Interest of Cervical Dilators in Second Trimester Termination of Pregnancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

355 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-14

Study Completion Date

2020-11-24

Brief Summary

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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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Detailed Description

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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.

Conditions

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Termination of Pregnancy (TOP)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Without cervical dilator

Induction of labour by oral of 400µg of misoprostol each 3 hours.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

With cervical dilatator

Intervention Type OTHER

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

Interventions

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With cervical dilatator

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No