Immediate postpartum insertion of the norplant contraceptive device.

OBJECTIVE: To determine the safety and efficacy of Norplant (Wyeth-Ayerst Laboratories, Philadelphia, PA) insertion immediately postpartum. DESIGN: Prospective study of 14 women receiving Norplant immediately postpartum compared with controls (n = 6) having a bilateral tubal ligation. Subjects were followed for 3 months postpartum, and data were analyzed by analysis of variance and chi2. SETTING: Academic Health Sciences Center. PATIENTS: Female subjects 18 to 35 years old who had an uncomplicated term pregnancy, normal spontaneous vaginal delivery, and did not breast-feed. INTERVENTION: A brief interview, physical exam, and blood and urine samples were evaluated during a 12-week postpartum period. MAIN OUTCOME MEASURES: Major complaints, serum chemistry panels, hematologic and coagulative measures, serum E2, P, levonorgestrel, PRL, LH, FSH, and urinary estrone-3 conjugates and pregnanediol-3-glucuronide concentrations. RESULTS: Serum levonorgestrel peaked at approximately 2,000 pg/mL (6,400 pmol/L) during the 1st week after Norplant insertion, declining to approximately 250 pg/mL (800 pmol/L) by the 8th week. Significant differences between Norplant and control groups included bleeding irregularities, headaches, alopecia, and abdominal discomfort. Serum electrolytes, metabolic markers, and blood components were within normal limits. Serum E2, P, and urinary steriod biomarkers indicated that steroid secretion was suppressed severely in the Norplant group compared with controls who exhibited normal postpartum ovarian activity. CONCLUSION: Norplant inserted immediately postpartum appears to be a safe and effective method of contraception. However, the long-term hypoestrogenic state and contraceptive efficacy beyond the 3-month postpartum period as observed in this study are concerns that need further clinical evaluation.

PIP: During December 1992 to October 1994, in Texas, clinical researchers conducted a prospective case control study (15 cases receiving Norplant immediately postpartum vs. 6 controls undergoing bilateral tubal ligation immediately postpartum) to determine the safety and efficacy of inserting the contraceptive implant Norplant (6 capsules inserted subdermally, each containing 35 mg levonorgestrel) immediately postpartum. They followed the cases and the controls for three months. The study subjects were 18-35 years old, received prenatal care at one of the Department of Obstetrics and Gynecology's (Texas Tech University Health Sciences Center) community clinics, had an uncomplicated term pregnancy and normal spontaneous vaginal delivery, and did not breast feed. They tended to be poor. During the first week after Norplant insertion, serum levonorgestrel levels peaked at about 2000 pg/ml, then fell abruptly until about the eighth week to about 250 pg/ml. This lower levonorgestrel level concerned the researchers because it is just slightly higher than levels associated with pregnancy. They were also concerned about the possibility of Norplant inducing a hypoestrogenic state in postpartum women. The Norplant group was more likely than the tubal ligation group to experience irregular bleeding (p 0.01), headaches (p 0.01), hair loss (p 0.05), and abdominal discomfort (p 0.05). The various serum metabolic biomarkers, serum electrolytes, and blood components fell into the normal range in both groups. The serum estradiol, progesterone, and urinary steroid biomarkers suggested that the Norplant group experienced very suppressed steroid secretion throughout the three month study period, while the controls had normal postpartum ovarian activity. Thus, ovarian activity was absent in the Norplant group. These findings suggest that postpartum insertion of Norplant is safe and effective. Yet further clinical evaluation is needed to address concerns about the long-term hypoestrogenic state and contraceptive efficacy beyond the three month postpartum period.

Comparison of the operating microscope and loupe for microsurgical tubal anastomosis: a randomized clinical trial.

Reversal of sterilization was performed by microsurgical tubal anastomosis in 72 women using either loupe (n = 36) or microscope (n = 36). The study design called for the randomization of patients within pairs, which were matched for method of sterilization and site of anastomosis. A significant difference between methods could not be demonstrated at 12 months (P = 0.39) or 24 months (P = 0.37) after the procedure.

PIP: This paper describes a randomized, controlled clinical trial to compare the efficacy of the loupe and the microscope in performing a microsurgical anastomosis of tubal segments other than the cornual-isthmic region. 72 women evaluated at the Johns Hopkins Hospital in Baltimore between January 1, 1978 and December 31, 1980, for reversal of sterilization met the criteria for entry into the trial: under 36 years of age and at least 5 cm of oviduct remaining. The surgeon was informed of which device to use for magnification just prior to the procedure. The study design called for the randomization of patients within pairs, which were matched for method of sterilization and site of anastomosis. No significant differences were observed between the loupe and microscope groups in age, parity, or interval from sterilization to reversal. 75% of each group had had an ampullary-isthmic anastomosis, 22% of the loupe and 20% of the microscope group had had an amupllary-ampullary anastomosis, and 3% of the loupe and 6% of the microscope group had had an isthmic-isthmic anastomosis. At 12 and 24 months after the reversal procedures, no differences could be demonstrated between the groups with respect to total pregnancies, term pregnancies, spontaneous abortions, or ectopic pregnancies. 23 of 36 loup patients and 19 of 36 microscope patients had term pregnancies, but the differences were not significant.

