Pre-induction Dilation of CervixNCT02899689
Induction of Labor in Women With Unfavorable Cervix: Dilapan Versus Foley Bulb
A study testing Dilapan and Foley Catheter in people with Pre-induction Dilation of Cervix, run by The University of Texas Medical Branch, Galveston at 2 sites in United States.
Trial summary
Women undergoing mechanical cervical ripening for labor induction will be randomized to Dilapan-S® versus Foley bulb. The investigators hypothesized that osmotic cervical dilators (Dilapan-S®) are as effective as Foley bulb catheter in rates of vaginal delivery. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pre-induction Dilation of Cervix
- What is being tested?
- Dilapan and Foley Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 419 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2016to Feb 2018
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant woman scheduled for induction of labor.
- Age between 18 and 45 years.
- Understanding and capable to sign informed consent.
- Singleton pregnancy.
- Gestational age ≥ 37 0/7 weeks.
- Live fetus in cephalic presentation.
- Intact membranes.
- Pelvic exam (sterile vaginal exam) of less than or equal to 3cm and at most 60% effaced.
Who cannot join
- Iodine allergy.
- Active labor or oxytocin has been administered.
- Chorioamnionitis.
- Prior uterine or cervical surgery.
- Non reassuring fetal status requiring immediate delivery.
- Non-cephalic fetal presentation.
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- Active vaginal bleeding from cervical os.
- Placenta previa.
- EFW > 5000 gm(non diabetic) or > 4500gm (diabetic).
- Other contraindication to vaginal delivery.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Texas
Galveston, Texas, 77555
UTMB Galveston
Galveston, Texas, 77555
About this study
Official title: Induction of Labor in Women With Unfavorable Cervix: Randomized Control Study Comparing Dilapan to Foley Bulb
Women undergoing mechanical cervical ripening for labor induction will be randomized to Dilapan-S® versus Foley bulb. The investigators hypothesized that osmotic cervical dilators (Dilapan-S®) are as effective as Foley bulb catheter in rates of vaginal delivery.
Read the detailed description
Historically, mechanical methods were the first methods developed to ripen the cervix or to induce labor. Dilapan-S® a synthetic osmotic cervical dilator made of a patented hydrogel (AQUACRYL), works by stimulating the release of endogenous prostaglandins, which degrade collagen fibers and soften the cervix. Additionally, it dilates the cervix gradually and the effect is gentle as well as predictable. Recently, Dilapan-S® has been approved by the FDA as a mechanical dilator for cervical ripening. There are no data comparing this newly approved Dilapan-S® to the Foley catheter, the most commonly used mechanical dilator method. Therefore, The investigators propose a randomized controlled trial to determine the efficacy of Dilapan-S® compared with Foley catheter for cervical ripening before induction of labor in pregnant women greater than 37 weeks.
- Conditions
- Pre-induction Dilation of Cervix
- Being tested
- Dilapan, Foley Catheter
- Keywords
- Labor, Foley, Dilapan, Cervical Dilators, Induction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DilapanDevice
Also called Osmotic cervical dilator
Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, synthetic osmotic dilators (Dilapan-S) are inserted into the cervical canal with special attention to cross through the internal os.
Foley CatheterDevice
Also called Foley Bulb
Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, a Foley catheter is inserted into the cervix and the balloon is filled with 60 ml of sterile 0.9% NaCl.
| Study group | Role | What they receive |
|---|---|---|
| Foley Bulb Group | Active comparator | Patients will have a Foley catheter inserted into the internal cervical os. Receives: Device: Foley Catheter |
| Dilapan Group | Experimental | Patients will have Dilapan sticks inserted into the internal cervical os. Receives: Device: Dilapan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Vaginal Delivery
Proportion of patients that delivered vaginal. (%)
Measured: Through study completion, an average of 1-2 years
Secondary outcomes (5)
Time of Vaginal Delivery
Delivery time frame in mins from cervical dilator insertion
Measured: 2-4 days
Time to Reach Active Stage of Labor as ≥ 6cm Cervical Dilation
time from hospital admission to reach active stage of labor defined as ≥ 6 cm (mins)
Measured: 1-2 days
Change in Bishop Scores
Change in Bishop score from insertion to extraction of device. The total score is calculated by assessing the following five components on manual vaginal examination by a trained professional: Cervical dilation in centimeters. Cervical effacement as a percentage. Cervical consistency by provider assessment/judgement.
