# Safety of an anchor-based device for sacrospinous ligament fixation: A pilot case-control study

Nikolaos Evangelopoulos, Charlotte Delacroix, Syad Abdirahman, Renaud de Tayrac

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Nikolaos Evangelopoulos, Charlotte Delacroix, Syad Abdirahman, Renaud de Tayrac. Safety of an anchor-based device for sacrospinous ligament fixation: A pilot case-control study. European Journal of Obstetrics & Gynecology and Reproductive Biology, 2024, 299, pp.105-109. 10.1016/j.ejogrb.2024.06.012. hal-05069665

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Full length article

# Safety of an anchor-based device for sacrospinous ligament fixation: A pilot case-control study

Nikolaos Evangelopoulos*, Charlotte Delacroix, Syad Abdirahman, Renaud de Tayrac

Department of Obstetrics and Gynecology, Nimes University Hospital, University of Montpellier, Nimes, France

<figure><img src="image_3.png" /></figure>

## ARTICLE INFO

**Keywords:**

Sacrospinous ligament fixation

Hysteropexy

Anchor-based device

Anchorsure®

Suture capturing device

Capio™ SLIM

## ABSTRACT

**Introduction and hypothesis:** Sacrospinous ligament fixation (SSLF) is a popular surgical technique for treating apical prolapse. The use of suture-capturing devices (SCD), or the more recently introduced anchor-based device (ABD), is useful for a posterior approach but essential for an anterior one. The aim of our study was to assess the safety of the ABD, which was recently introduced to our unit, compared to the traditionally used SCD.

**Methods:** This was a pilot case-control study of 40 patients who had a SSLF, 20 of these represented all the patients who had the procedure with the aid of the ABD and 20 patients who had the procedure using the SCD over approximately the same duration. The main safety endpoints of this pilot study were patient reported postoperative pain scores and perioperative complications rate.

**Results:** The population characteristics were similar. The mean postoperative pain scores differed significantly only on postoperative day 1 in favor of the suture capturing device (3.40 [2.60] vs 1.60 [1.64], p = 0.013). The mean highest pain score was similar in both groups. Peri-operative complications rates were low and comparable between both groups. According to POPQ at 6 weeks follow-up the median Ba point was higher in the ABD group and this difference was significant (−3.00 [-3.00; -2.25] vs. −2.00 [-3.00; -1.50]; p = 0.03).

**Conclusion:** The anchor-based device for sacrospinal ligament fixation seems to have comparable safety profile to the traditionally used suture capturing devices.

## Brief summary

The anchor-based device (Anchorsure®) for sacro-spinous ligament fixation seems to have comparable safety profile to the traditionally used suture capturing devices.

## Introduction and hypothesis

Sacrospinous ligament fixation (SSLF) is one of the popular procedures for the treatment of apical prolapse with consistently good results. Since the transvaginal vaginal mesh ban by the U.S. Food and Drug Administration (FDA) in 2019, the use of native tissue transvaginal repair regained ground in the US and throughout Europe. Furthermore, the previous appeal of some of the mesh kits that utilized the paravesical space to fix mesh bilaterally to the sacrospinous ligaments, contributed to popularity of the anterior approach for sacrospinous ligament fixation (ASSLF), a procedure that was first described by Cespedes et al. in 2000 [1]. SSLF is considered an advantageous alternative to the classical posterior unilateral SSLF (The Richter's procedure) [2].

The fixation trajectory of an SSLF provides a more physiological cervico-vaginal axis, compared to Richter's technique, which is known to fix the apex too posteriorly and hence, increasing the risk for anterior compartment failures at the long-term [3]. Moreover, the bilateral fixation in SSLF mitigates vaginal lateral deviation resulting in a vaginal apex mimicking normal anatomy [4]. The procedure can also be performed during uterine sparing surgery with comparable outcomes [5]. Although bilateral posterior hysteropexy is theoretically feasible, it carries a non-negligible risk of postoperative defecatory obstruction [6]. Finally, the anterior approach allows a concomitant cystocele repair, commonly associated with an apical defect [7], without the need for an additional vaginal incision. However, unlike the posterior approach, ligament visualization is not possible. Hence a suture-capturing device (SCD) for suture placement on the sacrospinous ligament is commonly used.

