Collaborative Review Of Sterilization Research Articles

Efficacy of Tubal Surgery for Permanent Contraception: Considerations for the Clinician.

Permanent contraception meets the needs of many people certain in their decision to never become pregnant in the future. Female permanent contraception procedures became more common than male procedures during the 1970s and 1980s, when laparoscopic surgery became widely available. To better understand the efficacy of these new procedures, the US Centers for Disease Control and Prevention conducted a prospective cohort study, known as the Collaborative Review of Sterilization (CREST). For decades, results of this study have defined perioperative counseling around failure risks of such surgeries. However, laparoscopic technology and techniques have changed significantly in recent decades and evidence has emerged supporting noncontraceptive benefits of tubal excision. Therefore, we present here a review of updated information regarding permanent contraception failure in the modern context and implications for clinical practice and future research directions.

Long-Term Failure Rates of Interval Filshie Clips As a Method of Permanent Contraception.

Background: In 1996, the U.S. Collaborative Review of Sterilization (CREST) reported permanent contraception failure rates by method, but did not include the Filshie clip. Subsequent research provides data for Filshie clip failure rates up to 24 months, but rigorously designed and executed studies examining failure rates beyond 2 years are lacking.Objectives: To describe non-Filshie and Filshie procedures, identify failures, and calculate 10-year pregnancy rates among patients who have undergone interval permanent contraception procedures with Filshie clips.Study Design: We performed chart review for patients who underwent interval permanent contraception procedures between 2000 and 2014 at our institution. We identified births after permanent contraception by utilizing both chart review and the Utah Population Database. We report results from life table analysis, with censoring at failure, 49 years of age, or last observed date of service.Results: In this cohort of 693 patients, surgeons most commonly used Filshie clips for interval permanent contraception (N = 547, 78.8%). We classified pregnancies after Filshie clip procedures as verified (n = 4) or self-reported (n = 3). We obtained 5 years of data for 411 patients (59.3% of all permanent contraception procedures), and more than 10 years of data for 257 patients (37.1%). We calculated a cumulative 5- and 10-year pregnancy rate to be the same, including both verified and self-reported pregnancies, of 9.8 (95% confidence interval [CI] 4.1–23.3)/1000 women using Filshie clips. The 10-year rate of verified pregnancy is 2.8 (95% CI 1.0–15.7)/1000 women.Conclusion: Overall, long-term failure of Filshie clip interval permanent contraception procedures is infrequent, with a 10-year cumulative probability of failure of 4.1–23.3/1000 procedures performed. Filshie clips compare favorably with other methods of permanent contraception included in the CREST study, where the 10-year cumulative probability of failure ranged from 7.5 to 36.5/1000 procedures performed.

Long-Term Failure Rate of Laparoscopic Tubal Sterilization With Bipolar Coagulation In an Urban Teaching Clinic Population

Few contemporary studies have investigated the long-term failure rate of laparoscopic tubal sterilization. This study was conducted to determine the current long-term failure rate of laparoscopic tubal sterilization with bipolar coagulation among an urban teaching clinic population. These results were compared to earlier findings from the U.S. Collaborative Review of Sterilization (CREST) which investigated the failure rate of sterilizations performed from 1978 - 1986, 5-16 years prior to this study’s procedures.

The risk of pregnancy after vasectomy.

To describe the pregnancy rates among women whose husbands underwent vasectomy. Between 1985 and 1987, 573 women aged 18-44 years whose husbands underwent vasectomy in medical centers in 5 U.S. cities were enrolled in the U.S. Collaborative Review of Sterilization, a prospective cohort study of male and female sterilization. Women were interviewed by telephone at 1, 2, 3, and 5 years after their husbands underwent vasectomy. Among the 540 eligible women at risk for pregnancy, there were 6 pregnancies occurring from 6 to 72 weeks after vasectomy. The cumulative probability of failure per 1,000 procedures (95% confidence interval) was 7.4 (0.2, 14.6) 1 year after vasectomy and 11.3 (2.3, 20.3) at years 2, 3, and 5 [corrected]. Couples considering vasectomy should be counseled about the small, but real, risk of pregnancy following the procedure and that men are not sterile immediately after vasectomy.

