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Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

Operative hysteroscopy versus vacuum aspiration for incomplete spontaneous abortion (HY-PER): study protocol for a randomized controlled trial

Authors: Cyrille Huchon, Martin Koskas, Aubert Agostini, Cherif Akladios, Souhail Alouini, Estelle Bauville, Nicolas Bourdel, Hervé Fernandez, Xavier Fritel, Olivier Graesslin, Guillaume Legendre, Jean-Philippe Lucot, Isabelle Matheron, Pierre Panel, Cyril Raiffort, Arnaud Fauconnier

Published in: Trials | Issue 1/2015

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Abstract

Background

Incomplete spontaneous abortions are defined by the intrauterine retention of the products of conception after their incomplete or partial expulsion. This condition may be managed by expectant care, medical treatment or surgery. Vacuum aspiration is currently the standard surgical treatment in most centers. However, operative hysteroscopy has the advantage over vacuum aspiration of allowing the direct visualization of the retained conception product, facilitating its elective removal while limiting surgical complications. Inadequately powered retrospective studies reported subsequent fertility to be higher in patients treated by operative hysteroscopy than in those treated by vacuum aspiration. These data require confirmation in a randomized controlled trial comparing fertility rates between women undergoing hysteroscopy and those undergoing vacuum aspiration for incomplete spontaneous abortion.

Methods

After providing written informed consent, 572 women with incomplete spontaneous abortion recruited from 15 centers across France will undergo randomization by a centralized computer system for treatment by either vacuum aspiration or operative hysteroscopy. Patients will not be informed of the type of treatment that they receive and will be cared for during their hospital stay in accordance with standard practices at each center. The patients will be monitored for pregnancy or adverse effects by a telephone conversation or questionnaire sent by e-mail or post over a period of two years. In cases of complications, failure of the intervention or diagnosis of uterine cavity disease, patient care will be left to the discretion of the medical center team.

Discussion

If our hypothesis is confirmed, this study will provide evidence that the use of operative hysteroscopy can increase the number of pregnancies continuing beyond 22 weeks of gestation in the two-year period following incomplete spontaneous abortion without increasing the incidence of morbidity and peri- and postoperative complications. The standard surgical treatment of this condition would thus be modified. This study would therefore have a large effect on the surgical management of incomplete spontaneous abortion.

Trial registration

ClinicalTrials.gov Identifier: NCT02201732; registered on 17 July 2014.
Appendix
Available only for authorised users
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Metadata
Title
Operative hysteroscopy versus vacuum aspiration for incomplete spontaneous abortion (HY-PER): study protocol for a randomized controlled trial
Authors
Cyrille Huchon
Martin Koskas
Aubert Agostini
Cherif Akladios
Souhail Alouini
Estelle Bauville
Nicolas Bourdel
Hervé Fernandez
Xavier Fritel
Olivier Graesslin
Guillaume Legendre
Jean-Philippe Lucot
Isabelle Matheron
Pierre Panel
Cyril Raiffort
Arnaud Fauconnier
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0900-1

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