Use of Norplant contraceptive implants in the immediate postpartum period: safety and tolerance

Abstract

Objective: Our purpose was to determine the safety and tolerance of levonorgestrel contraceptive implants (Norplant, Wyeth-Ayerst, Philadelphia) when inserted immediately post partum, to document the effects on weight and blood pressure, and to determine the side effects.

Study design: After vaginal delivery, 250 women were randomized to receive Norplant within 48 hours of delivery (study group) or at the 4- to 6-week postpartum visit (control group). Baseline measurements were recorded and compared with those obtained at the 4- to 6-week follow-up visit. A diary was maintained by patients who recorded bleeding and side effects. Statistical analysis was performed with t test and chi 2 analysis.

Results: There were no episodes of acute postpartum hemorrhage or clinically significant bleeding. Compared with the control group, the immediate group reported significantly more bleeding days (p < 0.01). There was no significant difference between the two groups in the hemoglobin values obtained at 4 to 6 weeks post partum. The immediate insertion group reported significantly more headaches (p < 0.01) and acne (p = 0.01).

Conclusion: Norplant is well tolerated and should be available for interested patients immediately post partum.

PIP: During June 1992-February 1993, physicians in Charlotte, North Carolina, randomly assigned 250 women who had delivered vaginally at the Carolinas Medical Center to receive the contraceptive implant Norplant either before being discharged from the hospital on postpartum day 1, 2, or 3 or 4-6 weeks later at the scheduled postpartum follow-up visit. They wanted to ascertain whether insertion of Norplant in the immediate postpartum period was safe and well-tolerated. 26 women were lost to follow-up. 11 of these women were in the delayed insertion group, so they did not receive Norplant or an alternative contraceptive method, placing them at risk of pregnancy. Another 34 women in the same group returned for their follow-up visit but did not receive Norplant. The mean interval from delivery to insertion stood at 1.7 days for the immediate insertion group and 34.3 days for the delayed insertion group. No one in either group experienced acute postpartum hemorrhage. The immediate insertion group had much more bleeding and spotting than did the delayed insertion group (17 vs. 13.6 days, p 0.01, and 11.1 vs. 8.8 days, p = 0.03, respectively; 28.2 vs. 22.4 days for both spotting and bleeding, p 0.01). Since hemoglobin values of the two groups did not differ (12.9 vs. 12.7), the increased bleeding was not clinically significant. Women in the immediate insertion group were more likely than those in the delayed insertion group to have headaches on at least seven days between insertion and study follow-up (15.1% vs. 2.8%; p 0.01). They also were more likely to have acne during at least three days (18.9% vs. 6.4%; p 0.01). They were just as likely as the delayed insertion group to report nausea, hair loss, and hirsutism. 40% of the women in both groups had sexual intercourse before their 4-6 week follow-up visit. These findings show that Norplant can be safe and well-tolerated if inserted in the immediate postpartum period.