In our unit, we have traditionally used the Capio™ SLIM, for this procedure. More recently we started using a newly introduced anchor-based device (ABD) – Anchorsure®. The aim of this study was to report our initial results on the device's safety and patient reported

<footnote>* Corresponding author.</footnote>

<footnote>E-mail address: nikolaos.evangelopoulos@rhne.ch (N. Evangelopoulos).</footnote>
postoperative pain.

## Methods

### Study population

This was a pilot case control study to explore the initial outcomes of a newly introduced ABD (Anchorsure®) (Test device) in comparison to our traditionally used SCD (Capio™ SLIM) (Control device). Study data collection commenced in the end of June 2023. To ensure the last patient included would have had their postoperative 6-week follow-up information available, we searched the hospital records for eligible patients till the 7th of May 2023. The ABD was introduced to our unit in the last quarter of 2022. All patients with symptomatic apical prolapse who had any type of SSLF using the ABD were included in our study as the test device group. A similar number of patients who fulfilled the same criteria, and had complete records for outcomes of interest, but had their SSLF using the SCD over the same period were included as the control device group. All types of SSLF were considered eligible for inclusion irrespective of whether additional concomitant procedures for other compartments defects, stress urinary incontinence or hysterectomy were performed or not.

The surgical technique of SSLF is standardized in our unit and is performed, or directly supervised, by one of 4 experienced urogyne-cologists. The anterior bilateral approach is the preferred option in our unit. We perform a *peri*-incisional submucosal vaginal infiltration, with a solution of lidocaine and epinephrine, diluted with normal saline. Non-absorbable polypropylene sutures are placed into the middle portion of each of the sacrospinous ligaments. All surgeons were very experienced with the SCD but, apart from simulated training, had no prior clinical experience with the ABD.

The standard post-operative analgesia in our hospital care unit is paracetamol combined with a phloroglucinol derived antispasmodic agent, both orally administered. The second line analgesia treatment consists of oral administration of 50 mg Tramadol on an on-demand basis protocol.

### Outcomes of interest

The main endpoints of interest for this study were perioperative complications rates and patient reported postoperative pain. As secondary outcomes we collected information on patient reported urinary or bowel symptoms and POP-Q staging at the 6 weeks follow-up time-point. Patients were identified and data obtained from our unit's patients' electronic hospital record system.

Perioperative complications were categorized based on the Clavien-Dindo classification [8]. In our unit, postoperative pain is routinely assessed on admission to the gynecological ward and 6 to 8-hourly afterwards using a standardized visual analogue score. The highest patient reported score for each hospital stay postoperative day was used in our analysis. The same pain score is also used during patients' outpatient consultations, if they reported suffering from any chronic pain.

### Statistical analysis

Descriptive analyses were performed on this dataset. Continuous variables were assessed using Mann-Whitney and Welch tests, and the Chi² or Fisher tests were used for categorical data. Continuous variables are expressed as means and standard deviation (SD) or medians and interquartile ranges (IQR) and categorical data expressed as numbers and percentages. The significance level was set at 5 % for all the tests used.

### Ethics, research conduct and data management

This retrospective data analysis is classified as non-interventional

research according to Jardé law and was thus exempt from CER (French research ethics committee) authorization.

Data were collected on Microsoft Excel (Microsoft Corporation, Redmond, USA), in line with the French Data Protection Act and Freedoms Law and the reference methodology MR-004 relating to data processing in the context of health research. This research complied with law n°2012-300 of March 5, 2012, relating to research involving humans, Good Clinical Practices (I.C.H. version 4 of November 9, 2016, and decision of November 24, 2006) and the declaration of Helsinki.

## Results

A total of 20 patients had ABD assisted SSLF (cases) between August 22 and May 23 and were all included into our study. For the control group, we identified 20 patients with complete hospital records who had an SCD-assisted SSLF during the same time period (controls).

The baseline and pre-operative characteristics of the study population are presented in Table 1. Both of our study groups were comparable with regards to their demographics and pre-operative urogynecological assessments. There were also no statistically significant differences in the number or type of concomitant procedures planned at the time of the index SSLF. The anterior bilateral approach was chosen for the entire cohort with the exception of 2 patients, one in each group, who had bilateral posterior SSLFs.

