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Dilapan-S®: A Multicenter US E-registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04451109
Recruitment Status : Enrolling by invitation
First Posted : June 30, 2020
Last Update Posted : June 30, 2020
Sponsor:
Collaborator:
The University of Texas Medical Branch, Galveston
Information provided by (Responsible Party):
Medicem Technology s.r.o.

Brief Summary:
Objective of this registry is to collect a representative set of real world data on the use of Dilapan-S® for pre-induction cervical ripening in daily clinical practice. Upon completion of the registry, relevant collected data will be analyzed and published.

Condition or disease Intervention/treatment
Post Term Pregnancy Premature Rupture of Membrane Fetal Growth Retardation Oligohydramnios Gestational Diabetes High Blood Pressure in Pregnancy Device: Dilapan-S

Detailed Description:

In the US, 23% of pregnant women undergo labor induction. A recent randomized controlled trial showed that elective labor induction at term in low-risk nulliparous women is associated with a lower risk of cesarean delivery and preeclampsia, with no increase in adverse perinatal morbidities. Hence, one can assume that labor induction rates will increase. The majority of women undergoing induction have unfavorable cervixes and require cervical ripening agents. Dilapan-S®, a hygroscopic cervical dilator made from a patented hydrogel (AQUACRYL), has been used in the past for cervical ripening for early gestation uterine evacuation. Dilapan-S® was approved by the FDA for cervical ripening in the third trimester in 2015.

The Dilapan-S® rods are inserted into the cervical canal, are contained within the vagina, and do not require tension. Dilapan-S® works by absorbing fluid from cervical canal cells, resulting in reversible cell membrane dehydration and softening. In addition, the increase in the rod's volume creates a mechanical stretch and leads to the release of endogenous prostaglandins, causing cervical ripening. Recently, a multicenter prospective cohort study showed that Dilapan-S® is a safe and effective method for cervical ripening in term gestations. Lastly, our group performed non-inferiority randomized clinical trial comparing Dilapan-S® to Foley balloon for cervical ripening in term pregnancies and found that Dilapan-S® is non-inferior to Foley balloon for pre-induction cervical ripening at term.

The Dilapan-S® rods are inserted into the cervical canal, are contained within the vagina, and do not require tension. Dilapan-S® works by absorbing fluid from cervical canal cells, resulting in reversible cell membrane dehydration and softening. In addition, the increase in the rod's volume creates a mechanical stretch and leads to the release of endogenous prostaglandins, causing cervical ripening. Advantages of Dilapan-S® over Foley include FDA approval, safe profile, no protrusion from the introitus, no need to keep under tension and better patient satisfaction.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Dilapan-S®: A Multicenter US E-registry
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

Group/Cohort Intervention/treatment
Cases in which Dilapan-S was used for cervical ripening.
Every participating site will select 50 cases of pregnant women who underwent cervical ripening by Dilapan-S prior to induction of labor. These cases has to fulfill inclusion/exclusion criteria defined in the protocol.
Device: Dilapan-S
Application of Dilapan-S and all other procedures regarding cervical ripening and induction of labor will be carried out as per the hospital's standard practice.




Primary Outcome Measures :
  1. Rate of overall vaginal delivery [ Time Frame: right after child delivery ]

Secondary Outcome Measures :
  1. Rate of vaginal delivery within 24 hours [ Time Frame: 24 hours ]
  2. Rate of vaginal delivery within 36 hours [ Time Frame: 36 hours ]
  3. Time to reach active stage of labor defined as ≥6 cm [ Time Frame: 48 hours ]
    minutes

  4. Change in Bishop score [ Time Frame: 48 hours ]
    scale 0-13 (positive gain in Bishop score is considered to be a positive consequence of the intervention)

  5. Rate of spontaneous vaginal delivery [ Time Frame: right after child delivery ]
  6. Rate of operative vaginal delivery [ Time Frame: right after child delivery ]
  7. Rate of caesarean sections [ Time Frame: right after child delivery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Selected patients fulfilling eligibility criteria.
Criteria

Inclusion Criteria:

  • Pregnant woman whose plan of care is induction of labor
  • Maternal age ≥ 18 years
  • Gestational age ≥ 37 +0/7 weeks
  • Dilapan-S® used for cervical ripening

Exclusion Criteria:

  • Data not available for extraction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04451109


Locations
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United States, Texas
The University of Texas Medical Branch
Galveston, Texas, United States, 77555
Sponsors and Collaborators
Medicem Technology s.r.o.
The University of Texas Medical Branch, Galveston
Investigators
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Principal Investigator: Antonio Saad, MD The University of Texas Medical Branch, Galveston
Publications:
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Responsible Party: Medicem Technology s.r.o.
ClinicalTrials.gov Identifier: NCT04451109    
Other Study ID Numbers: Dilapan-S US E-registry
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Medicem Technology s.r.o.:
induction of labour
induction of labor
labour induction
labor induction
Dilapan
dilator
cervical ripening
cervical priming
preinduction
pre-induction
Additional relevant MeSH terms:
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Diabetes, Gestational
Fetal Membranes, Premature Rupture
Fetal Growth Retardation
Oligohydramnios
Pregnancy, Prolonged
Hypertension
Rupture
Pregnancy Complications
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Wounds and Injuries
Vascular Diseases
Cardiovascular Diseases
Obstetric Labor Complications
Fetal Diseases
Growth Disorders
Pathologic Processes