Pregnancy RelatedIDOMNCT03866772
Labor Induction With Double Balloon Device, Oral Misoprostol and Concomitant Use of Both
A study testing Misoprostol Oral Tablet and double balloon device for cervical ripening in people with Pregnancy Related, run by Bnai Zion Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Misoprostol Oral Tablet and double balloon device for cervical ripening
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jun 2019to 24 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- unfavourable cervix (Bishop score ≤ 4),
- indication for induction of labor (medical or obstetrical),
- 37 completed gestational weeks,
- vertex presentation,
- singleton pregnancy
- intact membranes.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Labor Induction With Double Balloon Device, Oral Misoprostol and Concomitant Use of Both. Multicenter Randomized Controlled Trial- IDOM Trial
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.
Read the 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.
- Conditions
- Pregnancy Related
- Being tested
- Misoprostol Oral Tablet, double balloon device for cervical ripening
- Keywords
- induction of labor, unfavorable cervix, misoprostol, cytotec, double balloon device, cervical ripening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol Oral TabletDrug
50 mcg oral consumption
double balloon device for cervical ripeningDevice
insertion for 6 hours and followed by the above mentioned protocol
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: double balloon device for cervical ripening |
| MISOPROSTOL+DOUBLE BALLOON | Active comparator | Not described Receives: Drug: Misoprostol Oral Tablet; Device: double balloon device for cervical ripening |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of cesarean delivery
percentage of cesarean delivery from all deliveries
Measured: from induction until delivery
Secondary outcomes (1)
Bishop score difference between groups
cervical change evaluation
Measured: after 6 hours and after 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start1 Jun 2019
- Primary completion24 Sep 2023
- Study completion24 Sep 2023
Why it stopped: RECRUTIMENT DIFICULTIES
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Inna.bleicher, Bnai Zion Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03866772
- Sponsor's protocol ID
- 0166-18-BNZ
- Acronym
- IDOM
- Status last verified
- Oct 2023
- First submitted
- 3 Mar 2019
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 19623003American 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.
PubMed 24565430Grobman 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.
PubMed 30089070Schoen 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.
PubMed 26341068Grobman 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.
PubMed 29138035Penfield 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.
PubMed 29078939Weeks 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.
PubMed 28342186Salim 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.
PubMed 29203813Husain 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.
PubMed 28561987Levine 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.
PubMed 27824758Jozwiak 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.
PubMed 22419277de 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.
PubMed 36996264
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Labor Induction With Double Balloon Device, Oral Misoprostol and Concomitant Use of Both. Multicenter Randomized Controlled Trial- IDOM Trial
- ClinicalTrials.gov ID
- NCT03866772
- Acronym / sponsor ID
- IDOM / 0166-18-BNZ
- Conditions
- Pregnancy Related
- Keywords
- induction of labor, unfavorable cervix, misoprostol, cytotec, double balloon device, cervical ripening
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: RECRUTIMENT DIFICULTIES
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 24 Sep 2023 (actual)
- Study completion
- 24 Sep 2023 (actual)
- First posted
- 7 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MISOPROSTOL | Active comparator | Drug: Misoprostol Oral Tablet* 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. |
| DOUBLE BALLOON | Active comparator | Device: double balloon device for cervical ripening* 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. |
| MISOPROSTOL+DOUBLE BALLOON | Active comparator | Drug: Misoprostol Oral Tablet, Device: double balloon device for cervical ripening |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- unfavourable cervix (Bishop score ≤ 4),
- indication for induction of labor (medical or obstetrical),
- 37 completed gestational weeks,
- vertex presentation,
- singleton pregnancy
Key exclusion criteria (8 listed)
- previous cesarean delivery
- previous uterine surgery (eg: myomectomy)
- noncephalic presentation
- multiple pregnancy
- pre-eclampsia with severe features
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Misoprostol Oral Tablet50 mcg oral consumption | Drug | MISOPROSTOL, MISOPROSTOL+DOUBLE BALLOON |
| double balloon device for cervical ripeninginsertion for 6 hours and followed by the above mentioned protocol | Device | DOUBLE BALLOON, MISOPROSTOL+DOUBLE BALLOON |
Primary outcome
the rate of cesarean delivery
Time frame: from induction until delivery
percentage of cesarean delivery from all deliveries
1 secondary outcome
Bishop score difference between groups
Time frame: after 6 hours and after 24 hours
Results and safety
The study was stopped early (reason given: RECRUTIMENT DIFICULTIES). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Background: PubMed 19623003ACOG 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.
- Background: PubMed 24565430American 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.
- Background: PubMed 30089070Grobman 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.
- Background: PubMed 26341068Schoen 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.
- Background: PubMed 29138035Grobman 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.
- Background: PubMed 29078939Penfield 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.
- Background: PubMed 28342186Weeks 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.
- Background: PubMed 29203813Salim 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.
- Background: PubMed 28561987Husain 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.
- Background: PubMed 27824758Levine 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.
- Background: PubMed 22419277Jozwiak 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.
- Derived from this study: PubMed 36996264de 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Misoprostol Oral Tablet and double balloon device for cervical ripening in people with Pregnancy Related, run by Bnai Zion Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: RECRUTIMENT DIFICULTIES). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of cesarean delivery (time frame: from induction until delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03866772, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.