Improving the Results Obtained with Current Intrauterine Contraceptive Devices

Transcription

1 Improving the Results Obtained with Current Intrauterine Contraceptive Devices MICHAEL S. BURNHILL, M.D., and CHARLES H. BIRNBERG, M.D. CAREFUL EXAMINATION of many of the clinical studies on the use of IUD's reveals a primary concern with the detailed analysis of results obtained from the programs. It is extremely difficult to find criteria for organizing a program, or teaching individual physicians to insert IUD's. The purpose of this presentation is to outline criteria for the selection of patients in whom an IUD is to be inserted, for the timing of the insertion, and for the management of side effects and complications. A simple, safe technic of insertion, as well as several pointers in the handling of the devices and instruments, will be discussed. TIMING, CONTRAINDICATIONS, AND SELECTION OF PATIENTS Timing of Insertion The importance of careful timing of the insertion of an IUD lies in two areas. One must be careful that the patient is not pregnant when the device is inserted. Only intramenstrual insertions can eliminate the occasional insertion into a pregnant uterus. No history of a last menses can be relied upon! lntramenstrual insertions are also less traumatic as the cervix is somewhat dilated and the side effects, such as bleeding, are masked by the menstrual flow. The other area requiring attention pertains to insertions in the puerperium. Immediate postpartum and postabortional insertions appear to be safe, although early postpartum insertions ( 3-7 weeks) are prone to end in uterine perforation. There is a great deal of difficulty in picking a safe time to insert devices, because of the various expediencies necessary in managing a large program. It is extremely important that the person inserting the device be made aware of the problems encountered in the course of inserting devices too soon postpartum, or inserting devices into an enlarged uterus. There is greater risk involved in the insertion of devices from 5 to 9 weeks post- 232

2 VoL. 20, No.2, 1969 IMPROVING IUD RESULTS 233 partum. At first impression the patulousness of the cervical canal would appear to make the insertion simple. However, patulousness is associated with an extremely soft myometrium that facilitates perforation in the flexed uterus. The optimum time of insertion is after full involution has occurred postpartum, and during the menstrual period. Contraindications to Insertion Two absolute contraindications to insertion of an IUD are: ( 1) intrauterine pregnancy, and ( 2) acute or subacute pelvic inflammatory disease, whether of tubal, cervical, or endometrial origin (particularly with a history of recent septic abortion). Relative contraindications include the following: 1. A history of gynecologic disease, such as abnormal menses, pelvic pain, genital tumors, or genital tract malignancy 2. Fibromyomas of the uterus, especially if distortion of the uterine cavity is present, or there is a history of menstrual abnormalities 3. Bicornuate or septate uteri 4. Anxiety syndromes or other emotional problems that may be aggravated by the presence of, or side effects from, an IUD 5. Extreme distortions of cervico-uterine anatomy, such as cervical stenosis or fixed, marked, ante-, or retroflexion of the uterus Selection of Patients If the woman has no historical or current contraindications to the insertion of an IUD, a careful pelvic examination should be done to determine if there are any factors that would predispose the patient to uterine perforation or poor results from the IUD. These include: 1. Extreme anteflexion or retroflexion, especially if the uterus does not move with cervical traction 2. Fixed, marked anteversion or retroversion 3. Cervical stenosis or irregular scarring of the cervical canal 4. An enlarged uterus, especially if softened or very irregular in shape 5. Cervical andjor uterine hypoplasia (In general if the cervix is less than ~' in. in circumference andjor the uterus sounds less than 2 in., an IUD cannot be tolerated (though you may be able to insert one) 6. Marked cervical deformities, such as extensive irregular lacerations, or history of repeated midtrimester abortions producing an incompetent cervical os. 7. A hyperinvoluted softened uterus, as seen in lactating women

