Failed Medical or Unspecified Induction of LaborInductionNCT02815865
Comparing Cervical Foley Catheter, Dinoprostone and a Combination of the Two for Labor Induction
A study testing Foley catheter and pitocin, Foley catheter and Dinoprostone and Dinoprostone in people with Failed Medical or Unspecified Induction of Labor, run by Kaplan Medical Center.
Trial summary
The investigators intend to conduct a randomized clinical trial comparing 3 methods of induction of labor in term primiparous women with singleton. First group will be women induced with Foley catheter and pitocin, second group Foley catheter and vaginal dinoprostone and third group will be induced with vaginal… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Failed Medical or Unspecified Induction of Labor
- What is being tested?
- Foley catheter and pitocin, Foley catheter and Dinoprostone and Dinoprostone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Feb 2018
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primiparous women
- 37 weeks pregnant or more
- cephalic live singleton,
- intact membranes
- Unfavorable cervix (bishop's score 6 or less)
Who cannot join
- Previous cesarean section or other uterine surgery
- severe IUGR
- severe preeclampsia
- Fetal malpresentation
- Multiple gestation
- Spontaneous labor (3 contraction in 10 min)
Show all 15Show fewer
- Premature rupture of membranes, PROM
- Category 2 or greater fetal heart rate tracing
- Contraindication for vaginal delivery
- Fever
- Vaginal bleeding (more than spotting or bloody show)
- Severe IUGR
- HIV carrier
- Sensitivity to either latex or PGE2
- polyhydramnios
About this study
Official title: A Randomized Controlled Study Comparing Cervical Foley Catheter, Vaginal Dinoprostone and a Combination of the Two Methods for Induction of Labor
The investigators intend to conduct a randomized clinical trial comparing 3 methods of induction of labor in term primiparous women with singleton. First group will be women induced with Foley catheter and pitocin, second group Foley catheter and vaginal dinoprostone and third group will be induced with vaginal dinoprostone alone. The investigators compare time for induction to delivery and way of delivery.
Read the detailed description
Introduction:
Labor induction, an iatrogenic initiation of labor is one of the most common obstetric procedures performed nowadays. The rate of induction of labor more than doubled from 1990 through 2010 from 9.6% to 23.8% in the United State alone. There are many methods to promote labor induction, including mechanical and pharmacological methods that can be used alone or in conjugation. Choosing the right method for the right patient can be challenging, and up until now there is limited information regarding the most suitable and effective approach for cervical ripening and labor induction. Out of the vast options for cervical ripening, the Foley catheter and vaginal prostaglandins are frequently used. To date, few clinical trials have compared the different methods to evaluate the effectiveness and the risk in each method. Two randomized controlled trials compared the Foley catheter method with the vaginal dinoprostone method. In one study, the Foley catheter was found to be superior to the vaginal dinoprostone with regards to time to delivery, whereas in the other study no difference was found. In an additional trial, Foley bulb with vaginal Misoprostol was compared to Misoprostol alone. The first treatment resulted in a shorter time to delivery. These finding did not correlate with previous trials that either found no difference or superiority to Misoprostol alone. A recent study comparing Foley catheter with PGE2 in term oligohydramnios pregnancies showed that time to delivery was shorter in the PGE2 group. A meta-analysis comparing Misoprostol with dinoprostone showed that the first is more effective, but the latter is safer. Since in some obstetrics conditions such as preeclampsia and Intrauterine growth restriction (IUGR) an expeditious induction of labor may be needed, a combination of methods may fasten the induction to delivery interval. A recent study presented as an oral presentation at the society of maternal fetal medicine a month ago used a combination of Foley catheter and prostaglandins to induce labor. They found that this arm had the shorter induction to delivery time and had no serious side effects.
In this study, The investigators intend to compare the mechanical (Foley catheter combined with Oxytocin) method, to a pharmacological one (dinoprostone-PGE2) and to a combination of the two methods in cervical ripening in an unfavorable cervix. The investigators will also examine if using the two methods in tandem will provide an additive effect.
The study will include 3 groups; in each group about 100 participants will be enrolled, which will be suited to the including and excluding criteria. The investigators have about 200 inductions per year of primigravida women. The investigators expect to enroll 300 participants in about 2 years' time.
