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With 12-month failure rates of 0.2% or less for Cyclofem and 0.4 ... At other times in a menstrual cycle as long as the possibility of pregnancy is ruled out. ... – PowerPoint PPT presentation

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Dr.Ashraf Fouda Ob/Gyn. Specialist Dommiatte
General Hospital
  • Injectable contraceptives contain hormonal drugs
    that provide women with safe, highly effective,
    and reversible contraceptive protection.

Two types of injectable contraceptives
  • (1) Progestogen-only formulations that contain a
    progestogen hormone and are effective for 2 or 3
    months and,
  • (2) Combined formulations that contain both a
    progestogen and an estrogen and are effective for
    1 month

Progestogen -only formulations
  • Consist of DMPA (depot med-roxyprogesterone
    acetate) and NET-EN (norethisterone enanthate).
  • DMPA is the injectable formulation most widely
    used worldwide.
  • DMPA is injected every 3 months.
  • NET-EN is injected every 2 months.

Combined formulations
  • The most extensively studied formulations are
    known by their brand names, Mesigyna
  • Monthly injectable.
  • Mesigyna contains the same progestogen as
    NET-EN. contains an added estrogen.

Combined formulations
  • Administered by a deep intramuscular injection
    into the muscle of the arm or buttock and are
    effective immediately, provided they are taken at
    specified times

  • All injectable contraceptives are slowly absorbed
    into the bloodstream from the injection site,
    with the body maintaining a sufficient level of
    hormone to provide contraception for 1 to 3
    months, depending on the type of injectable used

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Mode of Action
  • The immediate action of progestagen-only
    injectables (POIs) is to thicken cervical mucus,
    which then presents an obstacle to sperm
  • Also, ovulation is impaired.
  • There are additional changes in the endometrium
    that make it unfavourable to implantation
    however, the first two effects make fertilisation
    highly unlikely.

  • The reported failure rates of POIs are low, and
    come within the narrow range of
  • 0.1 to 0.6.

Beneficial Effects
  • Prevention of pregnancy
  • A single injection of a POI can provide highly
    effective protection against pregnancy for two or
    more months, depending on the formulation.
  • Delivery is simple, independent of coitus, and
    ensures periodic contact with medical or other
    trained health personnel.
  • This is a suitable method for women in whom
    oestrogens present health risks eg, those with
    a history of thromboembolic disorders - and those
    who have had side effects with the use of

Non-contraceptive health benefits
  • Clear benefits
  • Sickle cell disease In a two-year trial, women
    with sickle cell disease using DMPA had
    significantly fewer crises than women given a
  • Anaemia POIs can increase haemoglobin
    concentration, mainly by reducing menstrual blood

Non-contraceptive health benefits
  • Possible benefits
  • 1. Endometrial cancer
  • In a World Health Organization (WHO) study, women
    who had ever used DMPA had one-fifth the risk of
    developing endometrial malignancy observed in
    women who had not used DMPA.
  • The results, although not statistically
    significant, support the hypothesis that use of
    DMPA might protect against this form of cancer.
  • 2. Other
  • The use of POIs possibly protects against pelvic
    inflammatory disease (PID), seizures in women
    with epilepsy, uterine myoma, and endometriosis.


Menstrual irregularities
  • DMPA and NET-EN are associated with disruptions
    of the menstrual cycle including amenorrhoea,
    prolonged menses, spotting between periods, and
    heavy bleeding.
  • Less than one-third of women receiving DMPA
    report having normal menstrual cycles during the
    first year of use.

Menstrual irregularities
  • Amenorrhoea is the most common side-effect and
    its occurrence increases with duration of use
    from about 50 of DMPA users by the end of one
    year to 80 by the end of 5 years.
  • Women using NET-EN are less likely to experience

Menstrual irregularities
  • Heavy bleeding is uncommon (occurs in 1-2 of
    users), and prolonged bleeding is seldom heavy
    enough to be a threat to health.
  • Any woman who reports prolonged or heavy bleeding
    may need to be evaluated for anemia.
  • Anaemia treatments include nutritional advice
    an appropriate dosage of oral iron tablets.

