Early medical abortion with methotrexate and misoprostol: outcomes and satisfaction among women aged 15-21 years.

STUDY OBJECTIVE: To compare the outcomes of women aged 15-21 yr to those of older women in a multicenter case series of early medical abortion. DESIGN, SETTING, PARTICIPANTS: We enrolled 1973 women at 34 outpatient Planned Parenthood sites in a case series for medical abortion in the first seven weeks of pregnancy. We used methotrexate (50 mg/m(2)) and misoprostol (800 mg vaginally, repeated as needed). We compared women who started the abortion prior to their 22(nd) birthday to older women. Outcomes of abortion were classified as documented or presumed complete medical abortion, and documented or presumed suction curettage. During the first half of the study, we did an exit interview assessing patient satisfaction. RESULTS: A total of 330 women were under 22 yr and 1641 women over 21 yr. Younger women presented for abortion at the same gestational ages. Overall, younger women had a higher rate of complete medical abortion than did older women (89.4% vs 83%). However, the multiple regression model demonstrated a significant adverse effect of prior live birth (P = 0.006), but not patient age, on outcome. Younger women were less likely to have had prior live births. Younger women were more likely to return for follow-up (96.4% vs 92.9%); the regression model demonstrated a significant effect (P = 0.001) of prior birth on rates of follow-up. Side effects and satisfaction were similar for older and younger women. CONCLUSIONS: Younger women having medical abortion with methotrexate and misoprostol have better outcomes and similar satisfaction levels as do older women.

Early medical abortion with methotrexate and misoprostol.

OBJECTIVE: To evaluate the introduction of an early medical abortion program with methotrexate and misoprostol, using a standardized protocol. METHODS: A total of 1973 women at 34 Planned Parenthood sites participated in a case series of early medical abortion. Ultrasound was used to confirm gestational age of less than 49 days from the first day of the last menstrual period. Women were given intramuscular methotrexate 50 mg/m(2) of body surface area on day 1, and then they inserted misoprostol 800 microg vaginally at home on day 5, 6, or 7. Women were advised to have a suction curettage if the pregnancy appeared viable 2 weeks after methotrexate or if any gestational sac persisted 4 weeks after methotrexate. Outcomes were complete medical abortion and suction curettage. RESULTS: Sixteen hundred fifty-nine women (84.1%) had a complete medical abortion, and 257 (13.0%) had suction curettage. The most common reason for curettage was patient option (8.9%). At 2 weeks after methotrexate use, 1.4% of women had curettage because of a viable pregnancy; at 4 weeks, 1.6% of women had curettage because of a persistent but nonviable pregnancy. One percent of women had curettage because of physician recommendation, most commonly for bleeding. Suction curettage rates decreased with site experience (P <.006) and were lower at early gestational ages (P <.004) and in nulliparous women (P <.004). CONCLUSION: Medical abortion with methotrexate and misoprostol is safe and effective and can be offered in a community setting.

Instituting medical abortion services: changes in outcome and acceptability related to provider experience.

A prospective case series carried out at 34 Planned Parenthood sites studied the safety, efficacy, and acceptability of medical abortion with methotrexate and misoprostol in 1973 women. Women with pregnancies of 26 to 49 gestational days were given methotrexate followed by vaginal misoprostol. Eighty-one percent of women had documented complete medical abortions; abortion was not confirmed by examination in 6%, and 13% had documented suction curettage. The rate of suction curettage decreased with site experience, from 17% during the first 20 procedures to 10% at sites that had performed more than 50. Sites that had previous experience with either methotrexate or mifepristone medical abortion had a rate of 9% after they had performed at least 50 procedures. Exit interviews with 755 of the 902 women having abortions in the first year inquired about the level of comfort with the abortion and its overall acceptability. Women's satisfaction with the side effects did not directly correlate with site experience. Overall satisfaction with the abortion experience was related to whether the women had complete medical abortions or suction curettage.

