Clinical trial NCT03866772: Labor Induction With Double Balloon Device, Oral Misoprostol and Concomitant Use of Both
Official title: Labor Induction With Double Balloon Device, Oral Misoprostol and Concomitant Use of Both. Multicenter Randomized Controlled Trial- IDOM Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pregnancy Related
Keywords: induction of labor
unfavorable cervix
misoprostol
cytotec
double balloon device
cervical ripening
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-03-07
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Induction of labor is a common obstetrical procedure. It accounts for 20% of laboring women worldwide.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: the rate of cesarean delivery
timeFrame: from induction until delivery
Secondary outcomes:
measure: Bishop score difference between groups
timeFrame: after 6 hours and after 24 hours
Other outcomes:
measure: time to delivery
timeFrame: from induction to delivery and from ruptured membranes to delivery
measure: Use of other ripening methods after "failure" of the allocated method
timeFrame: 24 hours after initiation of the treatment
measure: Rate of achieving active phase of labor (≥ 5 cm cervical dilatation)
timeFrame: within 24 hours of initiation
measure: Cesarean delivery indication (non progressive labor or non reassuring fetal heart rate NRFHR)
timeFrame: from initiation until cesarean delivery
measure: Maternal morbidity
timeFrame: from initiation until delivery
measure: Patient satisfaction - by questioner
timeFrame: within 5 days from delivery
measure: tachysystole
timeFrame: from initiation until delivery
measure: Neonatal morbidity:
timeFrame: within 5 days from delivery
measure: use of oxytocin
timeFrame: within 24 hours
measure: use of emergent tocolysis
timeFrame: from induction until delivery
measure: how many doses of misoprostol
timeFrame: from induction until delivery
Locations:
city: Haifa
country: Israel
facility: Bnai Zion Mc
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.