Interest of Cervical Dilators in Second Trimester Termination of Pregnancy

Study Overview
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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.

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.

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

Conditions
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Termination of Pregnancy (TOP)

Intervention / Treatment
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* Other: With cervical dilatator


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Without cervical dilator<br>Induction of labour by oral of 400µg of misoprostol each 3 hours. | |
| Experimental: With cervical dilator<br>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<br>* Induction of labour by cervical placement of hygroscopic dilators (Dilapan-S Hygroscopic cervical dilator )<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of women achieving vaginal delivery within 12 hours | The beginning of labor will be defined as the placement of the first tablets of misoprostol in both groups. | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Induction-to-amniotomy interval | Time between the first placement of misoprostol tablets and artificial amniotomy. | 12 hours | 
| Induction-to-delivery interval | Time between the first placement of misoprostol tablets and delivery. | 24 hours | 
| Failure in induction of labor | Proportion of women not achieving vaginal delivery within 24 hours | 24 hours | 
| Pain assessment at the beginning of the procedure | Pain assessment with numerical scale at the placement of dilators and the first misoprostol tablets | Hour 0 | 
| Pain assessment of the whole procedure of TOP | Pain assessment of the whole procedure by numerical scale at discharge of the hospital | 48 hours | 
| Distress assessment at discharge after TOP | Distress assessment at discharge after TOP measured by impact of event scale revised(IES-R) | 4 months | 
| Assessment of acceptability of the whole procedure of TOP | Acceptability measured by the proportion of women who would opt for the same procedure after TOP | 4 months | 
| number of complications. | 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. | 4 months | 
| Duration of hospitalization. | Duration of hospitalization between admission and discharge and in delivery room. | 48 hours | 
| Cost of the procedure | Assessment of the whole procedure costs of TOP, including potential complications. | 4 months | 
| Among nullipara, proportion of women achieving vaginal delivery within 12 hours | The beginning of labor will be defined as the placement of the first tablets of misoprostol in both groups. | 12 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical dilators, induction of labor, cervical ripening, medical termination of pregnancy, second-trimester of pregnancy.