Dilapan-S®: A Multicenter US E-registry

Status Enrolling by invitation

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04451109
Study type	Observational
Source	Medicem Technology s.r.o.
Contact
Status	Enrolling by invitation
Phase
Start date	December 1, 2020
Completion date	December 31, 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05081037` - Integrated Hyperglycaemia Incentivised Postnatal Surveillance Study (I-HIPS)	N/A
Active, not recruiting	`NCT03249896` - Web/Smartphone-based Lifestyle Coaching Program in Pregnant Women With Gestational Diabetes	N/A
Terminated	`NCT03749889` - Low Carb vs Normal Carb in Pregnancy	N/A
Completed	`NCT03859193` - Education Nutritional Video for Gestational Diabetics	N/A
Recruiting	`NCT05037526` - Utility of Real Time Continuous Glucose Monitoring in the Care of Gestational Diabetes Versus Standard Care in Pregnancy Outcomes	N/A
Completed	`NCT06178250` - Placenta, Fetal Liver, Sectional Ductus Venosus Volumes Examined by Three-dimensional Ultrasound in the Second Trimester	N/A
Not yet recruiting	`NCT06310356` - Continuous Glucose Monitoring for Women With Gestational Diabetes	N/A
Not yet recruiting	`NCT06445530` - Nutrition Optimization and Community Upliftment for Postpartum Recovery	N/A
Recruiting	`NCT02590016` - Glucose Control During Labour in Gestational Diabetes Mellitus With Insulin Treatment: A Randomized Controlled Trial	Phase 4
Withdrawn	`NCT01947699` - Glycemic Profile in Women With Gestational Diabetes Treated With Glyburide	Phase 4
Not yet recruiting	`NCT00883259` - Metformin and Gestational Diabetes in High-risk Patients: a RCTs	Phase 4
Recruiting	`NCT03008824` - Micronutrients in Pregnancy as a Risk Factor for Diabetes and Effects on Mother and Baby	N/A
Active, not recruiting	`NCT01340924` - Relationship Between Gestational Diabetes and Type 2 Diabetes
Completed	`NCT00534105` - Lipid Metabolism in Gestational Diabetes	N/A
Recruiting	`NCT00371306` - Comparison of Glucovance to Insulin for Diabetes During Pregnancy	N/A
Completed	`NCT03388723` - Intergenerational Programming of Diabesity in Offspring of Women With Gestational Diabetes Mellitus
Recruiting	`NCT04521712` - Postpartum Glycemia in Women at Risk For Persistent Hyperglycemia	N/A
Enrolling by invitation	`NCT03307486` - Gestational Diabetes: a Cohort Study	N/A
Active, not recruiting	`NCT03301792` - Group Versus Traditional Prenatal Care for Diabetes	N/A
Enrolling by invitation	`NCT05603793` - YoUng Adolescents' behaViour, musculoskeletAl heAlth, Growth & Nutrition