3 234 BuRNHILL & BIRNBERG FERTILITY & STERILITY TECHNIC OF INSERTING AN IUD Figure 1 shows in schematic fashion the steps to be followed during the insertion of an IUD. Though the device shown is a bow, we strongly urge that a similar technic be employed for the insertion of any IUD. As can be seen from the diagrams, the safe insertion of an IUD requires fixation of the cervix with a tenaculum. This allows traction to be used during the procedure and eliminates most of the difficulties produced by malpositioning of the uterus, such as severe ante- or retroversion. We have found the White tonsil-seizing forcep or the Teale clamp to be the best instruments for this purpose. The teeth of these instruments are similar to those found in an Allis clamp. Much less bleeding and discomfort are encountered when these instruments are used. As can be seen from Fig. 1, a sound is used prior to the introduction of the inserter. This enables one to know the depth and direction of the uterus and gives some indication of whether any problems will be encountered during the insertion of the IUD, such as a tight cervical canal. The use of an appropriately sized dilator is recommended. This assures one that the introducer can be properly placed in the cavity. If difficulty is encountered during the insertion of the dilator, a smaller dilator should be inserted and left in place for a minute. Then the large dilator can usually be inserted. The inserter used for the bow employs a combination plastic sounddilator for its plunger. This instrument affords a simple way of ascertaining the depth of the endometrial cavity and the size of the cervical canal. The dilator end measures 23~ in. If the entire dilator tip fits into the cervicouterine cavity then it is generally possible to insert a large-size device (such as the standard bow or Loop C or D). If more than 3~ in. of the dilator protrudes, no device will be well tolerated. When the inserter is introduced into the cervical canal, care should be taken to inspect the plane in which the device has been loaded into the introducer. The position of the depth stop is of no value since the device can be at right angles to a horizontal stop (as with the loop inserter). The device must fold in the same plane as the uterus and not at right angles to the uterine cavity. Looking at the inserter at the time of introduction will prevent introduction of an IUD in the wrong plane. At the bottom of Fig. 1 are shown several positions that an IUD can assume within the endometrial cavity. As long as no part of the device straddles the cervico-isthmic junction the orientation of the IUD is of no great importance.

4 VoL. 20, No.2, 1969 IMPROVING IUD RESULTS 235 EQUIPMENT NEEEDED FOR INSERTING AN IUD. Tenaculum Scissors 8 Transverse Fig. 1. Technic for introducing new bow. Steps are: (1) careful bimanual examination; (2) visualization of cervix and traction with tenaculum; (3) sounding uterus; ( 4) dilating cervix (choose proper size of device; if dilator tip protrudes, use junior device); (5) inserting loaded introducer slowly and gently expelling bow (make sure device is in same plane as endometrial cavity); ( 11) removing plunger (wait 30 sec. for bow to resume shape); ( 7) removing introducer (use dilator to seat device, and trim tail to~ in. Final position of bow within endometrial cavity (8) may be vertical, transverse, or oblique.

5 236 BURNHILL & BIRNBERG FERTILITY & STERILITY SPECIAL POINTS ABOUT INSERTION At this point something should be said about the characteristics of the plastic IUD's. None of the plastic IUD's can be boiled. Their ability to return to their original design (their "memory") after placement in an introducer is impaired. The longer a device is left in the tube, the poorer will be its ability to remember its original shape. This is particularly true for the loop, which has a poorer recall than the bow. The devices should be loaded as close as possible to the time of insertion. If possible, no more than 5 min. should elapse between the loading and the introduction of the device. This same loss of memory makes it extremely important to seat the device in the endometrial cavity following its placement in the uterus. This is of special importance in the case of the loop. There is a propensity for the terminal filament of the loop to remain straightened in the upper cervical canal. This can occur whenever the cervical canal is lengthened. One can seat the device by pushing it into the uterine cavity, using a dilator or if necessary the inserter itself. This maneuver can be safely and successfully carried out only if countertraction is being applied to the cervix by a tenaculum. Aside from reducing the expulsion rate and side-effect rate, seating the device assures the physician that the IUD is in the cavity. It is also of great importance to understand that little or no force is needed to insert an introducer and to eject an IUD into the endometrial cavity. Should difficulty be encountered, the ejection should be halted and the initial steps of sounding and dilating repeated to ascertain the source of the difficulty. This should be emphasized, especially if paramedical personnel are involved in IUD programs. Where difficulties are encountered during the insertion the procedure should be stopped. Paramedical personnel should consult the physician in charge of the clinic and if none is available the insertion should be abandoned. A cardinal principle for success with an IUD program is the screeningout of unsuitable candidates and the avoidance of inserting IUD's where any difficulty is encountered. The few additional insertions obtained by relaxing the standards are far outweighed by the poor results obtained, and by the negative effect on the entire program produced by a group of dissatisfied users. THE HANDLING OF SIDE EFFECTS AND COMPLICATIONS Advising the Patient The results obtained with IUD' s can be improved if the patient is given some advice as to what to expect after the insertion of the device. She should be advised:

