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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
355
Induction of labour by cervical placement of hygroscopic dilators (Dilapan-S Hygroscopic cervical dilator )
Maternité Port Royal
Paris, France
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.
Time frame: 12 hours
Induction-to-amniotomy interval
Time between the first placement of misoprostol tablets and artificial amniotomy.
Time frame: 12 hours
Induction-to-delivery interval
Time between the first placement of misoprostol tablets and delivery.
Time frame: 24 hours
Failure in induction of labor
Proportion of women not achieving vaginal delivery within 24 hours
Time frame: 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
Time frame: Hour 0
Pain assessment of the whole procedure of TOP
Pain assessment of the whole procedure by numerical scale at discharge of the hospital
Time frame: 48 hours
Distress assessment at discharge after TOP
Distress assessment at discharge after TOP measured by impact of event scale revised(IES-R)
Time frame: 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
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Time frame: 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.
Time frame: 4 months
Duration of hospitalization.
Duration of hospitalization between admission and discharge and in delivery room.
Time frame: 48 hours
Cost of the procedure
Assessment of the whole procedure costs of TOP, including potential complications.
Time frame: 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.
Time frame: 12 hours