Phase 4
N=156
Immediate Versus Delayed Insertion of the Copper Intrauterine Device (IUD) After Medication Abortion
Contraception
Bottom Line
View on ClinicalTrials.gov: NCT00737178 ↗Enrolled (actual)
156
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: Use of the IUD for Contraception at Six Months — 49; 51 participants — p=0.24
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- CuT380A (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Columbia University
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Use of the IUD for Contraception at Six Months |
49; 51 | 0.24 |
| SECONDARY Insertion Rates |
69; 65 | <.01 sig |
| SECONDARY Expulsion and Removal Rates |
8; 7; 10; 5 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT00737178). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.