Early medical abortion with methotrexate. Outcome and satisfaction among women aged 15-20 years

Background: We investigated the outcomes of women under age 21 who participated in a multi-center case series of early medical abortion using methotrexate and misoprostol.Methods: We enrolled 1973 women in a case series for medical abortion in the first seven weeks of pregnancy, using a standardized protocol and consent for methotrexate (50 mg/m(2)) and misoprostol (800 mg vaginally, repeated as needed).For this study, women who presented for abortion prior to their 21(st) birthday were compared to older women. Outcomes of abortion were classified as complete medical abortion (CMA) and suction curettage (SC). Secondary outcomes included symptoms. We did an exit interview assessing patient satisfaction during the first year of the study, and have exit interview data for approximately half of the women enrolled.We assessed the relationship of age and outcomes first by bivariate analysis using SAS (SAS Institute, Inc., Cary, NC). A multiple logistic regression model was constructed using age, gestational age, and measures of parity.Results: There were 219 women who were under 21 (18 under the age of 18). Compared to older women, adolescents presented for abortion at the same gestational ages. Compared to older women, younger women were less likely to have finished college (2.8% vs. 38. 7%), and were less likely to have had previous pregnancies (45.4% vs 76.6%) and live births (20.2% vs. 51.3%)The distribution of symptoms during abortion, such as bleeding and cramping, was the same across age groups; the only symptom which was more frequently found in younger women was headache.Overall younger women had a slightly higher rate of CMA as older women (90.2% vs. 86.5%). However, the multiple regression (MR) model did not show an effect of the woman's age on CMA. MR demonstrated an adverse effect of prior live birth, and advancing gestational age on rates of CMA; younger women were less likely to have had prior live births.Younger women were just as likely to report overall satisfaction (86.7% vs. 84.6%) with the abortion procedure and other questions of satisfaction, but were less likely to agree that the bleeding and cramping were acceptable. Conclusions: Younger women having medical abortion with methotrexate and misoprostol have similar outcomes and satisfaction levels as do older women. There is no reason to discourage adolescents who seek abortion from using a medical technique.

The use of a large-scale surveillance system in Planned Parenthood Federation of America clinics to monitor cardiovascular events in users of combination oral contraceptives.

BACKGROUND: The publication of a series of papers based on three large, case-controlled studies raised questions about the safety of oral contraceptives (OCs) containing either desogestrel or gestodene as the progestational agent. In light of these studies, the Planned Parenthood Federation of America (PPFA) assessed the risk of thromboembolic events in patients who attended its clinics in the United States (U.S.). These PPFA patients were prescribed contraceptives containing one of the following progestins: desogestrel, levonorgestrel, norethindrone, or norgestimate. All of the contraceptives used contained either 30 or 35 microg of estrogen. METHODS: In this retrospective analysis, the association between the occurrence of a thromboembolic event, OC use, and progestin type was assessed in a group of PPFA patients. These patients were prescribed 2,265,087 woman-years (WY) of OCs from January 1, 1993 to December 31, 1995. RESULTS: Seventy events (deep vein thromboses [DVTs], pulmonary emboli [PEs], myocardial infarctions [MIs], and cerebral-vascular accidents [CVAs] were reported; a rate of 3 events per 100,000 WY of use. Five deaths occurred, at a rate of 0.22 per 100,000 WY of use. This low rate of incidents appears to be related to the younger age of PPFA patients and to the use of uniform guidelines for the selection and follow-up patients. Only the lower relative risk of PE reached statistical significance, when either norethindrone or norgestimate was compared to desogestrel-containing pills, but the absolute risk of these events was lower than in other published studies. Though the overall risk varied from a low of 1.895 events per 100,000 WY for norgestimate OC users to a high of 3.969 events per 100,000 WY for desogestrel OC users, these differences were not statistically significant. CONCLUSIONS: This study supports the conclusion that OCs containing 30 or 35 microg of estrogen, combined with one of the four previously identified progestins, carry an extremely low risk of a thromboembolic event, particularly when prescribing is based on a defined medical protocol. Overall, these four groups of low-dose estrogen-containing OCs appear safer than any previously published study has indicated.

Compliance, counseling and satisfaction with oral contraceptives: a prospective evaluation.

