Outpatient Induction of Labour Using Intracervical Foley Catheter
NCT ID: NCT05622968
Last Updated: 2025-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
88 participants
INTERVENTIONAL
2023-01-01
2024-09-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention
Women who are planned for elective delivery for obstetric indication(s) and undergo outpatient induction of labour using Foley catheter
Foley catheter
Insertion of 18G Foley catheter into the cervical canal and inflating the balloon to 60 mls using sterile water
Intravaginal prostaglandin E2
Insertion of intravaginal Dinoprostone
Control
Women who are planned for elective delivery for obstetric indication(s) and undergo inpatient induction of labour using intravaginal prostaglandin
Intravaginal prostaglandin E2
Insertion of intravaginal Dinoprostone
Interventions
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Foley catheter
Insertion of 18G Foley catheter into the cervical canal and inflating the balloon to 60 mls using sterile water
Intravaginal prostaglandin E2
Insertion of intravaginal Dinoprostone
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
ALL
No
Sponsors
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Hospital Kemaman
OTHER
Responsible Party
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Zahar Azuar Zakaria
Principal Investigator, Head of Obstetric & Gynecology Department, Senior Consultant
Principal Investigators
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Zahar Zakaria, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Kemaman
Locations
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Hospital Kemaman
Kampong Kemaman, Terengganu, Malaysia
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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NMRR ID-22-00349-EQQ
Identifier Type: -
Identifier Source: org_study_id
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