Induced; BirthGOHOMENCT04739683
Cervical Ripening With Foley Bulb Versus Dilapan-S at Home
A study testing Foley bulb placement and DILAPAN-S® placement in people with Induced; Birth and Induction of Labor Affected Fetus / Newborn, run by Christiana Care Health Services.
Trial summary
DILAPAN-S® was FDA-approved for pre-induction cervical ripening in 2015. Since that time, there have been limited studies comparing its efficacy, safety, and patient satisfaction to other mechanical cervical ripening techniques. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Induced; Birth, Induction of Labor Affected Fetus / Newborn
- What is being tested?
- Foley bulb placement and DILAPAN-S® placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2022to 30 Jun 2022
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically is not eligible unless the reduction occurred before 14 weeks 0 days gestational age.
- Gestational age at randomization between 39 weeks and 40 weeks 6 days (based on reliable EGA defined as ultrasound performed before 14 weeks 0 days, or a certain LMP consistent with ultrasonography before 21 weeks and 0 days.)
- Patient prefers outpatient cervical ripening
- Patient lives within a one-hour commute from the hospital.
Who cannot join
- Project gestational age at date of first ultrasound is > 20 weeks 6 days
- Refusal of blood products
- Participation in another interventional study that influences management of labor at delivery or perinatal morbidity or mortality
- Delivery planned elsewhere at a non-Christiana site
- Major maternal medical illness associated with increased risk for adverse pregnancy outcomes that would preclude her from an outpatient induction (e.g. any diabetes mellitus, lupus, any hypertensive disorder, cardiac disease, renal insufficiency)
- Medical indication for induction prior to 40 weeks 5 days due to any maternal
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- Heparin or low-molecular weight heparin use during the current pregnancy
- Cerclage in current pregnancy
- Prior uterine or cervical surgery (cesarean, myomectomy, cerclage, LEEP, cone biopsy, etc.)
- Known HIV positivity because of modified delivery plan
- Iodine or latex allergy
- Fetal demise or known major fetal anomaly
- Medical indication for induction prior to 40 weeks 5 days due to any fetal condition
- Known oligohydramnios, defined as amniotic fluid index < 5 cm or maximal vertical pocket < 2 cm
- Fetal growth restriction, defined as EFW < 10th percentile
- Plan for cesarean delivery or contraindication to labor
- Nonvertex fetal presentation
- Placenta previa, placenta accrete, or vasa previa
- Active genital herpes lesions
- Cervical dilation greater than 3 cm on initial evaluation
- Signs of labor (regular painful contractions with cervical change) on initial evaluation
- Active vaginal bleeding greater than bloody show on initial evaluation
- Ruptured membranes on initial evaluation
- Non-reassuring fetal status (category II or III fetal heart rate tracing) on initial evaluation
About this study
Official title: Cervical Ripening With Foley Bulb Versus Dilapan-S at Home: a Randomized Trial
DILAPAN-S® was FDA-approved for pre-induction cervical ripening in 2015. Since that time, there have been limited studies comparing its efficacy, safety, and patient satisfaction to other mechanical cervical ripening techniques. The purpose of this trial is to perform a noninferiority randomized clinical trial comparing DILAPAN-S® to the Foley catheter for outpatient cervical ripening in term elective labor inductions, examining time spent on the labor and delivery unit, patient safety, and patient satisfaction feedback.
Read the detailed description
In 2019, Grobman et al, published the ARRIVE trial showing that labor inductions without medical indication at 39 weeks gestation are associated with improved maternal and perinatal outcomes compared to expectant management.1 In the wake of these landmark findings, labor inductions without medical indication are becoming increasingly common not only on a nation scale, but locally as well. Recent data show that labor inductions without medical indication encompass nearly one third of all inductions at Christiana Care Health System.
Labor induction can include both mechanical and pharmacological measures to ripen the cervix and stimulate uterine contractions. The ultimate challenge, which has been the focus of numerous studies to date, is to determine which mechanical and/or pharmacological products and which clinical settings are safest and most efficacious for inducing labor.
