Better Contraceptive Choices: Immediate or Delayed Insertion of IUC After Second Trimester Abortion

University of British Columbia

Status and phase: Unknown; Phase 4

Conditions: Pregnancy

Treatments: Procedure: Interval insertion; Procedure: Immediate insertion

Study type: Interventional

Funder types: Other

Identifiers

NCT00877344

H09-00363

Details and patient eligibility

About

Hypothesis

Intrauterine contraception placed immediately after a second trimester abortion will result in fewer pregnancies than current standard practice of intended placement at 4 weeks post-abortion.

Study Design

Randomized Controlled Trial after their second trimester abortion comparing immediate with delayed insertion of IUC, and a non intervention control group choosing non-intrauterine contraception. Participants choosing an IUC will be randomly assigned to immediate or delayed insertion. The investigators primary outcome is pregnancy rate within one year.

Full description

This Randomized Controlled Trial will be offered to women choosing to have a LNG-IUC or CuT380 after an abortion for gestational ages from 12 to 24 weeks. [delete next insert]"and a non intervention control group offered to all others having abortions at this gestational age". Participants choosing an LNG-IUC or CUT380 will be randomly assigned to immediate or interval insertion. In conjunction with follow up visits and questionnaires, the British Columbia Linked Health Database access will determine pregnancy rate within one year for the two intervention groups [delete next insert] and in relation to the various contraceptive choices made by the women not choosing intrauterine contraception. All women will complete surveys at 3, 6, 12, 24, 36, 48 and 72 months on their satisfaction with the contraceptive method chosen and on their satisfaction with study participation.

Enrollment: 474 patients

Sex: Female

Ages: 10+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Have completed informed consent for an abortion at gestation between 12 weeks zero days and 23 weeks 6 days, and
2. Choosing an IUC (either LNG-IUC or CuT380-IUC) for contraception post abortion, and
3. Residents of British Columbia, registered with the Medical Services Plan health care system.

Exclusion criteria

1. Intention to move from BC within the next year
2. Intention to conceive within the next year.
3. Any of the following contraindications to use of a LNG-IUC or a CuT380-IUC
4. Post Randomization Exclusion:

uterine perforation at the time of abortion

bleeding of more than 500 cc during abortion

any of the above exclusions detected at time of abortion

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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474 participants in 2 patient groups

1

Experimental group

Description:

Immediate insertion of either a LNG-IUC or a Copper T380 IUD after 12-24 week abortion

Treatment:

Procedure: Immediate insertion

2

Experimental group

Description:

Interval insertion (two to four weeks post abortion) of either a LNG-IUC or a Copper T380 IUD after 12-24 abortion

Treatment:

Procedure: Interval insertion