Quickstart of Nexplanon® at Medical Abortion

Study Overview
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Brief Summary
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Women having abortions are at high risk for subsequent unintended pregnancy and repeat abortion. Clearly, encouraging contraceptive use after abortion is a high priority. Long acting reversible contraceptives (LARCs, Implants and intrauterine contraception) are the most effective methods to help women avoid a repeat unwanted pregnancy and abortion. Studies in surgical abortion patients, show that quickstart of a LARC - i.e., inserting it during the surgical procedure - is associated with substantially greater use of that method six months later than requiring women to return later to get the device. However, today a majority of women chose medical abortion. The clinical routine is to insert LARCs at the follow up 2 to 3 weeks after the abortion treatment. Frequently women choose to do part of the abortion treatment at home and do not return for a follow up. Thus, the possibility to quick start a contraceptive method in medical abortion would be a major advantage especially if this could be done at the time of administration of mifepristone.

Official Title
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Early Versus Delayed Insertion of Nexplanon® at Medical Abortion - a Randomized Controlled Equivalence Trial.

Conditions
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Early Pregnancy Termination, Medical Abortion, Postabortion Contraception

Intervention / Treatment
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* Drug: Mifepristone
* Drug: etonorgestrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women opting for medical abortion and post abortion Nexplanon no contraindicated to medical abortion or Nexplanon (according to the SMPc) gestational length up to and including 63 days (determined with ultrasonography) able and willing to provide informed consent Exclusion Criteria: unwilling to participate, unable to communicate in Swedish and English and minors (i.e. women < 18 years of age), contraindications to Nexplanon® women with pathological pregnancies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| Experimental: Etonorgestrel and mifepristone<br>Quickstart, insertion of Nexplanon on the day of mifepristone in medical abortion | Drug: Mifepristone<br>* Day one of medical abortion<br>Drug: etonorgestrel<br> <br> * Other names: Nexplanon, Contraceptive implant;|
| Active Comparator: mifepristone<br>Mifepristone on day 1. Nexplanon insertion at 3 weeks FU after the medical abortion | Drug: Mifepristone<br>* Day one of medical abortion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete abortions without surgical intervention | Efficacy of the medical abortion treatment | at 3 weeks follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unplanned pregnancy | Numbers of pregnancies within the first year following the index abortion | during one year FU | 
| Number of women with complications | reports and rates of AE/SAE | evaluated at the 3weeks FU | 
| Rate of implant insertion | Compliance, contraceptive usage | up to 1year FU | 
| Bleeding | Bleeding will be evaluated with regard to both bleeding during the medical abortion and bleeding patterns during the one year FU | Evaluated at 1 year FU | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medical abortion, postabortion contraception, LARC, Nexplanon, subdermal contraceptive implant