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Contraceptive Implants Sample Protocols

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					                                 SAMPLE PROTOCOL
                              CONTRACEPTIVE IMPLANTS
                                        2011 Version



I.   General Information

     Currently, there is only one contraceptive implant marketed in the US. Implanon is a
     single-rod implant which is effective for up to 3 years. It contains etonogestrel (3-
     ketodesogestrel), the active metabolite of desogestrel, in an ethylene vinyl acetate
     (EVA) core surrounded by an EVA membrane. In clinical trials the pregnancy rates
     were extremely low with a Pearl Index of 0.38 pregnancies per one hundred women-
     years of use. Follicular development is not completely impeded, so estradiol levels
     are not significantly decreased.

     Some sites may also care for clients who have had a contraceptive implant inserted
     in another country, or who have older implants which are no longer marketed in the
     US. These include Jadelle or Norplant 2, a two-rod system as well as the original
     Norplant, which is a six-capsule system.


     Personnel
     1. Only clinicians (APN, PA, or physician) who have undergone a training course in
        Implanon insertion and removal approved by the manufacturer are permitted to do
        so.
     2. Each site may create a system for granting clinical privileges to clinicians (APN,
        PA, or physician) who will insert and/or remove the implant.
         The system should include a proctoring program in which there is direct
             observation of at least one implant insertion and removal unless the clinician
             has been observed successfully inserting and removing Norplant.
     3. Only physicians, APNs, or PAs with previous surgical experience, or who have
        performed successful removals under the direct supervision of an experienced
        clinician shall remove other contraceptive implants. Another clinician with
        experience in successful removals should also be available (on site or by phone)
        for assistance with difficult procedures.


II. CLIENT SELECTION

     Indications — Implant placement may occur if
     1. contraindications do not exist
     2. a long-term, high-efficacy, not-coitus-dependent, private method is desired

     Contraindications —
     1. Reproductive Tracts Infections and Disorders
         Breast cancer —current (USMEC, 4), suspected, and past (USMEC, 3)




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Special Conditions Requiring Further Evaluation
   Decisions regarding individualized management, follow-up intervals, or the need for
   additional testing or referral should be based on protocols approved by the Medical
   Director or in consultation with the Medical Director. These conditions include
   1. Rheumatic Diseases
        systemic lupus erythematosus (SLE) — only when antiphospholipid antibodies
           are positive or unknown. (USMEC, 3)
           o Informed Consent should be given and documented in the medical
               record.
           o The following are NOT special conditions for the implant:
                negative antiphospholipid antibodies (USMEC, 2)
                thrombocytopenia (USMEC, 2)
                immunosuppressive treatment (USMEC, 2)
   2. Neurologic Conditions
        currently being treated for meningioma — consult with oncologist or
           neurosurgeon
   3. Reproductive Tract Infections and Disorders
        undiagnosed abnormal uterine bleeding that is suspicious for a serious
           condition (USMEC, 3) — the condition must be evaluated before inserting the
           implant
           o Women ≥ age 35 with undiagnosed abnormal uterine bleeding suspicious
               for cancer must have an endometrial biopsy prior to insertion of the
               implant.
           o Endometrial biopsy should be considered in women < age 35 with
               abnormal bleeding who have risk factors for endometrial
               hyperplasia/cancer prior to insertion of the implant.
                personal or family history of ovarian, breast, colon or endometrial
                    cancer
                tamoxifen use
                chronic anovulation
                obesity
                unopposed estrogen therapy
                prior endometrial hyperplasia


FYI — Abnormal Bleeding: What is suspicious for cancer?

Bleeding that is suspicious for endometrial cancer is characterized by the following
 non-cyclic (anovulatory)
 unpredictable
 abnormal pattern persisting for at least three months

Bleeding that is not suspicious tends to be cyclic (ovulatory, monthly) but may be longer
or heavier than normal. It is often due to a structural abnormality rather than
anovulation.