CONTEXT: Oral contraceptive users' risk of accidental pregnancy may be higher than it should be, because of inconsistent pill-taking. However, few reliable data are available on pill users' everyday experiences with their method, especially characteristics that may affect consistency of use. METHODS: Two months after initiating or resuming oral contraceptive use, a nationwide sample of 943 women completed questionnaires examining their compliance with instructions for proper use, the quality of their interactions with their provider, their satisfaction with the method, and the frequency and costs of visits or calls to their providers because of pill-related side effects. Regression analyses were used to determine the factors associated with compliance difficulties and method dissatisfaction. RESULTS: In all, 47% of users missed one or more pills per cycle, and 22% missed two or more. Women who lacked an established pill-taking routine, who did not read and understand all of the informational material accompanying the pill package, or who experienced spotting or heavy bleeding had increased odds of missing two or more pills per cycle. Method satisfaction was most likely among women who were aware of the pill's noncontraceptive benefits, were satisfied with their relationship with their provider, had used the pill in the past and experienced few side effects. Some 22% of users called their provider at least once about pill-related side effects, and 9% made at least one visit for this reason; these women spent $25 and $62, respectively, to treat side effects. CONCLUSIONS: Improving pill use is a shared responsibility of the provider, the patient and, to a lesser degree, pill manufacturers. Awareness of potential difficulties such as inadequate counseling is a key step in helping women use oral contraceptives effectively.

PIP: The Organon Contraceptive Use Study, a prospective cohort study (1994-96) of 943 US women (mean age, 25 years) recruited through private medical practices, Planned Parenthood clinics, and a health maintenance organization, examined oral contraceptive (OC) use patterns. 95% of study participants began or switched to a new OC brand at study enrollment. At follow up 2 months after enrollment, 47% of pill users reported missing 1 or more pill per cycle and 22% missed 2 or more pills in each cycle. Those who missed 1 or more pill were significantly more likely than those who did not to lack an established pill-taking routine, not to have read or understood the informational material accompanying the pill, and to have experienced spotting or heavy bleeding. 34% rated the OC as a very good method and another 30% considered it a good method. Method satisfaction was significantly higher among OC users who were aware of the pill's noncontraceptive health benefits, had a good relationship with their OC provider, had used the pill in the past, and experienced few side effects. 22% of OC recipients called their provider at least once about pill-related side effects and 9% visited at least once for this reason; these women spent US$25 and $62, respectively, to treat side effects. Recommended, to increase patient compliance and satisfaction with OCs, are measures such as counseling on potential side effects, evaluations of consistency of use at all follow-up contacts, and attention to the quality of the provider-client relationship.

Single dose methotrexate therapy: application to interstitial ectopic pregnancy.

A woman with a small (6-mm gestational sac) interstitial pregnancy had complete resolution after medical therapy alone. A single cycle of methotrexate 50 mg/m2 was used as outpatient treatment without any operative procedure either for diagnosis or intervention. The guidelines that have evolved for selection of women for single dose methotrexate treatment for both intrauterine and tubal ectopic pregnancies may be applicable to interstitial ectopic pregnancy as well. A suggested framework for treatment decisions is presented.

Utilization of intrauterine contraceptive devices by patients of the Planned Parenthood Federation of America.

PIP: Since 1988, IUD use by patients at Planned Parenthood of America clinics has remained constant at 0.7% of the approximately 1.8 million patients receiving contraception each year. In the past 7 years, only 18 perforations, 60 infections, and 27 difficult removals have been reported from these clinics. Moreover, there has been no evidence that the IUD poses health risks to acceptors or a major expense to the provider's malpractice insurance company. In large part, Planned Parenthood's excellent safety record associated with IUD use reflects implementation of a uniform set of IUD guidelines. These guidelines permit Planned Parenthood clinicians to provide prophylactic antibiotics in cases where an acceptor considered at low current risk of sexually transmitted diseases has a past history of pelvic inflammatory disease, gonorrhea, chlamydia infection, or mucopurulent cervicitis. Implementation of these guidelines is augmented by careful physical examination and explanation of the risks and benefits of IUD use. Planned Parenthood also distributes forms outlining the risk associated with pregnancy with an IUD in place. Finally, Planned Parenthood, unlike most other clinics, makes IUDs available to nulliparous women who clearly understand the risks.^ieng

Compliance and oral contraceptives: a review.

