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Biomedical subjects

A M Kaunitz

Publications and source records attributed to A M Kaunitz.

At least 37 records · Page 2Linked to original sources

Efficacy of maintenance therapy after acute tocolysis: a meta-analysis.

OBJECTIVE: Our purpose was to analyze published randomized trials assessing the efficacy of maintenance tocolytic therapy after short-term tocolysis in patients with acute preterm labor. STUDY DESIGN: We supplemented a search of entries in electronic databases with references cited in original studies and review articles to identify randomized trials assessing the efficacy of maintenance tocolytic therapy after resolution of the acute preterm labor episode. Two masked investigators performed independent trial quality evaluation and data abstraction of each trial. We calculated an estimate of the odds ratio and risk difference for dichotomous outcomes, using both a random- and fixed-effects model. Continuous outcomes were pooled with a variance-weighted average of the within-study difference in means. RESULTS: Of 17 studies identified, 12 met our criteria for meta-analysis. These 12 trials included 1590 patients, including 855 who received maintenance tocolysis and 735 comparison patients who received placebo or no maintenance treatment. Compared with placebo or no treatment, the pooled odds ratio for preventing preterm delivery was 0.95 (95% confidence interval, 0. 77-1.17), and the odds ratio for preventing recurrent preterm labor was 0.81 (95% confidence interval, 0.64-1.03). In addition, use of maintenance tocolytic therapy was not associated with decreased rates of neonatal respiratory distress syndrome, perinatal deaths, or differences in birth weight. Although no difference was noted in mean gestational age at delivery, those receiving tocolytic agents had a longer latency period. CONCLUSION: Maintenance tocolytic therapy after successful treatment of an acute episode of preterm labor does not reduce the incidence of recurrent preterm labor or preterm delivery and does not improve perinatal outcome. Accordingly, the results of this meta-analysis do not support the use of maintenance tocolytic therapy after successful treatment of preterm labor.

Female↗

Oral contraceptive health benefits: perception versus reality.

Many women remain unaware of classic oral contraceptive (OC) noncontraceptive health benefits even as new health advantages emerge from experience and research. An extensive body of evidence has established that OC protect women against dysmenorrhea and menorrhagia, menstrual cycle irregularities, iron deficiency anemia, ectopic pregnancy, pelvic inflammatory disease, ovarian cysts, benign breast disease, endometrial cancer, and ovarian cancer. In addition, the FDA has stated for the first time that an OC-triphasic norgestimate/35 micrograms ethinyl estradiol--is an effective treatment for moderate acne vulgaris. OC use also appears to prevent osteopenia in hypoestrogenic women. In addition to these noncontraceptive health benefits, OC have proven valuable in the management of a variety of gynecologic disorders, including dysfunctional uterine bleeding, persistent anovulation, premature ovarian failure, functional ovarian cysts, pelvic pain (including secondary dysmenorrhea), mittelschmerz, endometriosis, and the control of bleeding in women with blood dyscrasias. Educating healthcare providers and women about these important noncontraceptive health benefits will result in increased compliance, greater continuation, and fewer unintended pregnancies.

Acne Vulgaris↗

Comparative safety, efficacy, and cycle control of Lunelle monthly contraceptive injection (medroxyprogesterone acetate and estradiol cypionate injectable suspension) and Ortho-Novum 7/7/7 oral contraceptive (norethindrone/ethinyl estradiol triphasic). Lunelle Study Group.