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   4. Gastrointestinal Conditions
        current severe liver dysfunction (severe cirrhosis, end stage liver disease)
          (USMEC, 3)
           o Mild compensated cirrhosis and viral hepatitis (acute, carrier, chronic) are
             not special conditions to implants. (USMEC, 1)
         liver tumors —
           o benign — history of or current hepatocellular adenoma (USMEC, 3)
           o malignant — history of or current hepatoma (USMEC, 3)
           o focal nodular hyperplasia is not a special condition to implants.
              (USMEC, 2)


III. CLIENT EDUCATION AND INFORMED CONSENT

   Client education and informed consent should include:
   1. education regarding all contraceptive options available
   2. discussions about the implant that supplement and reinforce the required written
       materials
   3. signing and maintaining in client’s medical record:
        Consent form for placement of Contraceptive Implant for each insertion and
           Consent form for Removal for each removal
   4. education regarding the purpose, importance, and scheduling of well-woman
       screening and prevention visits, when indicated
   5. providing the client with
        written information on the use, effectiveness, and medically recognized
           benefits and risks of the available methods of contraception for new
           contraceptors. Written information should be offered to all others.
        a copy of manufacturer’s FDA-approved, Patient Labeling leaflet. The
           importance of reading the leaflet should be explained.
        written information on the use, effectiveness, and medically recognized
           benefits and risks of Contraceptive Implants
        for clients with systemic lupus erythematosus (SLE) — when antiphospholipid
           antibodies are positive or unknown, Informed Consent intended for Use of
           Hormone Birth Control by Women with Special Conditions
        other written materials
           o after-care instructions including signs to report to the provider and
               emergency contact information
           o the user card that comes in the package
           o a copy of the request form(s) signed by the client, if the client so requests




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IV. PRESCRIBING IMPLANTS

   Prescription — Single rod implant (Implanon) is approved for three years of use.

   Requirements for Prescribing —
   1. There is no time at which a pelvic exam is required for continued provision of the
      method as long as all eligibility requirements are met.
       Targeted history should have been completed within the past year.
          Components of targeted history include:
          o contraindications and special conditions (as listed above)
          o evaluation of risks for sexually transmitted infections
          o possible pregnancy
          o history of breast mass
          o post-delivery and lactational status
       Clients with an undiagnosed breast mass or history of an unresolved follow-
          up of a breast mass that is not being managed by another healthcare
          provider should be evaluated (internally or by referral.)
          o If breast mass is suspicious for carcinoma must not insert the implant.
          o Should offer an alternative contraceptive, if needed, while breast
              evaluation is being arranged.
       When ―Special Conditions‖ exist (See above, Item II, Special Conditions
          Requiring Further Evaluation)
          o Further medical evaluation should be performed by a qualified, licensed
              health care provider before prescribing the method.
          o Medical evaluation should be performed before each reinsertion.
       Clients who report symptoms of, or partner contact with, STIs should be
          managed by the provider or referred for management
       Whenever a client presents with symptoms of a possible problem, an
          appropriate physical examination should be performed, if indicated.
   2. Clients should be encouraged to obtain a periodic well woman visit, regularly
      scheduled Pap tests, follow-up for any abnormal Pap tests or other screening
      tests, and indicated STI screening (consider offering test at visit). This must be
      documented in the chart.
   3. For women 40 and over, both an annual breast exam and a screening
      mammogram should be recommended. However, clients who obtain either an
      annual breast exam or an annual screening mammogram may receive the
      implant.
       The client’s self-report (of previous breast exam or mammogram results) is
          adequate proof and must be documented in the chart.
       Clients in this age group who refuse both the annual clinical breast exam and
          screening mammogram and wish to initiate the implant
          o Should sign a Release When Test/Service/ Consultation Will Not Be
              Obtained As Recommended and annually after that if she requests other
              services
          o should be educated on the benefits of annual clinical breast exam and
              mammography as well as the risks of undiagnosed breast cancer. This
              must be documented in the chart.




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Timing of Initiation — The table below should be followed when initiating the implant.
Alternative timings should be individualized to ensure contraceptive protection.

CURRENT
METHOD             INSERT IMPLANT                                           BACKUP

No effective       Anytime in cycle if it is reasonably certain client is   If more than five
contraception in   not pregnant. (See FYI below.)                           days since
current cycle       If possibility of pregnancy is suspected, a            menstrual
                       highly sensitive urine test must be performed.       bleeding started,
                       If pregnancy test is negative and client             backup for seven
                       understands risk of possible very early              days.
                       pregnancy, insert implant and advise client to
                       repeat urine test in two weeks. Offer EC as
                       appropriate.

