Clinical trial NCT01920022: Quickstart of Nexplanon® at Medical Abortion
Official title: Early Versus Delayed Insertion of Nexplanon® at Medical Abortion - a Randomized Controlled Equivalence Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Early Pregnancy Termination
Medical Abortion
Postabortion Contraception
Keywords: medical abortion
postabortion contraception
LARC
Nexplanon
subdermal contraceptive implant
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2013-08-09
Enrollment: 551
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Complete abortions without surgical intervention
timeFrame: at 3 weeks follow up
Secondary outcomes:
measure: Unplanned pregnancy
timeFrame: during one year FU
measure: Number of women with complications
timeFrame: evaluated at the 3weeks FU
measure: Rate of implant insertion
timeFrame: up to 1year FU
measure: Bleeding
timeFrame: Evaluated at 1 year FU
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset/Östra
city: Linköping
country: Sweden
facility: Universitetssjukhuset
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset
city: Stockholm
country: Sweden
facility: Danderyds Hospital
city: Stockholm
country: Sweden
facility: Södersjukhuset
city: Örebro
country: Sweden
facility: Universitetssjukhuset i Örebro
city: Edinburgh
country: United Kingdom
facility: Chalmers Sexual and Reproductive Health Service
Study officials:
affiliation: Karolinska Institutet
name: Kristina Gemzell-Danielsson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hognert H, Kopp Kallner H, Cameron S, Nyrelli C, Jawad I, Heller R, Aronsson A, Lindh I, Benson L, Gemzell-Danielsson K. Immediate versus delayed insertion of an etonogestrel releasing implant at medical abortion-a randomized controlled equivalence trial. Hum Reprod. 2016 Nov;31(11):2484-2490. doi: 10.1093/humrep/dew238. Epub 2016 Sep 22.