Intrauterine Contraception (IUC) After Medical Abortion

Study Overview
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Brief Summary
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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.

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

Conditions
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IUC Insertion After Medical Abortion

Intervention / Treatment
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* Other: Timing of IUC insertion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Delayed IUC insertion<br>Patients randomised to delayed, routine, insertion had their IUC inserted at 3-4 weeks (day 21-35 after mifepristone treatment | Other: Timing of IUC insertion<br>* 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.<br>* Other names: Women were free to chose the type of IUC;|
| Active Comparator: Early IUC insertion<br>Patients randomised to early insertion had their IUC inserted on day 5-9 after mifepristone treatment. | Other: Timing of IUC insertion<br>* 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.<br>* Other names: Women were free to chose the type of IUC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expulsion | Expulsions are recorded up to 6 months after the IUC insertion | 6 months after IUC insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PID | Pelvic inflammatory disease reported or diagnosed at FU | within 6 months of IUC insertion | 
| serum hemoglobin | S-Hb was measured at IUC insertion and at 4 weeks post insertion | 4 weeks post IUC insertion | 
| 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 | 
| Bleeding patterns | Bleeding patterns during the first 4 weeks post IUC insertion | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Copper IUD, LNG-IUS, intrauterine contraception, medical abortion, postabortion contraception