Compliance difficulties are more common among oral contraceptive (OC) users than generally appreciated by clinicians, in part because unintended pregnancy is a relatively infrequent consequence and in part because more common manifestations such as spotting and bleeding may not be recognized as resulting from poor compliance. While improving compliance is a shared responsibility of patients, clinicians, and manufacturers, the clinician is the focal point for these efforts. Counseling must be individualized, which requires knowledge of factors that predict compliance and an understanding of the patient's decision-making process as it relates to medications. Most OC compliance research has focused on adolescents, where predictors of poor compliance include multiple sex partners, low evaluation of personal health, degree of concern about pregnancy, and previous abortion. Good compliance has been linked with patient satisfaction with the clinician, the absence of certain side effects, establishing a regular daily routine to take OCs, and reading information distributed with OC packaging.

PIP: The findings of decades of research on user compliance of drug treatment regimens can be reduced to a simple statement that a third of users always comply, a third never complies, and a third sometimes complies. The efficacy of oral contraceptives (OC), however, relies on compliance even though poor compliance has no immediate or uniform consequences. Research on OC compliance has focused on adolescents because of their high pregnancy rates and their high reliance on OCs. Young women frequently use OCs in a sporadic fashion. While most adolescents are as compliant as older women, only 26% of those aged 14 and younger take their OC daily as compared to 40% of all other age groups. Attempts have been made to identify factors predicting noncompliance using 1) the individualistic model, which measures a number of factors using statistical techniques; 2) the health belief model which postulates that health-seeking behavior depends upon perception of health risk, and 3) the patient-provider model which highlights the importance of communication techniques. Factors which have been found to influence OC use are the occurrence of side effects, the routine followed, and failure to read and/or understand the packaging information. Little is known about the influence of patient-provider interactions, and only a few strategies to improve compliance have been studied. To improve compliance, health care providers should properly counsel women on their choice of method, side effects, OC misinformation and beneficial effects, correct use, missed pill instructions, and how to get additional information. Proper follow-up techniques should also be used. OC users can improve compliance by following a regular routine, carefully reading packaging information, knowing what to do if an OC is missed, and identifying a back-up method. Manufacturers should encourage research into compliance predictors and factors, incorporate findings into tools to help clinicians identify those at risk, use packaging that encourages compliance, and develop standardized and comprehensible written materials.

Complications of first-trimester abortion: a report of 170,000 cases.

One hundred seventy thousand first-trimester abortions were performed in three free-standing clinics of Planned Parenthood of New York City from 1971-1987. Seventy percent of the procedures were done under local anesthesia; the remainder under intravenous methohexital. No preoperative medications or routine postoperative antibiotics were given. High-risk patients were referred to a hospital. The clinics operated under uniform written guidelines. Experienced physicians performed the procedures. There were no deaths in this series of patients. One hundred twenty-one patients were hospitalized (0.71 per 1000) for suspected perforation, ectopic pregnancy, hemorrhage, sepsis, or recognized incomplete abortion. There was no major extirpative surgery performed. There were an additional 1438 minor complications (8.46 per 1000). Overall, there were 9.05 complications per 1000 abortions. The complication rates for procedures done under general anesthesia and local anesthesia were similar. We conclude that outpatient abortion on selected patients to the 14th week from the last menstrual period is a safe procedure.

Inserting IUDs safely.

