Quickstart of Nexplanon® at Medical Abortion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

551 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-10-31

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.

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Detailed Description

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Conditions

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Early Pregnancy Termination Medical Abortion Postabortion Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Etonorgestrel and mifepristone

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

Group Type EXPERIMENTAL

Mifepristone

Intervention Type DRUG

Day one of medical abortion

etonorgestrel

Intervention Type DRUG

mifepristone

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

Group Type ACTIVE_COMPARATOR

Mifepristone

Intervention Type DRUG

Day one of medical abortion

Interventions

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Mifepristone

Day one of medical abortion

Intervention Type DRUG

etonorgestrel

Intervention Type DRUG

Other Intervention Names

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Nexplanon, Contraceptive implant

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No