Quickstart of Nexplanon® at Medical Abortion

Phase 4

Completed

• Conditions: Postabortion Contraception; Medical Abortion; Early Pregnancy Termination
• Interventions: Drug: Mifepristone; Drug: etonorgestrel

• Registration Number: NCT01920022
• Lead Sponsor: Karolinska Institutet

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-06
• Study First Submitted QC: 2013-08-07
• Study First Posted: 2013-08-09
• Study Start: 2013-10
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-24
• Last Update Posted: 2016-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 551

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Etonorgestrel and mifepristone	etonorgestrel	Quickstart, insertion of Nexplanon on the day of mifepristone in medical abortion
mifepristone	Mifepristone	Mifepristone on day 1. Nexplanon insertion at 3 weeks FU after the medical abortion
Etonorgestrel and mifepristone	Mifepristone	Quickstart, insertion of Nexplanon on the day of mifepristone in medical abortion

Primary Outcome Measures

Name	Time	Method
Complete abortions without surgical intervention	at 3 weeks follow up	Efficacy of the medical abortion treatment

Secondary Outcome Measures

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

Trial Locations

Locations (7)

Universitetssjukhuset; 🇸🇪 Linköping, Sweden

Universitetssjukhuset i Örebro; 🇸🇪 Örebro, Sweden

Chalmers Sexual and Reproductive Health Service; 🇬🇧 Edinburgh, United Kingdom

Sahlgrenska Universitetssjukhuset/Östra; 🇸🇪 Göteborg, Sweden

Danderyds Hospital; 🇸🇪 Stockholm, Sweden

Södersjukhuset; 🇸🇪 Stockholm, Sweden

Karolinska Universitetssjukhuset; 🇸🇪 Stockholm, Sweden