The highest possible score is 13 and the lowest possible score is 0. Bishop scores of less than 6 usually require that a cervical ripening method (pharmacologic or physical, such as a foley bulb) be used before other method
Measured: 12-24 hrs
Operative Deliveries
Proportion of patients that delivered vaginal by forceps assistance or vacuum (%) assistance.
Measured: 1-4 days
Cesarean Deliveries
Proportion of patients that delivered by cesarean (%).
Measured: 1-4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pre-induction Dilation of CervixStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 419 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Medicem International CR s.r.o.
- Responsible party
- Sponsor
- Investigators
- Antonio Saad, MD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02899689
- Sponsor's protocol ID
- 15-0272
- Status last verified
- Nov 2018
- First submitted
- 31 Aug 2016
- Last updated
- 18 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction of Labor in Women With Unfavorable Cervix: Randomized Control Study Comparing Dilapan to Foley Bulb
- ClinicalTrials.gov ID
- NCT02899689
- Acronym / sponsor ID
- 15-0272
- Conditions
- Pre-induction Dilation of Cervix
- Keywords
- Labor, Foley, Dilapan, Cervical Dilators, Induction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 419 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- Medicem International CR s.r.o.
- Study start
- Sep 2016
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 14 Sep 2016 (estimated)
- Results
- Posted 18 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Women undergoing mechanical cervical ripening for labor induction will be randomized to Dilapan-S® versus Foley bulb. The investigators hypothesized that osmotic cervical dilators (Dilapan-S®) are as effective as Foley bulb catheter in rates of vaginal delivery.
Detailed description
Historically, mechanical methods were the first methods developed to ripen the cervix or to induce labor. Dilapan-S® a synthetic osmotic cervical dilator made of a patented hydrogel (AQUACRYL), works by stimulating the release of endogenous prostaglandins, which degrade collagen fibers and soften the cervix. Additionally, it dilates the cervix gradually and the effect is gentle as well as predictable. Recently, Dilapan-S® has been approved by the FDA as a mechanical dilator for cervical ripening. There are no data comparing this newly approved Dilapan-S® to the Foley catheter, the most commonly used mechanical dilator method. Therefore, The investigators propose a randomized controlled trial to determine the efficacy of Dilapan-S® compared with Foley catheter for cervical ripening before induction of labor in pregnant women greater than 37 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Foley Bulb Group | Active comparator | Device: Foley CatheterPatients will have a Foley catheter inserted into the internal cervical os. |
| Dilapan Group | Experimental | Device: DilapanPatients will have Dilapan sticks inserted into the internal cervical os. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Pregnant woman scheduled for induction of labor.
- Age between 18 and 45 years.
- Understanding and capable to sign informed consent.
- Singleton pregnancy.
- Gestational age ≥ 37 0/7 weeks.
Key exclusion criteria (10 listed)
- Iodine allergy.
- Active labor or oxytocin has been administered.
- Chorioamnionitis.
- Prior uterine or cervical surgery.
- Non reassuring fetal status requiring immediate delivery.
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 |
|---|---|---|
| DilapanAlso: Osmotic cervical dilatorUsing a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, synthetic osmotic dilators (Dilapan-S) are inserted into the cervical canal with special attention to cross through the internal os. | Device | Dilapan Group |
| Foley CatheterAlso: Foley BulbUsing a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, a Foley catheter is inserted into the cervix and the balloon is filled with 60 ml of sterile 0.9% NaCl. | Device | Foley Bulb Group |
Primary outcome
Rate of Vaginal Delivery
Time frame: Through study completion, an average of 1-2 years
Proportion of patients that delivered vaginal. (%)
5 secondary outcomes
Time of Vaginal Delivery
Time frame: 2-4 days
Time to Reach Active Stage of Labor as ≥ 6cm Cervical Dilation
Time frame: 1-2 days
Change in Bishop Scores
Time frame: 12-24 hrs
Operative Deliveries
Time frame: 1-4 days
Cesarean Deliveries
Time frame: 1-4 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
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.
Antonio Saad, MD principal investigator
Assistant Professor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dilapan and Foley Catheter in people with Pre-induction Dilation of Cervix, run by The University of Texas Medical Branch, Galveston at 2 sites 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 8 inclusion and 10 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 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 18 Nov 2020). 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?
Rate of Vaginal Delivery (time frame: Through study completion, an average of 1-2 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 NCT02899689, which also lists 1 linked publication.
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 Nov 2020.