The mean patient reported postoperative pain scores was significantly lower in the SCD group on day 1 postoperative (1.60 [1.64] vs. 3.40 [2.60] p = 0.013). However, there were no significant differences in either the highest reported pain score or pain on Day 0 between both groups (Table 2).

There were no significant differences between both groups with regards to rate of *peri*-operative complications categorized according to the Clavien-Dindo classification (Table 2). The majority of patients in

<table><caption>**Table 1**
Baseline and pre-operative characteristics.</caption><thead><tr><th></th><th>ABD (Cases)<br>[N = 20]</th><th>SCD (Controls)<br>[N = 20]</th><th>p</th><th>test</th></tr></thead><tbody><tr><td>Mean age (SD)</td><td>71.9 (7.06)</td><td>69.2 (9.33)</td><td>0.35</td><td>M-W</td></tr><tr><td>Mean BMI (SD)</td><td>25.2 (4.25) [N<br>= 17]</td><td>26.1 (4.86) [N =<br>18]</td><td>0.57</td><td>Welch</td></tr><tr><td>History of chronic body<br>pain, n (%)</td><td>3 (15 %)</td><td>1 (5 %)</td><td>0.6</td><td>Fisher</td></tr><tr><td>Previous hysterectomy, n<br>(%)</td><td>2 (10 %)</td><td>1 (5 %)</td><td>1</td><td>Fisher</td></tr><tr><td>Recurrent prolapse, n (%)</td><td>4 (20 %)</td><td>2 (10 %)</td><td>0.66</td><td>Fisher</td></tr><tr><td>Preoperative defecatory<br>problems, n (%)</td><td>6 (30 %)</td><td>7 (35 %)</td><td>0.74</td><td>Chi2</td></tr><tr><td>Preoperative urinary<br>symptoms, n (%)</td><td>13 (65 %)</td><td>12 (60 %)</td><td>0.74</td><td>Chi2</td></tr><tr><td>Preoperative POP-Q<br>stage, n (%)</td><td>[N = 19]</td><td>[N = 20]</td><td></td><td></td></tr><tr><td>2<sup>nd</sup> stage</td><td>10 (53 %)</td><td>8 (40 %)</td><td></td><td></td></tr><tr><td>3<sup>rd</sup> stage</td><td>9 (47 %)</td><td>9 (45 %)</td><td></td><td></td></tr><tr><td>4<sup>th</sup> stage</td><td>0 (0 %)</td><td>3 (15 %)</td><td></td><td></td></tr><tr><td>Preoperative POPQ score,<br>median (IQR)</td><td></td><td></td><td></td><td></td></tr><tr><td>Point Ba</td><td>1.00 (-0.750;<br>2.00)</td><td>1.50 (0; 3.00)</td><td>0.55</td><td>M-W</td></tr><tr><td>Point Bp</td><td>-2.00 (-2.50;<br>-1.12)</td><td>-1.00 (-2.00; 0)</td><td>0.14</td><td>M-W</td></tr><tr><td>Point C</td><td>0.500 (-1.00;<br>2.00)</td><td>0 (-1.00; 0)</td><td>0.62</td><td>M-W</td></tr><tr><td>Planned concomitant<br>procedures, n (%)</td><td></td><td></td><td></td><td></td></tr><tr><td>Anterior colporraphy</td><td>19 (95 %)</td><td>20 (100 %)</td><td>1</td><td>Fisher</td></tr><tr><td>Posterior colporraphy</td><td>11 (55 %)</td><td>15 (75 %)</td><td>0.18</td><td>Chi2</td></tr><tr><td>Associated SUI surgery</td><td>1 (5 %)</td><td>1 (5 %)</td><td>1</td><td>Fisher</td></tr><tr><td>Concomitant<br>hysterectomy</td><td>4 (20 %)</td><td>6 (30 %)</td><td>0.47</td><td>Chi2</td></tr></tbody></table>