Requesting information about and obtaining reversal after tubal sterilization: findings from the U.S. collaborative review of sterilization

Objective: To determine the cumulative probabilities over 14 y of requesting information on sterilization reversal and of obtaining a reversal and to identify risk factors observable at sterilization for both measures of regret. Design: The U.S. Collaborative Review of Sterilization, a prospective cohort study. Setting: Fifteen medical centers in 9 cities. Patient(s): 11,232 women. Main Outcome Measure(s): Cumulative probabilities of requesting information on reversal and undergoing reversal. Result(s): The 14-y cumulative probability of requesting reversal information was 14.3% (95% confidence interval [CI], 12.4%–16.3%). Among women aged 18 to 24 y at sterilization, the cumulative probability was 40.4% (95% CI, 31.6%–49.2%). Women aged 18 to 24 y were almost 4 times as likely to request reversal information as were women ≥30 years of age (adjusted rate ratio [RR], 3.5; 95% CI, 2.8–4.4). Number of living children was not associated with requesting reversal information. The overall cumulative probability of obtaining reversal was 1.1% (95% CI, 0.5–1.6). Younger women (18 to 30 y) were more likely to obtain reversal (RR, 7.6; 95% CI, 3.2–18.3). Conclusion(s): Women who were sterilized at a young age had a high chance of later requesting information about reversal, regardless of their number of living children.

Higher Hysterectomy Risk for Sterilized than Nonsterilized Women: Findings from the U.S. Collaborative Review of Sterilization

Objective: To compare the risk of hysterectomy among previously sterilized women and women whose husbands had undergone vasectomy, and to evaluate whether this risk differed by age at surgical procedure or by method of tubal occlusion. Methods: Our study population comprised 7718 women enrolled in a prospective, multicenter cohort study between 1978 and 1986. After stratifying by the woman’s age at surgical procedure, we used the life-table approach and adjusted hazards ratios to examine whether the relative risk of hysterectomy during the 5 years after enrollment differed between the 7174 women who had been sterilized and the 544 women whose husbands had undergone vasectomy. Results: The 5-year cumulative probability of hysterectomy was 8% among the previously sterilized women and 2% among the women whose husbands had undergone vasectomy. Among women 34 years of age and younger at enrollment, sterilized women were 4.4 times as likely to have a hysterectomy as women whose husbands had undergone vasectomy (95% confidence interval [CI] 1.9, 10.0). Findings were similar for women 35 years of age and older (rate ratio = 4.6; 95% CI 1.4, 14.5). Each of the six most commonly used methods of tubal occlusion was associated with an increased risk of hysterectomy. Conclusion: Women undergoing tubal sterilization were more likely than women whose husbands underwent vasectomy to undergo hysterectomy within 5 years after sterilization, regardless of age at sterilization. An increased risk of hysterectomy was observed for each method of tubal occlusion.

"The Risk of Ectopic Pregnancy after Tubal Sterilization."

Background Tubal sterilization is an increasingly common method of contraception in the United States. Although pregnancy after sterilization is uncommon, it can occur and may be ectopic. We used data from the U.S. Collaborative Review of Sterilization to estimate the risk of ectopic pregnancy in women who had undergone the common types of tubal sterilization. Methods A total of 10,685 women undergoing tubal sterilization were followed in a multicenter, prospective cohort study. We intended to follow all the women for 5 years by means of annual telephone interviews; for women enrolled early in the study, we attempted an additional follow-up telephone interview 8 to 14 years after sterilization. To assess the risk of ectopic pregnancy in these women, we used cumulative life-table probabilities and proportional-hazards analysis. Results There were 47 ectopic pregnancies in the 10,685 women; the 10-year cumulative probability of ectopic pregnancy for all methods of tubal sterilization combined was 7.3 per 10...

