Long-term follow-up after quinacrine sterilization in Vietnam. Part II: interim safety analysis.
OBJECTIVE
To determine the long-term safety of nonsurgical sterilization with quinacrine.


METHODS
Observational cohort study.


METHODS
Rural provinces in northern Vietnam.


METHODS
Two thousand eight hundred forty women who had had quinacrine insertions and an age-matched comparison group of 1,658 women who had an intrauterine device (IUD) insertion between 1989 and 1993.


METHODS
Interviews in 1994, 1995, and 1996 and review of available medical records. This is a planned interim analysis.


METHODS
Ectopic pregnancies and the occurrence of other adverse health events.


RESULTS
Over 90% of women were interviewed at least once. Despite matching on age, the groups differed on baseline parity. The ectopic pregnancy rates were similar after either one or two insertions and were similar to the rate of ectopic pregnancies after surgical sterilization in the United States. The quinacrine group reported more gynecologic health problems than the IUD group. However, after correcting for information bias, there was no dose-response effect between the one- and two-insertion quinacrine groups, suggesting the possibility of recall bias or differing baseline health status.


CONCLUSIONS
Ectopic pregnancies do not appear to be increased compared with U.S. surgical sterilization rates. The data on other adverse events are more difficult to interpret.
Sokal
D
D
Family Health International, Research Triangle Park, NC 27709, USA. dsokal@fhi.org
Hieu
D T
DT
Weiner
D H
DH
Vinh
D Q
DQ
Huu Vach
T
T
Hanenberg
R
R
D000328:Adult; D015331:Cohort Studies; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007434:Intrauterine Devices; D000292:Pelvic Inflammatory Disease / Q000139:chemically induced; D011247:Pregnancy; D018873:Pregnancy Rate; D011271:Pregnancy, Ectopic / Q000139:chemically induced; D011796:Quinacrine / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D012449:Safety; D013245:Sterilization, Reproductive / Q000379:methods*; D014744:Vietnam; D016387:Women's Health
D011796:Quinacrine