Menstrual irregularities
  • Treatments for heavy bleeding include non-aspirin
    anti-inflammatory drugs such as ibuprofen,
    short-term use of combined oral contraceptives or
    estrogen, or early administration of the next
    injection (not sooner than 4 weeks after the
    previous injection).
  • If these measures are not effective or the
    womans health is threatened, POIs should be

Other Side-Effects
  • After menstrual changes, weight gain, headache,
    and dizziness are the next most common
    side-effects reported.
  • Most users of POIs put on weight and this is a
    common reason for discontinuation.
  • The average DMPA user gains 1.52.0 kg in the
    first year and some users continue to gain weight
    thereafter at about the same rate.
  • In clinical trials, between 3 and 19 of users
    of injectables have reported headache or
    dizziness. Few women discontinue for these

Possible Carcinogenicity
  • Clinical studies have found no association
    between DMPA use and cervical, ovarian, or liver
  • And have confirmed a substantial protective
    effect against endometrial cancer.
  • Studies have found no overall increase in risk of
    breast cancer.
  • Although some studies have indicated a small
    increased risk of breast cancer in some younger
    women following initial exposure, the studies
    show no trend toward increased risk among more
    long-term users.

Bone density
  • Findings to date suggest a relatively small and
    reversible effect, with no serious health risk
    for women of any age.
  • At present, medical experts recommend no
    restriction on use of injectables by adolescents
    over age 16.
  • Changes in calcium uptake by bone and decreases
    in urinary calcium excretion have been documented
    and there is a suggestion of a relation between
    long term use of DMPA and low bone mass.

Effect on fetal exposure
  • There are no known adverse effects of fetal
    exposure to injectables.
  • Studies of teenage children who were exposed to
    DMPA in utero show no significant differences in
    health, growth, or sexual development compared to
    other children.
  • Progestogen-only injectables can be used by
    breastfeeding women at 6 weeks postpartum without
    adverse effects on nursing infants.

Effect on Metabolism
  • The only metabolic effect of undoubted clinical
    importance is weight gain.
  • - Minor alterations of lipid metabolism,
    fluid/nitrogen balance, glucose tolerance,
    steroid metabolism, and immune function have been
    recorded but seem to be of no clinical
  • - Fewer data have been published on the metabolic
    effects of NET-EN, but its effect on most
    biochemical functions appears to be similar to
    that of DMPA.

Cardiovascular Effect
  • Data are insufficient to indicate whether there
    is any relation between DMPA use and
    cardiovascular complications.
  • Results of a WHO study suggest that there is
    little or no increased risk of cardiovascular
    disease associated with the use of
    progestagen-only injectables, although further
    investigation is needed into a possible increased
    risk of stroke among women with high blood

  • Fertility is not impaired after discontinuation
    of DMPA or NET-EN although its return is delayed.
  • The average time between the last DMPA injection
    and conception is about nine months, including
    the three months during which the injection is
  • More than 80 of women become pregnant within
    one year of discontinuing DMPA and 90 within two
  • The few data on NET-EN suggest that fertility
    returns more quickly with this agent.

Eligibility Criteria for Use of a Contraceptive
World Health Organization (WHO) developed
eligibility criteria for the use of various
contraceptive methods.
  • Category 1 A condition for which there is no
    restriction for the use of the contraceptive
  • Category 2 A condition where the advantages of
    using the method generally outweigh the
    theoretical or proven risks.
  • Category 3 A condition where the theoretical or
    proven risks usually outweigh the advantages of
    using the method.
  • Category 4 A condition which represents an
    unacceptable health risk if the contraceptive
    method is used.

