Outpatient Induction of Labour Using Intracervical Foley Catheter (OFC)

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)

Study Overview

• Status: Terminated
• Conditions: Pregnancy Related; Induction of Labor Affected Fetus / Newborn
• Intervention / Treatment: Device: Foley catheter; Drug: Intravaginal prostaglandin E2

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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Terengganu
    • Kampong Kemaman, Terengganu, Malaysia, 24000
      • Hospital Kemaman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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
• Contraindication to induction of labor
• Evidence of active phase of labor

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention; Women who are planned for elective delivery for obstetric indication(s) and undergo outpatient induction of labour using Foley catheter	Device: Foley catheter; Insertion of 18G Foley catheter into the cervical canal and inflating the balloon to 60 mls using sterile water; Other Names: urinary catheter; Drug: Intravaginal prostaglandin E2; Insertion of intravaginal Dinoprostone; Other Names: Dinoprostone
Placebo Comparator: Control; Women who are planned for elective delivery for obstetric indication(s) and undergo inpatient induction of labour using intravaginal prostaglandin	Drug: Intravaginal prostaglandin E2; Insertion of intravaginal Dinoprostone; Other Names: Dinoprostone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of induction of labour within 12 hours	The percentage of vaginal delivery within 12 hours of inpatient cervical ripening	From the start of inpatient cervical ripening and delivery
Success rate of induction of labour within 24 hours	The percentage of vaginal delivery within 24 hours of inpatient cervical ripening	From the start of inpatient cervical ripening and delivery
Delivery outcome	Percentage of caesarean section and instrumental delivery	Induction to delivery
Adverse event	Incidence of uterine tachysystole and hyperstimulation	Induction to delivery
Labour augmentation	Duration and maximum oxytocin dose used for labour augmentation	Induction to delivery
Maximum pain recorded	Maximum recorded contraction pain during cervical ripening (using Visual Analogue Scale of 10)	Induction to delivery
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	Induction to 24 hours after delivery
Analgesia requirement	Prevalence of analgesia required during induction of labour	Induction to delivery
Postpartum hemorrhage	Primary postpartum haemorrhage (blood loss of more than 500mls within 24 hours of delivery)	Delivery to 24 hours after delivery
Neonatal Apgar score	Incidence of low Apgar score (less than 7) at 5 minutes after delivery	Delivery to 10 minutes after birth
Neonatal intubation	Incidence of neonates requiring intubation	Delivery to 30 minutes after birth
Neonatal seizure	Incidence of neonate with seizure	Delivery to 24 hours after birth
Neonatal complication	Admission to the Neonatal Intensive Care Unit	Delivery to 24 hours after birth

Collaborators and Investigators

• Sponsor: Hospital Kemaman
• Investigators: Principal Investigator: Zahar Zakaria, MD, Hospital Kemaman

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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. Erratum In: BMC Pregnancy Childbirth. 2020 Jul 13;20(1):403. doi: 10.1186/s12884-020-03098-1.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): September 1, 2024

Study Registration Dates

• First Submitted: November 14, 2022
• First Submitted That Met QC Criteria: November 14, 2022
• First Posted (Actual): November 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 15, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Foley catheter; outpatient induction
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Dinoprostone
• Other Study ID Numbers: NMRR ID-22-00349-EQQ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share for now

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No