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.
You have requested "on-the-fly" machine translation of selected content from our databases. This functionality is provided solely for your convenience and is in no way intended to replace human translation. Show full disclaimer
Neither ProQuest nor its licensors make any representations or warranties with respect to the translations. The translations are automatically generated "AS IS" and "AS AVAILABLE" and are not retained in our systems. PROQUEST AND ITS LICENSORS SPECIFICALLY DISCLAIM ANY AND ALL EXPRESS OR IMPLIED WARRANTIES, INCLUDING WITHOUT LIMITATION, ANY WARRANTIES FOR AVAILABILITY, ACCURACY, TIMELINESS, COMPLETENESS, NON-INFRINGMENT, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. Your use of the translations is subject to all use restrictions contained in your Electronic Products License Agreement and by using the translation functionality you agree to forgo any and all claims against ProQuest or its licensors for your use of the translation functionality and any output derived there from. Hide full disclaimer
Details
1 CHI Poissy-St-Germain, Department of Gynecology and Obcstetrics, Poissy, France; Equipe d’accueil EA 7285 Risques, Cliniques et Sécurité en Santé des Femmes et en Santé Périnatale, Université Versailles-Saint-Quentin en Yvelines, Montigny le Bretonneux, France
2 Equipe d’accueil EA 7285 Risques, Cliniques et Sécurité en Santé des Femmes et en Santé Périnatale, Université Versailles-Saint-Quentin en Yvelines, Montigny le Bretonneux, France; APHP, Hôpital Bichat, Paris Diderot University, Department of Gynecology and Obstetrics, Paris, France
3 Hôpital La Conception, Department of Gynecology and Obstetrics, Marseille, France (GRID:grid.411535.7) (ISNI:0000000406389491)
4 Strasbourg University Hospital, Department of Gynecology and Obstetrics, Strasbourg, France (GRID:grid.412220.7) (ISNI:000000012177138X)
5 CHR Orleans, Department of Gynecologic Surgery and Obstetrics, Orléans, France (GRID:grid.413932.e) (ISNI:0000 0004 1792 201X)
6 Rennes University Hospital, Department of Gynecology and Obstetrics, Rennes, France (GRID:grid.411154.4) (ISNI:0000000121750984)
7 CHU Estaing Clermont Ferrand, Department of Gynecologic Surgery, Clermont Ferrand, France (GRID:grid.411163.0) (ISNI:0000 0004 0639 4151); Faculté de Medicine, ISIT – Université d’Auvergne, Place Henri Dunant, Clermont-Ferrand, France (GRID:grid.411163.0)
8 AP-HP, Hôpital Bicêtre, Department of Gynecology and Obstetrics, Le Kremlin Bicêtre, France (GRID:grid.413784.d) (ISNI:0000 0001 2181 7253); 82 Rue du Général Leclerc, CESP-INSERM U1018, Le Kremlin Bicêtre, France (GRID:grid.463845.8) (ISNI:0000 0004 0638 6872); Université Paris Sud, Le Kremlin Bicêtre, France (GRID:grid.5842.b) (ISNI:0000000121712558)
9 CHU de Poitiers, Université de Poitiers, Faculté de Médecine et Pharmacie, Department of Gynecology and Obstetrics, Poitiers, France (GRID:grid.5842.b)
10 Hôpital Alix de Champagne, CHU de Reims, Department of Gynecology and Obstetrics, Reims, France (GRID:grid.139510.f) (ISNI:0000000404723476)
11 CHU d’Angers, Department of Gynecology and Obstetrics, AngersPays De La Loire, France (GRID:grid.411147.6) (ISNI:0000000404720283)
12 Hôpital Jeanne-de-Flandre, CHRU de Lille, Department of Gynecology and Obstetrics, Lille, France (GRID:grid.414184.c) (ISNI:0000000405936676)
13 Centre Hospitalier Intercommunal, Villeneuve-Saint-Georges, Department of Gynecology and Obstetrics, Paris, France (GRID:grid.418059.1) (ISNI:0000 0004 0594 1811)
14 Centre Hospitalier de Versailles, Department of Gynecology and Obstetrics, Le Chesnay, France (GRID:grid.418080.5) (ISNI:0000000121777052)
15 APHP, Hôpital Louis Mourier, Département Hospitalier Universitaire Risque et Grossesse, Colombes, France Université Paris-Diderot, Department of Gynecology and Obstetrics, Paris, France (GRID:grid.50550.35) (ISNI:0000 0001 2175 4109)
16 Equipe d’accueil EA 7285 Risques, Cliniques et Sécurité en Santé des Femmes et en Santé Périnatale, Université Versailles-Saint-Quentin en Yvelines, Montigny le Bretonneux, France (GRID:grid.50550.35); CHI Poissy-St-Germain, Department of Gynecology and Obcstetrics, Poissy, France (GRID:grid.50550.35)