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The Contraceptive Diaphragm

Liz Summerhayes, R.N., N.P., C.N.M.

Introduction

Diaphragms, fashioned from herbs and food products have been available as a contraceptive method for centuries. The current diaphragms have been used in Europe for over 100 years. Margaret Sanger preferred the diaphragm over the cap and therefore the device received more attention since the 1920s.

Definition

These flat dome-shaped devices fabricated from latex contain a metal spring. There is also a silicone diaphragm that has an additional pouch for spermicide. The device acts as a physical and chemical barrier to sperm. It is recommended that all diaphragms be used with spermicidal jelly or cream.

The flat and coil spring diaphragms fold in one plane only. The arcing spring can be folded at any place on the dm and forms an arc or bow for insertion. The range for diaphragms sizes is usually 50MM to 105MM (5MM increments) however the majority of women are fit with 60-90MM.

Effectiveness

The most recent comparative study was that conducted in the 1980s randomly assigning the cervical cap and the diaphragm. Results of that study demonstrated a one year pregnancy rate for the diaphragm as 16.7 per 100 users. It was similar to that of the cap users 1 7.4 per 1 00. There have been many studies in the USA and Europe, this large study was an extensive comparison only with the cervical cap.

Benefits of Diaphragm Use

When used correctly, the diaphragm is highly effective in preventing pregnancy with minimal side effects. Additionally, there is some evidence that the spermicide non-oxynol-9 may inhibit the growth of some bacteria and viruses associated with sexually transmitted diseases. It allows for women to be in control of their method of contraception and avoids hormonal side effects sometimes caused by non-barrier methods.

Disadvantages of Diaphragm Use

As it is necessary for wormen to leave the diaphragm in place for no more than 2 hours prior to intercourse and repeat vaginal spermicide prior to each act of intercourse, this method can be considered to be messy and causes lack of spontaneity. Discomfort when the device is in place is another disadvantage. If incorrectly fit or there has been considerable weight gain or loss (+/- 10 pounds). Sometimes the rim of the diaphragm can be felt by the partner. Also the partner may object to the taste of the spermicide with oral sex if additional spermicide has been added into the vagina. For some women touching their genital area is uncomfortable and would lead to poor compliance.

Risks of Diaphragm Use

ALLERGIC REACTIONS. Either partner may have a sensitivity or an allergy to the latex or the spermicide. The non-latex (Milex®) diaphragm would be one option. Trying other brands of spermicides can often be the solution. Less concentrated spermicidal preparations as in the 2% offer effective backup without the irritation that may be caused to vaginal/penile tissue by more concentrated ones.

KNOWN LATEX ALLERGY IS AN ABSOLUTE CONTRAINDICATION TO USE OF THE ORTHO® OR KOROMEX® DIAPHRAGMS.

RECURRENT URINARY TRACT INFECTIONS. Several studies have shown that there is a higher incidence of infections in women using the diaphragm. This is often caused by the rim and pressure on the bladder wall. The softer rim, or flat spring diaphragm may reduce the incidence.

TOXIC SHOCK SYNDROME. There have been cases of TSS reported with the use of the diaphragm. It is necessary that women are advised that they should not use the diaphragm, during menstruation, for longer than 24 hours at a time and in the early postpartum period. They should also be advised of the signs and symptoms of TSS.

PREGNANCY. Use of the diaphragm may result in pregnancy.

Additionally, there is the question of birth defects being caused by the spermicidal jelly or cream with use of the diaphragm. Most authorities agree at this time that if there is a risk of fetal malformations, it is very small. No causal relationship has been proven.

Contraindication for use of the Diaphragm

Medical Contraindications

  • History of Toxic Shock Syndrome.
  • Allergy to rubber (latex) or spermicide except the Milex® silicone diaphragm.
  • Documented history of urinary tract infections.

Anatomical/User Contraindications

  • Inability to understand/carry out instructions for use.
  • Poor diaphragm fit.
  • Shallow vaginal "shelf " inability to stabilize the device. Poor vaginal tone. Presence of rectocele or cystocele.
  • Discomfort to either partner when device is in place.

Conditions that must be resolved prior to use

  • Acute cervicitis, vaginitis, or pelvic infection.
  • Abnormal Pap smear or undiagnosed vaginal/cervical lesions.
  • Cervical biopsy/laser/cryosurgery within the previous 8-12 weeks a negative Pap smear must precede use.
  • Full term delivery within the past 6 weeks.
  • Termination of pregnancy within the past 2 weeks.
  • Discomfort with touching genitals.
  • Difficulty with insertion or removal of device.

Styles o Diaphragms Available

The ALL-FLEX® Arcing Spring Diaphragm is manufactured by Ortho® pharmaceuticals. Sizes are 55mm through 105mm in 5mm increments.

The ORTHO® Coil Spring Diaphragm is also manufactured by Ortho® pharmaceuticals. Sizes 50mm through 105mm in 5mm increments.

The ORTHO-WHITE® Flat Spring Diaphragm is manufactured by Ortho® pharmaceuticals. Sizes are 55mm through 105mm in 5mm increments.

The WIDE-SEAL® Arcing Diaphragm is manufactured by Milex®. Sizes are 60mm through 95mm in 5mm increments.

The WIDE-SEAL® Omniflex coil Diaphragm is manufactured by Milex®. Sizes are 60mm through 9.5mm in 5mm increments.

The KORO-FLEX® Arcing Spring Diaphragm is manufactured by London International and distributed through Schmid Laboratories. Sizes are 60mm through 95mm in 5mm increments.

The KOROMEX® Coil Spring Diaphragm is manufactured by London International and distributed through Schmid Laboratories. Sizes are 50mm through 95mm in 5mm increments.

Cleaning Options for Diaphragm Fitting Devices

It is very important that the fitting diaphragms are scrubbed thoroughly in a liquid detergent and water prior to any of the next options. This will remove most of the bioburden. Ideally, immediately after fitting, the diaphragms should be thrown into a liquid soapy solution so that the debris does not dry on the device before cleansing.

Autoclave method.

Autoclave at 121 degrees C/15psi for 20 minutes unwrapped and 30 minutes wrapped.
Allow to air dry-do not put through "dry cycle."
Keep in container until ready to use.

CLOROX® method.

Soak in 1:10 dilution for 30 minutes.
Rinse thoroughly under running tap water.
Soak in 70% isopropyl (rubbing) alcohol for 15 minutes.
Rinse thoroughly under running tap water.
Allow to air dry and keep in container until ready to use.

CIDEX® GLUTERALDEHYDE method.

It is important to have adequate ventilation when using this method and running water.

Immerse in 2% cidex solution for 20 minutes at room temperature.
Rinse and place in boiling water for 30 minutes.
Allow to air dry and then keep in container until ready to use.

This method, although effective, will cause deterioration of the latex and as the solution is caustic can be a hazardous substance to use in an office setting.