Women May Experience Sterilization Failure Many Years After the Procedure, Long-Term Study Shows

10685 women aged 18-44 years entered the US Collaborative Review of Sterilization a multicenter prospective cohort study during 1978-86. They were of median age 30 years at the time of sterilization. Sterilization was accomplished using silicone rubber band in 31% of cases; bipolar coagulation among 21%; postpartum partial salpingectomy clip application and unipolar coagulation for 13-15% each; and interval partial salpingectomy for 4%. 198 pregnancies occurred among the study participants 143 of which were considered true sterilization failures. For all sterilization methods combined the cumulative 10-year probability of failure was 18.5/1000 procedures in the study cohort. The failure rate ranged from 7.5/1000 for unipolar coagulation and postpartum partial salpingectomy to 36.5/1000 for spring clip application. With every method except interval partial salpingectomy the 10-year probability of pregnancy was higher for the youngest women than for the oldest. Women aged 18-27 sterilized by bipolar coagulation or clip application were at highest risk. Disparities in method effectiveness however decreased as womens age at sterilization increased such that there were no statistically significant differences between methods among women aged 34-44. Black women were 2.5 times as likely as White women to experience method failure. The author notes potential sources of bias including the relatively low follow-up rates among young women and Blacks. These findings suggest that the risk of failure persists for many years after female sterilization.

"The Risk of Pregnancy after Tubal Sterilization: Findings from the U.S. Collaborative Review of Sterilization."

"The Risk of Pregnancy after Tubal Sterilization: Findings from the U.S. Collaborative Review of Sterilization."

The risk of pregnancy after tubal sterilization: Findings from the U.S. Collaborative Review of Sterilization

OBJECTIVE: Our purpose was to determine the risk of pregnancy after tubal sterilization for common methods of tubal occlusion. STUDY DESIGN: A multicenter, prospective cohort study was conducted in U.S. medical centers. A total of 10,685 women who underwent tubal sterilization was followed up for 8 to 14 years. The risk of pregnancy was assessed by cumulative life-table probabilities and proportional hazards models. RESULTS: A total of 143 sterilization failures was identified. Cumulative 10-year probabilities of pregnancy were highest after clip sterilization (36.5/1000 procedures) and lowest after unipolar coagulation (7.5/1000) and postpartum partial salpingectomy (7.5/1000). The cumulative risk of pregnancy was highest among women sterilized at a young age with bipolar coagulation (54.3/1000) and clip application (52.1/1000). CONCLUSIONS: Although tubal sterilization is highly effective, the risk of sterilization failure is higher than generally reported. The risk persists for years after the procedure and varies by method of tubal occlusion and age. (A M J O BSTET G YNECOL 1996;174:1161-70.)

Early complications of abdominal and vaginal hysterectomy.

In 1982, the Collaborative Review of Sterilization (CREST) study was published, reviewing the complications accompanying and following both abdominal and vaginal hysterectomy. This review was undertaken to see how these rates have changed in the ensuing years. All large series of abdominal and vaginal hysterectomy complications published subsequent to the CREST study were reviewed. Additionally, other studies that focused on specific complications were reviewed. It is concluded that the following changes related to hysterectomy morbidity have occurred since the publication of the CREST study: 1) the use of blood transfusion has diminished due to concern regarding human immunodeficiency virus contamination; 2) the rate of urinary tract infection has decreased primarily due to routine use of prophylactic antibiotics; and 3) inadvertent injury to the bladder has been noted more frequently at a rate of 1 to 2 percent. A particularly important category of complication is "unintended major surgical procedures which accompany or follow hysterectomy." This has been shown to occur at a rate of approximately 4 percent on general gynecology services. Finally, risk factors that add to the morbidity of hysterectomy are discussed.

