Does assessment of signs and symptoms add to the predictive value of an algorithm to rule out pregnancy?

Abstract

Background A World Health Organization-endorsed algorithm, widely published in international guidance documents and distributed in the form of a 'pregnancy checklist', has become a popular tool for ruling out pregnancy among family planning clients in developing countries. The algorithm consists of six criteria excluding pregnancy, all conditional upon a seventh 'master criterion' relating to signs or symptoms of pregnancy. Few data exist on the specificity to pregnancy among family planning clients of long-accepted signs and symptoms of pregnancy. The aim of the present study was to assess whether reported signs and symptoms of pregnancy add to the predictive value of an algorithm to rule out pregnancy.Methods Data from a previous observational study were used to assess the performance of the algorithm with and without the 'signs and symptoms' criterion. The study group comprised 1852 new, non-menstruating family planning clients from seven clinics in Kenya.Results Signs and symptoms of pregnancy were rare (1.5%) as was pregnancy (1%). Signs and symptoms were more common (18.2%) among the 22 clients who tested positive for pregnancy than among the 1830 clients (1.3%) who tested negative, but did not add significantly to the predictive value of the algorithm. Most women with signs or symptoms were not pregnant and would have been unnecessarily denied a contraceptive method using the current criteria. ConclusionsThe 'signs and symptoms' criterion did not substantially improve the ability of the algorithm to exclude pregnant clients, but several reasons (including use of the algorithm for intrauterine device clients) render it unlikely that the algorithm will be changed. G A popular algorithm for ruling out pregnancy among family planning clients subordinates six criteria predictive of nonpregnancy to one 'master criterion' based on signs and symptoms predictive of pregnancy.

Use of a checklist to rule out pregnancy: a systematic review

“…The PubMed search strategy for articles assessing a pregnancy checklist identified 453 articles, of which 4 analyses from 3 studies met inclusion criteria for this review (Table 1) [5][6][7][8]. All were diagnostic accuracy studies, comparing a pregnancy checklist to urine pregnancy testing, which was considered to be the reference standard.…”

“…A further analysis of the study from Kenya was conducted in order to examine the value of assessing signs and symptoms of pregnancy along with the other criteria in the checklist [5]. From the same 1852 enrolled women, the following signs and symptoms were recorded in 27 women (4 of whom were pregnant): uterine mass, nausea, abdominal pain, spitting, vomiting, engorged breasts, missed periods for 2 months, "giddiness," and "laziness."…”

“…The implication is that women who are not pregnant will not be denied contraception because a pregnancy test might not be available or feasible. In the one study that assessed the added utility of signs and symptoms of pregnancy, these criteria were not found to substantially improve the performance of the pregnancy checklist, although the number of women with signs and symptoms was small [5].…”

Performance of a checklist to exclude pregnancy at the time of contraceptive initiation among women with a negative urine pregnancy test

“…7 A study conducted at seven family planning clinics in Kenya enrolled 1,852 non-menstruating women seeking contraception. 8 The sensitivity, specificity, and NPV were 64%, 89%, and 99%, respectively. A second study of 263 women conducted in Nicaragua examined the sensitivity and specificity of the criteria among women enrolling in a randomized trial of oral contraceptives.…”

Using a Checklist to Assess Pregnancy in Teenagers and Young Women

“…Studies in international settings suggest the criteria perform well in predicting nonpregnant status. 5-8 The checklist has not been evaluated in the United States or among teenagers and young women. Delays in method initiation may be an important barrier to contraception among teenagers and young women, because many do not return to the clinic to begin their method 9 or lose motivation to use contraception while waiting to begin their method.…”