Interest of Cervical Dilators in Second Trimester Termination of Pregnancy

Not Applicable

Completed

• Conditions: Termination of Pregnancy (TOP)
• Interventions: Other: With cervical dilatator

• Registration Number: NCT03194230
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2017-06-13
• Study First Submitted QC: 2017-06-19
• Study First Posted: 2017-06-21
• Study Start: 2017-12-14
• Primary Completion: 2020-06-30
• Study Completion: 2020-11-24
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-12
• Last Update Posted: 2021-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 355

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
With cervical dilator	With cervical dilatator	Induction of labour by cervical placement of hygroscopic dilators for 3 hours and oral of 400µg tablets of misoprostol each 3 hours.

Primary Outcome Measures

Name	Time	Method
Proportion of women achieving vaginal delivery within 12 hours	12 hours	The beginning of labor will be defined as the placement of the first tablets of misoprostol in both groups.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Maternité Port Royal; 🇫🇷 Paris, France