AzTrials
AzTrials

Termination of Pregnancy (TOP)DILATOPNCT03194230

Interest of Cervical Dilators in Second Trimester Termination of Pregnancy

A study testing With cervical dilatator in people with Termination of Pregnancy (TOP), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Termination of Pregnancy (TOP)
What is being tested?
With cervical dilatator
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
355 participants
Where
1 siteFrance
Study dates
14 Dec 2017to 24 Nov 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Termination of pregnancy by surgical technique
  • cicatricial uterus
  • premature rupture of membranes
  • chorioamnionitis
  • multiple pregnancy
  • placenta praevia
Show all 14Show fewer
  • 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 locations and contacts

1 site in 1 country.

France1 site

  • Maternité Port Royal

    Paris, 75014

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
With cervical dilatator
Keywords
Cervical dilators, induction of labor, cervical ripening, medical termination of pregnancy, second-trimester of pregnancy.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • With cervical dilatatorOther

    Induction of labour by cervical placement of hygroscopic dilators (Dilapan-S Hygroscopic cervical dilator )

Study groups in NCT03194230
Study groupRoleWhat they receive
Without cervical dilatorNo interventionInduction of labour by oral of 400µg of misoprostol each 3 hours.
With cervical dilatorExperimentalInduction of labour by cervical placement of hygroscopic dilators for 3 hours and oral of 400µg tablets of misoprostol each 3 hours.
Receives: Other: With cervical dilatator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 hours

Secondary outcomes (11)

  1. Induction-to-amniotomy interval

    Time between the first placement of misoprostol tablets and artificial amniotomy.

    Measured: 12 hours

  2. Induction-to-delivery interval

    Time between the first placement of misoprostol tablets and delivery.

    Measured: 24 hours

  3. Failure in induction of labor

    Proportion of women not achieving vaginal delivery within 24 hours

    Measured: 24 hours

  4. Pain assessment at the beginning of the procedure

    Pain assessment with numerical scale at the placement of dilators and the first misoprostol tablets

    Measured: Hour 0

  5. Pain assessment of the whole procedure of TOP

    Pain assessment of the whole procedure by numerical scale at discharge of the hospital

    Measured: 48 hours

  6. Distress assessment at discharge after TOP

    Distress assessment at discharge after TOP measured by impact of event scale revised(IES-R)

    Measured: 4 months

  7. 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

    Measured: 4 months

  8. 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.

    Measured: 4 months

  9. Duration of hospitalization.

    Duration of hospitalization between admission and discharge and in delivery room.

    Measured: 48 hours

  10. Cost of the procedure

    Assessment of the whole procedure costs of TOP, including potential complications.

    Measured: 4 months

  11. 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.

    Measured: 12 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2017
  2. Study start14 Dec 2017
  3. Primary completion30 Jun 2020
  4. Study completion24 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
355 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03194230
Sponsor's protocol ID
P160908
Acronym
DILATOP
Status last verified
Aug 2025
First submitted
13 Jun 2017
Last updated
5 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vincienne M, Anselem O, Cordier AG, Le Ray C, Tsatsaris V, Benachi A, Goffinet F. Comparison of the Induction-to-Delivery Interval in Terminations of Pregnancy with or without Dilapan-S(R). Fetal Diagn Ther. 2018;43(1):61-67. doi: 10.1159/000458410. Epub 2017 Mar 29.

    PubMed 28351055

  • Jain JK, Mishell DR Jr. A comparison of misoprostol with and without laminaria tents for induction of second-trimester abortion. Am J Obstet Gynecol. 1996 Jul;175(1):173-7. doi: 10.1016/s0002-9378(96)70270-3.

    PubMed 8694046

  • Mazouni C, Vejux N, Menard JP, Bruno A, Boubli L, d'Ercole C, Bretelle F. Cervical preparation with laminaria tents improves induction-to-delivery interval in second- and third-trimester medical termination of pregnancy. Contraception. 2009 Jul;80(1):101-4. doi: 10.1016/j.contraception.2009.01.013. Epub 2009 Mar 4.

    PubMed 19501224

  • Pluchon M, Winer N. [Misoprostol in case of termination of pregnancy in the second and third trimesters. Trials]. J Gynecol Obstet Biol Reprod (Paris). 2014 Feb;43(2):162-8. doi: 10.1016/j.jgyn.2013.11.009. Epub 2014 Jan 16. French.

    PubMed 24440001

  • Gitz L, Morel O, Thiebaugeorges O, Sibiude J, Desfeux P, Barranger E. [Termination of pregnancy and intra-uterine fetal death after 14 weeks of pregnancy: Which protocol for induction of labour in 2010?]. J Gynecol Obstet Biol Reprod (Paris). 2011 Feb;40(1):1-9. doi: 10.1016/j.jgyn.2010.11.007. Epub 2010 Dec 23. French.

    PubMed 21185133

  • Thong KJ, Baird DT. A study of gemeprost alone, dilapan or mifepristone in combination with gemeprost for the termination of second trimester pregnancy. Contraception. 1992 Jul;46(1):11-7. doi: 10.1016/0010-7824(92)90127-f.

    PubMed 1424619

  • Anselem O, Jouannic JM, Winer N, Bouchghoul H, Vivanti AJ, Quibel T, Massardier J, Rousseau J, Ancel PY, Goffinet F, Tsatsaris V. Cervical Dilators Used Concurrently With Misoprostol to Shorten Labor in Second-Trimester Termination of Pregnancy: A Randomized Controlled Trial. Obstet Gynecol. 2022 Sep 1;140(3):453-460. doi: 10.1097/AOG.0000000000004887. Epub 2022 Aug 3.

    PubMed 35926202

Questions about this trial

What is this clinical trial studying?

A study testing With cervical dilatator in people with Termination of Pregnancy (TOP), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of women achieving vaginal delivery within 12 hours (time frame: 12 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03194230, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in