Dilapan-S Osmotic Dilator in Pre-induction of Labor

Medicem

Status: Completed

Conditions: Uterine Cervical Incompetence

Treatments: Device: Dilapan-S

Study type: Observational

Funder types: Industry

Identifiers

NCT02098382

DIS2013-002

Details and patient eligibility

About

Non-interventional prospective data collection designed to evaluate clinical outcome on the efficacy of the use of Dilapan-S in the indication of labor pre-induction in women with/without a history of Caesarean section. The evaluation will be based on prospective data collection in at least four obstetrics centers in the Czech Republic.

Full description

Nowadays there is a rising need for non-pharmacological cervical ripening methods as the use of prostaglandins is frequently limited by various contraindications. Dilapan-S is a hygroscopic uterine neck dilator. Its mode of action consists in the hydrophilic properties of the device absorbing fluids from surrounding tissue structures, thus expanding the volume of Dilapan-S sticks which subsequently exert radial pressure on the surrounding structures (uterine neck) to dilate progressively. Endocervical pressure on the uterine neck results not only in its mechanical dilatation but pressure on endocervical structures also stimulates the production of endogenous prostaglandins, which promote cervical ripening through its collagenolytic action. Although Dilapan-S is widely used in labor pre-induction, published study data comparing its clinical efficacy and safety in females with/without caesarean section in medical history are lacking.

Enrollment: 125 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Single pregnancy
• Pregnancy more than 36 weeks
• Vertex presentation of the fetus
• Cervix Score less than 4 points

Exclusion criteria

• Contraindication to vaginal delivery
• Pathological fetal station
• States after uterine body surgery - except for Caesarean section
• Clinical signs of uterine, vaginal or vulvar infection
• Fetus hypoxia (KTG recording evaluated as pathological prior to pre-induction initiation)

Trial design

125 participants in 1 patient group

Dilapan-S

Description:

125 Patients with / without caesarean section in their medical history

Treatment:

Device: Dilapan-S