Better Contraceptive Choices: Should your intrauterine contraceptive be put in when you have an abortion over 12 weeks gestation, or a month afterwards?

ISRCTN	ISRCTN19506752
DOI	https://doi.org/10.1186/ISRCTN19506752
Secondary identifying numbers	N/A

Submission date: 20/05/2010
Registration date: 15/06/2010
Last edited: 28/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Wendy V. Norman
Scientific

200- 1177 West Broadway
Vancouver
V6H 1G3
Canada

Phone	+1 604 761 7767
Email	wendy.norman@ubc.ca

Study information

Study design	Interventional multisite randomized controlled trial. Randomization by blocking (4) and stratified for parity and study site.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	Not available in web format, please use contact details to request a patient information sheet
Scientific title	Better Contraceptive Choices for Marginalized Women: A Randomised Controlled Trial Comparing Immediate or Interval Insertion of Intrauterine Contraception after Second Trimester Abortion
Study objectives	We hypothesize that intrauterine contraception (IUC) placed immediately after second trimester abortion will result in fewer pregnancies than current standard practice of intended placement at 4 weeks post-abortion.
Ethics approval(s)	The University of British Columbia, Children's and Women's Hospital Research Ethics Board (REB) approved on the 13th of April 2010 (ref: UBC Study ID: H10-00306)
Health condition(s) or problem(s) studied	Contraceptive management; Intrauterine contraceptive devices
Intervention	To women seeking a therapeutic abortion in their second trimester of pregnancy (over 12 weeks gestation) who are interested in intrauterine contraception, we offer a choice between two leading IUC devices currently available in Canada: LNG-IUC (containing 52 mg levonorgestrel, Mirena Intrauterine System, Bayer Inc, Toronto, Ont.) and CuT380-IUC (a T-shaped IUC offering 380mm2 surface area of copper, FlexiT380 (+), Prosan International, BV). The total duration of follow up is 5 years from the date of IUC insertion.
Intervention type	Other
Primary outcome measure	Pregnancy rate at one year among women randomized to immediate insertion compared to women randomized to a planned insertion at 4 weeks (interval insertion) for each of the two leading IUC devices. As many women randomized to an interval insertion will never have an IUC inserted, a real life condition for this current standard of care, we will analyse pregnancy rates based upon those randomized to each group, rather than upon those who insert an IUC. In this way we will analyse by intention to treat rather than by treatment received. Thus our primary outcome will reflect real life conditions and the true effectiveness of a health care delivery change to prevent unintended pregnancies (immediate insertions of IUC versus the current standard of planned interval insertions).
Secondary outcome measures	1. Costs and cost effectiveness 2. Rates of loss to follow up 3. Adverse events (such as infection or perforation: anticipated at under 1%) 4. Expulsion 5. Continuation of method 6. Satisfaction with IUC chosen and with insertion timing assigned These outcomes will be assessed initially at one year, and through questionnaires in this study and administrative data base access in subsequent studies, annually during the 5 year device effectiveness period.
Overall study start date	01/04/2010
Completion date	06/04/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	716 women; 358 (175-Mirena IUS & 183-Copper) recruited to each arm: immediate insertion vs planned interval insertion. (Amended on 13/03/2012: participant enrollment completed)
Key inclusion criteria	This study will be offered to all women who present at the study sites meeting all of the following criteria: 1. Have completed informed consent for an abortion over 12 and under 24 weeks gestational age 2. Have chosen an IUC (either LNG-IUS or CuT380-IUD) for contraception post abortion 3. Are residents of British Columbia (BC) registered with the Medical Services Plan health care system 4. Are able to give informed consent 5. No age limits. Women ot girls of any age, fulfilling the above criteria will be eligibile
Key exclusion criteria	1. Any of the following contraindications to use of a LNG-IUC or a CuT380-IUC: 1.1. Uterine cavity anomalies causing distortion of the endometrial canal including fibroids of > 5 cm, excluding repaired Uterine septum 1.2. Current untreated PID, Chlamydia, gonorrhea, cervicitis or lower genital tract infection 1.3. Wilsons Disease (if choosing a CuT380-IUC) 1.4. Undiagnosed abnormal uterine bleeding 1.5. Known uterine or cervical malignancy or cervical dysplasia 1.6. Known or suspected progestin-dependent neoplasia, including breast cancer (if choosing a LNG-IUC) 1.7. Active liver disease or dysfunction (if choosing a LNG-IUC) 1.8. Actual benign or malignant liver tumours (if choosing a LNG-IUC) 1.9. Hypersensitivity to levonorgestrel or any of the other ingredients in the formulation or component of the container components of MIRENA (if choosing a LNG-IUC) 1.10. Current bacterial endocarditis 1.11. Established immunodeficiency 1.12. Acute malignancies affecting blood or leukemias 1.13. Recent trophoblastic disease while hCG levels are elevated 2. Intention to move from BC within the next year 3. Intention to conceive within the next year 4. Post Randomization Exclusion: 4.1. Uterine perforation at the time of abortion 4.2. Bleeding of more than 500 cc during abortion 4.3. Any of the above exclusions detected at the time of abortion
Date of first enrolment	01/04/2010
Date of final enrolment	06/04/2015

Locations

Countries of recruitment

Canada

Study participating centre

200- 1177 West Broadway

Vancouver
V6H 1G3
Canada

Sponsor information

University of British Columbia (Canada)
University/education

Faculty of Medicine
200- 1177 West Broadway
Vancouver
V6H 1G3
Canada

Email	abc@email.com
"ROR"	https://ror.org/03rmrcq20

Funders

Funder type

Research council

Canadian Institutes of Health Research (CIHR) (Canada) (F09-04035)
Government organisation / National government

Alternative name(s): Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
Location: Canada

Women's Health Research Institute (Canada) (infrastructure support) (F08-05221)

No information available

Bayer Canada (solely by donation of Mirena devices with no financial support, nor input to study design or conduct) (F09-04254)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	14/06/2011		Yes	No
Other publications		12/07/2016	28/10/2022	Yes	No

Editorial Notes

28/10/2022: Publication reference added.
24/07/2020: No publications found.
31/01/2019: Internal review