II. History

  1. Lemon half was likely medieval predecessor to diaphragm
  2. Rubber form first described By Dr. Wilds 1838
  3. Introduced in U.S. by Margaret Sanger 1916

III. Preparations: Diaphragm Styles

  1. Arching Spring
    1. Characteristics
      1. Folds at 2 points (forms arc for insertion)
      2. Easiest diaphragm to insert
    2. Formulations:
      1. Ortho All-Flex (Latex)
      2. Milex Wide-Seal (Silicone)
      3. London Int. Koro-flex (Latex)
    3. Indications
      1. Women with poor vaginal support or Uterine Prolapse
      2. Women with anteverted or retroverted Cervix
  2. Coil Spring
    1. Characteristics
      1. No arc formed when folded
      2. Similar to flat spring diaphragm
      3. May be inserted with introducer
    2. Formulations
      1. Ortho Coil (Latex)
      2. London International Koromex (Latex)
      3. Milex Wide-Seal Omniflex (Silicone)
        1. Available directly from manufacturer only
    3. Indications
      1. Women with normal Pelvis and deep pelvic arch
  3. Flat Spring
    1. Characteristics
      1. Similar to coil spring diaphragm
      2. Thinner rim than with coil spring diaphragm
      3. May be inserted with introducer
    2. Formulations
      1. Ortho-White (Latex)
    3. Indications
      1. Women with shallow arch behind symphysis

IV. Efficacy

  1. Failure rates: 18% per year (2-20%)
    1. Similar to Cervical Cap
  2. Greater efficacy in older married women
    1. Intercourse less than 3 times per week
    2. Well trained on method
    3. Efficacy approaches 94%

V. Mechanism

  1. Covers Cervix
  2. Prevents sperm entry in upper genital tract
  3. Acts as receptacle for Vaginal Spermicide

VI. Advantages

  1. Non-hormonal contraceptive with moderate efficacy
  2. Safer option for monogamous women over age 35 years
  3. Less expensive than Oral Contraceptives or IUDs
  4. Offers greater sexual satisfaction than Condoms
  5. Female controlled Contraception (contrast with Condom)

VII. Contraindications

  1. History of Toxic Shock Syndrome
  2. Concurrent pelvic infection
  3. Not recommended if risk of Sexually Transmitted Disease
  4. Abnormal Pap Smear or cervical biopsy in last 12 weeks
  5. Vaginal Spermicide Allergy
    1. Consider alternative Spermicide brand
    2. Consider less concentrated Spermicide (2%)
  6. Latex Allergy
    1. Consider Milex Silicone Wide Seal Rim Diaphragm
  7. Woman unable to insert or remove diaphragm
  8. Anatomic constraints
    1. Markedly anteverted Cervix
    2. Poor diaphragm fit
    3. Shallow vaginal shelf making stabilization difficult
    4. Poor vaginal tone
    5. Presence of Rectocele or Cystocele

VIII. Adverse Effects

  1. Latex Allergy or Vaginal Spermicide Allergy (2-4%)
    1. See Contraindications above
    2. Often mistaken for Yeast Vaginitis
  2. Recurrent Urinary Tract Infection
    1. Reduced with the softer rim or flat spring type
  3. Toxic Shock Syndrome (2.4 cases per 100,000)
    1. Avoid use during Menses
    2. Avoid use for longer than 24 hours
    3. Avoid use immediately post-partum

IX. Dosing: Sizing

  1. Sizes available
    1. Most Common: 75 mm diameter
    2. Range: 50-105 mm diameter
  2. Fitting pearls
    1. Timing of Fitting (very similar to Cervical Cap)
      1. Postpartum: >6 weeks
      2. Post-Miscarriage or abortion: >2 weeks
      3. Refit needed after completing Lactation
      4. Refit needed after 15 pounds weight gain or loss
    2. Preparation for fitting
      1. Confirm no pelvic infection!
      2. Empty bowel and Bladder prior to fitting
    3. Estimate size
      1. Insert gloved middle finger into posterior fornix
      2. Mark where index finger reaches inferior pubic arch
      3. Find fitting diaphragm that approximated this size
    4. Check fitting for:
      1. Anterior rim: just behind Symphysis Pubis
      2. Posterior rim: lies at vaginal fornix
      3. Touches both lateral walls
      4. Covers Cervix and upper vagina
        1. Cervix felt through diaphragm
      5. Best fit
        1. Largest size patient can wear
        2. Patient not aware of something inside vagina
      6. Positional stability
        1. No mobility or play in diaphragm fit
        2. Diaphragm shape should remain domed
    5. Sterilize Diaphragm between patient fittings
      1. See Diaphragm Cleaning

