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

January 12, 2021 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

355

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Maternité Port Royal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

INSERM U1153

Investigators

  • Study Director: Vassilis Tsatsaris, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2017

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

November 24, 2020

Study Registration Dates

First Submitted

June 13, 2017

First Submitted That Met QC Criteria

June 19, 2017

First Posted (Actual)

June 21, 2017

Study Record Updates

Last Update Posted (Actual)

January 13, 2021

Last Update Submitted That Met QC Criteria

January 12, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P160908

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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