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NCT Number: NCT02318173

Dilapan-S/Dilasoft E-Registry in Induction of Labor

International Observational E-Registry on the use of DILAPAN-S® osmotic dilator / DILASOFT® osmotic dilator for cervical ripening prior to labour induction.

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Key information

Conditions

Labour Onset and Length Abnormalities Labor; Forced or Induced, Affecting Fetus or Newborn

Sex eligibility

Female

Study type

Observational

Primary location

Masaryk University, Brno, Czechia

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About this study

International Observational E-Registry to monitor current common clinical practice of use of Dilapan-S / Dilasoft for cervical ripening and following procedures of labour induction with the main focus on the duration of induced labor procedure .

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Indication for induction of labor
  • Unfavourable cervix

Exclusion criteria

  • Presence of overt genital tract infection

Treatment and study plan

Dilapan-S

Device

Synthetic osmotic dilators Dilapan-S, Dilasoft for cervical ripening prior to induction of labor in women with unfavourable cervix

Other names: Dilasoft

Primary outcomes

  1. Duration of Dilapan-S/Dilasoft insertion

    Time frame: max. up to 24 hrs; estimated average 12 hrs)

    duration of cervical ripening

  2. Induction - delivery interval

    Time frame: estimated maximum up to 72 hrs

    Overall duration of induced labor procedure

  3. Rate of vaginal deliveries within 24 hours

    Time frame: up to 24 hrs

    Rate of vaginal deliveries achieved within 24 hours from the beginning of induced labor procedure

Secondary outcomes

  1. Type of osmotic dilator used: Dilapan-S or Dilasoft

    Time frame: up to 24 hrs; estimated average 12 hrs

  2. Number of dilators inserted

    Time frame: up to 24 hrs; estimated average 12 hrs

  3. Bishop Score increase after extraction of osmotic dilators

    Time frame: up to 24 hrs; estimated average 12 hrs

  4. Complications during pre-induction

    Time frame: up to 24 hrs; estimated average 12 hrs

    uterine contractions, uterine hypersensitivity, effect on the foetus

  5. Agents / procedures used for induction of labour, if any

    Time frame: estimated maximum up to 72 hrs

    which, total dosage

  6. % of spontaneous vaginal deliveries following immediately after pre-induction

    Time frame: up to 24 hrs

  7. % of total spontaneous vaginal deliveries

    Time frame: estimated maximum up to 72 hrs

  8. % of instrumented vaginal deliveries

    Time frame: estimated maximum up to 72 hrs

  9. % of Caesarean sections

    Time frame: estimated maximum up to 72 hrs

  10. Foetal status

    Time frame: 0, 5 and 10 minutes after delivery (estimated maximum up to 72 hrs)

    Apgar score at 0, 5 and 10 minutes after delivery, venous and arterial cord pH and base excess measurements

  11. Maternal infectious complication and its relation to the use of Dilapan-S/Dilasoft

    Time frame: up to 72 hrs; Complications, if any, will be followed-up until stable situation has been reached.

    Clinical signs of maternal infection found at patient´s examination are defined as follows:

    • Body temperature > 37.8°C
    • Increased pain
    • Other overt clinical signs of infection e.g. vaginal discharge

    Laboratory test results that need to be correlated with clinical signs of infection:

    • CRP levels > 8 mg/l
    • Leukocyte count > 18 x 109/l
    • Positive microbiological testing

  12. Neonatal infectious complication and its relation to the use of Dilapan-S/Dilasoft

    Time frame: up to 72 hrs; Complications, if any, will be followed-up until stable situation has been reached.

    Clinical signs of neonatal infection found at patient´s examination are defined as follows:

    • Body temperature > 37.8°C
    • Increased pain
    • Other overt clinical signs of infection e.g. vaginal discharge

    Laboratory test results that need to be correlated with clinical signs of infection:

    • CRP levels > 8 mg/l
    • Leukocyte count > 18 x 109/l
    • Positive microbiological testing

Sponsors and collaborators

Lead sponsor

Medicem International CR s.r.o.

Industry

Registry information

Official study title

International Observational E-Registry on the Use of Dilapan-S / Dilasoft Osmotic Dilators for Cervical Ripening Prior to Labour Induction

Acronym: DSREGISTRYIL

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 17, 2014
Registry last updated
May 19, 2017

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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