Quickstart of Nexplanon® at Medical Abortion

Medical Abortion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01920022
• Other study ID #: QW2013
• Status: Completed
• Phase: Phase 4
• First received: August 6, 2013
• Last updated: February 24, 2016
• Start date: October 2013
• Est. completion date: October 2015

Study information

• Verified date: February 2016
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 551
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Early Pregnancy Termination
• Medical Abortion
• Postabortion Contraception

Intervention

Drug:
• Mifepristone
Day one of medical abortion
• etonorgestrel

Locations

Country	Name	City	State
Sweden	Sahlgrenska Universitetssjukhuset/Östra	Göteborg
Sweden	Universitetssjukhuset	Linköping
Sweden	Universitetssjukhuset i Örebro	Örebro
Sweden	Danderyds Hospital	Stockholm
Sweden	Karolinska Universitetssjukhuset	Stockholm
Sweden	Södersjukhuset	Stockholm
United Kingdom	Chalmers Sexual and Reproductive Health Service	Edinburgh

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Countries where clinical trial is conducted

Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete abortions without surgical intervention	Efficacy of the medical abortion treatment	at 3 weeks follow up	No
Secondary	Unplanned pregnancy	Numbers of pregnancies within the first year following the index abortion	during one year FU	No
Secondary	Number of women with complications	reports and rates of AE/SAE	evaluated at the 3weeks FU	Yes
Secondary	Rate of implant insertion	Compliance, contraceptive usage	up to 1year FU	No
Secondary	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	Yes