6 VoL.20,No.2,1969 IMPROVING IUD RESULTS To ignore spotting for the first 3 months after the insertion, as well as other minor menstrual abnormalities 2. To examine her napkins during the period to locate an expelled device 3. To come in for an examination in the event of heavy vaginal bleeding, severe pelvic pain, pelvic infection, or an expulsion 4. To use an additional type of contraception if she has expelled the device or has had extremely heavy menstrual bleeding 5. To avoid checking for the tail of the device, as it may be extremely difficult, if not impossible, to palpate 6. To return for a check-up after 2 menses Side Effects Spotting. The patient should be reassured that spotting is of little importance and will generally disappear. She may benefit from Vitamin C, 500 mg. 1-4 times daily. Menorrhagia. Several heavy periods may be expected if the IUD was slightly larger than the endometrial cavity, and a period of adaptation is required. However, a menstrual How that soaks through a double napkin in less than an hour is of some consequence. This will occur if the device is too large for the cavity. Adaptation cannot occur and it is necessary to shift to a smaller device, such as Loop A for Loop D, or the junior bow for the standard bow. Another cause for menorrhagia is partial expulsion of the IUD with the device straddling the cervico-isthmic junction. This can be handled by removing the device and placing it higher in the endometrial cavity. Mild menorrhagia can frequently be managed with oral vasoconstrictors such as Sudafed, * 60 mg. every 4 hr., Ornadet spansules, 1 capsule every 8 hr., andjor Vitamin C, 1000 mg. 4 times a day. If all of this is of no avail, the IUD should be removed and another method of contraception suggested. Pain. Mild pain (pelvic, back, menstrual, or ovulatory) can be alleviated with aspirin or other analgesics. Severe pain, particularly a persistent low backache, indicates that the device is stimulating the cervico-isthmic junction. Replacing a large device with a smaller one, or replacing a device that is straddling the cervico-isthmic junction should alleviate discomfort. Vaginal Discharge. Since IUD's stimulate ovulation there is frequently a tendency to note increased midcycle discharge. Any discharge associated with either an odor or a color should be specifically investigated and treated *Burroughs Wellcome & Co., Inc., Tuckahoe, N.Y. tsmith, Kline & French Laboratories, Philadelphia, Pa.

