Early Pregnancy Termination, Medical Abortion, Postabortion Contraception
Conditions
Keywords
medical abortion, postabortion contraception, LARC, Nexplanon, subdermal contraceptive implant
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.
Interventions
DRUGetonorgestrel
DRUGMifepristone
Day one of medical abortion
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete abortions without surgical intervention | at 3 weeks follow up | Efficacy of the medical abortion treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unplanned pregnancy | during one year FU | Numbers of pregnancies within the first year following the index abortion |
| Number of women with complications | evaluated at the 3weeks FU | reports and rates of AE/SAE |
| Rate of implant insertion | up to 1year FU | Compliance, contraceptive usage |
| 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 |
Countries
Sweden, United Kingdom
Outcome results
None listed