Immediate Versus Delayed Insertion of the Copper Intrauterine Device (IUD) After Medication Abortion

Phase 4

Completed

Conditions: Contraception

Interventions: Device: CuT380A

Registration Number: NCT00737178

Lead Sponsor: Columbia University

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 156

Inclusion Criteria

Undergoing medication abortion
18 or older
Desires IUD as birth control method for a minimum of six months
Speaks Spanish or English
Has a working phone number or pager
Is willing to attend visits and will be in the area for next six months
Has signed informed consent

Exclusion Criteria

Chlamydia, gonorrhea, or pelvic inflammatory disease within the past three months
Known bleeding diathesis including anti-coagulation
Uterine abnormality including sub-mucous myomas that significantly distort the uterine cavity
Current cervical, uterine, or ovarian malignancy
high-grade squamous intraepithelial lesion on most recent pap
IUD insertion contraindicated by the World Health Organization's Medical Eligibility Criteria for Contraceptive Use (category 3 or 4)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate IUD insertion	CuT380A	Insertion of CuT380A at the routine medication abortion follow-up visit one week after initiation of a medication abortion
Delayed IUD insertion	CuT380A	Insertion of CuT380A four to six weeks after initiation of a medication abortion

Primary Outcome Measures

Name	Time	Method
Use of the IUD for Contraception at Six Months	6 months	Six months after enrollment, we determined whether or not women were using the IUD through in-person exit interviews and phone interviews. This was an intention to treat analysis, comparing the proportion of women using the IUD based on their group assignment (immediate or delayed).

Secondary Outcome Measures

Name	Time	Method
Expulsion and Removal Rates	Within six months of medication abortion	Expulsion rates were defined as the number of IUDs expelled from the uterus among participants who had the IUD inserted during the study. Removal rates were defined as the number of IUDs that were electively removed by participant request among participants who had the IUD inserted during the study.
Insertion Rates	By six months after medication abortion	Insertion rates are the proportion of women in each allocation group (immediate, delayed) who ultimately had the IUD inserted within the 6 month study period.