An observational study in Post Term Pregnancy, Premature Rupture of Membrane and Fetal Growth Retardation, sponsored by Medicem Technology s.r.o.. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-22.
Sponsored by Medicem Technology s.r.o. · Observational
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.
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.
29 studies on the registry are indexed under Pregnancy, Prolonged; 2 are open to participants now.
Browse Pregnancy, Prolonged studies →This is the only study on the registry with Medicem Technology s.r.o. as lead sponsor.
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Selected patients fulfilling eligibility criteria.
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Exclusion Criteria:
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.
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
minutes
Time frame: 48 hours
Change in Bishop score
scale 0-13 (positive gain in Bishop score is considered to be a positive consequence of the intervention)
Time frame: 48 hours
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
Plan to share: No
Started Dec 2020 (actual). Primary completion is estimated for Dec 2024, 48 months after the start.
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This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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