Objective: To determine the safety and efficacy of Norplant (Wyeth-Aye
rst Laboratories, Philadelphia, PA) insertion immediately postpartum.
Design: Prospective study of 14 women receiving Norplant immediately p
ostpartum compared with controls (n = 6) having a bilateral tubal liga
tion. Subjects were followed for 3 months postpartum, and data were an
alyzed by analysis of variance and chi(2). Setting: Academic Health Sc
iences Center. Patients: Female subjects 18 to 35 years old who had an
uncomplicated term pregnancy, normal spontaneous vaginal delivery, an
d did not breast-feed. Intervention: A brief interview, physical exam,
and blood and urine samples were evaluated during a 12-week postpartu
m period. Main Outcome Measures: Major complaints, serum chemistry pan
els, hematologic and coagulative measures, serum E(2), P, levonorgestr
el, PRL, LH, FSH, and urinary estrone-3 conjugates and pregnanediol-3-
glucuronide concentrations. Results: Serum levonorgestrel peaked at ap
proximately 2,000 pg/mL (8,400 pmol/L) during the Ist week after Norpl
ant insertion, declining to approximately 250 pg/mL (800 pmol/L) by th
e 8th week. Significant differences between Norplant and control group
s included bleeding irregularities, headaches, alopecia, and abdominal
discomfort. Serum electrolytes, metabolic markers, and blood componen
ts were within normal Limits. Serum E(2), P, and urinary steroid bioma
rkers 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 t
he 3-month postpartum period as observed in this study are concerns th
at need further clinical evaluation.