Jadelle Implant for a Postnatal Woman. Contents. Department(s) affected Applicable for which Patients, Postnatal women

Transcription

1 Jadelle Implant for a Postnatal Woman Document Type Guideline Function Clinical practice Directorates National Women s Health Department(s) affected Maternity Applicable for which Patients, Postnatal women Clients or Residents? Applicable for which Staff? All clinicians in maternity including access holder lead maternity carers (LMCs) Keywords (not part of title) Contraception Author role only Registered Midwife Owner (see ownership structure) Clinical Director Obstetrics Edited by Clinical Policy Advisor Date first published November 2013 Date last published May 2014 Review frequency 3 years Unique Identifier NMP200/SSM/088 Contents 1. Purpose of guideline 2. Guideline management principles and goals 3. Definitions 4. Indications 5. Patient information 6. Contra-indications 7. Training 8. Procedure 9. Removal 10. Effects on breastfeeding 11. Timing of insertion 12. Supporting evidence 13. Associated ADHB documents 14. Disclaimer 15. Corrections and amendments Page 1 of 10

2 1. Purpose of guideline The purpose of this guideline is to facilitate the safe and effective use of the Jadelle implant for a postnatal woman requiring contraception, within National Women s Health, Auckland District Health Board (ADHB). 2. Guideline management principles and goals The Jadelle implant should be offered to a woman requesting long-term contraception. The woman should be fully informed of the efficacy, risks, benefits and potential adverse effects prior to giving consent. 3. Definitions The following terms are used within this guideline: Jadelle Levonorgestrel 4. Indications A contraceptive implant used to prevent pregnancy. The implant contains a synthetic hormone, levonorgestrel, which is also one of the active ingredients in many oral contraceptives. This is a second-generation synthetic progestogen used as an active ingredient in some hormonal contraceptives. Long-term contraception: Family planning Contra-indication to pregnancy eg medical condition, undergoing medical treatment etc Page 2 of 10

3 5. Patient information Jadelle is one of the most reliable forms of contraception, as it should prevent 99.5 percent of pregnancies; however, no contraception is 100 percent effective. Jadelle can cause irregular menstrual bleeding: 20% of women will have no bleeding at all 50% of women will have infrequent bleeding for the first three months 30% of women will have infrequent bleeding for the first six months Bleeding patterns in the first months following insertion are not predictive of future bleeding patterns Bleeding is likely to remain irregular One in seven women will have the Jadelle implant removed for bleeding problems. Jadelle is not associated with weight change, mood change, headaches or loss of libido. Non-comparative studies reported that acne may develop during use but few women discontinue use for this reason (NICE, 2013, see supporting evidence section). The Jadelle implant should be 99.5 percent effective against pregnancy for the licensed duration of use (five years) (NICE, 2013). A woman with a BMI >30kg/m 2 can use a progestogen only implant without restriction and without a reduction in contraceptive efficacy for the duration of the licensed use (Clinical Effectiveness Unit, 2009a, see supporting evidence section). Contraceptive cover is immediate if inserted day 1-5 of the cycle, immediately after a termination of pregnancy, or in the first 21 days postpartum (Clinical Effectiveness Unit, 2009a). Otherwise, a barrier method should be used for the first seven days following Jadelle insertion. Natural fertility should return as soon as the implant is removed. Jadelle implant is not effective against preventing sexually transmitted infections, and a barrier method should always be used with women who are at risk. Page 3 of 10

4 6. Contra-indications Hypersensitivity to levonorgestrel or any other component of Jadelle Current VTE on anticoagulation Current/arising ischemic heart disease Stroke Migraine headaches with aura at any age Unexplained vaginal bleeding suspicious for serious condition Gestational trophoblastic neoplasia when hcg is normal Breast disease (current or past history of breast cancer) Viral hepatitis (active disease) Cirrhosis (severe decompensated disease) Liver tumours (benign or malignant) Known or suspected pregnancy Drugs which induce liver enzymes eg rifampicin, rifabutin, St John s wort, griseofulvin, and certain anticonvulsants (phenytoin, carbamazepine, barbiturates, primidone, topiramate, oxcarbazepine) Page 4 of 10

