Induction of Labor Affected Fetus / NewbornDILATENCT04521062
Dilapan-S® for Induction of Labor The Feasibility Study
A study testing Dilapan S in people with Induction of Labor Affected Fetus / Newborn, run by Albany Medical College at 1 site in United States.
Trial summary
This is a prospective feasibility study to investigate Dilapan-S® as an outpatient method of cervical ripening in low risk pregnancies >=39 weeks. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Induction of Labor Affected Fetus / Newborn
- What is being tested?
- Dilapan S
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 31 Dec 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Planned induction of labor ≥ 39 weeks
- Singleton gestation
- Vertex presentation
- Cervical dilation <3cm
Who cannot join
- Placenta previa
- Placenta accreta
- Vasa previa
- Preterm prelabor rupture of membranes
- Non-english speaking
- <18 years old
Show all 22Show fewer
- Multiple gestation
- Prior cesarean delivery
- Prior myomectomy
- Fetal malpresentation
- Active vaginal bleeding
- Cervical dilation >1 cm
- Uterine anomaly (didelphysis, bicornuate)
- Intrauterine growth restriction <10th%
- Fetal anomalies
- Requirements to be inpatient
- Polyhydramnios (AFI>25cm or MVP>8cm)
- Chronic hypertension on medications
- Gestational hypertension/preeclampsia
- GDMA2, DM1, DM2
- Hepatitis B or C
- HIV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dilapan-S® for Induction of Labor - Assessing ouTpatient Placement and Effectiveness - The Feasibility Study (The DILATE Study).
This is a prospective feasibility study to investigate Dilapan-S® as an outpatient method of cervical ripening in low risk pregnancies >=39 weeks.
Read the detailed description
In 2019, the ARRIVE trial was published, demonstrating that in low risk nulliparous women, induction of labor at 39 weeks was associated with a decreased risk for hypertensive disorders of pregnancy and decreased risk for cesarean without any increased risk for severe neonatal complications or perinatal death. (1) Based on the results of this trial, hospitals have been questioning the feasibility of implementing a protocol which offers induction of labor to low risk women at ≥39 weeks. There are concerns regarding the ability of a busy labor and delivery to accommodate women presenting for inductions with an unfavorable cervix. Outpatient mechanical cervical ripening would allow for women to start the process of induction of labor at home. This is appealing because cervical ripening is typically the longest component of the induction process. Mechanical cervical ripening is the process by which balloons or dilators are placed into the cervix.
There is lack of evidence on Dilapan-S® as an outpatient method of cervical ripening despite the potential benefits of increased maternal satisfaction and decreased length of hospital stay. With this in mind we propose a preliminary study of 40 women to assess for feasibility of performing a large randomized control trial and assess safety with outpatient treatment. This initial study is intended to assess the feasibility of outpatient cervical ripening, next day induction of labor, and safety. After completion of this feasibility study, the investigators plan to initiate a randomized control trial to assess the efficacy of outpatient Dilapan-S® for mechanical cervical ripening.
- Being tested
- Dilapan S
- Keywords
- cervical ripening, induction of labor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dilapan SDevice
Placement of Dilapan S
| Study group | Role | What they receive |
|---|---|---|
| Dilapan S | Other | Placement of dilators Receives: Device: Dilapan S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to delivery
Length of time between induction of labor start and delivery (hours)
Measured: from induction start to delivery, estimated average 12 hours
Secondary outcomes (6)
APGAR score at 1and 5 min
APGAR score (number 0-10)
Measured: 1 and 5 minutes after birth
number of participants with maternal infection
chorioamnionitis, endometritis - Yes/No
Measured: during hospital admission, average 4 days
NICU admission
Neonatal admission to NICU (any admission) - Yes/No
Measured: through maternal hospital admission, average 4 days
Need for neonatal antibiotics
any antibiotic use in postnatal period (yes/no)
Measured: in the first 72 hours after delivery
Need for resipiratory support
any respiratory interventions after birth for neonate (composite of oxygen administration, respiratory distress syndrome, CPAP, intubation) (yes/No)
Measured: during hospital admission, average 4 days
mode of delivery
cesarean or vaginal (coded as cesarean delivery Y/N or vaginal delivery Y/N)
Measured: one time at the time of delivery, variable to occur during hospital admission, average 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start1 Aug 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Why it stopped: low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induction of Labor Affected Fetus / NewbornStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albany Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tara Lynch, MD, Principal investigator, Albany Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04521062
- Sponsor's protocol ID
- 5768
- Acronym
- DILATE
- Status last verified
- Apr 2023
- First submitted
- 7 Jul 2020
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dilapan-S® for Induction of Labor - Assessing ouTpatient Placement and Effectiveness - The Feasibility Study (The DILATE Study).
