Maureen E. Paul

Is pathology examination useful after early surgical abortion

OBJECTIVE To study if the pathologists examination of surgical abortion tissue offers more information than immediate fresh tissue examination by the surgeon. Immediate examination of the fresh tissue aspirate after surgical abortion helps reduce the risk of failed abortion and other complications. Regulations in some states also require a pathologist to analyze abortion specimens at added cost to providers. We conducted this study to evaluate the incremental clinical benefit of pathology examination after surgical abortion at less than 6 weeks gestation. METHODS As part of a prospective case series of women who had early surgical abortions at the Planned Parenthood League of Massachusetts during a 32‐month period, we collected data on clinical outcomes and the results of postoperative tissue examinations. Using outcomes verified by in‐person follow‐up as the “gold standard,” we calculated the validity of the tissue examinations by the surgeons and the outside pathologists. RESULTS A total of 676 women had documented outcomes and complete tissue examination data. The sensitivity (ability of the examiner to detect an outcome other than complete abortion) was 57% (95% confidence interval [CI] 35, 76) for the surgeons tissue inspections and 22% (95% CI 8, 44) for the pathologists examinations. The predictive value of a positive (abnormal) tissue screen was 14% (95% CI 8, 24) and 7% (95% CI 3, 17) for the surgeons and pathologists, respectively. CONCLUSION Routine pathology examination of the tissue aspirate after early surgical abortion confers no incremental clinical benefit. Although the surgeons tissue inspections predicted abnormal outcomes poorly, the pathologists did no better. Our results challenge the rationale for state regulations requiring pathologic analysis of all surgical abortion specimens.

Safety of digoxin for fetal demise before second-trimester abortion by dilation and evacuation

BACKGROUNDnDigoxin is used to induce fetal demise before dilation and evacuation (D&E) abortion. Published data on the safety of digoxin in abortion care are limited.nnnSTUDY DESIGNnWe conducted a retrospective cohort study with historical controls at a large family planning center. We reviewed the records of patients at 18 to 24 weeks gestation who received digoxin before D&E from May 15, 2007 (date the center initiated digoxin use), through March 31, 2008. We also reviewed the records of patients who presented for D&E without digoxin from February 22, 2006, through May 12, 2007. We compared the rates of immediate complications.nnnRESULTSnWe included 566 digoxin patients and 513 controls. Eleven spontaneous abortions occurred in the digoxin cohort; none occurred among controls (p<.001). We found 19 cases of infection in the digoxin cohort and three among controls (odds ratio 5.91; 95% confidence interval 1.74-20.07). Eleven digoxin patients were admitted to a hospital after the preoperative visit; no controls were admitted (p<.001).nnnCONCLUSIONSnPatients who received digoxin before D&E were more likely to experience spontaneous abortion, infection and hospital admission than controls who underwent D&E without digoxin.

The safety of deep sedation without intubation for abortion in the outpatient setting

STUDY OBJECTIVEnTo determine the rate of perioperative pulmonary aspiration in patients undergoing first and second-trimester surgical abortion during deep sedation with propofol, without intubation.nnnDESIGNnRetrospective review of cases of surgical and anesthetic complications reported to the Office of Quality Management of the surgical facility between August 1, 2001 and April 30, 2008.nnnSETTINGnLarge urban surgical abortion outpatient facility.nnnMEASUREMENTSnThe medical records of all surgical abortion patients who underwent hospital transfer were reviewed. From billing records, all patients who underwent abortion during deep sedation were identified. The primary outcome was the rate of perioperative pulmonary aspiration. Secondary outcomes included the rates of other anesthesia-related adverse events resulting in hospital transfer.nnnMAIN RESULTSnDuring the 81-month study period, the facility performed 62,125 surgical abortions during deep sedation, including 11,039 second-trimester abortions. Only one patient received endotracheal intubation. No cases of perioperative pulmonary aspiration occurred.nnnCONCLUSIONSnDeep sedation without intubation is a viable method of anesthesia for both first and second-trimester surgical abortions in the outpatient setting.

Standardizing the classification of abortion incidents: the Procedural Abortion Incident Reporting and Surveillance (PAIRS) Framework