M-W: Mann-Whitney.
<table><caption>**Table 2**

Outcomes of interest in both study groups.</caption><thead><tr><th></th><th>ABD (Cases)<br>[N]</th><th>SCD (Controls)<br>[N]</th><th>p</th><th>test</th></tr></thead><tbody><tr><td>Mean postoperative<br>pelvic pain score (SD)</td><td>[N = 20]</td><td>[N = 20]</td><td></td><td></td></tr><tr><td>Day 0</td><td>2.15 (1.84)</td><td>1.95 (1.93)</td><td>0.74</td><td>M-W</td></tr><tr><td>Day 1</td><td>3.40 (2.60)</td><td>1.60 (1.64)</td><td>0.013</td><td>Welch</td></tr><tr><td>Highest pain score</td><td>4.15 (2.06)</td><td>3.20 (1.94)</td><td>0.22</td><td>M-W</td></tr><tr><td>Median length of<br>hospital stay [Q25-<br>75]</td><td>[N = 20] 2.50<br>[2.00; 4.00]</td><td>[N = 20] 3.00<br>[2.00; 4.00]</td><td>0.5</td><td>M-W</td></tr><tr><td>Postoperative POP-Q<br>stage, n (%)</td><td>[n = 19]</td><td>[n = 20]</td><td>&lt;0.01</td><td>Fisher</td></tr><tr><td>0</td><td>12 (63 %)</td><td>3 (15 %)</td><td></td><td></td></tr><tr><td>1</td><td>6 (32 %)</td><td>14 (70 %)</td><td></td><td></td></tr><tr><td>2</td><td>1 (5.3 %)</td><td>3 (15 %)</td><td></td><td></td></tr><tr><td>Postoperative POP-Q,<br>median [Q25-75]</td><td></td><td></td><td></td><td></td></tr><tr><td>Point Ba</td><td>-3.00 [-3.00;<br>-2.25]</td><td>-2.00 [-3.00;<br>-1.50]</td><td>0.03</td><td>M-W</td></tr><tr><td>Point Bp</td><td>-3.00 [-3.00;<br>-2.25]</td><td>-2.00 [-3.00;<br>-2.00]</td><td>0.21</td><td>M-W</td></tr><tr><td>Point C</td><td>-7.00 [-7.00;<br>-6.50]</td><td>-7.00 [-7.00;<br>-6.00]</td><td>0.0503</td><td>M-W</td></tr><tr><td>Complications, n (%)</td><td>[n = 20]</td><td>[n = 20]</td><td>0.66</td><td>Fisher</td></tr><tr><td>None</td><td>13 (65 %)</td><td>16 (80 %)</td><td></td><td></td></tr><tr><td>Clavien-Dindo I</td><td>3 (15 %)</td><td>2 (10 %)</td><td></td><td></td></tr><tr><td>Clavien-Dindo II</td><td>3 (15 %)</td><td>2 (10 %)</td><td></td><td></td></tr><tr><td>Clavien-Dindo III</td><td>1 (5 %)</td><td>0 (0 %)</td><td></td><td></td></tr><tr><td>Postoperative OSUI, n<br>(%)</td><td>3 (19 %) [n =<br>16]</td><td>6 (43 %) [n =<br>14]</td><td>0.24</td><td>Fisher</td></tr><tr><td>POUR, n (%)</td><td>[n = 20]</td><td>[n = 20]</td><td>0.78</td><td>Fisher</td></tr><tr><td>None</td><td>14 (70 %)</td><td>16 (80 %)</td><td></td><td></td></tr><tr><td>Resolved<br>spontaneously</td><td>3 (15 %)</td><td>2 (10 %)</td><td></td><td></td></tr><tr><td>Intermittent or<br>indwelling catheter</td><td>3 (15 %)</td><td>2 (10 %)</td><td></td><td></td></tr></tbody></table>

M-W: Mann-Whitney.

POUR: Post-Operative Urinary Retention.

OSUI: Occult Stress Urinary Incontinence.

both groups, 65 % and 80 % in the ABD and SCD groups respectively, did not have recorded complications. In the ABD group, 3 (15 %) were classified to have a Clavien-Dindo I complication, because they had post-operative urinary retention (POUR), which did not require intermittent catheterization or an indwelling catheter on hospital discharge. In the SCD group, 2 (10 %) had the same complication, one of these also had vaginal stenosis. There were 3 (15 %) and 2 (10 %) patients who had POUR needing outpatient management with an indwelling catheter or intermittent self catheterisation and hence classified as Clavien-Dindo II in the ABD and SCD groups respectively. One of the patients, in the ABD group, complained of persistent pelvic pain that required local anaesthetic infiltration in the sacro-spinal region, and hence classified as Clavian-Dindo III (Table 2).

