Contraception Clinical Trial
Official title:
A Randomized Trial of Immediate Versus Delayed Insertion of the Copper T380A Following Medication Abortion
After medication abortion, women may quickly become pregnant again and therefore need an effective birth control method right away. Intrauterine devices (IUDs) are very effective for preventing pregnancy. IUDs are usually placed more than a month after abortion. This study will randomly assign women having a medication abortion to two groups, either having the IUD inserted one week after medication abortion or having the IUD inserted more than four weeks later. Women will be followed for six months to compare how many return for IUD placement in the two groups, how many are using the IUD after six months, experience with pain, bleeding, and cramping, how easy or difficult it is to insert the IUD, how many IUDs are expelled or removed, and how many women are using any birth control six months after the abortion.
Women presenting for medication abortion are highly motivated to initiate contraception and
are also at high risk for repeat pregnancy. Intrauterine devices (IUDs) are among the most
effective reversible methods. IUD insertion is routinely planned for at least four weeks
after medication abortion. This leaves women vulnerable to pregnancy while waiting for IUD
placement, and many will not return for this visit. While immediate IUD insertion after
surgical abortion is known to be safe and effective, it has not been studied after
medication abortion.
This study will recruit women undergoing medication abortion at Special Gynecology Services
who desire an IUD for contraception. Women will be randomized to two groups: immediate
insertion of the copper IUD at the routine one week follow up visit, or delayed insertion of
the copper IUD at least four weeks after the medication abortion.
The primary objective of this study is to compare six month IUD prevalence between the
immediate and delayed IUD insertion groups. Secondary outcomes include comparison of IUD
insertion rates, continuation rates, expulsion and removal rates, and use of any
contraception at six months. Pain experienced during insertion and provider ease of
insertion will be recorded. A diary collected for four weeks following medication abortion
will reveal the impact of early IUD placement on bleeding and cramping. Lastly, we will
correlate endometrial stripe thickness and IUD position to outcomes of interest:
continuation, expulsion, and removal rates.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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