Menstrual Complaints Rise with Increasing Years Since Tubal Sterilization

Data from the Collaborative Review of Sterilization initiated in 1978 in the United States were used. 8044 women enrolled in the study. Before surgery the women were interviewed to collect demographic medical and obstetric information. The study included data on 5070 women who had an interval sterilization between 1978 and 1983 at 1 of 12 medical centers located in 6 US states. Most participants were aged 30 or older at the time of sterilization. Significant changes occurred in menstrual functioning by the 5th year compared with the 1st year: the percentage of women who had more pain during menstruation increased from 27% to 35%; those who reported heavier bleeding increased from 41% to 49%; and those who experienced spotting increased from 7% to 10%. In contrast 1 year after sterilization only 27% of the women reported high levels of menstrual pain 41% had a heavier flow and 7% had spotting between periods. Cycle length had decreased significantly from 28.1 days per cycle to 27.9. Women who had undergone unipolar coagulation reported having the longest cycles while women sterilized with the spring clip had the shortest cycles. Those who had undergone thermocoagulation were most likely to have irregular cycles. Statistically significant associations were: black women reported less spotting and irregular cycles and fewer days of bleeding than did white women; women who were older when they were sterilized experienced less pain and more regular menstruation than did those who were younger; women with more lifetime pregnancies had less pain and shorter cycles than those with fewer pregnancies; and women who used an IUD before sterilization had fewer days of bleeding than those who used no contraceptive method. It is noted that use of the pill or an IUD before sterilization may confound the effects of sterilization. It was not clear whether the menstrual changes were related to sterilization aging or other factors since the women served as their own controls.

Evaluating the effects of tubal sterilization on menstrual function: selected issues in data analysis.

We examined selected issues in data analysis in the Collaborative Review of Sterilization (CREST). CREST is a multicentre, prospective, observational study of women undergoing tubal sterilization. We analysed menstrual function after sterilization in over 5000 women who were enrolled in the period 1978-1983 and followed for 5 years with yearly follow-up interviews. To take into account the dependency among repeated responses from the same individuals, we used the generalized estimating equations (GEE) approach to longitudinal data analysis. Marginal modelling resulted in a statistically significant increase in the odds of menstrual dysfunction at 5 years after tubal sterilization. Transitional modelling produced rates of menstrual dysfunction given a woman's menstrual function at baseline, after adjusting for other baseline characteristics such as method of contraception before sterilization. To examine the direction of the bias that could result from non-random missing data, we refitted our models using imputed values. The models with imputed values showed the same trends as the original models.

Menstrual function after tubal sterilization.

More than 10 million women in the United States have undergone tubal sterilization. There has been concern that this procedure may increase the risk of later menstrual dysfunction. The Collaborative Review of Sterilization (CREST) is a large, multicenter, prospective study of tubal sterilization in the United States. This report describes CREST participants who were interviewed immediately before sterilization and again in annual poststerilization interviews for up to 5 years between 1978 and 1988. The authors analyzed reported changes in six menstrual cycle characteristics for 5,070 women undergoing interval sterilizations. Longitudinal, multivariate regression was used to adjust for baseline menstrual function and other potential confounders. Five years after sterilization, 35% of the CREST participants reported high levels of menstrual pain, 49% reported heavy or very heavy menstrual flow, and 10% reported spotting between periods. In contrast to the fifth year, the first year of follow-up was similar to presterilization menstrual function; in the first year, 27% of participants reported high menstrual pain, 41% reported heavy menstrual flow, and 7% reported spotting. These findings may be affected by aging of the cohort and other study limitations, but they suggest that if tubal sterilization leads to changes in menstrual function, such changes may take some time to develop.

Risk factors for regret after tubal sterilization: 5 years of follow-up in a prospective study

The Collaborative Review of Sterilization is a prospective, multicenter study that interviewed 7,590 women before they underwent tubal sterilization and then conducted yearly follow-up interviews that included questions on sterilization regret. These women contributed 26,641 observations (for up to 5 years after the procedure, 1978 to 1988) to an analysis of the presterilization characteristics most consistently associated with poststerilization regret. Young age at the time of sterilization was the strongest predictor of regret, regardless of parity or marital status; among women 20 to 24 years of age at sterilization, an average of 4.3% reported regret over the follow-up period. The rate of regret was significantly lower for women 30 to 34 years of age (2.4%).

Unintended laparotomy associated with laparoscopic tubal sterilization

Although the complication rate for laparoscopic tubal sterilization is generally low, laparotomy is sometimes necessary to complete the sterilization or manage complications. To better characterize factors that predispose women to unintended laparotomy, we analyzed data from the Collaborative Review of Sterilization. Of the 5027 women undergoing laparoscopic tubal sterilization, 12 had unintended laparotomies to manage complications, whereas 39 women had unintended laparotomies because of technical inability to complete the laparoscopic procedure. Women with prior abdominal or pelvic surgery had an increased risk of unintended laparotomy (relative risk = 10.2, 95% confidence interval = 5.3 to 19.7). Women with a history of intrauterine device use or pelvic inflammatory disease had elevated risks that were not statistically significant (relative risk = 2.2 and 1.5, respectively). Comparative studies of alternative surgical approaches for tubal sterilization are needed to formulate recommendations for women who may be at increased risk of unintended laparotomy associated with the laparoscopic approach.