OBJECTIVESnTo develop and validate standardized criteria for assessing abortion-related incidents (adverse events, morbidities, near misses) for first-trimester aspiration abortion procedures and to demonstrate the utility of a standardized framework [the Procedural Abortion Incident Reporting & Surveillance (PAIRS) Framework] for estimating serious abortion-related adverse events.nnnSTUDY DESIGNnAs part of a California-based study of early aspiration abortion provision conducted between 2007 and 2013, we developed and validated a standardized framework for defining and monitoring first-trimester (≤14weeks) aspiration abortion morbidity and adverse events using multiple methods: a literature review, framework criteria testing with empirical data, repeated expert reviews and data-based revisions to the framework.nnnRESULTSnThe final framework distinguishes incidents resulting from procedural abortion care (adverse events) from morbidity related to pregnancy, the abortion process and other nonabortion related conditions. It further classifies incidents by diagnosis (confirmatory data, etiology, risk factors), management (treatment type and location), timing (immediate or delayed), seriousness (minor or major) and outcome. Empirical validation of the framework using data from 19,673 women receiving aspiration abortions revealed almost an equal proportion of total adverse events (n=205, 1.04%) and total abortion- or pregnancy-related morbidity (n=194, 0.99%). The majority of adverse events were due to retained products of conception (0.37%), failed attempted abortion (0.15%) and postabortion infection (0.17%). Serious or major adverse events were rare (n=11, 0.06%).nnnCONCLUSIONSnDistinguishing morbidity diagnoses from adverse events using a standardized, empirically tested framework confirms the very low frequency of serious adverse events related to clinic-based abortion care.nnnIMPLICATIONSnThe PAIRS Framework provides a useful set of tools to systematically classify and monitor abortion-related incidents for first-trimester aspiration abortion procedures. Standardization will assist healthcare providers, researchers and policymakers to anticipate morbidity and prevent abortion adverse events, improve care metrics and enhance abortion quality.

Enhancing resident training in abortion and contraception through hospital-community partnership.

OBJECTIVESnThe study was undertaken to assess the efficacy of a hospital-community rotation in abortion and contraception.nnnSTUDY DESIGNnThe program was developed and implemented by the Planned Parenthood League of Massachusetts (PPLM) and the Department of Obstetrics and Gynecology at Baystate Medical Center in November 2000. Abortion and contraceptive training is integrated into postgraduate year 3 and includes didactic presentations and 10 mandatory clinical sessions in first trimester abortion care.nnnRESULTSnFive residents complete the program annually. Before rotation, residents report their competence in first-trimester abortion procedure as 2 on a scale of 1 to 5 (1=not at all comfortable, 5=very comfortable). After rotation, the reported competency rating is 4.5 on the same scale. Residents, trainers, and staff report high satisfaction with the program.nnnCONCLUSIONnA collaborative hospital-community rotation in abortion and contraception increases residents clinical competence in these areas and is highly acceptable to residents, faculty, and staff.

Late termination of pregnancy for lethal fetal anomalies: a national survey of maternal–fetal medicine specialists

OBJECTIVEnThe objective was to ascertain the practices and opinions of US maternal-fetal medicine specialists regarding termination of pregnancy as a management option following late diagnosis of lethal fetal anomalies.nnnSTUDY DESIGNnWe conducted a cross-sectional mail survey of all US members of the Society of Maternal Fetal Medicine to ascertain how they manage pregnancies diagnosed with lethal fetal anomalies after 24 weeks of gestation. We analyzed the proportion of respondents that discuss termination of pregnancy as a management option, barriers to offering or accessing late termination services, and respondents opinions about what anomalies are lethal and when pregnancy termination should be permitted.nnnRESULTSnThe response rate was 41% (869/2119). Nearly all (93%) respondents discuss delivery near term or when complications arise, while 75% discuss the option of termination of pregnancy soon after the diagnosis of lethal fetal anomalies. Only 52% of the physicians indicated that their patients could obtain termination of pregnancy after 24 weeks at their affiliated medical centers or through providers within 50 miles. Real or perceived legal restrictions represented the most common reason for lack of local services. The proportion of respondents that felt strongly or very strongly that termination of pregnancy should be allowed was 76% for lethal anomalies and 58% for anomalies likely to result in significant long-term impairment.nnnCONCLUSIONnAlthough limited by a modest response rate, our study found that physicians do not consistently discuss immediate termination of pregnancy as an option following late diagnosis of lethal fetal anomalies, and they face numerous barriers to providing these services.nnnIMPLICATIONSnThis national survey supports the need for improved services for pregnant women who desire later termination of pregnancy following diagnosis of serious fetal anomalies. Helpful efforts might include educating physicians about the laws and regulations governing late termination of pregnancy, forging more consistent standards of care, and improving collaboration between MFM specialists and family planning providers to enhance access to care.

Integrating TeamSTEPPS® into ambulatory reproductive health care: Early successes and lessons learned

BACKGROUNDnMost medical teamwork improvement interventions have occurred in hospitals, and more efforts are needed to integrate them into ambulatory care settings. In 2014, Affiliates Risk Management Services, Inc. (ARMS), the risk management services organization for a large network of reproductive health care organizations in the United States, launched a voluntary 5-year initiative to implement a medical teamwork system in this network using the TeamSTEPPS model. This article describes the ARMS initiative and progress made during the first 2 years, including lessons learned.nnnMETHODSnThe ARMS TeamSTEPPS program consists of the following components: preparation of participating organizations, TeamSTEPPS master training, implementation of teamwork improvement programs, and evaluation. We used self-administered questionnaires to assess satisfaction with the ARMS program and with the master training course.nnnRESULTSnIn the first 2 years, 20 organizations enrolled. Participants found the preparation phase valuable and were highly satisfied with the master training course. Although most attendees felt that the course imparted the knowledge and tools critical for TeamSTEPPS implementation, they identified time restraints and competing initiatives as potential barriers. The project team has learned valuable lessons about obtaining buy-in, consolidating the change teams, making the curriculum relevant, and evaluation.nnnCONCLUSIONnAmbulatory care settings require innovative approaches to integration of teamwork improvement systems. Evaluating and sharing lessons learned will help to hone best practices as we navigate this new frontier in the field of patient safety.