Currently, transcervical Foley catheters are the gold-standard mechanical method of cervical ripening. However, new-emerging data has shown that hygroscopic cervical dilators, traditionally used for early pregnancy termination, may be a viable alternative. DILAPAN-S® , a hygroscopic dilator composed of a synthetic hydrogel was approved by the Food and Drug Administration for cervical ripening in 2015 and has been the subject of recent investigation. In a single-center, randomized, open-label trial consisting of 419 patients, Saad et al showed that DILAPAN-S® is not inferior to the Foley catheter for pre-induction cervical ripening at term; there was no significant difference in maternal and neonatal adverse events and patients with DILAPAN-S® were more satisfied than patients with the Foley catheter as far as sleep, relaxing time, and performance of desired daily activities.2
Furthermore, in the pursuit of improving patient satisfaction with consideration of healthcare resources, studies have investigated the safety and efficacy of outpatient mechanical cervical ripening.3 Sciscione et al, showed that in a low-risk population of 1,905 patients, no adverse outcomes were associated with outpatient Foley catheter cervical ripening and patients on average avoided 9.6 hours of hospitalizations compared to the inpatient group.4 The ACOG practice bulletin on induction of labor now states that outpatient cervical ripening, particularly mechanical methods, may be appropriate in select patients.5 Based on the literature cited above, it is plausible to hypothesize that DILAPAN-S® used for outpatient cervical ripening may optimize patient satisfaction and healthcare resource utilization without compromising patient safety and efficacy. The purpose of this trial is to perform a noninferiority randomized clinical trial comparing DILAPAN-S® to the Foley catheter for outpatient cervical ripening in term elective labor inductions, examining time spent on the labor and delivery unit, patient safety, and patient satisfaction feedback.
- Being tested
- Foley bulb placement, DILAPAN-S® placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foley bulb placementDevice
A 16 F Foley catheter with a 30-mL balloon and stylet is inserted into the endocervical canal under direct visualization by sterile speculum exam or by digital palpation. The Foley catheter is advanced to or past the internal os, and the balloon is filled with 30-40 mL of sterile water. The catheter is then placed on genital traction by taping the end of the catheter to the medial portion of the thigh.
DILAPAN-S® placementDevice
A bivalve speculum will be used to visualize and prepare the cervix with an antiseptic solution. The DILAPAN-S® (4 x 65 mm) will be inserted in the cervical canal until it traverses the internal os. As many dilators as needed to achieve the desired effect should be inserted. Specific number of pieces always depends on decision and clinical judgement of physician and indications. A gauze pad moistened with sterile water or saline may be inserted into the vagina to help keep the DILAPAN-S® in place, if needed
| Study group | Role | What they receive |
|---|---|---|
| Foley bulb | Active comparator | 16F latex or silicone Foley catheter inflated with 30-40 cc of sterile water. The catheter will be taped to the inner thigh with gentle traction. Receives: Device: Foley bulb placement |
| DILAPAN-S® | Active comparator | Synthetic hydrogel cervical dilator consists of the dilating part, the polypropylene handle, and the marker string. The dilating part is manufactured from an anisotropic xerogel of AQUACRYL. Receives: Device: DILAPAN-S® placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent on the labor and delivery unit
Length of time spent on the labor and delivery unit, hours
Measured: through study completion, an average of 2 years
Secondary outcomes (29)
Rate of vaginal delivery
Measured: through study completion, an average of 2 years
Rate of cesarean delivery
Measured: through study completion, an average of 2 years
Indication for cesarean delivery
Reasons for cesarean delivery include: non-reassuring fetal heart rate tracing, arrest of dilation, arrest of descent, failed induction of labor, maternal request, other
Measured: through study completion, an average of 2 years
Time from device insertion to delivery
Time from device (Foley bulb or Dilapan) insertion to delivery (vaginal or cesarean), hours
Measured: through study completion, an average of 2 years
Rate of vaginal delivery within 24 hours of device insertion
Measured: through study completion, an average of 2 years
Rate of vaginal delivery within 36 hours of device insertion
Measured: through study completion, an average of 2 years
Time from device insertion to expulsion or extraction
Time from device (Foley bulb or Dilapan) insertion to spontaneous expulsion or device removal, hours
Measured: through study completion, an average of 2 years
Rate of device expulsion at home
Percentage of patients whose device (Foley bulb or Dilapan) was expelled at home
Measured: through study completion, an average of 2 years
Rate of patients that received Pitocin
Measured: through study completion, an average of 2 years
Average number of Dilapan dilator rods used
Multiple Dilapan rods may be placed for cervical dilation. The number of rods used is at the discretion of the clinician.
