Intrauterine Contraception (IUC) After Medical Abortion

Not Applicable

Completed

• Conditions: IUC Insertion After Medical Abortion
• Interventions: Other: Timing of IUC insertion

• Registration Number: NCT01537562
• Lead Sponsor: Karolinska Institutet

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Primary Completion: 2010-04
• Study Completion: 2010-10
• Status Verified: 2012-02
• Study First Submitted: 2012-02-15
• Study First Submitted QC: 2012-02-22
• Last Update Submitted: 2012-02-22
• Study First Posted: 2012-02-23
• Last Update Posted: 2012-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 129

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delayed IUC insertion	Timing of IUC insertion	Patients randomised to delayed, routine, insertion had their IUC inserted at 3-4 weeks (day 21-35 after mifepristone treatment
Early IUC insertion	Timing of IUC insertion	Patients randomised to early insertion had their IUC inserted on day 5-9 after mifepristone treatment.

Primary Outcome Measures

Name	Time	Method
Expulsion	6 months after IUC insertion	Expulsions are recorded up to 6 months after the IUC insertion

Secondary Outcome Measures

Name	Time	Method
PID	within 6 months of IUC insertion	Pelvic inflammatory disease reported or diagnosed at FU
serum hemoglobin	4 weeks post IUC insertion	S-Hb was measured at IUC insertion and at 4 weeks post insertion
Compliance	6 months	impact on the number of women who return for IUC insertion, and compliance with IUC use during the first 6 months following insertion
Bleeding patterns	4 weeks	Bleeding patterns during the first 4 weeks post IUC insertion

Trial Locations

Locations (1)

WHO centre, Karolinska University Hospital; 🇸🇪 Stockholm, Sweden