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Completed

NCT Number: NCT03194230

Interest of Cervical Dilators in Second Trimester Termination of Pregnancy

The purpose of this study is to evaluate whether the use of cervical dilators for cervical ripening in case of second trimester medical termination of pregnancy (TOP) is effective to reduce duration of labor.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Maternité Port Royal

Paris, 75014, France

About this study

Termination of pregnancy is a distressing and painful procedure for women. The use of cervical dilators could shorten the duration of labor but can generate more pain. The investigators will compare two procedures of induction of labor for second trimester termination of pregnancy: one with the use of oral prostaglandins (misoprostol) only and one with the exact same procedure preceded by cervical ripening with hygroscopic cervical dilators. Epidural analgesia will be effective previously to the placement of cervical dilators and the first tablet of misoprostol. Efficacy will be determined based on the proportion of women achieving vaginal delivery within 12 hours. The beginning of labor will be defined as the first administration of misoprostol tablets in both groups.

The investigators will also evaluate safety by collecting hemorrhage endometritis, cervical tear. The investigators will compare psychological impact of these procedures, measured by the impact of event scale and acceptability 1 to 4 months later.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Termination of pregnancy requested by the patient and accepted by the weekly multidisciplinary counselling of fetal medicine
  • gestational age between 15 and 27 weeks and 6 days,
  • single pregnancy,
  • major patient,
  • French-speaking woman,
  • Patient with health insurance.

Exclusion criteria

  • Termination of pregnancy by surgical technique
  • cicatricial uterus
  • premature rupture of membranes
  • chorioamnionitis
  • multiple pregnancy
  • placenta praevia
  • myoma praevia
  • uterine malformation
  • unstable maternal pathology
  • psychiatric pathology
  • contraindication to mifepristone: severe asthma, adrenal insufficiency, porphyria, corticotherapy.
  • contraindication to misoprostol: hypersensitivity to prostaglandins.
  • contraindication to epidural analgesia: hemostasis disorder, spinal or medullary anomaly.
  • Bishop score > or = to 7 at arrival in birth room

Treatment and study plan

With cervical dilatator

Other

Induction of labour by cervical placement of hygroscopic dilators (Dilapan-S Hygroscopic cervical dilator )

Primary outcomes

  1. Proportion of women achieving vaginal delivery within 12 hours

    Time frame: 12 hours

    The beginning of labor will be defined as the placement of the first tablets of misoprostol in both groups.

Secondary outcomes

  1. Induction-to-amniotomy interval

    Time frame: 12 hours

    Time between the first placement of misoprostol tablets and artificial amniotomy.

  2. Induction-to-delivery interval

    Time frame: 24 hours

    Time between the first placement of misoprostol tablets and delivery.

  3. Failure in induction of labor

    Time frame: 24 hours

    Proportion of women not achieving vaginal delivery within 24 hours

  4. Pain assessment at the beginning of the procedure

    Time frame: Hour 0

    Pain assessment with numerical scale at the placement of dilators and the first misoprostol tablets

  5. Pain assessment of the whole procedure of TOP

    Time frame: 48 hours

    Pain assessment of the whole procedure by numerical scale at discharge of the hospital

  6. Distress assessment at discharge after TOP

    Time frame: 4 months

    Distress assessment at discharge after TOP measured by impact of event scale revised(IES-R)

  7. Assessment of acceptability of the whole procedure of TOP

    Time frame: 4 months

    Acceptability measured by the proportion of women who would opt for the same procedure after TOP

  8. number of complications.

    Time frame: 4 months

    Hyperthermia> 40 ° C, septicemia, endometritis defined by a fever associated with pelvic pain, positive bacteriological vaginal specimen and a biological infectious syndrome (leukocytosis greater than 15 000 / mm3 and C-Reactive Protein > 10 IU / mL).

    • Cervical injury.
    • Complications of prolonged decubitus: bedsores, thrombo-embolic complications.
    • Uterine rupture.
    • Post-partum hemorrhage defined by estimated blood losses greater than 500 mL.
  9. Duration of hospitalization.

    Time frame: 48 hours

    Duration of hospitalization between admission and discharge and in delivery room.

  10. Cost of the procedure

    Time frame: 4 months

    Assessment of the whole procedure costs of TOP, including potential complications.

  11. Among nullipara, proportion of women achieving vaginal delivery within 12 hours

    Time frame: 12 hours

    The beginning of labor will be defined as the placement of the first tablets of misoprostol in both groups.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Interest of Cervical Dilators in the Induction of Labor in Second Trimester Medical Termination of Pregnancy.

Acronym: DILATOP

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 21, 2017
Registry last updated
Sep 5, 2025

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.