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Poor recruitment
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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | Women who are planned for elective delivery for obstetric indication(s) and undergo outpatient induction of labour using Foley catheter |
|
| Control | Placebo Comparator | Women who are planned for elective delivery for obstetric indication(s) and undergo inpatient induction of labour using intravaginal prostaglandin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foley catheter | Device | Insertion of 18G Foley catheter into the cervical canal and inflating the balloon to 60 mls using sterile water |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
All low risk pregnant women with obstetric indication for induction of labour at term
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| Name | Affiliation | Role |
|---|---|---|
| Zahar Zakaria, MD | Hospital Kemaman | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Kemaman | Kampong Kemaman | Terengganu | 24000 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27513897 | Background | 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. | |
| Result | Royal College of Obstetricians and Gynaecologists. Evidence-based Clinical Guideline No. 9. Induction of labour | ||
| 19623003 |
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No plan to share for now
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| ID | Term |
|---|---|
| D062885 | Urinary Catheters |
| D015232 | Dinoprostone |
| ID | Term |
|---|---|
| D057785 | Catheters |
| D004864 | Equipment and Supplies |
| D011458 | Prostaglandins E |
| D011453 | Prostaglandins |
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| Intravaginal prostaglandin E2 | Drug | Insertion of intravaginal Dinoprostone |
|
|
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 |
| 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. |
| 24099451 | Result | 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. |
| 20687092 | Result | 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. |
| 28901007 | Result | 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. |
| 32605542 | Result | 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. |
| 34214801 | Result | 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. |
| 26365009 | Result | 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. |
| 27078202 | Result | 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. |
| 11704164 | Result | 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. |
| 29211328 | Result | 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. |
| 31793372 | Result | 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. |
| 24635460 | Result | 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. |
| D015777 |
| Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |