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Biomedical subjects

L E Laufe

Publications and source records attributed to L E Laufe.

At least 19 recordsLinked to original sources

Phase I prehysterectomy studies of the transcervical administration of quinacrine pellets.

To determine the safety of transcervical administration of quinacrine pellets as a method of voluntary female sterilization, three noncomparative Phase I clinical trials of the administration of 250 mg quinacrine were carried out in 21 women who were scheduled to undergo hysterectomy 24 h or one month later. Detailed results are presented for one of the trials using 10-min pellets. Six of 10 women had minor transitory complaints during the postinsertion 24-h follow-up period. Five women reported pelvic/abdominal cramping, one experienced headache, and one experienced dizziness. Blood chemistry values were not adversely influenced by the quinacrine. The average plasma level of quinacrine peaked at 3 h, 36.1 ng/ml, slightly lower than the value observed 4 h after oral administration of 200 mg in a previous study. An average of 27% of the administered dose was recovered in tampons. Quinacrine was detected in the plasma of two women at the four/six-week visit. Selected results are presented from two other trials that were halted because of slow recruitment. The transcervical administration of 250 mg of 10-min quinacrine pellets was well tolerated. However, based on recent mutagenicity testing and meetings with regulatory officials, it appears unlikely that the use of quinacrine for nonsurgical sterilization could be approved in the United States or Europe.

Abdominal Pain

Lamicel for induction of labor.

Lamicel is a synthetic osmotic cervical dilator currently used as a method of cervical dilation in first- and second-trimester pregnancy termination. It works by extracting fluid from the cervical tissue and softening the cervix. This study evaluated its effectiveness in nonelective medical induction of labor in high-risk patients. Forty inpatients who, for medical and obstetric reasons, required delivery within the next 24-48 hours were studied. Patients were evaluated to make certain that a 12- to 24-hour delay was safe for mother and child. The evening prior to the day of induction, a pelvic examination determined the Bishop score, and bacterial cultures were obtained from the endocervix. As many Lamicels as possible (usually one to three) were then placed in the endocervix without rupturing the membranes. The next morning the devices were removed, a repeat Bishop score obtained, amniotomy performed, internal monitors placed and oxytocin infusion initiated. Data were collected for preinsertion and postinsertion Bishop scores, induction-delivery times, duration of ruptured membranes, and cesarean and vaginal birth rates. Maternal and neonatal infectious morbidity was determined. A comparison group of patients with premature rupture of the membranes was selected. From data studied at our institution, patients were matched for parity and duration of labor (not significantly different from the Lamicel group). The study revealed that Lamicel can be an effective means of ripening the cervix for induction of labor.

Bacterial Infections

The use of prostacyclin analogue-containing suture for the prevention of postoperative venous thrombosis in the rat.

The ability of prostacyclin analogue incorporated into a controlled-release suture to prevent postoperative venous thrombosis was investigated. Thirteen rats underwent bilateral transection and anastomosis of the common femoral vein. In each animal, polycaprolactone suture containing 0.25 micrograms/cm of the prostacyclin analogue Iloprost (Schering Ag, Berlin, West Germany) was used to perform the anastomosis on one vessel. Similar suture without prostacyclin analogue was used on the contralateral vessel, which served as a control. Functional patency and luminal surface morphology were assessed 24 hours postoperatively. All anastomoses performed using suture containing prostacyclin analogue were patent. Among controls, five anastomoses were patent and eight were occluded. This difference was highly significant (p less than 0.005). All anastomoses performed with prostacyclin analogue-containing suture exhibited a uniform absence of thrombosis. In contrast, eight control veins exhibited a dense, well-organized fibrinous clot that filled the entire lumen, effectively sealing off the vessel. These results suggest that the prostacyclin analogue released from the suture was highly effective in inhibiting thrombus formation without adversely affecting the vessel's ability to achieve hemostasis.

Animals

Delivery type and neonatal mortality among 10,749 breeches.

