Clinical trial NCT00877344: Better Contraceptive Choices: Immediate or Delayed Insertion of IUC After Second Trimester Abortion
Official title: Better Contraceptive Choices: Immediate vs. Delayed Insertion of Intrauterine Contraception After Second Trimester Abortion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pregnancy
Keywords: Pregnancy
IUC
abortion
contraception
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Women's Health Research Institute of British Columbia
name: College of Family Physicians of Canada
First posted: 2009-04-07
Enrollment: 474
Sex: FEMALE
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study uses a drug (levonorgestrel-releasing intrauterine contraception ("Mirena" (R)), but as the study is conducted in Canada the FDA approval is not required. We have approval (a Letter of No Objection) from the Canadian Equivalent Institution: "Health Canada"
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pregnancy rate at one year
timeFrame: 12 months
Secondary outcomes:
measure: Rates at one year for Expulsion, Continuation of use, Satisfaction with method, Adverse events.
timeFrame: 60 months
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: Kelowna General Hospital Women's Services Clinic
state: British Columbia
city: Vancouver
country: Canada
facility: BC Women's Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Elizabeth Bagshaw Women's Clinic
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Wendy V. Norman, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Brian Fitzsimmons, MD
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Lyda Dicus
role: STUDY_CHAIR
References: