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. 2023 Apr 11;329(14):1197-1205.
doi: 10.1001/jama.2023.3415.

Operative Hysteroscopy vs Vacuum Aspiration for Incomplete Spontaneous Abortion: A Randomized Clinical Trial

Cyrille Huchon  1   2   3 , Hocine Drioueche  4 , Martin Koskas  2   5 , Aubert Agostini  6 , Estelle Bauville  7 , Nicolas Bourdel  8 , Hervé Fernandez  9   10 , Xavier Fritel  11 , Olivier Graesslin  12 , Guillaume Legendre  13 , Jean-Philippe Lucot  14 , Pierre Panel  15 , Cyril Raiffort  16 , Géraldine Giraudet  14 , Laurence Bussières  17 , Arnaud Fauconnier  2   3
Affiliations

Operative Hysteroscopy vs Vacuum Aspiration for Incomplete Spontaneous Abortion: A Randomized Clinical Trial

Cyrille Huchon et al. JAMA. .

Erratum in

  • Incorrect Interquartile Ranges.
    [No authors listed] [No authors listed] JAMA. 2023 Sep 26;330(12):1194. doi: 10.1001/jama.2023.17492. JAMA. 2023. PMID: 37750889 Free PMC article. No abstract available.

Abstract

Importance: Vacuum aspiration is commonly used to remove retained products of conception in patients with incomplete spontaneous abortion. Scarring of the uterine cavity may occur, potentially impairing future fertility. A procedural alternative, operative hysteroscopy, has gained popularity with a presumption of better future fertility.

Objective: To assess the superiority of hysteroscopy to vacuum aspiration for subsequent pregnancy in patients with incomplete spontaneous abortion who intend to have future pregnancy.

Design, setting, and participants: The HY-PER randomized, controlled, single-blind trial included 574 patients between November 6, 2014, and May 3, 2017, with a 2-year duration of follow-up. This multicenter trial recruited patients in 15 French hospitals. Individuals aged 18 to 44 years and planned for surgery for an incomplete spontaneous abortion with plans to subsequently conceive were randomized in a 1:1 ratio.

Interventions: Surgical treatment by hysteroscopy (n = 288) or vacuum aspiration (n = 286).

Main outcomes and measures: The primary outcome was a pregnancy of at least 22 weeks' duration during 2-year follow-up.

Results: The intention-to-treat analyses included 563 women (mean [SD] age, 32.6 [5.4] years). All aspiration procedures were completed. The hysteroscopic procedure could not be completed for 19 patients (7%), 18 of which were converted to vacuum aspiration (8 with inability to completely resect, 7 with insufficient visualization, 2 with anesthetic complications that required a shortened procedure, 1 with equipment failure). One hysteroscopy failed due to a false passage during cervical dilatation. During the 2-year follow-up, 177 patients (62.8%) in the hysteroscopy group and 190 (67.6%) in the vacuum aspiration (control) group achieved the primary outcome (difference, -4.8% [95% CI, -13% to 3.0%]; P = .23). The time-to-event analyses showed no statistically significant difference between groups for the primary outcome (hazard ratio, 0.87 [95% CI, 0.71 to 1.07]). Duration of surgery and hospitalization were significantly longer for hysteroscopy. Rates of new miscarriages, ectopic pregnancies, Clavien-Dindo surgical complications of grade 3 or above (requiring surgical, endoscopic, or radiological intervention or life-threatening event or death), and reinterventions to remove remaining products of conception did not differ between groups.

Conclusions and relevance: Surgical management by hysteroscopy of incomplete spontaneous abortions in patients intending to conceive again was not associated with more subsequent births or a better safety profile than vacuum aspiration. Moreover, operative hysteroscopy was not feasible in all cases.

Trial registration: ClinicalTrials.gov Identifier: NCT02201732.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Huchon reported grants from Assistance Publique-Hôpitaux de Paris (AP-HP) during the conduct of the study; personal fees from Nordic Pharma (lectures); and other from GlaxoSmithKline, Gedeon Richter, and Nordic Pharma (attending congress) outside the submitted work. Dr Bourdel reported personal fees from Surgar and nonfinancial support from STORZ outside the submitted work. Dr Fauconnier reported grants from the French Ministry of Health (to provide statistical analyses) during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Recruitment, Randomization, and Follow-up in the HY-PER Trial
aEleven participants were excluded after randomization and excluded from all further analyses (6 from the hysteroscopy group; 5 from the vacuum aspiration group). bAccording to the French law, participants who have withdrawn their consent cannot be included in the analysis. cThe intention-to-treat analysis was performed according to the treatment group to which the patients were assigned at randomization, regardless of the procedure they received and the duration of their follow-up. Individuals denoted as excluded were not included in the intention-to-treat analysis. dThe per-protocol analysis included all randomized patients except for those who did not receive the complete allocated surgery after randomization and the patients lost to follow-up. eThe intention-to-treat population and per-protocol population were used to assess the primary outcome. The primary outcome was the occurrence of an intrauterine pregnancy with a duration beyond 22 weeks of gestation in the 2 years after the randomization.
Figure 2.
Figure 2.. Pregnancy Rate Up to 2 Years in the Randomized Population
Cumulative ongoing intrauterine pregnancies with a duration beyond 22 weeks of gestation in hysteroscopic and vacuum aspiration groups. The median observation time in the hysteroscopy group was 307 days (IQR, 102-727 days), and for the vacuum aspiration group, it was 232 days (IQR, 116-611 days).
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