Manual compared with electric vacuum aspiration for abortion at less than 6 weeks of gestation: a randomized controlled trial.

OBJECTIVE: To evaluate whether manual or electric vacuum aspiration results in greater immediate confirmation of completed abortion at less than 6 weeks of gestation. METHODS: Five hundred pregnant women presenting for surgical abortion with mean gestational sac diameter of less than 12 mm or no visible sac on ultrasonography were randomized to manual or electric vacuum aspiration. Tissue examination was performed by operating physicians, not blinded to group assignment, and by trained medical assistants, blinded to group assignment. Patients with no products of conception on gross inspection underwent repeat aspiration as necessary and serial human chorionic gonadotropin monitoring. All patients were scheduled for follow-up visits. The primary outcome was detection of products of conception in patients with subsequently confirmed completed abortion. RESULTS: From April 2010 to October 2011, 252 patients were randomized to manual vacuum aspiration and 248 to electric vacuum aspiration. One hundred eighty-two (82%) patients in the manual vacuum aspiration group had products of conception identified and subsequently confirmed completed abortion compared with 164 (76%) patients undergoing electric vacuum patients (P=.13, relative risk 0.83, 95% confidence interval [CI] 0.64–1.07). In pregnancies of sac size 3 mm or less, including no visible sac, five of 29 (17%) patients undergoing manual vacuum aspiration had accurate identification of products of conception compared with four of 31 (13%) patients undergoing electric vacuum aspiration (P=.64, relative risk 0.85, 95% CI 0.44–1.63). Tissue reports of physicians and medical assistants had 90% concordance. Seventy-nine (16%) patients required human chorionic gonadotropin monitoring to confirm completed abortion. There were seven (1.4%) ongoing pregnancies, including four false-positive products of conception results and, among the latter, one presumed ectopic pregnancy. CONCLUSION: Our study supports providing abortions to women who request them before 6 weeks of gestation using either manual or electric vacuum aspiration. Early aspiration is highly effective, although human chorionic gonadotropin monitoring may be necessary to confirm complete abortion. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01085825. LEVEL OF EVIDENCE: I

Ensuring Access to Safe, Legal Abortion in an Increasingly Complex Regulatory Environment.

Restrictions on access to abortion in the United States have reached proportions unprecedented since the nationwide legalization of abortion in 1973. Although some restrictions aim to discourage women from having abortions, many others impede access by affecting the timeliness, affordability, or availability of services. Evidence indicates that these restrictions do not increase abortion safety; rather, they create logistic barriers for women seeking abortion, and they have the greatest effect on women with the fewest resources. In this commentary, we recall the important role that obstetrician-gynecologists (ob-gyns) have played, both before and after Roe v. Wade, in facilitating access to safe abortion care. Using the literature on abortion safety and access as a foundation, we propose several practical ideas about what we as ob-gyns can do to address the current threat to abortion access, whether or not we provide abortion services in practice. We hope that this commentary will encourage discourse within our profession and prompt other suggestions. As ob-gyns who are dedicated to addressing health disparities and promoting the health and well-being of our patients, we can make a difference.

Impact of teamwork improvement training on communication and teamwork climate in ambulatory reproductive health care

BACKGROUNDnWhile team training is associated with improved hospital-based team climate, less is known about effects in the ambulatory setting.nnnSTUDY DESIGNnIn 2014 and 2015, we enrolled 20 organizations, each operating various health centers, into this ongoing study. Evaluation tools include a communication behaviors assessment (CBA) and Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS® ) Teamwork Perceptions Questionnaire (T-TPQ), which staff completes at baseline, 6 months, and 1xa0year, and the Patients Insights and Views of Teamwork (PIVOT) survey, which patients complete at baseline and 1xa0year. We also assessed patient satisfaction. We analyzed T-TPQs paired at the individual level and CBAs and PIVOTs paired at the health center level. We also conducted key informant interviews with the first cohort.nnnRESULTSnCBAs showed that TeamSTEPPS tools and strategies were utilized, with 50% or more of centers reporting increases in all behaviors at 1xa0year; key informant interviews confirmed this. T-TPQ findings indicated that TeamSTEPPS implementation was associated with improved staff perceptions of teamwork at 6 months; lesser improvements were seen at 1xa0year. The PIVOT survey demonstrated significant improvements in select patient ratings of teamwork. Patient satisfaction improved at 1xa0year.nnnCONCLUSIONSnTeamSTEPPS has positive effects in the ambulatory reproductive health care environment. Improvements persisted at 1xa0year.