At the 6 weeks follow-up, the median point Ba was −3 in the ABD vs −2 in the SCD group (p = 0.03). Similarly, more patients were classified as POP-Q stage 0, while less patients had stages 1 and 2 in the ABD compared to the SCD group and these differences reached statistical significance (p < 0.01) (Table 2). Fewer patients reported postoperative occult stress urinary incontinence (OSUI) in the ABD group compared to controls however this difference was not statistically significant (19 % vs 43 %; p = 0.24). The clinical and patient reported outcomes are presented in Table 2.

## Discussion

In this study we present a retrospective analysis of our first experience with Anchorsure®, a newly introduced ABD to facilitate SSLF. We used a case-control study design to compare our chosen clinical and patient reported outcomes to the more widely used Capio™ SLIM SCD. A

bilateral SSLF was feasible for all of our study cohort. Moreover, an anterior (paravesical) approach was performed in 19 out of 20 patients in each group, where a device to aid with ligament fixation is most useful as direct ligament visualization is not possible.

We consider our study's main endpoints, immediate postoperative pain and peri-operative complications, as core indicators for procedure safety. Indeed, patient reported post-operative pain, either gluteal or posterior thigh, is one of the more commonly reported postoperative complaints following SSLF. Nerves supplying the coccygeus and levator ani have been shown to course over the mid-portion of the SSL, where SSLF sutures are placed [9]. Theoretically, Anchorsure® works by direct anchoring to the ligament, without the need for the half-circle movement used in case of SCD, and hence, less likely to cause nerve entrapment. Nevertheless, a potential drawback is that the anchor placement is considered permanent because it is difficult to visualize or remove in case of persistent pain or unsatisfactory primary implantation, however, tension relief of the anchor related suture is rather simple.

There were no significant differences in pain scores between both of our groups except at Day 1 postoperative, with a higher mean reported pain score in the ABD group. Of note, there was one patient who complained of persistent pain following an ABD-assisted SSLF and opted for local anesthetic infiltration.

There were no recorded serious perioperative complications in our cohort with either device. A possible serious complication to SSLF is a pudendal artery injury due to incorrect suture placement close to the ischial spine. However, this complication is relatively rare with an estimated prevalence of 0.2 % (n = 3 out of 1229 patients) [10]. Therefore, a much larger study would be required to assess the risk of such complication with ABD.

In contrast, post operative urinary retention (POUR) is a recognized common complication following ASSLF, albeit, transient. In our unit, the mainstay management of POUR is intermittent self-catheterization, however, some patients opt to be discharged with a temporary indwelling catheter. In our cohort, POUR occurred in 30 % and 20 % of our ABD and SCD groups respectively. Half of these patients, in each of the groups, were classified as Clavien Dindo II, as urinary catheterization was still necessary after hospital discharge. The rates of POUR reported in our study are comparable to those reported by other groups. Solomon et al reported a 37 % risk of POUR in their series of patients having been treated with bilateral ASSLF, however, 72 % of their study population had concomitant stress urinary incontinence (SUI) treatment [4]. Delacroix et al. published a 16 % POUR prevalence in an ASSFL population with only 4 % concomitant SUI treatment [11]. In our study, 5 % of our patients had a concomitant SUI procedure.

Being a relatively new device, there is still limited number of studies that are currently published on the use of an ABD. Two recent RCTs, of comparable design and size, compared Anchorsure® and Capio™ SLIM with regards to short-term postoperative pain and complications. Plair et al (n = 47) followed up their cohort for 6 weeks post operative and reported no differences between the two devices [12]. Similarly, McKenzie et al. (n = 43), reported no differences between their groups' anatomical outcomes at 1 year follow-up [13]. Interestingly, our anatomical outcomes, as assessed on POPQ, were better in our ABD compared to the SCD group. Indeed, the median point Ba was −3 in the ABD vs −2 in the SCD group (p = 0.03), suggesting better anterior compartment correction in the ABD group. Despite the prospective design and careful methodology of the aforementioned RCTs, the two studies included only a few cases of ASSLF and bilateral fixation. We chose to study the new ABD, mainly, during the anterior bilateral approach for SSLF, to mitigate sample heterogeneity, and because we find that the overall thinner device sheath is mainly advantageous in the more limited paravesical space. Our search also identified a third Anchorsure® related study, where the authors retrospectively compared unilateral and bilateral posterior Anchorsure® SSLF after vaginal hysterectomy, with similar medium term results [14].

