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Three Part Question

In [women with early pregnancy and vaginal bleeding] does [a speculum exam] [change the physician's management or diagnosis]?

Clinical Scenario

24 year old gravida 1, para 0 female at 7 weeks gestation presents to the emergency department with a one day history of vaginal spotting, suprapubic abdominal cramping and nausea. You perform a digital exam and wonder if a speculum exam is really necessary.

Search Strategy

Ovid interface on the world wide web 1966-May 2007
Pubmed interface on the world wide web 1966-May 2007
(pregnancy and speculum).mp. [mp=ti,ot, ab,nm, hw] limit to human

Search Outcome

Altogether 93 papers were found in OVID and Pubmed, of which 90 were irrelevant or of insufficient quality. No further papers were found by scanning the references of relevant papers. All relevant papers are summarized below.

Relevant Paper(s)

Author, date and country	Patient group	Study type (level of evidence)	Outcomes	Key results	Study Weaknesses
Mol, B., M.D., et al. January 1999 Netherlands	382 women with suspected ectopic pregnancy, based on positive urine pregnancy test and presence of abdominal pain, vaginal bleeding, or risk indicators.	A prospective study evaluating the likelihood ratio (LR) of ectopic pregnancy using various abnormalities found on abdominal, speculum and digital examination as compared to transvaginal ultrasound and serum beta-HCG.	LR of ectopic pregnancy normal speculum exam 0.77	Normal speculum exam 45/116 patient with ectopic pregnancy. Normal speculum exam 10/43 patients with miscarriage	This study calculated likelihood ratios of ectopic pregnancy based on physical exam findings. This was based on final diagnosis made with ultrasound and serum beta-HCG. It did not show if the physical exam findings would or should change the physician's management or diagnosis.
			LR of ectopic pregnancy with rebound tenderness on abdominal exam 3.7	24/118 patients with ectopic pregnancy had rebound tenderness.
			LR of ectopic pregnancy with muscle rigidity on abdominal exam 8.0	7/116 patients with ectopic pregnancy had muscular rigidity. Only 2 other women had this sign.
Hoey, R., Allan, K. July 2004 United Kingdom	236 stable women less than 20 weeks gestation with vaginal bleeding and no known cervical carcinoma.	A prospective study that allowed physicians to fill out a questionnaire regarding their diagnosis and managment plan following digital exam and then again following speculum exam.	1.3% (3 patients) had a change in management based on speculum exam	Original management plan was for ultrasound. After speculum exam the plan changed to gynecological referral. The reasons were as follows: open cervical os and products of conception visualized, amniotic fluid visualized, and patient request.	Results are based on physician questionnaire, which in itself may have an element of error based on truthfulness of reporting. Does not address other causes of bleeding such as carcinoma.
			4.2% (10 patients) had a change in diagnosis following speculum exam.	7/10 women diagnosis was changed from threatened abortion to inevitable abortion. 1/10 missed abortion changed to threatened abortion. 1/10 unsure diagnosis changed to inevitable abortion. 1/10 inevitable abortion changed to threatened abortion.
Chilaka, V., et al. July 2000 United Kingdom	564 women presenting with antepartum hemorrhage.	Prospective observational study evaluating findings of speculum exam, pregnancy complications and outcomes, and level of physician performing exam.	Most speculum exams did not contribute to a clinically significant diagnosis	69% were normal exams, 21.3% showed cervical ectopy.	The study did not give gestational age of presenting patients. It did not address miscarriange as requiring significant intervention.
			None of the speculum exams revealed a diagnosis that resulted in a significant intervention.	0% revealed a significant carcinoma.

Comment(s)

The critical diagnoses that must be assessed in bleeding in early pregnancy are ectopic pregnancy, miscarriage, and cervical carcinoma. The first two seem to be adequately diagnosed with serum testing and ultrasound, based on these articles. Miscarriage diagnosis can be altered in respect to the specific type of miscarriage with a speculum examination Also, beneficial intervention can be provided by removing products or clot from the cervical os. Cervical carcinoma is a diagnosis best made by a specialist and often times missed by examiners who do not see this often. It is also a rare diagnosis and very unlikely if history reveals a recent normal Pap test. Only one study, Hoey and Allan, directly addresses the question posed. From this study the management and diagnosis are not changed in a significant amount of cases based on speculum exam. In this study it should be noted that all patients did receive a digital exam prior to speculum exam. The cases that were changed were cases of miscarriage. All studies did address that each case needs to be assessed on an individual basis and that the comfort level and experience of the examiner is relevant.

Clinical Bottom Line

In women with bleeding during early pregnancy a speculum exam does not significantly change the physicians diagnosis or management when a digital exam has been performed, although each case must be taken on an individual basis.

References

1. Mol, B., M.D., et al. Should patients who are suspected of having an ectopic pregnancy undergo physical examination? Fertility and Sterility January 1999, pages 155-157
2. Hoey, R., Allan, K. Does speculum examination have a role in assessing bleeding in early pregnancy. Emergency Medicine Journal July 2004, pages 461-463
3. Chilaka, V. et al. Practice observed: is speculum examination on admission a necessary procedure in the management of all cases of antepartum haemorrhage? Journal of Obstetrics and Gynaecology July 2000, pages 396-398