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Induced; BirthNCT05062343

Cook Balloon vs Dilapan-S for Outpatient Cervical Ripening

A study testing Dilapan-S and Cook Cervical Ripening Balloon in people with Induced; Birth, run by Brigham and Women's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this study is to compare Cook balloon and Dilapan-S for outpatient cervical ripening to see if Dilapan-S is non-inferior in increasing Bishop score compared to the Cook balloon. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Induced; Birth
What is being tested?
Dilapan-S and Cook Cervical Ripening Balloon
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
1 May 2022to 19 Jul 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • No healthy volunteers
  • Adult

Who may be able to join

  • 18-50 years of age
  • Term (37-41 6/7 weeks gestational age)
  • Low risk (i.e. without any maternal or fetal co-morbidity) and who are candidates for outpatient cervical ripening per the Brigham and Women's outpatient cervical ripening protocol
  • Singleton pregnancy
  • Cephalic presentation

Who cannot join

  • Prior cesarean section
  • Any contraindication to outpatient cervical ripening per Brigham and Women's outpatient cervical ripening protocol
  • Non-English-speaking

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Brigham and Women's HospitaL

    Boston, Massachusetts, 02115

Other trials in United States

About this study

The goal of this study is to compare Cook balloon and Dilapan-S for outpatient cervical ripening to see if Dilapan-S is non-inferior in increasing Bishop score compared to the Cook balloon.

Read the detailed description

Upon presentation for cervical ripening appointment, a sterile vaginal exam will be completed to assign Bishop score, as per standard routine. Once the patient has been consented and randomized, the participant will have a Cook catheter or Dilapan-S inserted. For the Cook catheter, the uterine component of the balloon will be inflated to maximum 60mL, the vaginal balloon will not be inflated per standard practice and per the literature that shows slightly increased pain and negligible improvement in cervical ripening. The catheter will be taped to the inner thigh with gentle traction. For Dilapan-S, 3-5 dilators will be placed.

After placement, the patient will be discharged home with strict return precautions per the outpatient cervical ripening protocol. Patients must return to labor and delivery within 24 hours of cervical ripening agent placement at their scheduled inpatient induction time.

Upon return to labor and delivery, if not already expelled, the mechanical ripening device will be removed, and an examiner blinded to the cervical ripening method will complete a sterile vaginal exam to assign a Bishop score.

At that point health care providers will manage active labor per usual practice. Labor interventions are at the discretion of the healthcare provider. The need for operative delivery or cesarean section will be at the discretion of the healthcare provider.

Conditions
Induced; Birth
Being tested
Dilapan-S, Cook Cervical Ripening Balloon
Keywords
Induction of labor, Cervical ripening

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dilapan-SDevice

    Osmotic dilator

  • Cook Cervical Ripening BalloonDevice

    Also called Cook catheter

    Double balloon catheter for cervical ripening

Study groups in NCT05062343
Study groupRoleWhat they receive
Dilapan-SActive comparatorAfter randomization, the patient will have Dilapan-S placed via sterile speculum exam with placement of 3-5 rods. The rods will remain in place until expelled or up to 24 hours or until the scheduled return to labor and delivery. At presentation to labor and delivery, the rods will be confirmed expelled or will be removed and a blinded examiner will complete a sterile cervical exam. At that point the primary health care providers will manage further labor per their standard practice.
Receives: Device: Dilapan-S
Cook CatheterActive comparatorAfter randomization, the patient will have the Cook catheter placed via sterile vaginal or speculum exam with the uterine component of the balloon inflated to maximum 60mL. The balloon will remain in place until expelled or up to 24 hours or until the scheduled return to labor and delivery. At presentation to labor and delivery, the Cook catheter will be confirmed expelled or will be removed and a blinded examiner will complete a sterile cervical exam. At that point the primary health care providers will manage further labor per their standard practice.
Receives: Device: Cook Cervical Ripening Balloon

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Bishop Score

    Difference in Bishop score calculated from exam at time of device removal minus Bishop score calculated from exam at time of device placement. Bishop score, or cervical score, ranges from a minimum of 0 to maximum of 13. Higher scores indicate that the cervix is more favorable, or ready for labor. Thus, change in Bishop score could range from -13 to +13 with a higher number showing more change in the score, or more cervical ripening.

    Measured: Up to 24 hours

Secondary outcomes (7)

  1. Patient Satisfaction

    Patient Satisfaction score based on patient survey. Range from 0 (unsatisfied) to 10 (highly satisfied).

    Measured: Assessed upon device removal, within 24 hours

  2. Mode of Delivery: Vaginal Delivery, Cesarean Delivery

    Mode of delivery, vaginal (including spontaneous vaginal, forceps and vacuum) and cesarean delivery

    Measured: Assessed at the time of delivery, within 1 week

  3. Time on Labor and Delivery

    Time from admission on labor and delivery until delivery. Measured in hours.

    Measured: Assessed at the time of delivery, within 1 week

  4. Maternal Length of Stay

    Admission Date/Time to Discharge Date/Time

    Measured: Assessed at end of study period (week 4)

  5. Cervical Ripening Success Score: No Failure, Failure

    Failure defined by: inability to place intervention agent or need for further cervical ripening after removal

    Measured: Assessed at the time of device removal, within 24 hours

  6. Composite Maternal Morbidity: Morbidity, no Morbidity

    Morbidity defined as any one of the following: higher-order laceration, blood transfusion, endometritis, wound infection, venous thromboembolism, hysterectomy, ICU admission or death

    Measured: Assessed at end of study period (week 4)

  7. Composite Neonatal Morbidity: Morbidity, no Morbidity

    Morbidity defined as any one of the following: culture-proven neonatal sepsis, neonatal blood transfusion, hypoxic-ischemic encephalopathy, intraventricular hemorrhage grade 3 or 4, or therapeutic hypothermia

    Measured: Assessed at end of study period (week 4)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2021
  2. Study start1 May 2022
  3. Primary completion19 Jul 2023
  4. Study completion19 Jul 2023

Resources

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
Model description
Randomized Controlled Trial
Masking
Single blind
Who is masked
Care provider
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05062343
Sponsor's protocol ID
2021P002625
Status last verified
Oct 2023
First submitted
9 Sep 2021
Last updated
27 Oct 2023
Data monitoring committee
No
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 30089070

  • Saad 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 30790569

  • Ausbeck EB, Jauk VC, Xue Y, Files P, Kuper SG, Subramaniam A, Casey BM, Szychowski JM, Harper LM, Tita AT. Outpatient Foley Catheter for Induction of Labor in Nulliparous Women: A Randomized Controlled Trial. Obstet Gynecol. 2020 Sep;136(3):597-606. doi: 10.1097/AOG.0000000000004041.

    PubMed 32769658

  • Saunders SJ, Saunders R, Wong T, Saad AF. Out-of-Hospital Cervical Ripening With a Synthetic Hygroscopic Cervical Dilator May Reduce Hospital Costs and Cesarean Sections in the United States-A Cost-Consequence Analysis. Front Public Health. 2021 Jun 18;9:689115. doi: 10.3389/fpubh.2021.689115. eCollection 2021.

    PubMed 34222185

Questions about this trial

What is this clinical trial studying?

A study testing Dilapan-S and Cook Cervical Ripening Balloon in people with Induced; Birth, run by Brigham and Women's Hospital 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 27 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 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?

Yes. Results are posted in the registry (first posted 27 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Bishop Score (time frame: Up to 24 hours). 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 NCT05062343, which also lists 4 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 27 Oct 2023.

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