Measured: through study completion, an average of 2 years
Change in Bishop score before and after mechanical cervical ripening
Change in Bishop score from initial assessment to first exam following device expulsion/removal.
Measured: through study completion, an average of 2 years
Time from device insertion to active stage of labor
The active stage of labor is defined as cervical dilation greater than or equal to 6cm, hours
Measured: through study completion, an average of 2 years
Rate of artificial rupture of membranes
Measured: through study completion, an average of 2 years
Rate of epidural or spinal anesthesia during labor
Measured: through study completion, an average of 2 years
Rate of analgesia needed for device insertion
Analgesia methods may include butorphanol, neuraxial blockade, nitric oxide, etc.
Measured: through study completion, an average of 2 years
Rate of complications from device insertion
Complications include: incidental rupture of membranes, device malfunction/breakage, vaginal bleeding (defined as gross blood apparent on glove, perineum, vagina, or within Foley catheter lumen), cervical laceration, vasovagal reaction
Measured: through study completion, an average of 2 years
Rate of tachysystole
Defined as at least 6 contractions in 10 minutes for 2 consecutive 10-minute periods
Measured: through study completion, an average of 2 years
Rate of postpartum hemorrhage
Defined as 1,000 mL or blood loss accompanied by signs or symptoms of hypovolemia within 24 hours after the birth process
Measured: through study completion, an average of 2 years
Rate of shoulder dystocia
Measured: through study completion, an average of 2 years
Rate of suspected intraamniotic infection
Defined as the presence of maternal intrapartum fever and one or more of the following: maternal leukocytosis, purulent cervical drainage, or fetal tachycardia
Measured: through study completion, an average of 2 years
Rate of any serious maternal morbidity
Serious maternal morbidities include uterine rupture, admission to an intensive care unit, and sepsis
Measured: through study completion, an average of 2 years
Rate of maternal death
Measured: through study completion, an average of 2 years
Maternal satisfaction
A two-part maternal satisfaction survey will be administered immediately after device placement and then postpartum day one
Measured: through study completion, an average of 2 years
Rate of 1 minute Apgar score < 5
Rate of 1 minute Apgar score less than 5
Measured: through study completion, an average of 2 years
Rate of 5 minute Apgar score < 7
Rate of 5 minute Apgar score less than 7
Measured: through study completion, an average of 2 years
Rate of NICU admission
Rate of neonates admitted to the NICU
Measured: through study completion, an average of 2 years
Rate of NICU admission > 48 hours
Rate of neonates requiring NICU admission for longer than 48 hours
Measured: through study completion, an average of 2 years
NICU length of stay
Length of NICU admission, days
Measured: through study completion, an average of 2 years
Rate of any adverse neonatal outcome
Includes death, severe respiratory distress syndrome (defined as intubation and mechanical ventilation for a minimum of 12 hours), hypoxic-ischemic encephalopathy, seizure, culture-proven neonatal sepsis, birth trauma (bone fracture, intracranial hemorrhage, neurologic injury, retinal hemorrhage), hypotension requiring vasopressor support, receipt of total body cooling.