The use of suture-capturing or anchor-based devices is considered
optional when accessing the SSLs through a posterior approach, as direct visualization of the ligament is possible. We prefer to use the anterior approach in our unit given the more anatomical result of fixation resulting in a closer to a physiological vaginal axis and the ability to achieve bilaterality of fixation, thus reducing the risk of anterior compartment recurrence without increasing the risk of postoperative defecatory problems, even with uterine conservation. Indeed, it has been reported that anterior compartment recurrence following posterior SSLF hysteropexy can be as high as 33%, compared to a 7.7% in case of vaginal hysterectomy with uterosacral ligament suspension [15]. Similarly, Winkler et al. reported an anterior recurrence rate of 22-25% after SSLF using the Richter technique, in their literature research [16]. Currently, there are no RCTs comparing ASSLF and Richter's SSLF. However, in a large-scale retrospective study involving 1359 SSLF procedures, of which 81% were bilateral, 3.2% of recurrences needed surgery and this risk was significantly higher with a posterior approach, irrespective of whether a mesh was used or not. Even though the registry data didn't allow for identification of the compartment presenting a recurrence, the authors explained the difference by the higher risk of anterior decompensation following a Richter's SSLF [17]. The effectiveness of bilateral ASSLF with uterine sparing was also shown to be similar to vaginal hysterectomy with apical suspension [18]. Moreover, bilaterality of fixation seems to lead to less vaginal distorsion and sexual dysfunction [19].

We recognize that our study has several limitations, the non-randomized retrospective design and small sample size being the main ones. However, the results of our study with regards to safety are important and generalizable to other tertiary urogynecological units contemplating the introduction of this anchor-based device to their practice. The 6-week follow-up showed satisfactory short-term anatomical results for both groups in general, albeit, slightly better in the ABD group. However, given the aforementioned limitations and the short follow-up duration, this observation has limited significance and thus not discussed further. Finally, this study provided pilot comparative data on several core clinical urogynecological outcomes that will be useful in formally assessing the sample size of a future definitive randomized controlled trial comparing these devices or different SSLF approaches utilizing Anchorsure®.

## Conclusion

When comparing perioperative complications and patient reported postoperative pain, the sacro-spinous ligament fixation anchor-based device (Anchorsure®) seems to have a comparable safety profile to the traditionally used suture capturing devices. There was a trend to better clinical outcomes according to POPQ staging and scores, particularly for the anterior compartment. However, because of our small sample size, nature of our design, and short follow-up duration, these results should be interpreted with caution till further and more robust evidence is available.

Renaud de Tayrac: Financial support for research by Neomedic and AB Medica; Honorarium for sponsored session by Neomedic.

## Funding

No funding

## Authors' contribution

Evangelopoulos Nikolaos: Project development, data collection, statistical analysis, manuscript writing and editing.

Charlotte Delacroix: Data collection, manuscript editing.

Syad Abdirahman: Data collection

Renaud de Tayrac: Project development, data collection, manuscript editing.

## CRediT authorship contribution statement

**Nikolaos Evangelopoulos:** Writing – original draft, Methodology, Data curation, Conceptualization. **Charlotte Delacroix:** Writing – review & editing, Data curation. **Syad Abdirahman:** Data curation. **Renaud de Tayrac:** Writing – review & editing, Supervision, Data curation, Conceptualization.

## Declaration of competing interest

The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Renaud de Tayrac reports financial support was provided by Neomedic. Renaud de Tayrac reports was provided by AB Medica. Renaud de Tayrac reports a relationship with Neomedic that includes: speaking and lecture fees. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

## Acknowledgement

The authors would like to thank superviseme LTD - medical writing services (http://www.superviseme.eu) for their help with the medical writing and editing of the manuscript.

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[9] Roshanravan SM, Wieslander CK, Schaffer JI, Corton MM. Neurovascular anatomy of the sacrospinous ligament region in female cadavers: Implications in sacrospinous ligament fixation. p. 660.e1-6. Am J Obstet Gynecol 2007;197(6). https://doi.org/10.1016/j.ajog.2007.08.061

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