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Status unknownNCT01795599Updated Sep 1, 2014

Cervical Preparation for Surgical Abortion at 12-14 Weeks: a Prospective, Randomized, Evaluator-blinded, Multicenter, Controlled Comparison Between Mifepristone, Misoprostol and Their Combination

A Phase 3 interventional study of Mifegyne ® and Gymiso® in Surgical Abortion, sponsored by Assistance Publique Hopitaux De Marseille. Status unknown at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-09-01.

Sponsored by Assistance Publique Hopitaux De Marseille · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
198
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

More than 100 000 surgical abortions are annually performed in France. About four in ten women will have an abortion in their life. Abortion complications are cervical tearing (0.1-1.18%), uterine perforation (0.09-19.8‰), hemorrhage (1.5‰) and infection (5-20%). These complications can first compromise the vital prognosis and are involved in 10% of the worldwide maternal mortality (20 000 women by year), then lead to infertility which is hard to treat (uterine synechiae) or impossible to treat (hysterectomy for control of bleeding), and are finally responsible for obstetrical pathologies as late miscarriages or premature delivery due to cervical insufficiency. All that complications are linked to cervical laceration of the surgical abortion, that can be reduced by the recommended use of mifepristone or misoprostol as cervical preparation for the abortions after 12 weeks. However, it does not exist data evaluating the superiority of one of the two molecules or their combination. These data could optimize the cervical preparation and thus reduce the abortion complications with a direct impact on maternal mortality, infertility and obstetrical complications. Thus, it seems to be important to evaluate these two molecules and their combination.

Objectives To compare mifepristone, misoprostol and their combination in the cervical preparation of the surgical abortion between 12 and14 weeks for their efficacy, complications and side-effects.

02

Conditions studied

  • Surgical Abortion
03

In context

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Woman of 18 or more years old;
  • Woman presenting a only intra-uterine pregnancy, the term of which is upper to 11 LIMITED COMPANIES 6 days and inferior strictly to 14 LIMITED COMPANIES, estimated(esteemed) by echography by a measure of the crânio-caudal length included between 55 and 84 millimeters; ·Woman wishing a TERMINATION OF PREGNANCY;

Exclusion criteria

Exclusion Criteria:

  • minor Woman;
  • Woman presenting a multiple pregnancy;
  • Woman presenting an uterine deformation (compartmentalized womb, cocked hat, fibroid praevia);
  • Woman presenting a disorder of the coagulation defined by biological parameters (TP(BUSINESS RATE,PRACTICAL CLASS,PRACTICAL CLASSES) \< 70 %, TCA report(relationship) patient / witness \< 1,20);
  • Woman presenting an allergy or a sentimentality known about one of the active substances or about one of the excipients;
  • Woman presenting a contraindication to the mifepristone: chronic suprarenal insufficiency, unchecked severe asthma by treatment(processing), porphyrie hereditary, allergy was known about the active substance or about one of the excipients;
  • Woman presenting a contraindication to the misoprostol: sentimentality in the active substance, in one of the excipients or in the other prostaglandines;
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
198 participants (estimated)

Study arms

  • Experimental
    mifepristone/misoprostol

    Drug: Mifegyne ® · Drug: Gymiso®

  • Active comparator
    misoprostol

    Drug: Gymiso®

  • Active comparator
    mifepristone

    Drug: Mifegyne ®

Interventions

  • DrugMifegyne ®
  • DrugGymiso®
06

What researchers measure

Primary outcomes

  1. reduction of the bleeding

    Time frame: 24month

Secondary outcomes

  1. reduction of the complications

    Time frame: 24 MONTHS

07

Study locations

1 of 1 sites recruiting
  • Assistance Publique Hopitaux de Marseille
    Marseille, 13354, France
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01795599
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Feb 20, 2013
Start date
May 2013
Primary completion
Feb 2015 (estimated)
Completion
Aug 2015 (estimated)
Last update
Sep 1, 2014

Study contacts

aubert AGOSTINI
Contact
aubert.agostini@ap-hm.fr
LOIC MONDOLONI
study director · Assistance Publique Hopitaux De Marseille

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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