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start30 Jun 2022
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Why it stopped: Withdrawn due to another study which superseded it.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Induced; BirthStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Collaborators
- Medicem International CR s.r.o., Medicem Technology s.r.o.
- Responsible party
- Principal investigator, Anthony Sciscione, DO, Christiana Care Health Services
- Investigators
- Anthony C Sciscione, DO, Principal investigator, Christiana Care Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04739683
- Sponsor's protocol ID
- DDD#604684
- Acronym
- GOHOME
- Status last verified
- Sep 2022
- First submitted
- 29 Jan 2021
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 30089070Saad AF, Villarreal J, Eid J, Spencer N, Ellis V, Hankins GD, Saade GR. A randomized controlled trial of Dilapan-S vs Foley balloon for preinduction cervical ripening (DILAFOL trial). Am J Obstet Gynecol. 2019 Mar;220(3):275.e1-275.e9. doi: 10.1016/j.ajog.2019.01.008. Epub 2019 Feb 18.
PubMed 30790569Levine LD, Sciscione AC. Foley Catheter for Outpatient Cervical Ripening: Review of the Evidence and a Proposed Model of Care. Am J Perinatol. 2019 Dec;36(14):1528-1532. doi: 10.1055/s-0038-1677473. Epub 2019 Jan 23. No abstract available.
PubMed 30674049Sciscione AC, Bedder CL, Hoffman MK, Ruhstaller K, Shlossman PA. The timing of adverse events with Foley catheter preinduction cervical ripening; implications for outpatient use. Am J Perinatol. 2014 Oct;31(9):781-6. doi: 10.1055/s-0033-1359718. Epub 2013 Dec 17.
PubMed 24347259ACOG 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 19623003Albers LL. The duration of labor in healthy women. J Perinatol. 1999 Mar;19(2):114-9. doi: 10.1038/sj.jp.7200100.
PubMed 10642971
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Ripening With Foley Bulb Versus Dilapan-S at Home: a Randomized Trial
- ClinicalTrials.gov ID
- NCT04739683
- Acronym / sponsor ID
- GOHOME / DDD#604684
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn due to another study which superseded it.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Collaborators
- Medicem International CR s.r.o., Medicem Technology s.r.o.
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 5 Feb 2021 (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.
DILAPAN-S® was FDA-approved for pre-induction cervical ripening in 2015. Since that time, there have been limited studies comparing its efficacy, safety, and patient satisfaction to other mechanical cervical ripening techniques. The purpose of this trial is to perform a noninferiority randomized clinical trial comparing DILAPAN-S® to the Foley catheter for outpatient cervical ripening in term elective labor inductions, examining time spent on the labor and delivery unit, patient safety, and patient satisfaction feedback.
Detailed description
In 2019, Grobman et al, published the ARRIVE trial showing that labor inductions without medical indication at 39 weeks gestation are associated with improved maternal and perinatal outcomes compared to expectant management.1 In the wake of these landmark findings, labor inductions without medical indication are becoming increasingly common not only on a nation scale, but locally as well. Recent data show that labor inductions without medical indication encompass nearly one third of all inductions at Christiana Care Health System.
Labor induction can include both mechanical and pharmacological measures to ripen the cervix and stimulate uterine contractions. The ultimate challenge, which has been the focus of numerous studies to date, is to determine which mechanical and/or pharmacological products and which clinical settings are safest and most efficacious for inducing labor.
