Objectives
1. Describe the reasons abortion at less than six weeks gestation was impractical in the 1970�s. What advances in technology have not made it practical.
2. Explain the concept of �discriminatory zone� and its implications for providing medical abortion, early surgical abortion and detecting ectopic pregnancy.
3. Discuss the benefits of surgical abortion at less than six weeks to the patient, to the physician and to the staff.
4. Discuss the skills and services needed to provide medical abortion.
5. Understand the pitfalls of relying only on pathologic examination of curettings to confirm the removal of an intrauterine pregnancy.

History of Early Surgical Abortion

 After abortion became widespread in the United States in the early 1970s, technical limitations to very early (less than six gestational weeks) surgical abortion became evident. Pregnancy tests commercially available at that time detected levels of human chorionic gonadotropin (hCG) of 1500-2000 IU/L (first International Reference Preparation) making it impossible, outside of a research setting, to confirm a pregnancy before six weeks gestation. Moreover, clinicians found it difficult to visually confirm the presence of products of conception in the surgical specimen and pathological examination often failed to identify villi.  Most retrospective studies of abortion complications indicated an much higher risk of complications such as febrile morbidity, hemorrhage requiring blood transfusion and unintended major surgery for gestations of less than six[i],[ii] During the last 15 years technological advances such as vaginal ultrasound, high-sensitivity urine pregnancy tests, and readily available serum b-hCG tests have moved the diagnosis of normal and ectopic pregnancy well within the first six gestational weeks.^[iii]  This technology also allows very early pregnancy termination.

            The availability of home pregnancy tests for less than ten dollars that are positive as soon as eight days after conception has created patient demand for early pregnancy termination.^[iv]   Most women who have made a decision to terminate a pregnancy wish to have the abortion done as soon as possible as long as there is no additional risk.  Our study of 2,400 cases has shown that pregnancies less than 6 weeks gestation can be safely terminated using manual vacuum aspiration. The use of a hand-held vacuum syringe with a 7 mm rigid cannula combined with pre and post operative vaginal ultrasound to demonstrate complete aspiration is a safe and effective technique for early abortion.  The surgical technique is only slightly more difficult than that of endometrial biopsy.  If the observation of chorionic membrane and villi do not confirm a complete abortion, follow up with serum b-hCG is required. This approach has the additional advantage of quickly detecting unsuspected ectopic pregnancy. 

Ultrasound in Early Surgical Abortion

Ultrasound is used to date the early pregnancy and to confirm the removal of the gestational sac and the decidua.  The approximate gestational age can be determined because of the sequential appearance of the embryonic structures.  When there is no gestational sac by vaginal ultrasound and the pregnancy test is positive, the gestation is 3 weeks (LMP) or is an ectopic pregnancy.  When there is a gestational sac visualized the pregnancy is 4 weeks or (rarely) an ectopic pregnancy with a pseudosac.  When the gestational sac and yoke sac are visualized but there is no fetal pole the gestation is 5 weeks.^[v]  Alternately the gestational sac diameter can be measured and the gestational age determined by the average diameter of the sac. The formula to calculate the gestational age is:

Gestational age (days)=mean sac diameter (mm) + 30

  The ultrasound is also useful for detecting abnormal anatomy (fibroids, uterine septa) that might complicate the abortion procedure.

Surgical Procedure

Two models of hand held syringes of slightly different design are available in North America. The IPAS* syringe has a valve that allows the vacuum to be created prior to inserting the cannula into the uterus.  The Milex syringe has a locking plunger that prevents inadvertent loss of pressure during the procedure but the vacuum must be created after the cannula is inside the uterus.  I will describe the use of the IPAS syringe although the Milex can be used with minor modification.

  The abortion procedure is exactly the same as other first trimester procedures up to insertion of the cannula through the cervical os. The use of local anesthesia, conscious IV sedation, general anesthesia and other adjuncts will not be described in this text.  The 7 mm cannula is firmly seated into the opening of the syringe.  The valves are then closed and the plunger is extended (pulled out) to create a vacuum.  The cannula is then inserted with a twisting motion through the cervix, which has been dilated, to a 21 French circumference using tapered (Pratt) dilators. The valves are then released and the uterine contents removed with both rotation and back and forth movements. Often the white gestational tissue can be seen passing through the cannula.  When the uterus is felt to be empty the cannula is removed.  When the cannula tip is removed from the uterus a rush of air can be heard assuring that the vacuum has been maintained during the procedure. A vaginal ultrasound examination of the uterine cavity while the patient is still on the examination table confirms the removal of the gestational sac and decidua.  When the OR does not have a readily accessible ultrasound machine the post op ultrasound can be limited to only those cases in which appropriate membranes and villi are not seen in the curettings.  The use of the hand held syringe and the large bore (7 mm) cannula allows the gestational membranes and villi to be removed relatively intact.  The gestational tissue is then easy to identify with thorough washing and floating in a backlit dish.  In those cases in which definite gestational membranes and villi are not identified, blood is drawn for an immediate b-hCG.  In our experience gestational tissue is not identified in about one case out of every 20 under six week gestations or in about 50% of gestations in which the gestational sac is not seen on vaginal ultrasound.  The cost of the b-hCG testing is far outweighed by the benefit to the patient of early identification of unsuspected ectopic pregnancy and the convenience of an early procedure.[vi]

 When the b-hCG is drawn it is necessary to use a specific follow up protocol.  If the initial b-hCG is above that of the laboratory�s discriminatory zone the patient must be sent for immediate evaluation of a possible ectopic pregnancy.  If the initial b-hCG is less than the lab�s discriminatory zone a follow up b-hCG must be drawn in 24-72 hours.  If the level fails to drop by at least 50% in the second study the patient must be evaluated for possible ectopic pregnancy. Most of the ectopic pregnancies detected by this method are suitable for treatment with methotrexate, thereby avoiding a surgical procedure.*  

Examination of the Products of Conception

An integral part of any surgical abortion procedure is the examination of the products of conception.  The surgical procedure is not complete until the surgeon has examined and ascertained that the products of conception are complete and correlate with the gestational age.  Many of the delayed complications of abortion will be minimized when complete removal of the appropriate amount of gestational tissue is confirmed by a systematic examination of the tissue by the clinician. Physicians performing first trimester abortions will inevitably encounter patients whose pregnancies are ectopic but who have not yet experienced symptoms typical of more advanced ectopic pregnancies. A formal, microscopic examination of the tissue by a pathologist, while useful in screening for molar pregnancy, does not reliably provide the most relevant clinical information.  Other reasons for pathological examination include requirements by state laws and as a means of disposal of aspirated tissue. The clinician should confirm not only that gestational tissues (membranes, villi, fetal parts) are present but also that the amount of tissue is consistent with the gestational age. A pathological examination can be signed out as �positive for trophoblastic tissue� when the main portion of the pregnancy remains in the uterus or is a cornual or tubal ectopic pregnancy^, It is common for the pathologist to fail to detect a small 3 or 4 week gestational sac because of the relatively large amount of decidual tissue. Careful examination of aspirated tissue is the key to early diagnosis of ectopic pregnancy and is the responsibility of the physician who has performed an abortion.

