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


CONCLUSIONS
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.


BACKGROUND
ClinicalTrials.gov Identifier: NCT02201732 ; registered on 17 July 2014.
Department of Gynecology and Obcstetrics, CHI Poissy-St-Germain, 10 Rue du champ Gaillard, BP 3082, CEDEX 78303, Poissy, France. cyrillehuchon@yahoo.fr.|Equipe d'accueil EA 7285 Risques, Cliniques et Sécurité en Santé des Femmes et en Santé Périnatale, Université Versailles-Saint-Quentin en Yvelines, 78180, Montigny le Bretonneux, France. cyrillehuchon@yahoo.fr.
Cyrille
C
Huchon
Equipe d'accueil EA 7285 Risques, Cliniques et Sécurité en Santé des Femmes et en Santé Périnatale, Université Versailles-Saint-Quentin en Yvelines, 78180, Montigny le Bretonneux, France. martin.koskas@wanadoo.fr.|Department of Gynecology and Obstetrics, APHP, Hôpital Bichat, Paris Diderot University, Paris, France. martin.koskas@wanadoo.fr.
Martin
M
Koskas
Department of Gynecology and Obstetrics, Hôpital La Conception, 147, Boulevard Baille, Cedex 5 13385, Marseille, France. Aubert.AGOSTINI@ap-hm.fr.
Aubert
A
Agostini
Department of Gynecology and Obstetrics, Strasbourg University Hospital, 1 Avenue Molière, 67000, Strasbourg, France. Cherif.YOUSSEF.AZER@chru-strasbourg.fr.
Cherif
C
Akladios
Department of Gynecologic Surgery and Obstetrics, CHR Orleans, 1 Porte Madeleine, 45000, Orléans, France. souhail.alouini@chr-orleans.fr.
Souhail
S
Alouini
Department of Gynecology and Obstetrics, Rennes University Hospital, 16 Rue de Bulgarie, B.P. 90347, Cedex 2, F-35203, Rennes, France. Estelle.BAUVILLE@chu-rennes.fr.
Estelle
E
Bauville
Department of Gynecologic Surgery, CHU Estaing Clermont Ferrand, 63058 Cedex 1, Clermont Ferrand, France. nicolas.bourdel@gmail.com.|Faculté de Medicine, ISIT - Université d'Auvergne, Place Henri Dunant, 63000, Clermont-Ferrand, France. nicolas.bourdel@gmail.com.
Nicolas
N
Bourdel
Department of Gynecology and Obstetrics, AP-HP, Hôpital Bicêtre, 78 Rue du Général Leclerc, Le Kremlin Bicêtre, 94270, France. herve.fernandez@bct.aphp.fr.|CESP-INSERM U1018, 82 Rue du Général Leclerc, Le Kremlin Bicêtre, 94276, France. herve.fernandez@bct.aphp.fr.|Université Paris Sud, 63 Rue Gabriel Péri, Le Kremlin Bicêtre, 94270, France. herve.fernandez@bct.aphp.fr.
Hervé
H
Fernandez
Department of Gynecology and Obstetrics, CHU de Poitiers, Université de Poitiers, Faculté de Médecine et Pharmacie, Inserm CIC1402, 2 Rue de la Milétrie, F-86000, Poitiers, France. xavier.fritel@univ-poitiers.fr.
Xavier
X
Fritel
Department of Gynecology and Obstetrics, Hôpital Alix de Champagne, CHU de Reims, 45 Rue Cognacq-Jay, 51092, Reims, France. ograesslin@chu-reims.fr.
Olivier
O
Graesslin
Department of Gynecology and Obstetrics, CHU d'Angers, 4, Rue Larrey, 49033 Cedex 01, AngersPays De La Loire, France. g_legendre@hotmail.com.
Guillaume
G
Legendre
Department of Gynecology and Obstetrics, Hôpital Jeanne-de-Flandre, CHRU de Lille, 59037, Lille, France. Jean-Philippe.LUCOT@CHRU-LILLE.FR.
Jean-Philippe
JP
Lucot
Department of Gynecology and Obstetrics, Centre Hospitalier Intercommunal, Villeneuve-Saint-Georges, Paris, France. isabelle.matheron@chiv.fr.
Isabelle
I
Matheron
Department of Gynecology and Obstetrics, Centre Hospitalier de Versailles, 177, Rue de Versailles, 78157, Le Chesnay, France. ppanel@ch-versailles.fr.
Pierre
P
Panel
Department of Gynecology and Obstetrics, APHP, Hôpital Louis Mourier, Département Hospitalier Universitaire Risque et Grossesse, Colombes, France Université Paris-Diderot, Paris, France. cyril.raiffort@lmr.aphp.fr.
Cyril
C
Raiffort
Equipe d'accueil EA 7285 Risques, Cliniques et Sécurité en Santé des Femmes et en Santé Périnatale, Université Versailles-Saint-Quentin en Yvelines, 78180, Montigny le Bretonneux, France. afauconnier@chi-poissy-st-germain.fr.|Department of Gynecology and Obcstetrics, CHI Poissy-St-Germain, 10 Rue du champ Gaillard, BP 3082, 78300, Poissy, France. afauconnier@chi-poissy-st-germain.fr.
Arnaud
A
Fauconnier
D000027:Abortion, Incomplete / Q000175:diagnosis / Q000601:surgery*; D000028:Abortion, Induced / Q000009:adverse effects / Q000379:methods*; D000293:Adolescent; D000328:Adult; D002985:Clinical Protocols; D005260:Female; D005298:Fertility; D005602:France; D006801:Humans; D015907:Hysteroscopy / Q000009:adverse effects; D011247:Pregnancy; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014619:Vacuum Curettage / Q000009:adverse effects; D055815:Young Adult