Currently, transcervical Foley catheters are the gold-standard mechanical method of cervical ripening. However, new-emerging data has shown that hygroscopic cervical dilators, traditionally used for early pregnancy termination, may be a viable alternative. DILAPAN-S® , a hygroscopic dilator composed of a synthetic hydrogel was approved by the Food and Drug Administration for cervical ripening in 2015 and has been the subject of recent investigation. In a single-center, randomized, open-label trial consisting of 419 patients, Saad et al showed that DILAPAN-S® is not inferior to the Foley catheter for pre-induction cervical ripening at term; there was no significant difference in maternal and neonatal adverse events and patients with DILAPAN-S® were more satisfied than patients with the Foley catheter as far as sleep, relaxing time, and performance of desired daily activities.2
Furthermore, in the pursuit of improving patient satisfaction with consideration of healthcare resources, studies have investigated the safety and efficacy of outpatient mechanical cervical ripening.3 Sciscione et al, showed that in a low-risk population of 1,905 patients, no adverse outcomes were associated with outpatient Foley catheter cervical ripening and patients on average avoided 9.6 hours of hospitalizations compared to the inpatient group.4 The ACOG practice bulletin on induction of labor now states that outpatient cervical ripening, particularly mechanical methods, may be appropriate in select patients.5 Based on the literature cited above, it is plausible to hypothesize that DILAPAN-S® used for outpatient cervical ripening may optimize patient satisfaction and healthcare resource utilization without compromising patient safety and efficacy. The purpose of this trial is to perform a noninferiority randomized clinical trial comparing DILAPAN-S® to the Foley catheter for outpatient cervical ripening in term elective labor inductions, examining time spent on the labor and delivery unit, patient safety, and patient satisfaction feedback.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Foley bulb | Active comparator | Device: Foley bulb placement16F latex or silicone Foley catheter inflated with 30-40 cc of sterile water. The catheter will be taped to the inner thigh with gentle traction. |
| DILAPAN-S® | Active comparator | Device: DILAPAN-S® placementSynthetic hydrogel cervical dilator consists of the dilating part, the polypropylene handle, and the marker string. The dilating part is manufactured from an anisotropic xerogel of AQUACRYL. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically is not eligible unless the reduction occurred before 14 weeks 0 days gestational age.
- Gestational age at randomization between 39 weeks and 40 weeks 6 days (based on reliable EGA defined as ultrasound performed before 14 weeks 0 days, or a certain LMP consistent with ultrasonography before 21 weeks and 0 days.)
- Patient prefers outpatient cervical ripening
- Patient lives within a one-hour commute from the hospital.
Key exclusion criteria (24 listed)
- Project gestational age at date of first ultrasound is > 20 weeks 6 days
- Refusal of blood products
- Participation in another interventional study that influences management of labor at delivery or perinatal morbidity or mortality
- Delivery planned elsewhere at a non-Christiana site
- Major maternal medical illness associated with increased risk for adverse pregnancy outcomes that would preclude her from an outpatient induction (e.g. any diabetes mellitus, lupus, any hypertensive disorder, cardiac disease, renal insufficiency)
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 bulb placementA 16 F Foley catheter with a 30-mL balloon and stylet is inserted into the endocervical canal under direct visualization by sterile speculum exam or by digital palpation. The Foley catheter is advanced to or past the internal os, and the balloon is filled with 30-40 mL of sterile water. The catheter is then placed on genital traction by taping the end of the catheter to the medial portion of the thigh. | Device | Foley bulb |
| DILAPAN-S® placementA bivalve speculum will be used to visualize and prepare the cervix with an antiseptic solution. The DILAPAN-S® (4 x 65 mm) will be inserted in the cervical canal until it traverses the internal os. As many dilators as needed to achieve the desired effect should be inserted. Specific number of pieces always depends on decision and clinical judgement of physician and indications. A gauze pad moistened with sterile water or saline may be inserted into the vagina to help keep the DILAPAN-S® in place, if needed | Device | DILAPAN-S® |
Primary outcome
Time spent on the labor and delivery unit
Time frame: through study completion, an average of 2 years
Length of time spent on the labor and delivery unit, hours
