The University of Texas Medical Branch
Galveston, Texas, 77555, United States
NCT Number: NCT04451109
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.
This study is active but is not currently recruiting participants.
18 year and older
Female
Observational
Galveston, Texas, 77555, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: right after child delivery
Time frame: 24 hours
Time frame: 36 hours
Time frame: 48 hours
minutes
Time frame: 48 hours
scale 0-13 (positive gain in Bishop score is considered to be a positive consequence of the intervention)
Time frame: right after child delivery
Time frame: right after child delivery
Time frame: right after child delivery
Medicem Technology s.r.o.
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07615946
Delayed Onset of Labour, Female Urogenital Diseases and Pregnancy Complications
Karachi, Sindh, Pakistan
View Trial DetailsNCT04848701
Female Urogenital Diseases and Pregnancy Complications, Post Term Pregnancy
Bursa, Turkey (Türkiye)
View Trial DetailsNCT07263490
ART, Abruptio Placentae
Copenhagen, Denmark
View Trial DetailsNCT02997345
Female Urogenital Diseases and Pregnancy Complications, Fetal Membranes, Premature Rupture
Denver, Colorado, United States
View Trial Details