Immediate Versus Delayed IUD Insertion After Second Trimester Medical Abortion

Study Overview
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Brief Summary
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The main objective of the study is to compare use, in a randomised controlled trial, of the the copper IUD if inserted immediately after completion of a second trimester medical abortion, to standard care with insertion 3-4 or more weeks after abortion at community health centres.

Official Title
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Immediate Versus Delayed Insertion of the Copper IUD After Second-trimester Medical Abortion - a Randomised Controlled Trial.

Conditions
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Contraception

Intervention / Treatment
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* Device: Copper Intrauterine device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to speak English, Afrikaans or Xhosa; Requesting and eligible for abortion according to standard practice at the hospital; Gestational age 13-20 weeks verified by ultrasound; Interested and eligible for the copper IUD as a post-abortion contraceptive method; Willingness to participate in the trial including follow-up; Able to provide a working phone & telephone number to allow for contact; Willing and able to provide informed consent Staying within one hour travel time of GSH Exclusion Criteria: Active pelvic inflammatory disease, pelvic tuberculosis; severe thrombocytopenia; Positive N. Gonorrhea or C. Trachomatis that has not been adequately treated Copper allergy Hb <10g/dL Uterine anomaly preventing placement of the IUD; cervical cancer or carcinoma in-situ, untreated high grade squamous intraepithelial lesions Hemorrhage; or ruptured uterus History of ectopic pregnancy Wilsons' disease

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate group:<br>The Copper Intrauterine device will be inserted within 24 hours of the expulsion of the fetus and placenta or after surgical evacuation for placental remains, and prior to discharge from the facility. | Device: Copper Intrauterine device<br>* Immediate insertion of the copper intrauterine device after completion of abortion<br>|
| No Intervention: Delayed Group<br>The Copper Intrauterine device will be inserted at a local community health centre 14-28 days after discharge. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of the copper IUD | Number of women using the IUD | 6 weeks after second trimester abortion | 
| Insertion of the IUD | Number of IUD insertions | 6 weeks after second trimester abortion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of the IUD at 3 months post-abortion | Number of women using the IUD | 3 months after second trimester medical abortion | 
| Use of the IUD at 6 months post-abortion | Number of women using the IUD | 6 months after second trimester medical abortion | 
| Spontaneous expulsion of the IUD | Number of full and partial expulsions | 6 weeks post-abortion | 
| Spontaneous expulsion of the IUD | Number of full and partial expulsions | Between 6 weeks and 3 months post abortion | 
| Spontaneous expulsion of the IUD | Number of full and partial expulsions | Between 3 and 6 months post abortion | 
| Removal of IUD and associated factors | Number of removals | within 3 and 6 months post-abortion | 
| Abortion-related and IUD-related complications | Number of complications | within 3 months post-abortion | 
| Women's satisfaction and acceptability of the IUD | 5 point scales | Reported at 3 and 6 months post-abortion | 
| Recurrent pregnancy | Number of recurrent pregnancies | At 6 months post-abortion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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second trimester medical abortion, Immediate versus delayed insertion, copper intrauterine device