29 secondary outcomes
Rate of vaginal delivery
Time frame: through study completion, an average of 2 years
Rate of cesarean delivery
Time frame: through study completion, an average of 2 years
Indication for cesarean delivery
Time frame: through study completion, an average of 2 years
Time from device insertion to delivery
Time frame: through study completion, an average of 2 years
Rate of vaginal delivery within 24 hours of device insertion
Time frame: through study completion, an average of 2 years
Rate of vaginal delivery within 36 hours of device insertion
Time frame: through study completion, an average of 2 years
Time from device insertion to expulsion or extraction
Time frame: through study completion, an average of 2 years
Rate of device expulsion at home
Time frame: through study completion, an average of 2 years
Rate of patients that received Pitocin
Time frame: through study completion, an average of 2 years
Average number of Dilapan dilator rods used
Time frame: through study completion, an average of 2 years
Change in Bishop score before and after mechanical cervical ripening
Time frame: through study completion, an average of 2 years
Time from device insertion to active stage of labor
Time frame: through study completion, an average of 2 years
Rate of artificial rupture of membranes
Time frame: through study completion, an average of 2 years
Rate of epidural or spinal anesthesia during labor
Time frame: through study completion, an average of 2 years
Rate of analgesia needed for device insertion
Time frame: through study completion, an average of 2 years
Rate of complications from device insertion
Time frame: through study completion, an average of 2 years
Rate of tachysystole
Time frame: through study completion, an average of 2 years
Rate of postpartum hemorrhage
Time frame: through study completion, an average of 2 years
Rate of shoulder dystocia
Time frame: through study completion, an average of 2 years
Rate of suspected intraamniotic infection
Time frame: through study completion, an average of 2 years
Rate of any serious maternal morbidity
Time frame: through study completion, an average of 2 years
Rate of maternal death
Time frame: through study completion, an average of 2 years
Maternal satisfaction
Time frame: through study completion, an average of 2 years
Rate of 1 minute Apgar score < 5
Time frame: through study completion, an average of 2 years
Rate of 5 minute Apgar score < 7
Time frame: through study completion, an average of 2 years
Rate of NICU admission
Time frame: through study completion, an average of 2 years
Rate of NICU admission > 48 hours
Time frame: through study completion, an average of 2 years
NICU length of stay
Time frame: through study completion, an average of 2 years
Rate of any adverse neonatal outcome
Time frame: through study completion, an average of 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- 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 30790569Saad AF, Villarreal J, Eid J, Spencer N, Ellis V, Hankins GD, Saade GR. A randomized controlled trial of Dilapan-S vs Foley balloon for preinduction cervical ripening (DILAFOL trial). Am J Obstet Gynecol. 2019 Mar;220(3):275.e1-275.e9. doi: 10.1016/j.ajog.2019.01.008. Epub 2019 Feb 18.
- Background: PubMed 30674049Levine LD, Sciscione AC. Foley Catheter for Outpatient Cervical Ripening: Review of the Evidence and a Proposed Model of Care. Am J Perinatol. 2019 Dec;36(14):1528-1532. doi: 10.1055/s-0038-1677473. Epub 2019 Jan 23. No abstract available.
- Background: PubMed 24347259Sciscione AC, Bedder CL, Hoffman MK, Ruhstaller K, Shlossman PA. The timing of adverse events with Foley catheter preinduction cervical ripening; implications for outpatient use. Am J Perinatol. 2014 Oct;31(9):781-6. doi: 10.1055/s-0033-1359718. Epub 2013 Dec 17.
- 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 10642971Albers LL. The duration of labor in healthy women. J Perinatol. 1999 Mar;19(2):114-9. doi: 10.1038/sj.jp.7200100.
- 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.
Anthony C Sciscione, DO principal investigator
Christiana Care Health Services
Questions about this trial
What is this clinical trial studying?
A study testing Foley bulb placement and DILAPAN-S® placement in people with Induced; Birth and Induction of Labor Affected Fetus / Newborn, run by Christiana Care Health Services.
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 4 inclusion and 24 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: withdrawn, as of the sponsor's last update on 21 Sep 2022. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 spent on the labor and delivery unit (time frame: through study completion, an average of 2 years). 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 NCT04739683, which also lists 6 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 21 Sep 2022.