- ClinicalTrials.gov ID
- NCT04521062
- Acronym / sponsor ID
- DILATE / 5768
- Keywords
- cervical ripening, induction of labor
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low recruitment
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 20 Aug 2020 (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.
This is a prospective feasibility study to investigate Dilapan-S® as an outpatient method of cervical ripening in low risk pregnancies >=39 weeks.
Detailed description
In 2019, the ARRIVE trial was published, demonstrating that in low risk nulliparous women, induction of labor at 39 weeks was associated with a decreased risk for hypertensive disorders of pregnancy and decreased risk for cesarean without any increased risk for severe neonatal complications or perinatal death. (1) Based on the results of this trial, hospitals have been questioning the feasibility of implementing a protocol which offers induction of labor to low risk women at ≥39 weeks. There are concerns regarding the ability of a busy labor and delivery to accommodate women presenting for inductions with an unfavorable cervix. Outpatient mechanical cervical ripening would allow for women to start the process of induction of labor at home. This is appealing because cervical ripening is typically the longest component of the induction process. Mechanical cervical ripening is the process by which balloons or dilators are placed into the cervix.
There is lack of evidence on Dilapan-S® as an outpatient method of cervical ripening despite the potential benefits of increased maternal satisfaction and decreased length of hospital stay. With this in mind we propose a preliminary study of 40 women to assess for feasibility of performing a large randomized control trial and assess safety with outpatient treatment. This initial study is intended to assess the feasibility of outpatient cervical ripening, next day induction of labor, and safety. After completion of this feasibility study, the investigators plan to initiate a randomized control trial to assess the efficacy of outpatient Dilapan-S® for mechanical cervical ripening.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dilapan S | Other | Device: Dilapan SPlacement of dilators |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Planned induction of labor ≥ 39 weeks
- Singleton gestation
- Vertex presentation
- Cervical dilation <3cm
Key exclusion criteria (22 listed)
- Placenta previa
- Placenta accreta
- Vasa previa
- Preterm prelabor rupture of membranes
- Non-english speaking
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 |
|---|---|---|
| Dilapan SPlacement of Dilapan S | Device | Dilapan S |
Primary outcome
Time to delivery
Time frame: from induction start to delivery, estimated average 12 hours
Length of time between induction of labor start and delivery (hours)
6 secondary outcomes
APGAR score at 1and 5 min
Time frame: 1 and 5 minutes after birth
number of participants with maternal infection
Time frame: during hospital admission, average 4 days
NICU admission
Time frame: through maternal hospital admission, average 4 days
Need for neonatal antibiotics
Time frame: in the first 72 hours after delivery
Need for resipiratory support
Time frame: during hospital admission, average 4 days
mode of delivery
Time frame: one time at the time of delivery, variable to occur during hospital admission, average 4 days
Results and safety
The study was stopped early (reason given: low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- 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.
Tara Lynch, MD principal investigator
Albany Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dilapan S in people with Induction of Labor Affected Fetus / Newborn, run by Albany Medical College at 1 site in United States.
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 22 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 18 Apr 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 United States. 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: low recruitment). 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 to delivery (time frame: from induction start to delivery, estimated average 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2023.