On enrollment the patient will receive a number and will be assigned to one of the three groups. All the participants will be assigned to a 20 minute reassuring monitor before insertion the device.
A perineal US will be performed before the intervention to evaluate Angle of progression (AOP), cervical length and head position.
Group 1: Foley and Oxytocin protocol The patient will lie in a lithotomy position and will be covered by sterile sheets. A direct visualization of the cervix will be achieved with sterile speculum, the cervix will be sterilized with iodine, if the patient is allergic to iodine "septal- scrub" will be used. The Foley will be inserted through the internal cervical os, filled with 80 ml of normal saline, and taped to the patient thigh with gentle traction. An hour after placing the Foley bulb, monitor will be performed. If less than 3 contractions per 10 min interval appears in the monitor the patient will be transferred to the delivery room and Oxytocin will be administrated. If 3 contraction or more appear in 10 min. interval, further intervention will be personalized according to medical decision.
The Foley catheter will be removed if any of the following will occur:
- Expulsion
- Non reassuring fetal heart rate, NRFHR
- Tachysystole
- spontaneous rupture of membranes, SROM
- If 24 12 hours elapsed since placement.
Group 2:
Foley with dinoprostone protocol. First the Foley bulb will be placed as instructed above. An hour after placing the Foley bulb, a monitor will be performed. If less than 3 contractions per 10 min. interval appears in the monitor a propess tape will be placed in the posterior fornix. The patient will be left recumbent for 30 minutes. One hour after placing the dinoprostone, fetal monitor will be performed. If less than 3 contractions per 10 min interval appears in the monitor the patient will be remained for observation and a monitor will be performed every 6 hours. If after placing the Foley bulb 3 contractions or more appear in 10 minutes interval the patient will be excluded from the research and further intervention will be personalized according to medical decision
Group 3 Dinoprostone protocol Dinoprostone will be removed from the freezer in direct connection with insertion. The patient will lie in a lithotomy position. Dinoprostone will be inserted to the posterior vaginal fornix using small amount of water soluble lubricant according to the manufactory protocol. The reminding of the tap will be inserted to the vagina. The patient will be left recumbent for 30 minutes. An hour after placing the dinoprostone, fetal monitor will be performed and then every 6 hours. If less than 3 contractions per 10 min interval appears in the monitor the patient will be transferred for observation and a monitor will be performed every 6 hours. If 3 contraction or more appear in 10 min. interval the patient will be examined and in dilatation of 3 cm or more will be transferred to the delivery room.
The dinoprostone will be removed if any of the following will occur:
- NRFHR
- Tachysystole
- SROM
- If 24 hours elapsed since placement In all the groups, if after 24 hours since the start of the study, the bishop score will be still less than 6 and active labor will not initiate the same method (study arm) will be repeated. If after the second try the cervix is still unripe the patient will be defined as failed induction.
- Being tested
- Foley catheter and pitocin, Foley catheter and Dinoprostone, Dinoprostone
- Keywords
- Primiparous, Foley catheter, Dinoprostone, Induction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foley catheter and pitocinDevice
Also called Ballon
Foley catheter will be inserted through the cervix and inflated with 80 ml saline, pitocin will be initiated 1 hour later in the delivery room
Foley catheter and DinoprostoneDevice
Foley catheter will be inserted through the cervix and inflated with 80 ml saline Dinoprostone 3 mg will be inserted 1 hour later to the posterior fornix
DinoprostoneDrug
Dinoprostone 3 mg will be inserted to the posterior fornix
| Study group | Role | What they receive |
|---|---|---|