Artificial insemination with fresh donor semen using the cervical cap technique: a review of 278 cases.

Two hundred twenty-six patients received artificial insemination with fresh donor semen (AID) using the cervical cap technique; 52 patients underwent the procedure for 2 conceptions. Using life-table analysis to adjust for uneven patient follow-up, the cumulative pregnancy rate was 62.5% after 6 months of AID, and 82.4% after 10 months. Moreover, using a mathematical model of cumulative pregnancy following AID, the estimated cure rate was not significantly different from 100%, and the estimated monthly probability of pregnancy among those cured was 15.5%. Age was found to be inversely related to pregnancy success, while parity had no effect. For those who continued to undergo AID beyond 6 months, the monthly probability of pregnancy did not decline. Patients can be advised that their chance of conception with AID should approach that of normal fertile couples.

Cul-de-sac fluid in women with endometriosis: fluid volume and prostanoid concentration during the proliferative phase of the cycle--days 8 to 12.

Cul-de-sac fluid from women with histologically confirmed endometriosis (n = 45) or with no evidence of endometriosis (n = 17) was removed during the proliferative phase of the menstrual cycle (days 8 to 12) and analyzed for prostaglandin E2 (PGE2), prostaglandin F2 alpha (PGF2 alpha), 15-keto-13,14-dihydroprostaglandin F2 alpha (PGFM), and thromboxane B2 (TXB2). The fluid volume was recorded. Peripheral blood was also obtained to determine the concentration of PGFM. Prostanoid concentrations (PGE2, PGF2 alpha, PGFM, TXB2) in women with endometriosis were not significantly different from a comparable group of disease-free women. Furthermore, a meaningful elevation of prostanoid with increasing severity of disease could not be demonstrated. Plasma PGFM was not significantly different from controls. There was, however, an elevation of PGFM with severity of disease, although this increase was not statistically significant (P = 0.11). An increase in fluid volume was not demonstrated in women with endometriosis, as compared with controls.

Tubal anastomosis following unipolar cautery.

Twenty-five of 48 women (52%) sterilized by unipolar cautery techniques conceived following tubal anastomosis, of whom 17 (36%) had a living child. The overall cumulative probability of conception at the end of follow-up as determined by life-table analysis was 76%. Increasing age, parity, and the duration of the interval from sterilization to reversal did not influence pregnancy success. A decreased pregnancy rate was associated with ampullary-isthmic anastomosis; however, a pregnancy was least likely to occur in women with shortened oviducts of less than or equal to 4 cm (P less than 0.01). A decreased pregnancy rate in cautery-sterilized patients undergoing reversal may be related to the destruction of a larger segment of the fallopian tube. Interestingly, 71% of the cautery-sterilized patients were noted to have associated tubal disease such as endometriosis and/or proximal hydrosalpinx. The influence of these findings on subsequent pregnancy success remains to be established.

Pregnancy outcome following treatment of intrauterine adhesions.

Twenty-five patients were evaluated for reproductive failure and menstrual dysfunction before and after therapy of intrauterine adhesions. The patients were classified according to the extent of adhesion formation by means of a classification proposed by Toaff and Ballas. A pretherapy successful pregnancy rate of 32% was increased to 52% posttherapy. The spontaneous abortion rate of 78% was improved to 20% posttherapy. Altered menstrual function was noted in six of 25 patients. A correlation between the extent of intrauterine adhesion formation and pregnancy outcome following therapy could not be demonstrated. The authors recommend the adoption of a classification system based on hysteroscopic findings which may serve as a standard method of reporting to allow for comparison of treatment regimens and ultimately for prediction of pregnancy outcome.

PIP: 25 patients with intrauterine synechiae were observed between 1960-79 at the Dept. of Obstetrics and Gynecology at the Johns Hopkins Hospital, Baltimore, Maryland. Therapy consisted of hysteroscopy, dilatation and curettage, and lysis of adhesions; repeat procedures were performed when needed. 80% of patients had repeated pregnancy loss, and 20% had secondary infertility. According to the Toaff and Ballas classification, the majority of patients had grade 1 and grade 2 disease, (1/10-1/5 of the uterine cavity was occupied by filling defects), while only 6 patients had 1/3 or more of the uterine cavity obliterated. 19 patients reported normal menses. Lysis of adhesions greatly improved the reproductive performance of patients; a pretherapy successful pregnancy rate of 32% was increased to 52% posttherapy, and a spontaneous abortion rate of 78% was improved to 20%. A correlation between the extent of uterine adhesions and subsequent pregnancy outcome following therapy could not be demonstrated and there was nothing to indicate a correlation between the extent of synechiae and alteration of the menstrual flow. Some authors have suggested an increase in the occurrence of intrauterine adhesions related to the increasing number of induced abortions. Several classification systems have been suggested to categorize the severity of adhesion formation; a uniform classification should be adopted based on hysteroscopic findings, so that comparison of specific treatment regimens may be performed.