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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Termination of Pregnancy (TOP)

Treatments: Other: With cervical dilatator

Study type: Interventional

Funder types: Other

Identifiers

NCT03194230

P160908

Details and patient eligibility

About

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.

Full 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.

Enrollment: 355 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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355 participants in 2 patient groups

Without cervical dilator

No Intervention group

Description:

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

With cervical dilator

Experimental group

Description:

Induction of labour by cervical placement of hygroscopic dilators for 3 hours and oral of 400µg tablets of misoprostol each 3 hours.

Treatment:

Other: With cervical dilatator