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

Pregnancy Related Clinical Trial

— IDOM  

Official title:

Labor Induction With Double Balloon Device, Oral Misoprostol and Concomitant Use of Both. Multicenter Randomized Controlled Trial- IDOM Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03866772
• Other study ID #: 0166-18-BNZ
• Status: Terminated
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: September 24, 2023

Study information

• Verified date: October 2023
• Source: Bnai Zion Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 250
• Est. completion date: September 24, 2023
• Est. primary completion date: September 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Drug:
• Misoprostol Oral Tablet
50 mcg oral consumption

Device:
• double balloon device for cervical ripening
insertion for 6 hours and followed by the above mentioned protocol

Locations

Country	Name	City	State
Israel	Bnai Zion Mc	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Bnai Zion Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (11)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	time to delivery	Mean time to delivery	from induction to delivery and from ruptured membranes to delivery
Other	Use of other ripening methods after "failure" of the allocated method	if the allocated measure was defined as "failed" after 24 hours, other methods will be used to ripen the cervix.	24 hours after initiation of the treatment
Other	Rate of achieving active phase of labor (= 5 cm cervical dilatation)	how many women had more than 5 cm cervical dilatation	within 24 hours of initiation
Other	Cesarean delivery indication (non progressive labor or non reassuring fetal heart rate NRFHR)	what was the indication for surgery	from initiation until cesarean delivery
Other	Maternal morbidity	advanced tears (3rd and 4th degree) post partum hemorrhage uterine rupture, amnionitis	from initiation until delivery
Other	Patient satisfaction - by questioner	question addressing pain (bearable or unbearable, was the treatment comfortable for the women and would she do it again if necessary	within 5 days from delivery
Other	tachysystole	more than 5 contractions in 10 min with or without fetal heart rate changes	from initiation until delivery
Other	Neonatal morbidity:	neonatal care unit admission, meconium with\without fetal heart rate changes, Apgar 5' <7 ,	within 5 days from delivery
Other	use of oxytocin	if it was in use at all (yes\no) and if yes- so for how long (time from initiation until delivery)	within 24 hours
Other	use of emergent tocolysis	IV atosiban for tachysystole	from induction until delivery
Other	how many doses of misoprostol	counting the number of administered doses	from induction until delivery
Primary	the rate of cesarean delivery	percentage of cesarean delivery from all deliveries	from induction until delivery
Secondary	Bishop score difference between groups	cervical change evaluation	after 6 hours and after 24 hours