Dilapan-S®: A Multicenter US E-registry
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|ClinicalTrials.gov Identifier: NCT04451109|
Recruitment Status : Enrolling by invitation
First Posted : June 30, 2020
Last Update Posted : June 30, 2020
|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|
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.
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|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|
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.
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.
- Rate of overall vaginal delivery [ Time Frame: right after child delivery ]
- Rate of vaginal delivery within 24 hours [ Time Frame: 24 hours ]
- Rate of vaginal delivery within 36 hours [ Time Frame: 36 hours ]
- Time to reach active stage of labor defined as ≥6 cm [ Time Frame: 48 hours ]minutes
- 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)
- Rate of spontaneous vaginal delivery [ Time Frame: right after child delivery ]
- Rate of operative vaginal delivery [ Time Frame: right after child delivery ]
- Rate of caesarean sections [ Time Frame: right after child delivery ]
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
|United States, Texas|
|The University of Texas Medical Branch|
|Galveston, Texas, United States, 77555|
|Principal Investigator:||Antonio Saad, MD||The University of Texas Medical Branch, Galveston|