Labor Induction With Double Balloon Device, Oral Misoprostol and Concomitant Use of Both
NCT ID: NCT03866772
Last Updated: 2023-10-30
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
250 participants
INTERVENTIONAL
2019-06-01
2023-09-24
Brief Summary
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Detailed Description
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In the past, studies showed that cesarean delivery rates (CDR) are higher in women who are induced. These studies were comparing induction to spontaneous labor, which is not the management in practice, and when the comparison was made between induction and expectant management, the conclusion was that the induction does not increase CDR and can even reduce its' rate.
Failure of induction depends on the definition, and even among randomized controlled trials, this definition may vary greatly.
The decision whether to use a mechanical or pharmacological agent depends on Bishop score, parity, contraindications to one of the methods and patient-doctor preference.
Recently, more data are available regarding induction with oral misoprostol (OM) and this method is becoming more popular because OM is effective, safe, convenient, cheap and easy to administer.
If mechanical induction is preferable, either single or double balloon device (DBD) can be used. These methods have been previously studied and neither found to be superior.
A recent study showed that, insertion of the DBD for 6 hours in nulliparous women, results in shorter time to delivery (26 hours vs. 31.4 hours, p=0.015), similar Bishop score after removal ( 5.74 vs. 5.26, p=0.2) without increasing the rate of cesarean deliveries (19% vs 32%, p=0.135) when compared to insertion of the DBD for 12 hours as instructed by the manufacturer. Several studies have shown that a combination of pharmacological and single balloon device results in higher rates to achieve vaginal delivery when compared to each method separately
The investigators hypothesize that with the combination of DBD for 6 hours and OM we will be able to reduce the rate of cesarean deliveries when compared to each method separately.
To date, there are no studies that compared double balloon device with oral misoprostol used concomitantly.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MISOPROSTOL
* oral misoprostol, 50 microgram, every 4 hours
* Repeat treatment every 4 hours until active labour begins: regular painful contractions (≥ 3 in 10 min), cervical dilatation ≥ 3 cm
* maximal number of doses: 6
* Oxytocin infusion can be initiated 4 hours after the last dose of Misoprostol.
* Failure of induction will be considered if no cervical change nor uterine contractions have begun during 24 hours of treatment.
* Electronic fetal monitoring should be performed for 30 min after administration of misoprostol and 60 min after any tachysystole.
Misoprostol Oral Tablet
50 mcg oral consumption
DOUBLE BALLOON
* Insertion of the DBD as instructed by the manufacturer, removal after 6 hours.
* Artificial rupture of membranes (AROM) if suitable + IV oxytocin administration
* If AROM cannot be performed- oxytocin infusion will be initiated at first.
* If Bishop \<3 after DBD removal, clinical evaluation and lag time before considering other methods for ripening is suitable and is up to the physician on call.
double balloon device for cervical ripening
insertion for 6 hours and followed by the above mentioned protocol
MISOPROSTOL+DOUBLE BALLOON
Misoprostol Oral Tablet
50 mcg oral consumption
double balloon device for cervical ripening
insertion for 6 hours and followed by the above mentioned protocol
Interventions
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Misoprostol Oral Tablet
50 mcg oral consumption
double balloon device for cervical ripening
insertion for 6 hours and followed by the above mentioned protocol
Eligibility Criteria
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Inclusion Criteria
* indication for induction of labor (medical or obstetrical),
* 37 completed gestational weeks,
* vertex presentation,
* singleton pregnancy
* intact membranes.
Exclusion Criteria
* previous uterine surgery (eg: myomectomy)
* noncephalic presentation
* multiple pregnancy
* pre-eclampsia with severe features
* oligohydramnios (Maximal vertical pocket ≤2)
* estimated fetal weight \<10% percentile
* any contraindication to Vaginal delivery
18 Years
50 Years
FEMALE
Yes
Sponsors
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Bnai Zion Medical Center
OTHER_GOV
Responsible Party
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Inna.bleicher
principle investigator
Locations
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Bnai Zion Mc
Haifa, , Israel
Countries
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References
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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.
American College of Obstetricians and Gynecologists (College); Society for Maternal-Fetal Medicine; Caughey AB, Cahill AG, Guise JM, Rouse DJ. Safe prevention of the primary cesarean delivery. Am J Obstet Gynecol. 2014 Mar;210(3):179-93. doi: 10.1016/j.ajog.2014.01.026.
Grobman WA, Rice MM, Reddy UM, Tita ATN, Silver RM, Mallett G, Hill K, Thom EA, El-Sayed YY, Perez-Delboy A, Rouse DJ, Saade GR, Boggess KA, Chauhan SP, Iams JD, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Labor Induction versus Expectant Management in Low-Risk Nulliparous Women. N Engl J Med. 2018 Aug 9;379(6):513-523. doi: 10.1056/NEJMoa1800566.
Schoen C, Navathe R. Failed induction of labor. Semin Perinatol. 2015 Oct;39(6):483-7. doi: 10.1053/j.semperi.2015.07.013. Epub 2015 Sep 2.
Grobman WA, Bailit J, Lai Y, Reddy UM, Wapner RJ, Varner MW, Thorp JM Jr, Leveno KJ, Caritis SN, Prasad M, Tita ATN, Saade G, Sorokin Y, Rouse DJ, Blackwell SC, Tolosa JE; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Defining failed induction of labor. Am J Obstet Gynecol. 2018 Jan;218(1):122.e1-122.e8. doi: 10.1016/j.ajog.2017.11.556. Epub 2017 Nov 11.
Penfield CA, Wing DA. Labor Induction Techniques: Which Is the Best? Obstet Gynecol Clin North Am. 2017 Dec;44(4):567-582. doi: 10.1016/j.ogc.2017.08.011.
Weeks AD, Navaratnam K, Alfirevic Z. Simplifying oral misoprostol protocols for the induction of labour. BJOG. 2017 Oct;124(11):1642-1645. doi: 10.1111/1471-0528.14657. Epub 2017 May 15. No abstract available.
Salim R, Schwartz N, Zafran N, Zuarez-Easton S, Garmi G, Romano S. Comparison of single- and double-balloon catheters for labor induction: a systematic review and meta-analysis of randomized controlled trials. J Perinatol. 2018 Mar;38(3):217-225. doi: 10.1038/s41372-017-0005-7. Epub 2017 Dec 4.
Husain S, Husain S, Izhar R. Oral misoprostol alone versus oral misoprostol and Foley's catheter for induction of labor: A randomized controlled trial. J Obstet Gynaecol Res. 2017 Aug;43(8):1270-1277. doi: 10.1111/jog.13354. Epub 2017 May 31.
Levine LD, Downes KL, Elovitz MA, Parry S, Sammel MD, Srinivas SK. Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1357-1364. doi: 10.1097/AOG.0000000000001778.
Jozwiak M, Bloemenkamp KW, Kelly AJ, Mol BW, Irion O, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2012 Mar 14;(3):CD001233. doi: 10.1002/14651858.CD001233.pub2.
de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
Other Identifiers
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0166-18-BNZ
Identifier Type: -
Identifier Source: org_study_id
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