7 238 BuRNHILL & BIRNBERG FERTILITY & STERILITY with appropriate medicaments if monilial or trichomonal in origin. The use of tampons, particularly in the presence of a tailed device, is an invitation to cervicitis andjor endometritis. Nonspecific persistent leukorrhea associated with the use of a tailed IUD can frequently be cured by removing the device and reinserting one without a tail. Delayed Menses. A persistent corpus luteum or follicle cystosis is occasionally the cause of delayed menses. The patient should be advised to wait a week. If she has still not menstruated a trial of hormonally induced withdrawal bleeding may be attempted. The immunologic KL appears to have a high percentage of false positives with this condition; therefore, a biologic pregnancy test is preferable. Other Side Effects. In general, side effects produced by the introduction of too large a device can be handled by replacing the large device with a smaller one. We have found that about half of the women complaining of either menorrhagia or uterine discomfort following the introduction of a standard bow can be relieved by substituting a junior bow. A chronic expeller can best be handled by inserting a device of different design-i.e., inserting a standard bow when Loop D has been expelled. Acute pelvic infection can best be handled by use of the appropriate antibiotic. We have noted that it may be necessary to remove the device if the infection does not respond rapidly to antibiotics. This is especially true if there is any suspicion of recent septic abortion. The development of side effects some time after the insertion of a device should alert one to the possibility of a smoldering endometritis. This illness begins with either the appearance of spotting, menometrorrhagia, or malodorous vaginal discharge, or bloating and lower abdominal discomfort at any time during the menstrual cycle. Pelvic examination confirms the malodorous discharge, the presence of leukocytes without monilia or trichomonads, and frequently the presence of a foul-smelling agglutinate on the protruding tail of the device. Recently we embarked on a study of the effect of the tail of the IUD on the development of delayed endocervicitis or endometritis. Though this study is in its early stages we are reasonably sure that the addition of a tail has resulted in the development of a genital tract infection in about a fourth of our patients. This tendency appears to be exaggerated in those women who are consistent tampon users. Therapy consists of local medicaments, douching, broad-spectrum antibiotics, and forbidding the use of tampons. Should this therapy fail or the condition recur, the IUD should be removed and cultured. After treatment with the appropriate antibiotic, a reinsertion of a tailless device can be tried after several normal periods have occurred.

8 VoL. 20, No.2, 1969 IMPROVING IUD RESULTS 239 Complications Pregnancy. The patient should be reassured that the presence of the device will not injure the developing fetus. The increased incidence of abortion noted in pregnancies occurring in patients who have an IUD in situ may be induced. There is little doubt that removal of an IUD in the first few weeks of amenorrhea is associated with a very high incidence of abortion. An ectopic pregnancy should be considered in the presence of pain andjor an adnexal mass. Pelvic Inflammatory Disease. Acute rapidly fulminating pelvic inflammatory disease or an exacerbation of chronic pelvic inflammatory disease may occur any time after the insertion of a device (though it usually occurs soon after insertion). A tailless device may be left in situ while the patient is treated with the appropriate antibiotics. A tailed device is best removed during treatment. A second occurrence of pelvic inflammatory disease with an IUD in position is generally sufficient reason to remove the IUD permanently. Perforation. Perforations may occur, usually during the insertion of the IUD, particularly in the early puerperium, during lactation, or with a severely flexed uterus. The perforation itself is usually asymptomatic. Frequently the ectopic device is detected only after the patient becomes pregnant, or if she requests removal of the device. The patient should be advised of a perforation as soon as it is detected. A closed device should be removed through either a colpotomy or laparotomy. Open devices appear to be much more benign if left in the peritoneal cavity, since there is no risk of intestinal obstruction. However, some intra-abdominal problems have been reported following perforations with open devices, and the devices are probably best removed if the patient's physical condition permits an operation. SUMMARY AND CONCLUSIONS Careful training of the personnel involved with the insertion of IUD's, and the observance of strict criteria for the insertion of the devices, will improve the results being obtained from present national family-planning programs. Particular attention should be given to the dangers of insertion in the early puerperium and during lactation. It is of great importance to develop a consistent ritual for safely inserting devices. This includes a careful history, a bimanual examination, traction on the cervix with a tenaculum, sounding of the uterus, use of a dilator to measure the size of the cervical canal and the depth of the endometrial cavity, slow and gentle insertion of the introducer and expulsion of the

9 240 BuRNHILL & BIRNBERG FERTILITY & STERILITY IUD, and finally, seating of the device to be sure of its placement in the endometrial cavity. The methods outlined for handling the side effects and complications following the use of IUD' s are designed to decrease removal rates. Fewer but better-done insertions on properly selected women may greatly improve the results obtained from an IUD program. 191 Ocean Ave. Brooklyn, N. Y