PIP: A comprehensive discussion of safe insertion of IUDs in the contemporary U.S. setting, when any IUD complication may provoke litigation, includes explanations of complications listed on package inserts, what to look for in the pelvic exam, now to handle the inserter, whether to give prophylactic antibiotics or a cervical block, follow-up management, and advice on safe sex and hygiene. The similarities and differences in listed contraindications for the ParaGard and Progestasert IUDs are analyzed. It is important to know these listed contraindications to avoid being the sole defendant in a court case. Neither explicitly rules out nulliparas, and some women who have completed childbearing may be willing to risk ectopic pregnancy. The physician must be sure to avoid any possible risks of pelvic infection, however. It is important to postpone IUD insertion if there is any suggestion of lower genital tract infection. Similarly, IUD insertion is intended to last for years, so a paracervical block is recommended if access is difficult. Tips for ensuring scrupulous asepsis are suggested. Women for whom prophylactic antibiotics are advised include diabetics, those with heart valve disease or transplants. IUD patients should be clearly identified when they call in with complaints, and seen urgently. Finally, a sexual history should be taken to avoid candidates who engage in anal sex practices.^ieng

The rise and fall and rise of the IUD.

PIP: The history of IUD use, from the ring used by Richter in 1909 to the present, is described as 3 surges of popularity. The 1st IUDs were catgut rings with or without tails, and the Pust stainless and Ota rings. A worldwide pandemic or gonorrhea, and the population policies before and during World War II ended the popularity of IUDs temporarily. In 1959 IUDs re-emerged, proliferating to over 100 models, most of which were barium impregnated polyethylene, such as the Lippes Loop. Other models that had lesser success were several stainless springs that predisposed to embedding and perforations and the Majzlin spring with a multifilament tail that caused pelvic infection. The Dalkon shield, also bearing a multifilament nylon tail, brought the second wave of IUDs to a rapid end in the 1980s, because its multifilament tail increased risk of infection, midtrimester amnionitis, ectopic pregnancy, tubo-ovarian abscess, infertility, hysterectomy, and death. Robbins Company eventually recalled the Dalkon shield, and later became bankrupt from lawsuits. Other IUD makers, such as Searle, manufacturer of the well-tolerated and popular Copper-7, and Ortho, were subject to litigation, and removed their IUDs from the market, even though their products were still approved by the FDA. During this interim, several new copper bearing IUDs were being developed and tested. The TCU380A, like a Tatum-T with twice as much copper, developed and brought through FDA approval by the Population Council, was licensed and marketed by GynoPharma Corporation as the ParaGard. ParaGard is the most effective IUD to date for U.S. women, with pregnancy rates 1/100 after 2 years of use. Simultaneously, the Alza Corporation released Progestasert, a progesterone-releasing IUD. Progestasert has a 1.3% failure rate, and must be replaced yearly, but is the IUD of choice and therapeutic for women with dysmenorrhea or heavy menstrual flow. Progestasert appears to lessen tubal inflammation, but consequently permits more ectopic pregnancies than other IUDs.^ieng

Risk management in pregnancy termination.

This chapter reminds those who provide abortion services that crises are inevitable in the medical, counselling and administrative areas of the facility. After more than 10 years of providing safe, legal abortions, the author notes that the different types of crises that occur are already known and that it is possible to prepare for them. Indeed, it is necessary to prepare for a crisis before it occurs. The essence of crisis management is to: (a) identify each possible crisis and prepare a plan to cope with it, (b) train personnel to avert and/or manage a crisis, and to be sure that this training is carried out at appropriate intervals to provide sufficient trained staff at all times and (c) have on hand an up-to-date, adequate stock of the appropriate supplies and equipment to deal with medical and other emergencies. Four crisis management 'dicta' are given: Prepare yourself, your personnel, and your facility to be able to handle crisis. When a medical crisis, as listed, has occurred, the patient should be rapidly transported to the hospital and observed there for a suitable period of time. A medical crisis must be treated as the life-threatening event that it is, regardless of personal ego damage, social disruptions and/or financial considerations. The more personnel trained in cardiopulmonary resuscitation, the better.