An open-label, nonrandomized, parallel, controlled study compared the efficacy, safety, and cycle control of a new monthly injectable contraceptive containing 25 mg of medroxyprogesterone acetate (MPA) and 5 mg of estradiol cypionate (E2C) (MPA/E2C) (Lunelle Monthly Contraceptive Injection) with that of a norethindrone 0.5, 0.75, 1.0 mg/0.035 mg ethinyl estradiol (NET/EE) triphasic oral contraceptive (Ortho-Novum 7/7/7). At study enrollment, women chose either the injections or the oral contraceptive. A higher proportion of women in the NET/EE group (65.1%) than in the MPA/E2C group (48.7%) had used hormonal contraception during the month before the study (p < 0.01). Overall, 55.5% (434/782) of MPA/E2C users and 67.6% (217/321) of NET/EE users completed the 60-week trial. One-year contraceptive efficacy (13 cycles of 28 days) for MPA/E2C and NET/EE was based on 8008 and 3434 woman-cycles of use, respectively. During the first year, one pregnancy occurred in an NET/EE user for a life table rate of 0.3; no pregnancies occurred in users of MPA/E2C. One additional pregnancy in the NET/EE group occurred during the 15th treatment cycle. After the first treatment cycle, women in both groups experienced regular menses, with an average cycle length of 28 days in MPA/E2C users and 27 days in NET/EE users. Although MPA/E2C users were more likely to experience bleeding irregularities, only 2.5% (19/775) cited metrorrhagia as a reason for discontinuing treatment. The adverse events reported in both treatment groups are consistent with those expected with the use of combined hormonal contraceptives. Overall, the results of this first Phase III US clinical trial of MPA/E2C confirm this method's high contraceptive efficacy and safety, as shown in previous studies by the World Health Organization. These results suggest that a monthly combination injectable would represent a welcome new contraceptive option for women in the US.

Contraceptive Agents, Female↗

Cervical ripening and labor induction with a controlled-release dinoprostone vaginal insert: a meta-analysis.

OBJECTIVE: To systematically review published randomized trials that compared efficacy of a 10-mg, controlled-release dinoprostone vaginal insert with other prostaglandins for cervical ripening and labor induction. DATA SOURCES: We supplemented a search of entries in electronic databases with references cited in original studies and review articles to identify randomized clinical trials of dinoprostone vaginal inserts for cervical ripening and labor induction. METHODS OF STUDY SELECTION: We evaluated, abstracted data, and assessed the quality of randomized clinical trials on the efficacy of dinoprostone vaginal inserts as cervical ripening and labor induction agents. Only published randomized trials were included in this meta-analysis. TABULATION, INTEGRATION, AND RESULTS: Seventeen studies were identified, eight of which met our criteria for metaanalysis. Those eight trials included 964 subjects, 490 of whom were allocated to dinoprostone vaginal inserts and 474 to other prostaglandin (PG) preparations. We calculated an estimate of the odds ratio (OR) and risk difference for dichotomous outcomes, using a random- and fixed-effects model. Continuous outcomes were pooled using a variance-weighted average of within-study difference in means. Compared with women who received other PG preparations, those who received dinoprostone vaginal inserts had lower incidence of vaginal delivery within 12 hours of PG application (OR 0.55, 95% confidence interval 0.39, 0.79). Vaginal inserts were associated with longer intervals to vaginal delivery and lower rates of active labor. There were no differences in cesarean delivery rates, incidence of hyperstimulation, or need for oxytocin augmentation between dinoprostone and other PGs. CONCLUSION: Dinoprostone vaginal insert was less effective than other prostaglandins for cervical ripening and labor induction.

Administration, Intravaginal↗

Infertility. A clinical guide for the internist.

Infertility is a common condition that internists practicing primary care may increasingly encounter. Abnormal male semen parameters, ovulation disorders, and tubal dysfunction account for most cases of infertility. By performing a complete initial evaluation and through appropriate and timely referral, internists can contribute to the care and improve outcomes for couples with this condition (Table 9).

Female↗

Cesarean scar pregnancy: imaging and treatment with conservative surgery.

BACKGROUND: Pregnancy in a cesarean scar represents a rare type of secondary abdominal pregnancy. Early diagnosis can be challenging and optimal treatment is unknown. CASE: A 21-year-old woman presented for an abortion at 8 weeks' gestation. A cesarean delivery had been performed 5 months earlier. Suspecting a cervical pregnancy, her physician referred her to us, and an 8-week cesarean scar gestation was diagnosed and then confirmed by serial sonograms, cystoscopy, and magnetic resonance imaging. The patient elected pregnancy termination, which was accomplished by hysterotomy with uterine preservation followed by intramuscular methotrexate. CONCLUSION: We report a case of cesarean scar pregnancy treated surgically with uterine preservation. This approach should be considered when cesarean scar ectopic pregnancy is diagnosed.