Data on 10,749 breech presentations were analyzed for the effect of delivery type on neonatal mortality. Most of the data are from developing countries, and most of the hospitals have higher mortality than is found in Europe or the United States. The simultaneous effect of type of hospital where the delivery occurred, type of breech, birthweight, and parity were examined. The benefit of cesarean delivery was greater for nulliparae than multiparae, greater for footlings than for frank or complete breeches, and greater for larger babies than smaller ones. This last finding probably reflects the quality of neonatal care in developing country hospitals rather than the value of cesarean section. Maternal mortality and morbidity was higher among women delivered abdominally than among those delivered vaginally.

Adult

Survey of obstetric forceps training in North America in 1981.

In April, 1983, a questionnaire was sent to all 144 United States and Canadian members of the Association of Professors of Gynecology and Obstetrics to survey residency training and current use of obstetric forceps in 1981. One hundred five programs (73%), responsible for at least 283,000 births in 1981, were subsequently analyzed. All training programs used outlet forceps and all programs but one used midforceps for delivery. Hospitals with high cesarean birth rates did not perform significantly fewer midforceps operations. Hospitals with high midforceps rates did not also have high outlet forceps rates nor did these high rates closely reflect the personal attitude to obstetric forceps of the director of the obstetric training program. Simpson's forceps were most commonly used for outlet forceps and occipitoanterior midforceps operations, whereas Kielland's forceps were selected by 76% of programs for rotational midcavity deliveries. Staff obstetricians were the primary instructors of forceps technique in the delivery room in only 50% of United States programs; all Canadian respondents reported the staff obstetrician as the principal educator in obstetric residency forceps training.

Attitude of Health Personnel

Postpartum insertion of modified intrauterine devices.

The immediate postpartum insertion of standard intrauterine devices (IUDs) and those specially modified for postpartum use was evaluated in a multicenter clinical trial. The immediate postpartum insertion of IUDs was not associated with any increased risk of perforation or infection, although expulsion rates were higher than with interval insertions. The expulsion rate varied widely between centers using similar devices, suggesting that training in insertion is essential. Postpartum IUD insertions can be a practical contraceptive option for patients and providers of medical services.

Adult

The introduction of postpartum intrauterine devices in the People's Republic of China.

In China, which has a commitment to family planning and, in particular, to the one-child family, a postpartum IUD should be widely accepted and could have significant impact on the Chinese family planning program. This report presents the introduction of the Delta T and Delta Loop devices, with 200 immediate postpartum insertions. Fifty-two deliveries were by cesarean section. The 6-month expulsion rates were 13.3 and 17.2 for the Delta T and Delta Loop, respectively. There was one pregnancy reported. Analysis suggests that the two devices are suitable for use in the postpartum period for Chinese women.

Adult

Comparison of the Lippes Loop D and tapered Lippes Loop D intrauterine devices.

The tapered Lippes Loop D (LLD) is compared to the standard LLD to evaluate efficacy and termination events. The tapered device was designed with the intention of lowering the expulsion rate below the rate for women with standard Lippes Loops. The two devices were randomly assigned to 989 women in two studies. Expulsion rates for the tapered device were lower at six months (p less than 0.10) and at 12 months (p less than 0.05). When the women were divided into groups by uterine measurement, the differences continued to be significant for women with larger uteri but not for those with smaller uteri. Comparison of other pertinent event rates showed no significant differences. Analysis of the data indicates that the tapered LLD represents an improvement in expulsion rates over the standard LLD.

Female

Endometriosis and the development of tuboperitoneal fistulas after tubal ligation.