X. Technique

  1. Spermicide required (e.g. Nonoxynol-9 2%)
    1. Reapply for each act of intercourse
    2. Nonoxynol-9 should not be used if HIV risk
      1. No protection against Sexually Transmitted Disease
      2. Increases risk of HIV Transmission
  2. On insertion:
    1. Confirm dome shape to diaphragm (not inside out)
    2. Confirm no breaks in diaphragm surface
  3. Timing of placement
    1. Place up to 6 hours prior to intercourse
    2. Must remain in place for at least 6 hours after sex
    3. Do not leave in place longer than 24 hours
    4. Do not douche while device inserted
  4. Cleaning and storage
    1. See Contraceptive Diaphragm Cleaning
    2. Clean carefully with warm soapy water
    3. Check diaphragm for breaks in the surface
    4. Store in a clean dry storage container

XI. Suppliers

  1. Ortho (Advanced Care Products)
    1. (908) 218-6573
  2. Milex
    1. (800) 621-1278
  3. Quality Health Products (London Int.)
    1. (800) 233-7672

XII. References

  1. Apgar in Pfenninger (1994) Procedures, p. 750-6
  2. Nelson (1999) Gynecology Conf., CMEA, San Diego
  3. Summerhayes (1999) Gynecology Conf., CMEA, San Diego
  4. Allen (2004) Am Fam Physician 69(1):97-106 [PubMed]

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Ontology: Vaginal contraceptive diaphragm (device) (C0042241)

Definition (NCI_NICHD) A contraceptive device made of soft flexible material, usually of thin rubber, that is designed to cover the cervix uteri prior to sexual intercourse to prevent the entry of spermatozoa.
Definition (NCI) A medical contraceptive device of soft flexible material, usually of thin rubber, that is designed to cover the cervix uteri prior to sexual intercourse to prevent the entry of spermatozoa. To enhance efficacy, a spermicidal agent is often placed within the device. Antimicrobial agent(s) can also be used to prevent sexually transmitted diseases. Efficacy of vaginal diaphragm against infections is very limited.
Definition (SPN) A contraceptive diaphragm is a closely fitting membrane placed between the posterior aspect of the pubic bone and the posterior vaginal fornix. The device covers the cervix completely and is used with a spermicide to prevent pregnancy. This generic type of device may include an introducer.
Concepts Medical Device (T074)
MSH D003274
SnomedCT 20359006, 146728005, 268570000, 169495008, 336704008
English Diaphragm, Vaginal, Diaphragms, Vaginal, Diaphragms, DIAPHRAGM, CONTRACEPTIVE (AND ACCESSORIES), Diaphragm Pessaries, Vaginal Diaphragms, Vaginal contracep diaphragm, DIAPHRAGM, Diaphragm, Contraceptive diaphragm, device, Pessaries, Occlusive, Diaphragms, Contraceptive, Pessaries, Diaphragm, Vaginal contraceptive diaphragm (device), contraceptives diaphragm, contraceptive diaphragm, diaphragm contraception, diaphragm contraceptive, Diaphragm for contraceptive use, Contraceptive diaphragm, Diaphragm contraception, Vaginal contraceptive diaphragm, Contraceptive diaphragm, device (physical object), Vaginal contraceptive diaphragm (physical object), Diaphragms (Birth Control), Vaginal Diaphragm, diaphragms
French Diaphragme vaginal (dispositif contraceptif), Pessaire vaginal anticonceptionnel, Pessaires vaginaux anticonceptionnels, Diaphragme vaginal, Pessaire vaginal, Pessaires vaginaux
Norwegian Pessar
Spanish diafragma anticonceptivo (objeto físico), diafragma anticonceptivo, diafragma vaginal anticonceptivo (objeto físico), diafragma vaginal anticonceptivo