Adult↗

Labor induction with prostaglandin E1 misoprostol compared with dinoprostone vaginal insert: a randomized trial.

OBJECTIVE: To compare the safety, efficacy, and costs of intravaginal misoprostol versus dinoprostone vaginal inserts for cervical ripening and labor induction. METHODS: Two hundred twenty-three labor induction patients were assigned randomly to one of two treatment groups: 1) intravaginal misoprostol or 2) dinoprostone vaginal inserts. Fifty micrograms of misoprostol were placed in the posterior vaginal fornix every 3 hours for a maximum period of 24 hours. Ten milligrams of dinoprostone was administered in a single application as a vaginal insert for 12 hours. RESULTS: Among 223 patients evaluated, 108 were allocated to the misoprostol group and 115 to the dinoprostone group. The median interval from induction to vaginal delivery was significantly shorter in the misoprostol group: 698 (range 395-1053) versus 1041 (range 792-1531) minutes (P < .001). Vaginal delivery within 12 hours of ripening occurred in 40.7% of patients who received misoprostol compared with 19.1% for those receiving dinoprostone (P < .001); no significant difference between the groups was noted for vaginal delivery within 24 hours. Uterine tachysystole occurred more frequently in patients in the misoprostol group (21.3%) than in the dinoprostone group (7.0%) (P = .004). Nevertheless, no statistically significant differences were noted between the groups with respect to intrapartum complications, including uterine hyperstimulation, mode of delivery, and neonatal or maternal adverse outcomes. The average cost per patient for misoprostol treatment was $85 compared with $606 for treatment with the vaginal insert. CONCLUSION: Intravaginal misoprostol and the dinoprostone vaginal insert appear to be safe agents for cervical ripening and labor induction. However, misoprostol is less expensive and more effective than the dinoprostone vaginal insert.

Dinoprostone↗

Devices for endometrial sampling. A comparison.

OBJECTIVE: To compare the clinical performance of two endometrial sampling devices, the GynoSampler and Pipelle. STUDY DESIGN: During a single office visit, gynecology patients at Women's Hospital, Los Angeles, and the teaching clinic of the University of Florida Health Science Center, Jacksonville, underwent two endometrial biopsies, one with each device. The specimen adequacy, pain associated with the sampling procedure and ease of use of the two devices were compared. RESULTS: One hundred women, 50 at each clinical center, were evaluated. No significant differences in specimen adequacy were noted, with at least 90% of specimens retrieved with each device sufficient for diagnosis. Patient discomfort ratings were similar for the two devices. However, physicians performing the biopsies noted that the GynoSampler device was easier to use than the Pipelle based on three parameters (P < .05). CONCLUSION: Although the GynoSampler and Pipelle appear comparable from the perspectives of diagnostic performance and patient discomfort, the GynoSampler was easier to use.

Adult↗

Randomized trial of two doses of the prostaglandin E1 analog misoprostol for labor induction.

OBJECTIVE: Our purpose was to compare the safety and effectiveness of intravaginally administered misoprostol at doses of 25 micrograms and 50 micrograms for indicated labor induction in patients with an unfavorable cervix. STUDY DESIGN: Three hundred ninety-nine patients received either 25 micrograms or 50 micrograms of misoprostol, placed intravaginally in the posterior fornix, in this randomized double-blind trial. The dose was repeated every 3 hours until adequate labor was achieved (at least three contractions in 10 minutes). RESULTS: Among 399 patients evaluated, 192 patients were allocated to the 25 micrograms group and 207 patients to the 50 micrograms group. The start-to-delivery interval was shorter in the 50 micrograms group (826 minutes vs 970 minutes, p = 0.02). The incidence of vaginal delivery after one dose was higher in the 50 micrograms group (38.2% vs 25.0%, p = 0.007). Patients receiving 25 micrograms required oxytocin augmentation more frequently than did those receiving 50 micrograms (27.1% vs 16.9%, p = 0.02). No differences were noted in the cesarean or other operative delivery rates among patients in the two treatment groups. The incidence of newborns with a cord pH < 7.16 was greater in the 50 micrograms group (13.0% vs 6.8%, p = 0.04). Although the incidence of hyperstimulation was similar between the groups, the incidence of tachysystole was higher in the 50 micrograms group (32.8% vs 15.6%, p = 0.0001). CONCLUSIONS: Although a dose of 50 micrograms is associated with a shorter start-to-delivery interval and a higher incidence of vaginal delivery after one dose, 25 micrograms of intravaginal misoprostol is effective and associated with a lower incidence of tachysystole and cord pH values < 7.16.