Hysterectomy performed within 1 year after tubal sterilization

In the United States, approximately 650,000 women of reproductive age undergo tubal sterilization each year and some of these women later have hysterectomies. Little is known about risk factors for having hysterectomy after tubal sterilization. For examination of this issue, we analyzed data from the Collaborative Review of Sterilization, an ongoing multicenter prospective study designed to assess the safety and efficacy of female sterilization operations. In 1979 and 1980, 4002 women 15 to 44 years of age had interval tubal sterilization; of these women, 64 had hysterectomies within 15 months, which yielded a cumulative incidence of 1.6%. Women with a history of menstrual complaints, leiomyomata, ovarian cysts, or endometriosis before their tubal sterilization had an increased risk of hysterectomy, compared with women without such a history. However, 98% of women with a history of these conditions did not have a hysterectomy within 15 months after tubal sterilization. Further follow-up of these women should help to better delineate their long-term risks.

Regret after decision to have a tubal sterilization

To determine characteristics associated with regretting sterilization that can be determined preoperatively, we analyzed data from the Collaborative Review of Sterilization (CREST), a multicenter, prospective, observational study. Of 5022 women, 2.0% regretted having had a tubal sterilization at 1 year after the procedure and 2.7% did so after 2 years. Using a multivariate analysis to identify risk factors for regret, we found that almost all characteristics were more closely associated with regret at 1 year than at 2 years postoperatively. Of the characteristics we examined that could be objectively determined preoperatively, we considered only age less than 30 years and (for whites) a concurrent cesarean section to be risk factors for regret at 2 years after sterilization. However, in absolute terms, less than 10% of women with both those risk factors regretted having the procedure.

Safety of abortion and tubal sterilization performed separately versus concurrently

Concurrent abortion and sterilization are preferred by many women to avoid a second hospitalization, operation, and, in some instances, general anesthesia. Several authors have shown concern, however, that the two procedures carry a higher risk of morbidity when performed concurrently versus separately. To determine whether the concurrent performance of sterilization and induced abortion is as safe as the two procedures performed separately, we selected women undergoing these procedures from two separate multicenter, prospective, national United States studies: the Joint Program for the Study of Abortion and the Collaborative Review of Sterilization. Using standard definitions of major morbidity, we calculated the crude rate of one or more major complications to be 0.9% for the abortion-only group, 1.7% for the group concurrent abortion and tubal sterilization. Thus our data suggest that performing concurrent abortion and sterilization is as safe as performing those procedures separately.

Confirmation of the preoperative diagnoses for hysterectomy

Few previous studies have examined the relationship between the preoperative and pathologic diagnoses for hysterectomy. To determine the percentage of preoperative diagnoses that were confirmed by pathologic examination, we analyzed data from the Collaborative Review of Sterilization, a multicenter study of hysterectomies and tubal sterilizations in women aged 15 to 44 years. Data were collected from patient interviews and chart reviews. Of the 1851 women included in this study, 1283 (69%) had abdominal hysterectomies and 568 (31%) had vaginal hysterectomies. Overall, 52% of the hysterectomies were performed for a preoperative diagnosis that could potentially be confirmed by pathologic examination. Pathologic examination actually confirmed the preoperative diagnosis of endometrial hyperplasia in 95% of the cases, cervical intraepithelial neoplasia in 89%, leiomyomas in 84%, pelvic inflammatory disease in 75%, adenomyosis in 48%, and endometriosis in 47%. Among all of the potentially confirmable diagnoses, 80% were confirmed. The remaining 48% of the women who had hysterectomies had preoperative diagnoses that were not amenable to confirmation by pathology. Most of these were for one of three diagnoses: menstrual bleeding disorders, pelvic pain, or pelvic relaxation. In 47% of these cases, pathologic examination showed leiomyoma or adenomyosis; no abnormalities were found in 38% of these cases.