5 7. Training Formal training is required for the insertion and removal of Jadelle implants to ensure practitioner competence. At the completion of Jadelle training, the practitioner must demonstrate competency and satisfy the requirements outlined below. The practitioner must also continue to maintain competency and attend regular updates. A family planning specialist, an obstetrician or gynaecologist should conduct the training. Practitioners must complete all of the following requirements below before being deemed competent: a. Complete pre-reading materials; b. Watch video on insertion procedure; c. Practical session on plastic arm model; d. Observe 2-3 Jadelle insertion procedures; e. Perform 3-4 Jadelle insertions on women under supervision or until deemed as competent; f. Demonstrate appropriate documentation (medication chart, clinical notes) in the woman s clinical record; g. Final sign off by trainer when competent. On completion of training, it is expected that the practitioner should be able to: Describe the action and efficacy of the Jadelle implant Describe the adverse effects and contra-indications of Jadelle insertion Explain the importance of aseptic technique during Jadelle insertion Describe the correct placement of the Jadelle implants during insertion Describe the aftercare patient advice once insertion has been completed Explain the important points that should be documented once insertion has finished Follow up The practitioner is encouraged to keep a record of their first 20 cases of unsupervised insertions and to follow up with a phone call one week post insertion to ensure that the implants can be felt subdermally. The practitioner must advise the woman of appropriate interventions to take if there are concerns raised and, if appropriate, the woman may be advised to return for further assessment by a gynaecology specialist. Page 5 of 10

6 8. Procedure Before the procedure, the woman should be given the Contraceptive Implant information leaflet (see associated ADHB documents section), informed of the potential side effects, and understand that it may be removed at any time, at her request. The woman must also be informed of the efficacy, risks, and bleeding pattern changes to be expected with Jadelle (see patient information section). The Jadelle implant must be prescribed in the woman s clinical record. a. The implants should be inserted in the inner aspect of the upper left arm in a right handed woman, and in the right arm in left a handed woman, approximately 8cm above the fold in the elbow, using a strict aseptic technique; b. Before insertion, the skin is cleaned with an antiseptic and the insertion area anaesthetised with a local anaesthetic; c. An incision of 2mm is made in the skin with a scalpel; the implants are inserted with the trocar sub-dermally, in the shape of a V opening towards the armpit; d. Proper insertion should later facilitate removal and result in minimal scarring; e. After insertion of the second implant, the edges of the incision are pressed together, closed with steri-strips, a skin suture and dressed with a waterproof dressing and pressure bandage; f. The woman should be advised to keep the insertion area dry for three days. The gauze bandage may be removed after 24 hours, the waterproof dressing and steristrips should be removed at 4-5 days. The woman should be asked to check that she is able to feel both implants under the skin and, if not, to contact a health professional. The woman should also be advised that discolouration, bruising and swelling are common and should subside within a few days. She should be encouraged to not bump the insertion site, or lift anything heavy with that arm during this time; g. Following insertion, if it is suspected that the system is not in the correct position, it should be removed and a new one inserted (Family Planning 2012, see supporting evidence section); h. Ensure the procedure is documented in the clinical record and that correspondence is sent to the woman s general practitioner. Page 6 of 10

7 9. Removal The Jadelle implant must only be removed by a trained doctor, midwife or nurse. a. Before removal, locate the implants by palpation, clean the skin with an antiseptic solution and inject a small amount of local anaesthetic under the narrow V end of the implants; b. Make an incision and push each implant with your fingers gently towards the incision; c. Using mosquito forceps open the tissue capsule, grasp the end of the implant with the Crile forceps, release the mosquito forceps and gently remove the implant; d. Repeat the procedure for the second implant; e. After the removal, close the incision with a sterile skin closure; f. Be sure that both implants are intact (Family Planning 2012). 10. Effects on breastfeeding Research from both randomised and observational studies show that progesterone only contraception initiated either shortly after delivery or beyond, does not appear to affect a woman s ability to breastfeed successfully (Kapp, Curtis, & Nanda, 2010; Roberts, 2013, see supporting evidence section). Levonorgestrel, the active ingredient of Jadelle, appears to produce limited, if any effect on milk volume or quality (Hale, 2012, see supporting evidence section). Numerous studies of varying size have found that the use of levonorgestrel implants as a contraceptive, beginning at (or after) day seven postpartum, has no negative impact on the quality of breastmilk and results in either no effect or an increase in the milk supply and duration of lactation (see supporting evidence section). Page 7 of 10

