Placement of an intrauterine device within 48 hours after early medical abortion : a randomized controlled trial

• BACKGROUND: Intrauterine devices are safe, well tolerated and known to reduce the risk of unwanted pregnancies. At medical abortion, intrauterine devices are placed at a follow-up visit. Patients who miss this visit risk being left without contraception.OBJECTIVE: To study if placement of an intrauterine device within 48 hours of completed medical abortion up to 63 days' gestation leads to higher user rates at six months after the abortion compared with placement at two to four weeks after abortion. Furthermore, to compare continued use of intrauterine devices, safety and patient satisfaction between groups.STUDY DESIGN: We performed an open-label, randomized, controlled, multicenter, superiority trial (phase 3). A total of 240 patients requesting medical abortion up to 63 days' gestation and opting for intrauterine device were allocated to placement within 48 hours of complete medical abortion (intervention group) or at 2-4 weeks after abortion (control group). We defined the abortion as complete after bleeding of clots and cessation of heavy bleeding following use of misoprostol. Patients answered questionnaires at 3, 6 and 12 months. Primary outcome was use of intrauterine device at 6 months post abortion. Secondary outcomes included expulsion rate, pain at placement, adverse events and complications from the abortion, acceptability, and pregnancies and their outcomes. Differences in non-parametric continuous variables were analyzed by the Mann-Whitney U-test and differences in dichotomous variables were analyzed by Chi square test or Fisher's exact test. A p-value of < 0.05 was considered statistically significant.RESULTS: In the intervention group, 91/111 (82%) used an intrauterine device at six months after the abortion, compared to 87/112 (77.7%) in the control group with a difference in proportion of 4.3% (95% CI -0.062, 0.148, p=0.51). Attendance rate and rate of successful intrauterine device placement were similar between groups. Patients in the intervention group had lower pain scores at placement of the intrauterine device (mean pain score VAS 32.3, SD 29) compared to the control group (mean pain score VAS 43.4, SD 27.9, p=0.002). Patients preferred their allocated time of placement significantly more often in the intervention group, (83/111, 74.8%) compared to the control group (70/114, 61.4%, p=0.03). Use of ultrasound at intrauterine device placement (because of doubts concerning complete abortion) was more common in the intervention group (43/108, 39.8%) compared to the control group (15/101, 14.9%, p<0.001) and in one patient in the control group, a retained gestational sac was found. Three patients in the intervention group and two patients in the control group had a vacuum aspiration. No difference was found in intrauterine device expulsion rates between the groups. In the intervention group, 9/97 (9.3%) patients experienced expulsion during the first six months after abortion and 4/89 (4.5%, p=0.25) in the control group. There were no perforations or infections requiring antibiotic treatment.CONCLUSION: Placement of an intrauterine device within 48 hours after medical abortion at ≤ 63 days' gestation does not lead to higher user rates at six months after the abortion, compared with intrauterine device placement at 2-4 weeks after abortion. When compared with placement at a follow-up visit after 2-4 weeks, intrauterine device placement within 48 hours after early medical abortion appears safe, is preferred by patients and associated with lower pain scores.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Reproduktionsmedicin och gynekologi (hsv//swe)

MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Obstetrics, Gynaecology and Reproductive Medicine (hsv//eng)

Nyckelord

Abortion

Contraception

Copper

Family Planning Services

Hormone Releasing

IUD

Induced

Intrauterine Devices

Long-Acting Reversible Contraception

Medicated

Postabortion intrauterine device insertion

Publikations- och innehållstyp

ref (ämneskategori)

art (ämneskategori)