The present study details gross and histologic findings of 79 previously ligated fallopian tubes from 3 groups of patients. Of 20 oviducts removed after documented sterilization failure (group I), 6 revealed a process compatible with endometriosis. Four of nine previously ligated fallopian tubes removed at the Johns Hopkins Hospital (group II) were successfully injected with India ink. In two patients histologic examination demonstrated the India ink in epithelium-lined spaces that lay beyond the muscle of the tubal wall extending from the tubal lumen to the serosal surface. Fifty oviducts were studied in twenty-five patients requesting reversal of their sterilizations (group III). A higher percentage of fistulas was demonstrated in patients with less than 4 cm of remaining proximal tubal segment. Furthermore, most of these fistulas were demonstrated in patients for whom 3 years had elapsed since the original sterilization procedure. Patients sterilzed by laparoscopic cautery methods were observed to have a higher percentage of fistula formation and histologic documentation of endometriosis at the sterilization site as compared with patients sterilized by other methods. Our observations suggest that ligation of the oviduct within 4 cm of the uterine cornu may predispose to the development of endometriosis and subsequent fistula formation in the tip of the ligated oviduct.

Endometriosis

Technical failures in tubal ring sterilization: Incidence, perceived reasons, outcome, and risk factors.

Six centers participated in comparative studies of female sterilization conducted by the international Fertility Research Program. The incidence of technical failures (or failed attempts) was compared between patients sterilized with the tubal ring and those sterilized with other tubal occlusion techniques. The tubal ring was associated with a higher failure rate than electrocoagulation, the Rocket clip, or the modified Pomeroy technique. Of 1,035 tubal ring sterilizations, there were 38 technical failures. Reasons given by the operators for the failures, by frequency of occurrence, were surgical complications, conditions preexisting in the patients, and problems with the instruments. Most of these failures were remedied by changing to other techniques. In two patients, the procedure was completed by changing the approach from laparoscopy to laparotomy. In five others, sterilization was not completed. Case-control analysis was performed and three risk factors were delineated: obesity, prior use of an intrauterine contraceptive device and previous abdominal operations.

Abdomen

An epidemiologic study of risk factors associated with pregnancy following female sterilization.

Data on 14,700 female sterilization patients were collected by the International Fertility Research Program (IFRP) from 1972 to 1978 and analyzed to determine risk factors associated with the incidence of pregnancy following sterilization. With a case-control approach, it was found that younger patients (less than or equal to 34 years old) and those who did not lactate after sterilization had a higher risk of becoming pregnant. Patients who were sterilized in the early phases of a service program had a higher risk of pregnancy than those sterilized later. In the laparoscopic series, the relative risk of pregnancy was four times greater in patients who had the prototype spring clip than in patients who had the Falope ring. The relative risk increased to 7.0 when patients who had the prototype spring clip were compared to those who had the Falope ring, electrocoagulation, or the Rocket clip. Patients sterilized by electrocoagulation had a low pregnancy risk, but the risk of an ectopic pregnancy was significantly higher than for those sterilized with mechanical devices. In the culdoscopic series, the tantalum clip had an unacceptable pregnancy risk.

Adult

Nonsurgical female sterilization.

The development of a safe, effective nonsurgical method of female sterilization that can be performed by paramedical personnel remains a high priority. The method should have a blind delivery system and require only one application. Methyl cyanoacrylate and quinacrine hydrochloride are the two most promising chemical agents. Quinacrine has evolved from instillations of a solution to the development of pellets to the use of an IUD vector. By using an IUD vector to deliver the quinacrine, tubal occlusion can be achieved with a reduction in total dosage and with one insertion instead of the three necessary with the solution and pellet methods.

Animals

Menstrual pattern changes in laparoscopic sterilization patients whose last pregnancy was terminated by therapeutic abortion. A two-year follow-up study.

Women were used as their own controls in the comparison of presterilization and poststerilization menstrual patterns. Five parameters were studied: regularity of cycle length, duration and amount of flow and incidence of dysmenorrhea and intermenstrual bleeding. Three parameters in the electrocoagulation group (regularity of cycle length and duration and amount of flow) and one parameter in the tubal ring group(duration of flow) showed significant changes after sterilization. However, by controlling for the effect of previous contraceptive methods used, no significant menstrual pattern changes following sterilization were discerned in either technique group.

Abortion, Therapeutic