Efficacy and Safety

In peer-reviewed studies, Dilapan-S® has been proven to
predictably
ripen the cervix and result in high rates of vaginal delivery.1-5

Clinical efficacy Flexible cervical ripening Safety profile Patient satisfaction

Consistent clinical efficacy

Dilapan-S® achieves reliable cervical ripening success

In 2 clinical studies, the majority of women who used Dilapan-S® did not require additional cervical ripening.1,2

93 % (N=444) Gupta 2018 2
87 % (N=208) Saad 2019 1

Potential Complications/Risks: Complications may include: device entrapment and/or fragmentation, expulsion, or retraction; patient discomfort or bleeding; spontaneous rupture of membranes; spontaneous onset of labor; cervical laceration.

Twisting of device during removal may cause the device to break.

(See Instructions for Use)

Broad worldwide use

Dilapan-S® is available in 40+ countries.6

Dilapan-S® prepares women for successful vaginal delivery

In 3 clinical studies, Dilapan-S® achieved a vaginal delivery rate ranging from 70% to 81%.1-3*

70% (310/444)
Gupta 20182†
81% (169/208)
Saad 20191
75% (44/61)
Vlk 20143

In 4 clinical studies, Dilapan-S® achieved a vaginal delivery rate ranging from 52% to 75% among vaginal birth after cesarean (VBAC) populations.2-5*

52% (21/41)
Gupta 20182
65% (22/34)
Vlk 20143
75% (9/12)
Maier 20154
55% (18/33)
Maier 20185

*Includes ventouse/vacuum and/or forceps assisted delivery.
†Includes women with a history of previous cesarean delivery.

Count on predictable cervical ripening from Dilapan-S®

Flexible cervical ripening window2,7,8

12-24 hours consistent ripening

AVERAGE TIME

to successful cervical ripening 12-15 hours

MAXIMUM

insertion time 24 hours

80% of rod expansion occurs within 4-6 hours

Careful placement of the device is essential to avoid traumatic injury to the cervix or uterus.

(See Instructions for Use)

Favorable safety profile

No pharmacologically active substances

Dilapan-S® works with the body, without medications.7-9

No uterine tachysystole

In 2 large studies representing a total of 640 women (including VBAC patients) using Dilapan-S®, there were no cases of uterine tachysystole related to Dilapan-S® use during cervical ripening.3,8

Non-serious adverse events

Of 444 women treated with Dilapan-S® during induction of labor2:

  • <1% reported cramping or pain
  • 2.7% experienced bleeding during Dilapan-S® insertion or removal
  • No maternal infections (including chorioamnionitis, urinary tract infections, endometritis, and wound infections) were attributed to use of Dilapan-S® by the investigating physicians
  • No serious adverse neonatal outcomes were attributed to use of Dilapan-S®

Instruct patients to: Report any excessive bleeding, pain, or temperature elevation, and to avoid bathing, douching, and intercourse.

A proven, versatile cervical ripening agent for a broad variety of patients

In a clinical study of 444 women, the average increase in Bishop score with Dilapan-S® was +3.6.2

+3.6 

All Women

+3.7 

Nulliparous

+3.5 

Multiparous

+3.8 

TOLAC

Broad utility across patient types1,2,5

  • NULLIPAROUS
  • MULTIPAROUS
  • ELECTIVE (≥39 WEEKS)
  • POST-DATES (>41 WEEKS)
  • OBESITY
  • DIABETES
  • PREECLAMPSIA
  • TOLAC
  • OLIGOHYDRAMNIOS

Dilapan-S® is contraindicated in the presence of clinically apparent genital tract infection.

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Patient Satisfaction

Significantly higher patient satisfaction with Dilapan-S®1

In a head-to-head trial with 419 pregnant women, patients were more satisfied with Dilapan-S® compared with Foley balloon in 3 domains (P<0.05).

Patients who received Dilapan-S® reported1:

  • Better sleep (P=0.01)
  • More relaxing time (P=0.001)
  • Ability to perform daily activities (P=0.001)

93% of patients described the comfort of insertion as fully acceptable3

ALMOST 80% of patients were able to sleep during cervical ripening3

Patients should return to the physician for removal of Dilapan-S® at the indicated time and should be instructed not to attempt self-removal under any circumstances.

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