Intrauterine Contraception (IUC) After Medical Abortion

IUC Insertion After Medical Abortion Clinical Trial

Official title:

Early Versus Delayed Insertion of Intrauterine Contraception After Medical Abortion- a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01537562
• Other study ID #: WIUC12
• Status: Completed
• Phase: N/A
• First received: February 15, 2012
• Last updated: February 22, 2012
• Start date: February 2007
• Est. completion date: October 2010

Study information

• Verified date: February 2012
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

Today a large proportion of early abortions are medical, in accordance to the woman's choice. The main objective of the present study was to compare, in a randomised fashion, initiation of intrauterine contraception (IUC) at about 1 week versus 3 to 4 weeks post medical abortion with regard to expulsions and safety.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: October 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• age above 18

• elective medical abortion up to 9 weeks (63 days) of amenorrhea

• general good health and

• good understanding of Swedish language.

Exclusion Criteria:

• pathological pregnancies or abnormality of the uterus

• complications after the medical abortion, such as on-going pregnancy retained gestational sac or endometritis

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• IUC Insertion After Medical Abortion

Intervention

Other:
• Timing of IUC insertion
Patients randomised to early insertion had their IUC inserted on day 5-9 after mifepristone treatment while patients randomised to delayed insertion had the IUC insertion at about 3 to 4 weeks after mifepristone.

Locations

Country	Name	City	State
Sweden	WHO centre, Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expulsion	Expulsions are recorded up to 6 months after the IUC insertion	6 months after IUC insertion	Yes
Secondary	PID	Pelvic inflammatory disease reported or diagnosed at FU	within 6 months of IUC insertion	Yes
Secondary	serum hemoglobin	S-Hb was measured at IUC insertion and at 4 weeks post insertion	4 weeks post IUC insertion	Yes
Secondary	Compliance	impact on the number of women who return for IUC insertion, and compliance with IUC use during the first 6 months following insertion	6 months	No
Secondary	Bleeding patterns	Bleeding patterns during the first 4 weeks post IUC insertion	4 weeks	Yes