Dilapan-S®: A Multicenter US E-registry

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Dilapan-S®: A Multicenter US E-registry

Conditions
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Post Term Pregnancy, Premature Rupture of Membrane, Fetal Growth Retardation, Oligohydramnios, Gestational Diabetes, High Blood Pressure in Pregnancy

Intervention / Treatment
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* Device: Dilapan-S


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases in which Dilapan-S was used for cervical ripening.<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of overall vaginal delivery |  | right after child delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of vaginal delivery within 24 hours |  | 24 hours | 
| Rate of vaginal delivery within 36 hours |  | 36 hours | 
| Time to reach active stage of labor defined as ≥6 cm | minutes | 48 hours | 
| Change in Bishop score | scale 0-13 (positive gain in Bishop score is considered to be a positive consequence of the intervention) | 48 hours | 
| Rate of spontaneous vaginal delivery |  | right after child delivery | 
| Rate of operative vaginal delivery |  | right after child delivery | 
| Rate of caesarean sections |  | right after child delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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induction of labour, induction of labor, labour induction, labor induction, Dilapan, dilator, cervical ripening, cervical priming, preinduction, pre-induction