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Pregnancy RelatedOFCNCT05622968

Outpatient Induction of Labour Using Intracervical Foley Catheter

A study testing Foley catheter and Intravaginal prostaglandin E2 in people with Pregnancy Related and Induction of Labor Affected Fetus / Newborn, run by Hospital Kemaman at 1 site in Malaysia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 50 years
What is being tested?
Foley catheter and Intravaginal prostaglandin E2
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
88 participants
Where
1 siteMalaysia
Study dates
1 Jan 2023to 1 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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.

Who cannot join

  • 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
Show all 17Show fewer
  • 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
  • Contraindication to induction of labor
  • Evidence of active phase of labor

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

  • Hospital Kemaman

    Kampong Kemaman, Terengganu, 24000

Other trials in Malaysia

About this study

Official title: Outpatient Cervical Ripening With Foley Catheter for Induction of Labour in Low Risk Women: a Quasi-experimental Study (OFC Study)

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)

Read the detailed description

The study will be conducted among pregnant women in 2 to 5th pregnancy who have no significant risk factors and planned for induction of labour. The eliiable women will be recruited from 4 health clinics within the district (of Kemaman, Malaysia) and located within 20 km from the hospital.

Willing participants will be seen in the hospital at the planned induction date and reassessed. Should they be suitable for induction of labour using Foley catheter on outpatient basis, a 18G Foley catheter will be inserted into the cervical canal and the balloon inflated with sterile water (60 mls). The fetal well being will be assessed and the women allowed to go home with instruction related to the induction and the study.

Those who do not enter the active phase of labour will be admitted to the ward 24 hours later and will undergo inpatient induction of labour using intravaginal prostaglandin (Dinoprostone) according to the local protocol.

These women will be compared with a control group comprising of women with similar characteristics and undergo inpatient induction of labour with intravaginal Dinoprostone.

Being tested
Foley catheter, Intravaginal prostaglandin E2
Keywords
outpatient induction, Foley catheter

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Foley catheterDevice

    Also called urinary catheter

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

  • Intravaginal prostaglandin E2Drug

    Also called Dinoprostone

    Insertion of intravaginal Dinoprostone

Study groups in NCT05622968
Study groupRoleWhat they receive
InterventionActive comparatorWomen who are planned for elective delivery for obstetric indication(s) and undergo outpatient induction of labour using Foley catheter
Receives: Device: Foley catheter; Drug: Intravaginal prostaglandin E2
ControlPlacebo comparatorWomen who are planned for elective delivery for obstetric indication(s) and undergo inpatient induction of labour using intravaginal prostaglandin
Receives: Drug: Intravaginal prostaglandin E2

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Induction of labour (intravaginal prostaglandin) to delivery

Secondary outcomes (13)

  1. Success rate of induction of labour within 12 hours

    The percentage of vaginal delivery within 12 hours of inpatient cervical ripening

    Measured: From the start of inpatient cervical ripening and delivery

  2. Success rate of induction of labour within 24 hours

    The percentage of vaginal delivery within 24 hours of inpatient cervical ripening

    Measured: From the start of inpatient cervical ripening and delivery

  3. Delivery outcome

    Percentage of caesarean section and instrumental delivery

    Measured: Induction to delivery

  4. Adverse event

    Incidence of uterine tachysystole and hyperstimulation

    Measured: Induction to delivery

  5. Labour augmentation

    Duration and maximum oxytocin dose used for labour augmentation

    Measured: Induction to delivery

  6. Maximum pain recorded

    Maximum recorded contraction pain during cervical ripening (using Visual Analogue Scale of 10)

    Measured: Induction to delivery

  7. Incidence of chorioamnionitis

    maternal temperature is greater than or equal to 39.0°C or when the maternal temperature is 38.0-38.9°C and one additional clinical risk factor is present

    Measured: Induction to 24 hours after delivery

  8. Analgesia requirement

    Prevalence of analgesia required during induction of labour

    Measured: Induction to delivery

  9. Postpartum hemorrhage

    Primary postpartum haemorrhage (blood loss of more than 500mls within 24 hours of delivery)

    Measured: Delivery to 24 hours after delivery

  10. Neonatal Apgar score

    Incidence of low Apgar score (less than 7) at 5 minutes after delivery

    Measured: Delivery to 10 minutes after birth

  11. Neonatal intubation

    Incidence of neonates requiring intubation

    Measured: Delivery to 30 minutes after birth

  12. Neonatal seizure

    Incidence of neonate with seizure

    Measured: Delivery to 24 hours after birth

  13. Neonatal complication

    Admission to the Neonatal Intensive Care Unit

    Measured: Delivery to 24 hours after birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2022
  2. Study start1 Jan 2023
  3. Primary completion1 Sep 2024
  4. Study completion1 Sep 2024

Why it stopped: Poor recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05622968
Sponsor's protocol ID
NMRR ID-22-00349-EQQ
Acronym
OFC
Status last verified
Jan 2025
First submitted
14 Nov 2022
Last updated
17 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No plan to share for now

Publications

  • 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.

    PubMed 27513897

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

  • 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.

    PubMed 19623003

  • 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.

    PubMed 24099451

  • 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.

    PubMed 20687092

  • 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.

    PubMed 28901007

  • 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.

    PubMed 32605542

  • 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.

    PubMed 34214801

  • 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.

    PubMed 26365009

  • 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.

    PubMed 27078202

  • 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.

    PubMed 11704164

  • 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.

    PubMed 29211328

  • 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.

    PubMed 31793372

  • 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.

    PubMed 24635460

Questions about this trial

What is this clinical trial studying?

A study testing Foley catheter and Intravaginal prostaglandin E2 in people with Pregnancy Related and Induction of Labor Affected Fetus / Newborn, run by Hospital Kemaman at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Induction of labour-delivery interval (time frame: Induction of labour (intravaginal prostaglandin) to delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05622968, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.

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