                   See Algorithm A, below.
Current correct    Any time in cycle                                        Finish COC,
use of hormonal    On or before next DMPA injection is due                  patch, or ring
contraception                                                               cycle
                   NOTE: If switching from DMPA and it had been
                   initiated beyond first seven days of menstrual
                   bleeding, urine pregnancy test must be performed
                   before the implant may be inserted.
IUC                Any time in cycle
                    within five days of onset of menses                    None, may
                                                                            remove IUC at
                                                                            time of insertion
                      beyond first five days and has had sexual            Delay removal of
                       intercourse this cycle                               IUC until next
                                                                            menses
                      beyond first five days and has not had sexual        Back-up for
                       intercourse this cycle                               seven days
Post-surgical      Immediately up to five days post procedure               None
procedure for
elective or
spontaneous
abortion
Post early         Immediately up to five days post passing                 None
pregnancy loss     pregnancy, if known
– no procedure
                   If not known, see ―no effective contraception‖
                   above
Post-medication    OK to initiate prior to confirmation of termination
abortion           pregnancy
                    Day of misoprostol up to seven days after              None



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CURRENT
METHOD            INSERT IMPLANT                                      BACKUP

                      mifepristone
                     Beyond seven days after mifepristone and        Backup for seven
                      before resuming intercourse                     days.

Post delivery        Less than 21 days postpartum — anytime          None
after 24 weeks       More than 21 days postpartum, no                Back-up for seven
– nursing and         intercourse — anytime                           days
not nursing          More than 21 days postpartum, intercourse       See ―no effective
                      has been resumed                                contraception‖
                                                                      above



FYI — How can a provider be reasonably certain a woman is not pregnant — by her
history?

The provider can be reasonably certain that the woman is not pregnant if she has no
symptoms or signs of pregnancy and meets any of the following criteria:
 has not had intercourse since last normal menses
 has been correctly and consistently using a reliable method of contraception
 is within the first seven days after normal menses
 is within four weeks postpartum for non-lactating women
 is within the first seven days post-abortion or miscarriage
 is fully or nearly fully breastfeeding, amenorrhoeic, and less then six months
   postpartum

(Selected Practice Recommendations for Contraceptive Use, 2002)


   Insertion
   1. The manufacturer’s instructions for insertion should be followed.
       If the implant cannot be palpated post insertion, client must be advised to use a
          non hormonal method of contraception until placement is verified. See item V.
          Guidelines for Management of Side Effects and Complications, Lost Implant,
          below.
   2. Systems and protocols should be in place for the management of vaso-vagal
      fainting episodes.
   3. A mechanism should be in place to maintain a record of the implant lot numbers
      separate from the client chart.
   4. Documentation
       A record of the procedure, including date of procedure, which arm it was
          placed in, and the lot number of the implant inserted must be documented in
          the medical record.
       The record must also document that the clinician and client confirmed
          placement by palpating the implant after insertion.




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          A peel-off label is included in the package. It can be affixed to a sheet in the
           client’s medical record to document the above elements of the insertion
           procedure.
          Complete the user card and give it to the client.


V. GUIDELINES FOR MANAGEMENT OF SIDE EFFECTS AND COMPLICATIONS

   Irregular Bleeding
   1. Counseling women about expected menstrual variations before insertion may
       decrease the frequency of complaints.
   2. Obtain/perform
        interval history, with focus on the possibility of pregnancy or genital tract
           infection
        pelvic examination, as indicated, to exclude pregnancy, infection, or an
           anatomic lesion
        laboratory tests
           o highly sensitive pregnancy test, if indicated
           o hematocrit or hemoglobin, if history suggests prolonged, frequent or heavy
                bleeding. If hematocrit <30% or hemoglobin <10gm/dl, seek physician
                consultation.
           o gonorrhea and chlamydia tests, if a cervical or upper tract infection is
                suspected.
   3. If no obvious cause of bleeding is found, reassure the client that the bleeding
       patterns are not dangerous and may resolve with time.
   4. If frequent or prolonged bleeding becomes problematic
        Medications may be given that include, but are not necessarily limited to
           o Ibuprofen 800 mg PO TID for five days
           o ethinyl estradiol (Estinyl) 20–50 mcg, estradiol (Estrace)1-2 mg or
                conjugated equine estrogen (Premarin) 0.625–2.5 mg once daily for 21
                days
           o combined oral contraceptives for one cycle
        Counsel the client that while this regimen may temporarily improve her
           bleeding pattern, there is a substantial possibility that the irregular pattern will
           return after discontinuation of treatment.
        Removal may be required if women do not respond to treatment and continue
           to find the bleeding bothersome.


