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Active, Not Recruiting

NCT Number: NCT04451109

Dilapan-S®: A Multicenter US E-registry

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dilapan-S

Device

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.

Primary outcomes

  1. Rate of overall vaginal delivery

    Time frame: right after child delivery

Secondary outcomes

  1. Rate of vaginal delivery within 24 hours

    Time frame: 24 hours

  2. Rate of vaginal delivery within 36 hours

    Time frame: 36 hours

  3. Time to reach active stage of labor defined as ≥6 cm

    Time frame: 48 hours

    minutes

  4. 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)

  5. Rate of spontaneous vaginal delivery

    Time frame: right after child delivery

  6. Rate of operative vaginal delivery

    Time frame: right after child delivery

  7. Rate of caesarean sections

    Time frame: right after child delivery

Sponsors and collaborators

Lead sponsor

Medicem Technology s.r.o.

Other

Collaborators

  • The University of Texas Medical Branch, Galveston

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Jun 30, 2020
Registry last updated
Nov 22, 2024

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.

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