induction in outpatient settings. Cochrane Database Syst Rev. 2017 Sep 13;9(9):CD007701. doi: 10.1002/14651858.CD007701.pub3.

    PMID: 28901007RESULT

  • Dong S, Khan M, Hashimi F, Chamy C, D'Souza R. Inpatient versus outpatient induction of labour: a systematic review and meta-analysis. BMC Pregnancy Childbirth. 2020 Jun 30;20(1):382. doi: 10.1186/s12884-020-03060-1.

    PMID: 32605542RESULT

  • Croll DMR, Hoge PC, Verhoeven CJM, de Boer MA, Bloemenkamp KWM, de Heus R. Changes in local protocols on inpatient cervical priming and introduction of outpatient priming: A nationwide survey in the Netherlands. Eur J Obstet Gynecol Reprod Biol. 2021 Aug;263:148-152. doi: 10.1016/j.ejogrb.2021.06.004. Epub 2021 Jun 10.

    PMID: 34214801RESULT

  • Amorosa JM, Stone JL. Outpatient cervical ripening. Semin Perinatol. 2015 Oct;39(6):488-94. doi: 10.1053/j.semperi.2015.07.014. Epub 2015 Sep 11.

    PMID: 26365009RESULT

  • Kruit H, Heikinheimo O, Ulander VM, Aitokallio-Tallberg A, Nupponen I, Paavonen J, Rahkonen L. Foley catheter induction of labor as an outpatient procedure. J Perinatol. 2016 Aug;36(8):618-22. doi: 10.1038/jp.2016.62. Epub 2016 Apr 14.

    PMID: 27078202RESULT

  • Sciscione AC, Muench M, Pollock M, Jenkins TM, Tildon-Burton J, Colmorgen GH. Transcervical Foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting. Obstet Gynecol. 2001 Nov;98(5 Pt 1):751-6. doi: 10.1016/s0029-7844(01)01579-4.

    PMID: 11704164RESULT

  • Diederen M, Gommers J, Wilkinson C, Turnbull D, Mol B. Safety of the balloon catheter for cervical ripening in outpatient care: complications during the period from insertion to expulsion of a balloon catheter in the process of labour induction: a systematic review. BJOG. 2018 Aug;125(9):1086-1095. doi: 10.1111/1471-0528.15047. Epub 2018 Jan 10.

    PMID: 29211328RESULT

  • Stephenson E, Borakati A, Simpson I, Eedarapalli P. Foley catheter for induction of labour: a UK observational study. J Obstet Gynaecol. 2020 Nov;40(8):1064-1068. doi: 10.1080/01443615.2019.1676213. Epub 2019 Dec 3.

    PMID: 31793372RESULT

  • Turnbull D, Adelson P, Oster C, Bryce R, Fereday J, Wilkinson C. Psychosocial outcomes of a randomized controlled trial of outpatient cervical priming for induction of labor. Birth. 2013 Jun;40(2):75-80. doi: 10.1111/birt.12035. Epub 2013 Mar 25.

    PMID: 24635460RESULT

MeSH Terms

Interventions

Urinary CathetersDinoprostone

Intervention Hierarchy (Ancestors)

CathetersEquipment and SuppliesProstaglandins EProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Zahar Zakaria, MD

    Hospital Kemaman

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Head of Obstetric & Gynecology Department, Senior Consultant

Study Record Dates

First Submitted

November 14, 2022

First Posted

November 21, 2022

Study Start

January 1, 2023

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

January 17, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

No plan to share for now

Locations

MY(1)