FYI — Expected Bleeding Patterns

The majority of Implanon users will experience an alteration of bleeding patterns during
the first year of use. Infrequent bleeding, defined as less than three bleeding episodes
in 90 days, is the most common variation, occurring in 50 percent of women in the first
three months of Implanon use, declining to 30 percent after six months. Prolonged
bleeding is defined as at least one episode in 90 days that lasts at least 14 days.

Prolonged bleeding is also more common in the first three months (approximately 20
percent) declining to about 10 percent with time. Frequent bleeding, defined as >5
bleeding episodes in 90 days, occurs less than 10 percent of the time. Less than one



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percent of clients had low hemoglobin levels. Bleeding patterns will vary with time and
will not necessarily show a trend or remain consistent throughout the duration of use of
Implanon.


   Amenorrhea/Possible Pregnancy
   1. Obtain/perform
       interim history update, focusing on pregnancy signs and symptoms
       pelvic examination, as indicated, to evaluate uterine softening or enlargement,
            adnexal tenderness or mass
       highly sensitive urine pregnancy test
            o If positive, evaluate for symptoms and signs of ectopic pregnancy; begin
                workup or refer immediately if suspected. Strongly consider removal of
                the implant if method failure is suspected. Not necessary to remove the
                implant if a luteal phase pregnancy is suspected. Must remove if client
                intends to continue the pregnancy.
            o If negative, counsel and reassure the client that amenorrhea while using
                the implant is an expected side effect and not dangerous.
   2. If client becomes pregnant while using the implant she should be cautioned about
      the possibility of ectopic pregnancy. Studies have reported a higher ectopic
      pregnancy risk in progestin-only contraceptive failures compared to pregnancy in
      women using no contraception


FYI — About Amenorrhea and Pregnancy

About 20% of the time, while using Implanon, the patient can expect to experience
amenorrhea. The absolute risk of pregnancy while using Implanon is low. (Rate of 0.00–
0.09 per 100 woman-years compared to 43.07 per 100 woman-years for a non-
contraceptor.) No ectopic pregnancies were reported in the clinical trials.


   Thrombotic Stroke or Ischemic Heart Disease
   Must weigh the risks and benefits of continuing implant if woman develops ischemic
   heart disease or thrombotic stroke while using the method. (USMEC, 3)

   Headache
   1. Obtain a headache history to determine if headache is migraine with aura.
   2. Must weigh the risks and benefits of continuing implant if a client develops
      migraine aura, with or without headache, after implant insertion. (USMEC, 3)
   3. If migraine with aura is ruled out, explain that implant removal is unlikely to
      change the headache pattern.




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FYI — What is Migraine Aura?

Aura — Most auras (99%) are visual. Sensory symptoms may also occur (31%) — but
rarely in the absence of visual symptoms.

Aura consists of at least one of the following, without motor weakness
 Visual symptoms including positive features (e.g., flickering lights, spots or lines)
   and/or negative features (i.e., loss of vision)
   o Most visual auras start as flickering uncolored zig-zag lines in the center of the
       visual field, gradually progressing laterally to the periphery of one hemifield, or a
       laterally spreading scintillating scotoma (area of lost or depressed vision within
       the visual field, surrounded by an area of normal or less depressed vision)
   o Scotoma typically perceived as a bright spot, gradually increasing in size to the
       shape of the letter ―C,‖ developing scintillating zig-zag edges.
 Sensory symptoms including positive features (i.e., pins and needles) and/or
   negative features (i.e., numbness). They rarely occur in the absence of visual
   symptoms or in the leg.
 Dysphasic speech disturbances (MacGregor & Mishell, 2005)

Onset of visual aura typically occurs over several minutes. From onset to full
enlargement of the zig-zag lines is usually about 10-20 minutes. Duration of aura is less
than one hour — typically 20-30 minutes. It is fully reversible. If a headache occurs
(99% are followed by headache), it begins after the aura has resolved. There may be a
gap between aura and headache of one hour or less.