Contra-indications (category 4)
  • POIs should not be used in the presence of
  • Confirmed or suspected pregnancy
  • Malignant disease of the breast

Conditions requiring careful consideration
(category 3)
  • POIs should generally not be used in the presence
  • Diabetes with vascular disease or of gt20 years
  • Cerebrovascular or coronary artery disease
  • Acute liver disease
  • 4.benign or malignant liver tumours
  • Severe hypertension/ (BPgt180/110 mm Hg)
  • Hypertension with vascular disease
  • Focal migraine.
  • severe cirrhosis

Other Conditions (category 2)
  • - Women with mild to moderate hypertension,
    diabetes (without vascular complications),
    hyperlipidaemias, or mild (compensated) cirrhosis
    can generally use POIs.
  • - Careful screening and appropriate monitoring
    will allow the benefits of using POIs to outweigh
    any potential risks.

Mode of Action
  • Combined injectable contraceptives (CICs) exert
    their contraceptive effect mainly by suppressing
  • In addition, thickening of the cervical mucus
    (mainly due to the progestagen) presents an
    obstacle to sperm penetration.
  • The receptivity of endometrium to the blastocyst
    is also reduced.

  • In clinical trials, Cyclofem /Cycloprovera and
    Mesigyna/Norigynon have both proved highly
    effective contraceptives
  • With 12-month failure rates of 0.2 or less for
    Cyclofem and 0.4 for Mesigyna.

Beneficial Effects
  • A single injection of a CIC can provide highly
    effective protection against pregnancy for one
  • Delivery is simple and independent of coitus,
    and in general CICs are associated with better
    cycle control than POIs.

  • In clinical trials, side-effects of CICs included
    irregular bleeding, amenorrhoea, heavy bleeding,
    prolonged bleeding, headaches, dizziness, and
    body weight changes.
  • However, these side-effects are much less common
    than with the use of POIs.

Return of Fertility
  • The return of fertility following CIC use is
    noticeably shorter than that observed for POIs.
  • More than 50 of women become pregnant within six
    months of discontinuing CICs and 80 within one

Eligibility Criteria
  • Until sufficient clinical data become available,
    the eligibility criteria for the use of combined
    injectable contraceptives are based on data from
    combined oral contraceptives

Special Situations
  • Injectable contraceptives have important
    advantages in adolescents however, in those
    under 16 years of age there are concerns
    regarding the hypo-oestrogenic effects of POIs,
    which may affect the post-menarche increase of
    bone mineral density.

Women Over 35
  • POIs and CICs can be used by most healthy women
    over 35.
  • Any increase in risk of cardiovascular disease
    will be minimal for these women if they do not
    smoke and have no other risk factors, such as
    hypertension or diabetes.

Postpartum (in Breast feeding Women)
  • If a woman wishes to start injectable
    contraception during breastfeeding a POI should
    be recommended.
  • DMPA and NET-EN have no apparent negative
    influence on milk production or the duration of
    lactation and infants whose mothers have
    received DMPA while breastfeeding seem to develop
    normally, both physically and mentally.

Postpartum (in Breast feeding Women)
  • The question of possible consequences of the
    transfer of the injectable steroid to the
    breastfed infant has yet to be resolved.
  • The amounts of steroid transmitted in the milk
    and absorbed by the infant are known to be small.

Postpartum (in Breast feeding Women)
  • Short-term follow-up studies of children
    breastfed by mothers using progestagen-only
    contraceptives have given reassuring results, but
    longer-term studies are yet to be evaluated.
  • It is recommended that breastfeeding women should
    not start POIs before the sixth week postpartum.

Postpartum (in Breastfeeding Women)
  • There are no data on the effects of CIC
    formulations on the quantity and quality of
    breast milk or the duration of lactation.
  • Until such data become available, CICs should
    generally be withheld until six months after
    delivery or until the infant is weaned, whichever
    is the earlier

Postpartum (in Non-Breast feeding Women)
  • To avoid increasing the risk of thromboembolic
    complications in the postpartum period, CICs
    should not be used during the first three weeks
    after delivery.
  • After 21 days, blood coagulation and
    fibrinolysis are essentially back to normal.
  • POIs can be started at any time after delivery.

Drug Interaction
  • Drugs that induce liver enzymes may lessen the
    efficacy of hormonal contraceptives.
  • Such drugs which are commonly used in long-term
    treatments include the antibiotics rifampicin and
    griseofulvin and the anticonvulsants phenytoin,
    carbamazepine, and barbiturates.