| Foley catheter and pitocin | Active comparator | Intervention: Foley catheter and pitocin Foley catheter will be inserted through the cervix and inflated with 80 ml saline, pitocin will be initiated 1 hour later in the delivery room Receives: Device: Foley catheter and pitocin |
| Foley catheter and dinoprostone | Active comparator | Intervention: Foley catheter and dinoprostone Foley catheter will be inserted through the cervix and inflated with 80 ml saline dinoprostone 3 mg will be inserted 1 hour later to the posterior fornix Receives: Device: Foley catheter and Dinoprostone |
| Dinoprostone | Active comparator | Intervention: Dinoprostone 3 mg will be inserted to the posterior fornix Receives: Drug: Dinoprostone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from induction to delivery (in hours)
Measured: up to 24 hours
Mode of delivery
Vaginal delivery or Cesarean section
Measured: up to 24 hours
Secondary outcomes (5)
Time form induction to active labor (in hours)
Measured: up to 24 hours
Rate of deliveries within 24 hours
Measured: up to 24 hours
Tachysystole
monitor recording of 5 or more contraction in a 10 minutes period with fetal heart deceleration
Measured: up to 24 hours
Neonatal Apgar scores (in a 1-10 scale)
Neonatal Apgar score in the first, 5th and 10th minutes after the delivery
Measured: up to 24 hours
Neonatal intensive care unit admission
Measured: up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startAug 2016
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Failed Medical or Unspecified Induction of LaborStudies 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaplan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roni Levy, Kaplan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815865
- Sponsor's protocol ID
- 12014kmc
- Acronym
- Induction
- Status last verified
- Jun 2016
- First submitted
- 26 Feb 2016
- Last updated
- 1 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
1. Martin JA, Hamilton BE, Ventura SJ, Mathews TJ. Births: final data for 2010. Natl Vital Stat Rep 2012;61:1-72. 2. Jozwiak M, Oude Rengerink K, Ten Eikelder ML, van Pampus MG, Dijksterhuis MG, de Graaf IM, et al. Foley catheter or prostaglandin E2 inserts for induction of labour at term: an open-label randomized controlled trial (PROBAAT-P trial) and systematic review of literature. European journal of obstetrics, gynecology, and reproductive biology. 2013;170(1):137-45. 3. Carbone JF, Tuuli MG, Macones GA. Combination of Foley bulb and vaginal misoprostol compared with vaginal misoprostol alone for cervical ripening and labor induction: a randomized controlled trial. Obstetrics and gynecology. 2013;121(2 Pt 1):247-52. 4. Kashanian M, Akbarian AR, Fekrat M. Cervical ripening and induction of labor with intravaginal misoprostol and Foley catheter cervical traction. International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics. 2006;92(1):79-80. 5. Chung JH, Huang WH, Nageotte MP. A prospective randomized controlled trial that compared misoprostol, Foley catheter, and combination misoprostol-Foley catheter for labor induction. AJOG. 2003;189(4):1031-5. 6. LD Levine, S. Parry. MA. Elovitz. Foley or Misoprostol for the Management of Induction (The 'FOR MOMI' trial): A four-arm randomized clinical trial. AJOG 214, 1, S4, 2016.
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.
PubMed 36996264
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study Comparing Cervical Foley Catheter, Vaginal Dinoprostone and a Combination of the Two Methods for Induction of Labor
- ClinicalTrials.gov ID
- NCT02815865
- Acronym / sponsor ID
- Induction / 12014kmc
- Keywords
- Primiparous, Foley catheter, Dinoprostone, Induction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Kaplan Medical CenterUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 28 Jun 2016 (estimated)
- 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 investigators intend to conduct a randomized clinical trial comparing 3 methods of induction of labor in term primiparous women with singleton. First group will be women induced with Foley catheter and pitocin, second group Foley catheter and vaginal dinoprostone and third group will be induced with vaginal dinoprostone alone. The investigators compare time for induction to delivery and way of delivery.