Premonitory phase symptoms that occur one or two days before a migraine attack are
not aura. Neither are generalized visual spots or flashing occurring during the
premonitory phase or during the headache itself. In addition, blurry vision is not
diagnostic of migraine with aura. (MacGregor & Mishell, 2005)

Diagnosing Aura — three key questions to ask clients to determine if they have aura:
Do you ever have visual disturbances that
 start before the headache?
 last up to one hour?
 resolve before the headache begins?

Ask the woman for a description of her visual disturbance if any of the above questions
are answered positively. Watch her hands as she describes her symptoms. If her hand
moves up in a wavy circular area beside her head, aura is more likely than if she leaves
her hand down. Ask the woman to draw her visual symptom — women with aura
commonly draw a jagged crescent or indicate a scintillating letter ―C‖ with a dark spot
within it. (MacGregor & Mishell, 2005)




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Distinguishing Migraine with Aura from Headache with Focal Neurological
Symptoms or Headache with Symptoms Suggesting Cerebral Ischemia

 Features of Migraine with Aura               Features of Cerebral Ischemia
  slow onset of aura, taking several          rapid spread of motor/sensory
    minutes to spread to maximum                 symptoms, taking only seconds to
    distribution                                 spread
  visual symptoms                             visual symptoms
    o usually symmetrical                        o visual loss is monocular
    o typical — scintillating scotoma that       o not typical — scintillating or
        spreads gradually                           spreading features
    o not typical — transient monocular          o typical — transient monocular
        blindness                                   blindness
  sensory symptoms                            sensory symptoms
    o positive — ―pins and needles‖              o sensation of numbness
    o rarely effects legs                        o sudden, new onset
    o past history of similar attacks
        common

Use the web link below to view the ―Burnhill Lecture‖ presentation given by Dr. Anne
MacGregor at the ARHP/NMC meeting in September 2004:
http://www.arhp.org/files/RH04_MacGregor.ppt. Accessed January 4, 2006.

(Gervil M, 1998), (MacGregor, 2001)), and (Russell & Olsen, 1996)


FYI — Headaches

Headache is a relatively common complaint among implant users, although it is unclear
whether implant significantly increases the frequency of headaches. Headache is an
infrequent cause for removal.


   Weight Gain
   1. Counsel regarding control of weight gain with adequate exercise and moderate
      dietary restriction. Many women notice weight stabilization or improvement with
      time.
   2. If these measures fail and weight gain becomes problematic, implant removal may
      become necessary. However, only 2.3 percent of women in clinical trials
      discontinued Implanon because of weight gain.


FYI — Weight Gain

In clinical trials 6.4 percent of Implanon users report weight gain. In another trial, the
weight gain with Implanon over two years was essentially the same as with non-medicated
IUDs, suggesting that there is a normal weight increase over time unrelated to



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contraceptive method.


   Infection or Bleeding at Insertion Site — Rare, seen in fewer than one percent of
   clients.
   1. Evaluate for acute infection, hematoma, or localized superficial thrombophlebitis.
   2. Obtain temperature; inspect insertion site, proximal and distal arm, and axillary
       lymph nodes.
   3. If bleeding, manage with application of steri-strip and pressure dressing to the
       insertion site.
   4. If infection,
        Obtain culture from insertion site.
        Clean site with a skin antiseptic, e.g., Betadine or Hibiclens.
        Provide prescription for dicloxacillin or cephalexin 500 mg PO QID for seven
            days.
        Suggest the use of moist, warm compresses or a heating pad at home.
        Ask the client to return in 3-4 days to evaluate her progress.
        If the infection does not appear to be responding, removal of the implant by an
            experienced clinician may be necessary.