Prevention of STD/HIV Transmission
  • Strict aseptic techniques should be maintained
    when giving the injections to avoid the risk of
    transmitting any infection including HIV.
  • Injectable contraceptives do not protect against
    STD/HIV infection.
  • Therefore, when there is a risk of sexual
    transmission of infection, condoms should always
    be used in addition to injectable contraceptives.

Elective Surgery
  • It is advisable to stop using CICs about four
    weeks before elective surgery that will involve
    prolonged immobilisation, and to restart them two
    weeks after the woman has returned to mobility.
  • Alternative effective contraception, including
    POIs, should be advised during this time.
  • In emergency procedures, the surgeon may
    consider prophylactic anticoagulant measures

Sickle Cell Disease
  • Either POIs or CICs can be used by women with
    sickle cell disease but POIs are a more suitable
  • In addition to their contraceptive effect, there
    is some evidence of benefit on the disease itself.

  • Clients considering the use of injectable
    contraception should be clearly informed about
    the advantages and disadvantages of the agents,
    their side-effects, their cost, and the
    alternative contraceptive options.
  • Where once-a-month injectables are available,
    clients should be told about the differences
    between these injectables and POIs.
  • Women who desire a rapid return to fertility on
    discontinuation of their contraceptive should be
    advised to use CICs where available or another

some misconceptions about injectables
Do injectable contraceptives cause infertility ?
  • No.
  • Although a woman's return to fertility can be
    delayed after injectables are discontinued,
    injectables do not damage fertility.

Do injectable contraceptives increase cancer
risks ?
  • No.
  • Overall increase in cancer risk has not been
    demonstrated in long-term, multicountry studies
    of injectable users.

When amenorrhea occurs, does menstrual blood
build up in the body, leading to disease ?
  • No.
  • Amenorrhea is not a  health risk.
  • It does not cause  blood to build up in the body.

Can injectable contraceptives transmit disease ?
  • No.
  • Injectable contraceptives are sterile
    preparations that are free from disease- causing
  • Contaminated needles and syringes used to
    administer injectables can transmit disease,

special injection techniques
  • Injectable contraceptives are administered using
    deep intramuscular injection techniques.
  • The injection site should not be massaged
    afterwards, since this may accelerate absorption
    of the drug.

  • Because DMPA is an aqueous suspension, a DMPA
    vial must be shaken vigorously before it is
    loaded into the syringe, to resuspend any active
    ingredient in the bottom of the vial.
  • The syringe should then be checked to ensure that
    it contains the correct dosage.

  • NET-EN is an oil-based solution that needs
    special care to ensure that all the solution is
    both loaded and injected without leakage.
  • Warming the vial to body temperature makes it
    easier to draw into the syringe.
  • Since Mesigyna is an oil-based solution similar
    to NET-EN, the same attention to leakage applies.

When can the initial injection be given ?
Progestogen -Only Injectables
  • DMPA and NET-EN
  • During the first 7 days of the menstrual cycle.
  • Injectables will be immediately effective.
  • Immediately after abortion.
  • At other times in a menstrual cycle as long as
    the possibility of pregnancy is ruled out.
  • At 6 weeks postpartum.

Combined Injectables Mesigyna
  • During the first 5 days of the menstrual cycle.
  • Injectables will be immediately effective.
  • Immediately after abortion.
  • At other times in a menstrual cycle as long as
    the possibility of pregnancy is ruled out.
  • At 6 months postpartum.

Margin for the follow-up re-injection
Progestogen-Only Injectables DMPA and NET-ENup
to 2 weeks (14 days) early or late
  • Combined Injectables Mesigyna
  • Up to 3 days early or late

Breast feeding
  • Progestogen-Only Injectables DMPA and NET-EN
  • Suitable for women who are breastfeeding at 6
    weeks postpartum.
  • Combined Injectables Mesigyna
  • Not suitable for women who are fully breast
    feeding until 6 months postpartum.

Thank you
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