Discriminatory zone and detection of ectopic pregnancy

For the clinician to implement this protocol, it is necessary to understand the concepts underlying the modern detection of ectopic pregnancy.  The concept of a discriminatory hCG zone was introduced Kadar in 1981.[i] The discriminatory zone is defined as that level of hCG at which a intrauterine pregnancy should always be seen on ultrasound. The original concept was of little use in management of ectopic pregnancies since it was formulated using abdominal ultrasound. The required hCG level of 6500 IU/L (second International Reference Preparation) was present at initial presentation in less than 10% of patients with ectopic pregnancies. The concept was adapted for the more sensitive (5-10 MHz) endovaginal transducer by Bernaschek[ii] and others; the discriminatory zone was in the 1000 to 2000 IU/L range and, therefore, much more useful since this level was usually present by the time the ectopic pregnancy became symptomatic. ³ Although many clinicians now require the visualization of a gestational sac on vaginal ultrasound before performing a surgical abortion, the experience with the protocol described here demonstrates that such visualization is not necessary. Goldstein first proposed that visualization of a gestational sac is not a necessary prerequisite for a pregnancy termination if the patient is followed closely by �-hCG measurements.[iii] Such "biochemical visualization" assures that the pregnancy is terminated. In his series of 21 patients with no gestational sac on endovaginal scan, 17 (81%) had villi by gross or microscopic exam. The described here uses modified gross exam (3X magnification) since microscopic tissue reports are not immediately available and are often misleading. Kadar, following a similar protocol (albeit with abdominal ultrasound), recommended against doing a curettage when the gestational sac was not seen. ⁷ His protocol required the patient to return in a week for further evaluation and curettage; this extra week, if an ectopic pregnancy is present, could result in serious consequences. Also patients may not be able to return or may be lost to follow up. In our study seven out of fourteen of our patients with ectopic pregnancies had their diagnosis made and treatment begun the day they came for their abortion. Of the 242 patients with a 3 week (21 to 27 day) gestation, 51% went home the day of surgery with assurance that their pregnancy was terminated and that no further evaluation (other than routine follow up) was needed. Had the recommendation of Kadar been followed, all 242 patients would have had to return in one week and 13 (5.4%) women would have had a delay in the diagnosis of their ectopic pregnancy.

Costs of the protocol

  It is important to understand the necessary costs of establishing this protocol as part of clinical abortion practice. Minor costs include a manual vacuum aspiration syringe and a fluorescent magnifying lens. A potential major expense could be an ultrasound machine with a vaginal transducer. However, many ob/gyn physicians already have an ultrasound machine in the office or clinic; thus, the need for an ultrasound machine is not likely to result in any additional cost. Extra staff time will be needed to contact patients who do not return as scheduled, follow-up on laboratory results, and explain the extra instructions sometimes necessary for these patients. The most notable extra cost is the quantitative �-hCG tests. Still, a relatively small number of the 2399 patients required follow-up �-hCG evaluation. Only 283 hCG tests were required to evaluate the 125 patients in whom no gestational sac was seen in the curettage specimen at a total cost of $9905 ($35.00 per test.) This cost averages to $79.20 per patient for those with no gestational sac visualized but, when apportioned among the entire patient population, is only $4.13 per patient. The average cost of �-hCG evaluation to find an ectopic pregnancy was $707.50 ($9905 and 14 ectopic pregnancies.)The direct cost of surgical treatment of ectopic pregnancy has been estimated at $8000 and $9482 and the direct costs of MTX treatment of ectopic pregnancy at $670.[iv] Since the ectopic pregnancies in this series were diagnosed very early in gestation, this protocol may potentially increase the number of women eligible for medical rather than surgical treatment. Also, there is less potential for tubal damage when the ectopic pregnancy is diagnosed 1-3 weeks before clinical symptom. It is possible that this protocol incurs unnecessary expense and instrumentation in women who would have otherwise had an early spontaneous abortion and not required medical care or surgical intervention.

Starting to provide early surgical abortions

For those planning to offer early abortion procedures it is important to Adopt the whole package! Adhere to the protocol by using the correct instruments and following the algorithm.  The high efficacy and low complications will not be achieved if you adapt, pick and choose from the methodology.  Wait until after your first 1,000 cases to try a different idea.  Order the film (Surgical Abortion Before Six Weeks Gestation) and review it with your staff.  A knowledgeable, well informed staff will be your greatest asset both in informing and reassuring the patients and in making sure there is good follow up. The belief that early abortion is more painful and fraught with risk of failure and complications is deeply ingrained in the psyche of your staff, the medical community and the general public.  Your staff will create a self-fulfilling prophecy if they tell patients that it will be more painful.  You must make sure that receptionist, nurses, counselors, volunteers, and administrative staff know about the procedure.