8 11. Timing of insertion Research suggests that the timing of insertion has no effect on lactation and should be inserted at a time that best suits the woman (National Institute for Health and Care Excellence (NICE) 2013, see supporting evidence section). There are several circumstances in which it may be appropriate to delay insertion of the Jadelle until Lactogenesis III is established, usually around day nine (The Academy of Breastfeeding Medicine 2005, see supporting evidence section). Existing low supply or history of lactation failure History of breast surgery Multiple birth Preterm birth Compromised health of mother and/or baby However, it is important to remember that 50% of first menstruations following delivery are preceded by ovulation. It is recommended that a reliable contraceptive method should be used from 21 days postpartum. This allows for a sperm survival time of up to seven days before the earliest likely ovulation: days postpartum (Guillebaud 1993, see supporting evidence section). Therefore, it is recommended that the Jadelle should be inserted by day 21 postpartum. Page 8 of 10

9 12. Supporting evidence Bahamondes, L. (2008). Subdermal implantable contraceptives versus other forms of reversible contraceptives or other implants as effective methods of preventing pregnancy: RHL commentary. The WHO Reproductive Health Library. Geneva: World Health Organisation Clinical Effectiveness Unit (2009a). Progestogen-only Implants. England: Faculty of Sexual and Reproductive Healthcare Clinical Effectiveness Unit (2009b). UK Medical Eligibility Criteria for Contraceptive Use. England: Faculty of Sexual and Reproductive Healthcare Cochrane Database of Systematic Reviews, Hormonal and Non-hormonal birth control during breastfeeding Family Planning (2012). Contraceptive Implant. New Zealand: Family Planning Guillebaud, J. (1993). Postpartum contraception unnecessary before three weeks. BMJ, 307, Hale, T.W. (2012). Medications and Mothers Milk: A manual of lactational pharmacology, (15 th ed.). Amarillo, TX: Hale Publishing Kapp, N., Curtis, K., & Nanda, K. (2010). Progestogen-only contraceptive use among breastfeeding women: a systematic review. Contraception, 82 (17-37). Doi: /j.contraception Lawrence, R.A., & Lawrence, R.M. (2011). Breastfeeding: a guide for the medical profession (7 th ed.). Maryland Heights, Missouri: Elsevier Medsafe (2012). Jadelle New Zealand Consumer Medicine Information National Institute for Health and Care Excellence (2013). Long acting reversible contraception Population Council (2013). Jadelle Roberts, H. (2013). Contraception after delivery. PowerPoint presentation presented to the New Zealand College of Midwives, May 2013 The Academy of Breastfeeding Medicine Protocol Committee, Clinical Protocol Number 13: Contraception during breastfeeding. The Academy of Breastfeeding Medicine Inc Truitt, S.T., Fraser, A.B., Gallo, M.F., Lopez, L.M., Grimes, D.A., & Schultz, K.F. (2010). Combined hormonal versus non-hormonal versus progestin only contraception in lactation. Cochrane Database of Systematic Reviews, 3. DOI: / CD Drugs.com Levonorgestrel use while Breastfeeding, revised 16/01/2014: Page 9 of 10

10 13. Associated ADHB documents Infant Feeding - Breastfeeding Informed Consent Jadelle Implant Insertion by Gynaecology Nurses and Doctors Medications - Allergies & Adverse Drug Reactions (ADRs) Identification, Documentation & Recording Medications - Prescribing Patient information Contraceptive Implant 14. Disclaimer No guideline can cover all variations required for specific circumstances. It is the responsibility of the health care practitioners using this ADHB guideline to adapt it for safe use within their own institution, recognise the need for specialist help, and call for it without delay, when an individual patient falls outside of the boundaries of this guideline. 15. Corrections and amendments The next scheduled review of this document is as per the document classification table (page 1). However, if the reader notices any errors or believes that the document should be reviewed before the scheduled date, they should contact the owner or the Clinical Policy Advisor without delay. Page 10 of 10