PIP: Risk management, or quality assurance, in 1st trimester abortion service delivery, is unique in medicine for having developed a systematic set of actions to prevent or mitigate medical complications as well as consequences of fires, vandalism, harassment, bombings, job actions, and counseling and administrative crises. Risk management principles should be incorporated into facility design, staff selection, equipment selection and maintenance, physician hiring and monitoring, patient screening, regular review of protocols for medical emergencies, high-risk tissue examination. Types of medical crises include cardio-pulmonary collapse, hemorrhage, visceral injury, shock, seizure, and coma. Counseling crises imply suicide or homicide threat, acute psychosis, and reactions of other clients and visitors. Under administrative crises were listed fire, threats or acute bombing, arson, or assault, power or water failures, personnel shortage, harassment, and hostile media. All types of crises are handled by developing a plan of action, training staff, repeating training regularly, and conducting drills, feedback sessions, equipment checks, and designing in security. It should be expected that medical crises will occur on the average in 1/400 terminations, which amounts to one every 2-3 years for a small clinic, or 1-2 per month for a large one. All staff, including counselors, should be able to recognize destabilizing vital signs and to do cardio-pulmonary resuscitation. Appropriate alarm signals should be prearranged to transport the patient to hospital, without concern for personal ego damage, social disruptions, lack of hospital privileges, insurance, or cost. Equipment necessary to handle medical crises is listed, as are security measures to minimize administrative crises. An example of a severe drug reaction and its efficient handling, a result of pre-planning, is detailed.

Treatment of women who have undergone chemically induced abortions.

The pathophysiology of abortion induced by the transcervical introduction of compounds containing mixtures of soap, cresol and phenol is complex. A plan is necessary for the treatment of such critically ill women. The complex, multisystem damage produced by those compounds requires an extremely sophisticated treatment approach to avoid the many pitfalls that beset those cases.

PIP: A review of the prelegal abortion scene in the US precedes discussion of the effect of injected soap, phenol, cresol, and their compounds. The latter is based on a review of 4 toxicology books. There is little difference in the symptoms after the instillation of phenols, cresols, or soaps. Any one of those agents can cause vaginal bleeding, abdominal pain and distension, nausea, vomiting, and cramps. The damage produced by the use of Lysol thus is due to both the phenol and soap components of the compound. Following instillation into the uterus, there is coagulation necrosis of the decidua and placental site. The toxin will invariable cause thrombosis of the intrauterine and parametrial veins. The thrombosis may spread to the entire pelvic vein plexus and paravaginal, paracervical, and ovarian veins. The liver and kidney are affected by the toxin. Icterus and bile pigments in the urine and clinical evidence of liver damage are seen often. Pulmonary edema has been described as have microscopic to massive pulmonary oil emboli and thrombosis. Depression of all bone marrow elements due to toxin has been reported. The red blood cells are further depressed in number because of hemolysis. Cerebral changes include oil emboli, cerebral coagulation, necrosis, and petechial hemorrhages. Until Studdiford and Douglas described gram-negative sepsis causing shock, patients admitted with hypotension accompanying septic abortion were thought to have concealed blood loss. Studdiford and Douglas showed that gram-negative septicemia could produce hypotension. With the advent of massive antibiotic therapy for septic abortion and septic shock, most of these patients could be saved. The kidneys, after exposure to phenolic-soap comounds, show mainly lower nephron changes. As long as the toxin is in the system those changes continue until irreversible renal damage occurs. It is essential to remove the source of the poison (the affected uterus) and then remove the circulating toxins. the main problem is removal of the circulating toxin. In addition to the problems produced by fixed and circulating toxin, it has been shown that most phenol-soap induced abortions are infected. Thus it is necessary to employ the optimal antibiotic therapy for septic incomplete abortion. The initial management phase moves along classic lines. First is monitoring the vital state and supporting the systems. This includes maintaining an intravenous solution with a large-bore needle, monitoring central venous pressure, measuring urinary output, monitoring the vital signs, maintaining adequate oxygenation, and supporting the blood pressure with blood vasopressors or other agents, as needed. Second is diagnosing the extent of the illness. Third is the initial treatment, which includes reestablishment of the blood volume with blood transfusions; aggressive coverage with double or triple antibiotic therapy; correction of hypofibrinogenemia with cryoprecipitate, fresh whole blood or fresh frozen plasma, as indicated; and avoidance of overhydration in the presence of actual or suspected renal failure. After antibiotic coverage has been established, removal of retained products of conception is indicated.