Labor Induction With Double Balloon Device, Oral Misoprostol and Concomitant Use of Both

NCT03866772 | Terminated FDA Device

• 1 other identifier: 0166-18-BNZ
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the rate of cesarean delivery between 3 methods of labor induction: double balloon device, oral misoprostol and combination of the two.

Conditions

Pregnancy Related

Keywords

induction of labor; unfavorable cervix; misoprostol; cytotec; double balloon device; cervical ripening

Outcome Measures

Primary Outcomes (1)

• the rate of cesarean delivery

  percentage of cesarean delivery from all deliveries

  from induction until delivery

Secondary Outcomes (1)

• Bishop score difference between groups

  after 6 hours and after 24 hours

Other Outcomes (11)

• time to delivery

  from induction to delivery and from ruptured membranes to delivery

• Use of other ripening methods after "failure" of the allocated method

  24 hours after initiation of the treatment

• Rate of achieving active phase of labor (≥ 5 cm cervical dilatation)

  within 24 hours of initiation

Study Arms (3)

MISOPROSTOL

ACTIVE COMPARATOR

* 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.

Drug: Misoprostol Oral Tablet

DOUBLE BALLOON

ACTIVE COMPARATOR

* 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.

Device: double balloon device for cervical ripening

MISOPROSTOL+DOUBLE BALLOON

ACTIVE COMPARATOR

Drug: Misoprostol Oral Tablet; Device: double balloon device for cervical ripening

Interventions

Misoprostol Oral Tablet DRUG

50 mcg oral consumption

MISOPROSTOL; MISOPROSTOL+DOUBLE BALLOON

double balloon device for cervical ripening DEVICE

insertion for 6 hours and followed by the above mentioned protocol

DOUBLE BALLOON; MISOPROSTOL+DOUBLE BALLOON

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: pregnant population
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• unfavourable cervix (Bishop score ≤ 4),
• indication for induction of labor (medical or obstetrical),
• completed gestational weeks,
• vertex presentation,
• singleton pregnancy
• intact membranes.

You may not qualify if:

• previous cesarean delivery
• 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

Sponsors & Collaborators

• Bnai Zion Medical Center: lead

Study Sites (1)

Bnai Zion Mc

Haifa, Israel

Location

Related Publications (12)

• 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.

  PMID: 19623003 BACKGROUND

• 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.

  PMID: 24565430 BACKGROUND

• 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.

  PMID: 30089070 BACKGROUND

• 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.

  PMID: 26341068 BACKGROUND

• 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.

  PMID: 29138035 BACKGROUND

• 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.

  PMID: 29078939 BACKGROUND

• 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.

  PMID: 28342186 BACKGROUND

• 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.

  PMID: 29203813 BACKGROUND

• 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.

  PMID: 28561987 BACKGROUND

• 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.

  PMID: 27824758 BACKGROUND

• 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.

  PMID: 22419277 BACKGROUND

• 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.

  PMID: 36996264 DERIVED

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: March 3, 2019
• First Posted: March 7, 2019
• Study Start: June 1, 2019
• Primary Completion: September 24, 2023
• Study Completion: September 24, 2023
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)