Administration, Intravaginal↗

Misoprostol for cervical ripening and labor induction: a meta-analysis.

OBJECTIVE: To analyze published randomized trials assessing the safety and efficacy of misoprostol for cervical ripening and labor induction. DATA SOURCES: We supplemented a search of entries in electronic data bases with references cited in original studies and review articles to identify randomized trials of misoprostol for cervical ripening and labor induction. METHODS OF STUDY SELECTION: Two blinded investigators performed independent trial quality evaluation and data abstraction of randomized clinical trials assessing the efficacy of misoprostol as a cervical ripening and labor-inducing agent. TABULATION, INTEGRATION, AND RESULTS: We calculated an estimate of the odds ratio (OR) and risk difference for dichotomous outcomes, using both a random- and fixed-effects model. Continuous outcomes were pooled using a variance-weighted average of the within-study difference in means. Of 16 studies identified, eight met our criteria for meta-analysis. These eight trials included 966 patients (488 received misoprostol and 478 were controls). Women who received misoprostol for cervical ripening and labor induction had a significantly lower overall cesarean rate (OR 0.67, 95% confidence interval [CI] 0.48, 0.93) and a higher incidence of vaginal delivery within 24 hours of misoprostol application (OR 2.64, 95% CI 1.87, 3.71). Use of misoprostol was associated with a higher incidence of tachysystole (OR 2.70, 95% CI 1.80, 4.04) but not hyperstimulation (OR 1.91, 95% CI 0.98, 3.73). The incidences of abnormal 5-minute Apgar scores and admissions to the neonatal intensive care unit were similar in the misoprostol and control groups. The pooled estimate of the mean interval from start of induction to delivery was 4.6 hours fewer (95% CI -3.5, -5.7) in the misoprostol group. CONCLUSION: Published data confirm the safety and efficacy of intravaginal misoprostol as an agent for cervical ripening and labor induction.

Cervix Uteri↗

Labor induction with intravaginal misoprostol in term premature rupture of membranes: a randomized study.

OBJECTIVE: To evaluate the safety and clinical effectiveness of intravaginal misoprostol, a synthetic prostaglandin E1 analogue, for labor induction in gravidas with premature rupture of membranes (PROM) at term. METHODS: One hundred forty-one pregnant women with term PROM were assigned randomly to one of two induction groups: 1) intravaginal misoprostol or 2) intravenous oxytocin by continuous infusion. RESULTS: Seventy subjects were allocated to the misoprostol group and 71 to the oxytocin group. The mean (+/- standard deviation) interval from induction to delivery was significantly shorter in the misoprostol group (416 +/- 276 compared with 539 +/- 372 minutes; P = .04). In 85.7% of patients in the misoprostol group, only one dose was required. Intrapartum complication rates, mode of delivery, and neonatal or maternal adverse event rates were similar in the two treatment groups. Uterine tachysystole occurred more frequently with misoprostol than with oxytocin (28.6% compared with 14.0%; P < .04). CONCLUSION: Intravaginal administration of misoprostol induces labor safely and effectively in patients with PROM at term.

Administration, Intravaginal↗

The role of androgens in menopausal hormonal replacement.

Androgen therapy may improve libido and psychologic symptoms in hypogonadal women. Such replacement may also cause undesirable lipoprotein changes and virilizing side effects. By detailing the benefits and risks, this article may help the clinician determine the role of androgen therapy as a supplement to conventional estrogen/progestin replacement in menopausal women.

Androgens↗