ABSTRACT
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.