   Expulsion — Rare, related to infection or placement of the implant too close to the
   insertion site.
   1. If partial expulsion, gently remove implant with a hemostat. Do not reuse. Clean
       incision with antiseptic and close with a steri-strip. If bleeding, apply pressure
       dressing.
   2. Advise client to use another method of contraception until a replacement implant
       has been inserted. Offer EC if appropriate.
   3. A replacement implant can be inserted in a different site.

   Lost Implant — Unable to palpate
   1. Carefully palpate.
   2. If not palpable, refer for high-frequency linear array ultrasound (see FYI —
      Visualizing Implanon, below)
   3. If not visible on ultrasound, refer for MRI.
   4. If not visible on MRI, contact the manufacturer for the procedure for measuring
      ENG blood levels.
   5. Until the presence of implant is confirmed, client must use another contraceptive
      method.


FYI — Visualizing Implanon

Implanon is not easily visualized with plain film x-ray. It must be identified by utilizing
ultrasound with a high frequency (>10 mhz) linear array transducer to detect the posterior
acoustic shadow cast by the implant (Shulman and Gabriel, 2006). The equipment used
for thyroid or breast ultrasound can be used for localization. Magnetic Resonance Imaging
(MRI) may also be useful.


   Cancer — If a woman develops a hormone sensitive cancer (such as breast cancer)



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   while on the implant, consultation with her cancer specialist must be obtained to
   continue the method.


VI. Follow-up

   Implant-Related Visits — At each implant-related medical visit
   1. Client should be queried about changes in personal history, possible side effects,
      and her menstrual cycle/bleeding pattern.
   2. Physical exam and laboratory testing should be performed, as indicated.
   3. Presence of implant should be documented in the client’s record.

   Return Visits — The implant-user should be advised to return for
   1. Evaluation if a significant implant-related problem is suspected and if any of the
      following occur
       unable to palpate rod
       very heavy vaginal bleeding or bleeding that lasts longer than 14 days
       delayed menses after a long interval of regular cycles
       concern about a possible pregnancy
       arm pain; pus, redness, or bleeding at the insertion site
       onset or worsening of episodes of migraine, aura, or severe headache
       client decides she wants the implant removed
   2. follow-up and surveillance of special conditions as per protocol and instructions
   3. periodic well-woman visits, regularly scheduled Pap tests, and indicated STI
      screening


VII. Removal of Implant

   Personnel —
   Only clinicians (APN, PA, physician) who have undergone a training course approved
   by the manufacturer and who have demonstrated skill in successful insertion and
   removal shall remove implants.

   Informed Consent —
   A consent form for removal of implants must be signed each time an implant is
   removed.

   Duration of Use —
   1. Clients should be counseled to return at or near the end of the third year of use to
      discuss removal.
   2. The implants should be removed by the end of the third year of use. Unless
      pregnancy is desired, an alternative method of contraception should be offered.
   3. Another implant may be inserted immediately after removal through the same
      incision and in a track parallel to the one removed.

   Procedure —
   The manufacturer’s instructions for removal should be followed.




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   Documentation —
   Documentation of the removal procedure should include length of time to remove if
   any problems or complications are encountered.


ALGORITHM A — QUICK START FOR CONTRACEPTIVE IMPLANTS


           1st day LMP ≤ 5                                   1st day LMP > 5
               days ago                                          days ago



             Insert                                           Possibility of
            Implant                                    Yes    pregnancy?
             today.
           No Backup.
                                      Urine
                                  pregnancy test               No
                                                                                  Insert
                                    Negative**                                   implant
                                                                                  today.
                                                                               Backup x7d.
            Advise that negative urine pregnancy test not
            conclusive but hormones not harmful to fetus.
              Document client’s understanding of risk.


                  Unprotected sex since LMP?
                                                                    Insert
                                                                   Implant
             ≤ 5 days        > 5 days           None                today.
               ago             ago                               Backup x7d.



          ECP today?
                                  Insert
                                 Implant
          Yes       No*           today.
                               Backup x7d.                            Advise client to
                                                                       repeat urine
                                                                      pregnancy test
         Insert                                                         in 2 weeks.
        Implant
       within 24
         hours.
      Backup x7d.


*ECP should be provided, if possible.



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**If urine pregnancy test is positive, refer as appropriate.

(RHEDI, 2005)




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