Detailed description
Introduction:
Labor induction, an iatrogenic initiation of labor is one of the most common obstetric procedures performed nowadays. The rate of induction of labor more than doubled from 1990 through 2010 from 9.6% to 23.8% in the United State alone. There are many methods to promote labor induction, including mechanical and pharmacological methods that can be used alone or in conjugation. Choosing the right method for the right patient can be challenging, and up until now there is limited information regarding the most suitable and effective approach for cervical ripening and labor induction. Out of the vast options for cervical ripening, the Foley catheter and vaginal prostaglandins are frequently used. To date, few clinical trials have compared the different methods to evaluate the effectiveness and the risk in each method. Two randomized controlled trials compared the Foley catheter method with the vaginal dinoprostone method. In one study, the Foley catheter was found to be superior to the vaginal dinoprostone with regards to time to delivery, whereas in the other study no difference was found. In an additional trial, Foley bulb with vaginal Misoprostol was compared to Misoprostol alone. The first treatment resulted in a shorter time to delivery. These finding did not correlate with previous trials that either found no difference or superiority to Misoprostol alone. A recent study comparing Foley catheter with PGE2 in term oligohydramnios pregnancies showed that time to delivery was shorter in the PGE2 group. A meta-analysis comparing Misoprostol with dinoprostone showed that the first is more effective, but the latter is safer. Since in some obstetrics conditions such as preeclampsia and Intrauterine growth restriction (IUGR) an expeditious induction of labor may be needed, a combination of methods may fasten the induction to delivery interval. A recent study presented as an oral presentation at the society of maternal fetal medicine a month ago used a combination of Foley catheter and prostaglandins to induce labor. They found that this arm had the shorter induction to delivery time and had no serious side effects.
In this study, The investigators intend to compare the mechanical (Foley catheter combined with Oxytocin) method, to a pharmacological one (dinoprostone-PGE2) and to a combination of the two methods in cervical ripening in an unfavorable cervix. The investigators will also examine if using the two methods in tandem will provide an additive effect.
The study will include 3 groups; in each group about 100 participants will be enrolled, which will be suited to the including and excluding criteria. The investigators have about 200 inductions per year of primigravida women. The investigators expect to enroll 300 participants in about 2 years' time.
On enrollment the patient will receive a number and will be assigned to one of the three groups. All the participants will be assigned to a 20 minute reassuring monitor before insertion the device.
A perineal US will be performed before the intervention to evaluate Angle of progression (AOP), cervical length and head position.
Group 1: Foley and Oxytocin protocol The patient will lie in a lithotomy position and will be covered by sterile sheets. A direct visualization of the cervix will be achieved with sterile speculum, the cervix will be sterilized with iodine, if the patient is allergic to iodine "septal- scrub" will be used. The Foley will be inserted through the internal cervical os, filled with 80 ml of normal saline, and taped to the patient thigh with gentle traction. An hour after placing the Foley bulb, monitor will be performed. If less than 3 contractions per 10 min interval appears in the monitor the patient will be transferred to the delivery room and Oxytocin will be administrated. If 3 contraction or more appear in 10 min. interval, further intervention will be personalized according to medical decision.
The Foley catheter will be removed if any of the following will occur:
- Expulsion
- Non reassuring fetal heart rate, NRFHR
- Tachysystole
- spontaneous rupture of membranes, SROM
- If 24 12 hours elapsed since placement.
Group 2:
Foley with dinoprostone protocol. First the Foley bulb will be placed as instructed above. An hour after placing the Foley bulb, a monitor will be performed. If less than 3 contractions per 10 min. interval appears in the monitor a propess tape will be placed in the posterior fornix. The patient will be left recumbent for 30 minutes. One hour after placing the dinoprostone, fetal monitor will be performed. If less than 3 contractions per 10 min interval appears in the monitor the patient will be remained for observation and a monitor will be performed every 6 hours. If after placing the Foley bulb 3 contractions or more appear in 10 minutes interval the patient will be excluded from the research and further intervention will be personalized according to medical decision
Group 3 Dinoprostone protocol Dinoprostone will be removed from the freezer in direct connection with insertion. The patient will lie in a lithotomy position. Dinoprostone will be inserted to the posterior vaginal fornix using small amount of water soluble lubricant according to the manufactory protocol. The reminding of the tap will be inserted to the vagina. The patient will be left recumbent for 30 minutes. An hour after placing the dinoprostone, fetal monitor will be performed and then every 6 hours. If less than 3 contractions per 10 min interval appears in the monitor the patient will be transferred for observation and a monitor will be performed every 6 hours. If 3 contraction or more appear in 10 min. interval the patient will be examined and in dilatation of 3 cm or more will be transferred to the delivery room.
