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Interest of Cervical Dilators in Second Trimester Termination of Pregnancy (DILATOP)

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ClinicalTrials.gov Identifier: NCT03194230
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : August 28, 2018
Sponsor:
Collaborator:
INSERM U1153
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Termination of Pregnancy (TOP) Other: With cervical dilatator Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 325 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Interest of Cervical Dilators in the Induction of Labor in Second Trimester Medical Termination of Pregnancy.
Actual Study Start Date : December 14, 2017
Estimated Primary Completion Date : August 14, 2020
Estimated Study Completion Date : February 14, 2021

Arm Intervention/treatment
No Intervention: Without cervical dilator
Induction of labour by oral of 400µg of misoprostol each 3 hours.
Experimental: With cervical dilator
Induction of labour by cervical placement of hygroscopic dilators for 3 hours and oral of 400µg tablets of misoprostol each 3 hours.
Other: With cervical dilatator
Induction of labour by cervical placement of hygroscopic dilators (Dilapan-S Hygroscopic cervical dilator )




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194230


Contacts
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Contact: Olivia Anselem, MD 158 41 37 63 ext +33 olivia.anselem@aphp.fr
Contact: Laurence Lecomte, PhD 1 71 19 64 94 ext +33 laurence.lecomte@aphp.fr

Locations
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France
Maternité Port Royal Recruiting
Paris, France, 75014
Contact: olivia Anselem, MD    1 58 41 37 63 ext +33    olivia.anselem@aphp.fr   
Contact: Vassilis Tsatsaris, MD, PhD    1 58 41 38 71 ext +33    vassilis.tsatsaris@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
INSERM U1153
Investigators
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Study Director: Vassilis Tsatsaris, MD, PhD Assistance Publique - Hôpitaux de Paris

Publications:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03194230     History of Changes
Other Study ID Numbers: P160908
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Cervical dilators
induction of labor
cervical ripening
medical termination of pregnancy
second-trimester of pregnancy.