Common mistakes in starting the protocol:

I�ll just turn the suction down on the machine, that should be just as good as using the hand held suction.

I�ll use the small, soft Karmann cannula.  Don�t you need a small cannula for a small pregnancy?

I�ll not worry about examining the tissue because we are going to send it for pathology and pathologist are the experts at identifying gestational tissue.

I�ll not use the ultrasound, I�ve got really sensitive fingers and can tell if it�s a 3, 4 or 5 week pregnancy.

I�ll not do the post op ultrasound, it has to be rolled in from the other room and that�s just too much trouble.  If I don�t see pregnancy tissue then I�ll just bring her back in.

Those hCG�s are just too expensive, I�ll just have her come back in a few days and see if the pregnancy test is negative.

Do not �gradually� introduce the protocol by doing only 4 and 5 week gestations but not 3 week gestations.  When a woman with an undiagnosed ectopic pregnancy walks into your office, you have incurred a liability for her care.  The best thing you can do to reduce your exposure is to see that she has a good outcome.  Telling her to return in a week or two and giving her �ectopic precautions� will provide you with only minimal protection if she has a bad outcome.  By doing the procedure and making the diagnosis you will have done her a favor by making an early diagnosis.  

The protocol and algorithm have a great deal of redundancy.  This gives you a second chance when things go wrong.  Everyone makes the occasional mistake, when there is redundancy it is necessary to make two mistakes in the same case to have a bad outcome.

  Examples of redundancy in the protocol:

You document the disappearance of the uterine contents twice (ultrasound and in examining POC)

When you don�t see definite POC you document the disappearance biochemically�don�t depend on pathologist seeing one villi

You learn to correlate the amount of gestational tissue you see post op with the ultrasound picture pre-op.

If you have a lab that fails to do the pregnancy test right (false positive) you quickly find out with your post-op b-hCG.

Other benefits of early procedure:

Truly minimizes the physiologic changes of pregnancy�no detectable change in clotting factors, less time of exposure to high estrogen.

Stress is known to be time related�someone who has been stressed for a week is more likely to have physical and psychological reaction than someone who has been stressed for a few days.

Sending women away to return at a later date is costly and inconvenient for the woman.

Equipment for Early Abortion:

  Vaginal ultrasound is essential for providing early abortions.

 Curettes can be ordered from :

Berkeley Medevices (800)227-2388

Or

Cheshire Medical Specialties

(800)243-3020

X-ray view box (to lay flat on counter for POC viewing) or slide viewbox from photography store.  A small one costs about $50.

A small (3�) speculum:

Order 3� Graves or Moore-Graves

Also, for wider opening you can use the Klopfer or Vu-More

 MedGyn Products

(800)451-9667

or

Cheshire Medical

(800)243-3020

 Film:

 IPAS, PO Box 999, Camboro, NC, 27510

(800) 334-8446

Summary: Steps in Protocol 

1.      Do pre-operative sensitive pregnancy test

2.      Do pre-operative vaginal ultrasound

3.      Do counseling, informed consent and lab work (Rh status) as with any abortion procedure

4.      Use short (3�) speculum

5.      Do procedure with hand held syringe (IPAS or Milex)

6.      Dilate cervix to 7 mm (#21 French with Pratt or Dennison dilator)

7.      Use 7 mm rigid cannula

8.      Do post-operative vaginal ultrasound to confirm removal of sac and/or decidua

9.      Float tissue and examine with back lighting

10. Order b-hCG when chorionic membrane with villi not positively identified

11. Repeat b-hCG in 24-72 hours in same lab

References