The dinoprostone will be removed if any of the following will occur:
- NRFHR
- Tachysystole
- SROM
- If 24 hours elapsed since placement In all the groups, if after 24 hours since the start of the study, the bishop score will be still less than 6 and active labor will not initiate the same method (study arm) will be repeated. If after the second try the cervix is still unripe the patient will be defined as failed induction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Foley catheter and pitocin | Active comparator | Device: Foley catheter and pitocinIntervention: Foley catheter and pitocin Foley catheter will be inserted through the cervix and inflated with 80 ml saline, pitocin will be initiated 1 hour later in the delivery room |
| Foley catheter and dinoprostone | Active comparator | Device: Foley catheter and DinoprostoneIntervention: Foley catheter and dinoprostone Foley catheter will be inserted through the cervix and inflated with 80 ml saline dinoprostone 3 mg will be inserted 1 hour later to the posterior fornix |
| Dinoprostone | Active comparator | Drug: DinoprostoneIntervention: Dinoprostone 3 mg will be inserted to the posterior fornix |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Primiparous women
- 37 weeks pregnant or more
- cephalic live singleton,
- intact membranes
- Unfavorable cervix (bishop's score 6 or less)
Key exclusion criteria (15 listed)
- Previous cesarean section or other uterine surgery
- severe IUGR
- severe preeclampsia
- Fetal malpresentation
- Multiple gestation
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 |
|---|---|---|
| Foley catheter and pitocinAlso: BallonFoley catheter will be inserted through the cervix and inflated with 80 ml saline, pitocin will be initiated 1 hour later in the delivery room | Device | Foley catheter and pitocin |
| Foley catheter and DinoprostoneFoley catheter will be inserted through the cervix and inflated with 80 ml saline Dinoprostone 3 mg will be inserted 1 hour later to the posterior fornix | Device | Foley catheter and dinoprostone |
| DinoprostoneDinoprostone 3 mg will be inserted to the posterior fornix | Drug | Dinoprostone |
Primary outcome
Time from induction to delivery (in hours)
Time frame: up to 24 hours
Mode of delivery
Time frame: up to 24 hours
Vaginal delivery or Cesarean section
5 secondary outcomes
Time form induction to active labor (in hours)
Time frame: up to 24 hours
Rate of deliveries within 24 hours
Time frame: up to 24 hours
Tachysystole
Time frame: up to 24 hours
Neonatal Apgar scores (in a 1-10 scale)
Time frame: up to 24 hours
Neonatal intensive care unit admission
Time frame: up to 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2016.
- Background1. Martin JA, Hamilton BE, Ventura SJ, Mathews TJ. Births: final data for 2010. Natl Vital Stat Rep 2012;61:1-72. 2. Jozwiak M, Oude Rengerink K, Ten Eikelder ML, van Pampus MG, Dijksterhuis MG, de Graaf IM, et al. Foley catheter or prostaglandin E2 inserts for induction of labour at term: an open-label randomized controlled trial (PROBAAT-P trial) and systematic review of literature. European journal of obstetrics, gynecology, and reproductive biology. 2013;170(1):137-45. 3. Carbone JF, Tuuli MG, Macones GA. Combination of Foley bulb and vaginal misoprostol compared with vaginal misoprostol alone for cervical ripening and labor induction: a randomized controlled trial. Obstetrics and gynecology. 2013;121(2 Pt 1):247-52. 4. Kashanian M, Akbarian AR, Fekrat M. Cervical ripening and induction of labor with intravaginal misoprostol and Foley catheter cervical traction. International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics. 2006;92(1):79-80. 5. Chung JH, Huang WH, Nageotte MP. A prospective randomized controlled trial that compared misoprostol, Foley catheter, and combination misoprostol-Foley catheter for labor induction. AJOG. 2003;189(4):1031-5. 6. LD Levine, S. Parry. MA. Elovitz. Foley or Misoprostol for the Management of Induction (The 'FOR MOMI' trial): A four-arm randomized clinical trial. AJOG 214, 1, S4, 2016.
- 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: Undecided
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.
Questions about this trial
What is this clinical trial studying?
A study testing Foley catheter and pitocin, Foley catheter and Dinoprostone and Dinoprostone in people with Failed Medical or Unspecified Induction of Labor, run by Kaplan Medical Center.
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 5 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 1 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Time from induction to delivery (in hours) (time frame: up to 24 hours). The study lists 2 primary outcomes in all. 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 NCT02815865, which also lists 2 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 1 Jul 2016.