Quickstart of Nexplanon® at Medical Abortion

Karolinska Institute

Status and phase: Completed; Phase 4

Conditions: Medical Abortion; Early Pregnancy Termination; Postabortion Contraception

Treatments: Drug: etonorgestrel; Drug: Mifepristone

Study type: Interventional

Funder types: Other

Identifiers

NCT01920022

QW2013

Details and patient eligibility

About

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.

Enrollment: 551 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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551 participants in 2 patient groups

Etonorgestrel and mifepristone

Experimental group

Description:

Quickstart, insertion of Nexplanon on the day of mifepristone in medical abortion

Treatment:

Drug: Mifepristone

Drug: etonorgestrel

mifepristone

Active Comparator group

Description:

Mifepristone on day 1. Nexplanon insertion at 3 weeks FU after the medical abortion

Treatment:

Drug: Mifepristone