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Background: Chlamydia infection has been associated with ectopic pregnancy, the leading acute gynaecological emergency in Kenya. In pregnancy, it is often asymptomatic yet it is not screened for during antenatal clinic visits.
Objective: To describe and compare the prevalence of Chlamydia infection in patients with ectopic and intrauterine pregnancy (incomplete abortion) at the Kenyatta National Hospital
Design: Cross sectional prospective study
Setting: Acute gynaecological ward at the Kenyatta National Hospital.
Subjects: Patients with ectopic pregnancy and incomplete abortion.
Methods: A cervical swab will be taken from a patient with an ectopic pregnancy post-operatively. On the same day, another swab will be taken from an age matched client presenting at the acute gynaecological ward with an incomplete abortion. Detection of Chlamydia antibodies in the samples will be done through rapid immunoassay. Social demographic profiles of the participants will also be extracted using a structured questionnaire.
Chlamydia trachomatis is an obligate intracellular bacterium that commonly attaches to columnar or transitional epithelium. C. trachomatis infections are an enormous public health problem throughout the world, accounting for most bacterial sexually transmitted diseases.1 WHO estimated that there were sixteen million new cases of chlamydia in sub-Saharan Africa in 1999 and 70-75% of infected women were asymptomatic.
A study in women undergoing tubal ligation found chlamydia prevalence to be 14.9%,2 while 9 % of women aged 18 - 40 years attending an STD clinic in Nairobi, were found to have Chlamydia.3 E. Lagarde, et al in a multicenter study in Kisumu, reported the prevalence of chlamydia to be 4.5% in women selected from the general population.4
Most pregnant women have asymptomatic infection but some present with urethral syndrome, urethritis or Bartholins gland infection.5 Chlamydia prevalence was 29% after screening 1090 women in labour and at 7 and 14 days postpartum in a study in Nairobi,6 while in Durban South Africa, cervical infections were diagnosed microbiologically in 8.2% of asymptomatic pregnant black women. These were N. gonorrhoea in 4.1% and C. trachomatis in 4.7%.7 Romoren et al in a study among 703 antenatal care attendees in Botswana found that the prevalence of chlamydia and gonorrhoea was 8% and 3% respectively.8 Ndinya-Achola et al found chlamydia in 8 % of pregnant women attending antenatal clinic in Nairobi, Kenya.9
Several studies found inconclusive or no evidence that Chlamydial infection causes abortion.24,25.26,27
Ectopic pregnancy is implantation of the blastocyst anywhere else other than in the endometrial lining of the uterine cavity. 95% of these involve the fallopian tubes. Other sites of implantation are cervix, ovary, broad ligament and intra-abdominal. Racheal E. L. et al detected anti-Chlamydia immunoglobulin in 51% and 67% of patients with ectopic pregnancy in the United Kingdom and Trinidad respectively.10
Abortion refers to the termination of pregnancy from whatever cause before the fetus is capable of extrauterine life. Spontaneous abortion refers to those terminated pregnancies that occur without deliberate measures, whereas induced abortion refers to termination of pregnancy through a deliberate intervention intended to end the pregnancy11. Another widely used term for spontaneous abortion is miscarriage. By convention, abortion is usually defined as pregnancy termination prior to 20 weeks' gestation or less than 500-g birth weight.
Qualitative lateral flow immunoassay is a method of determining the presence of an antigen (or antibody) in blood sample when the specimen is exposed to the specific antibody (or antigen) labelled with a fluorochrome and observing the antigen-antibody reaction of precipitation. During the test, a solution extracted from the cervical swab will be applied to the test devise. If Chlamydia antigen is present in the solution, it will react with antibodies at the test region of the devise and generate a coloured line (the test line). Another coloured line will appear at the control region of the devise indicating adequate volume of specimen (the control line). Chlamydia antigen may persist even after appropriate treatment; therefore the test will be positive in cases of past infection.
The DiaspotTM Chlamydia Rapid Test Device when compare to the gold standard for detection of Chlamydia antigens on cervical swabs, Polymerase Chain Reaction, has a sensitivity of 88.5 % and specificity of 96.7 %. Its relative accuracy is 93.7 %.11
Descriptions of a disease of human eyes resembling trachoma (meaningÂ 'rough eye') have been found in ancient Chinese and Egyptian manuscripts. In 1907, Halberstaedter and von Prowazek, working in Java, described the transmission of trachoma from man to orangutans by inoculating their eyes with conjunctival scrapings. In Giemsa-stained conjunctival epithelial cells, they found intracytoplasmic vacuoles (chlamydial inclusions) containing numerous minute particles (small chlamydial elementary bodies and larger chlamydial reticulate bodies) which they correctly inferredÂ represented the causal agent of trachoma. The newly discovered organisms were called the Chlamydozoa (from the Greek khlamus, a mantle / cloak) because of the blue-staining matrix in which the particles were apparently embedded [See: Collier 1990]. This was not correct, as the chlamydiae are not "mantled protozoans". However, the Greek-derived stem remains as a tribute to these outstanding workers.12
In 1929-30, widespread outbreaks occurred of an atypical and often severe pneumonia, acquired from psittacine birds (budgerigars, parrots), which was termed psittacosis. These outbreaks stimulated research, and Levinthal Coles and Lillie independently described minute basophilic particles in Giemsa stained blood and tissue from the infected birds and human patients. Bedson and co-workers soon proved the aetiological relationship of these particles with psittacosis and went on to define the characteristicÂ developmental cycle that now defines all members of the order Chlamydiales. Bedson referred to this agent as "an obligate intracellular parasite with bacterial affinities", a concept of great insight that was not generally accepted for another 30 years.13Â
As early as 1934, Thygeson, an ophthalmologist, had drawn attention to the resemblances between the development and morphology of the inclusions seen in trachoma and inclusion conjunctivitis and of those found in psittacosis. The finding of a common complement-fixing antigen strengthened the idea that these agents and those of lymphogranuloma venereum and of mouse pneumonitis were related within the same unique group. By 1935 the psittacosis agent had been grown in the chick embryo chorio-allantoic membrane.
The trachoma "virus" was first isolated in the chick-embryo yolk sac in China in 1957 by T'ang and colleagues and reported in the Chinese Medical Journal.14
The aetiological relationship of this organism with trachoma was proved in 1958 by the inoculation of human volunteers. Their aetiological role in inclusion conjunctivitis, and also in genital tract infection was confirmed by inoculating the eyes of volunteers and baboons
Names for these bacteria included 'Bedsonia', 'Miyagawanella' and 'Halprowia. The term 'Chlamydia' appeared in the literature in 1945. That chlamydiae were not viruses became evident in 1965 with the advent of tissue culture techniques and of electron microscopy, when evidence for bacterial rRNA, ribosomes and cell wall structures in chlamydiae finally became overwhelming.Â However chlamydiae were grouped with Rickettsia until the genus Chlamydia was validated by Page in 1966. For years, Chlamydiales was the only bacterial order that had just one family and one genus (Chlamydiaceae and Chlamydia, respectively).13 In the 1990s, with the introduction of new diagnostic methods, chlamydiae were described as emerging disease agents.
C. trachomatis is an exclusively human pathogen has been recognized as a major cause of sexually transmitted and perinatal infection.15 Worldwide incidence has been estimated at 92 million annually, with about 16 million occurring in sub-Saharan Africa. This is second to South and South-east Asia with 43 million annual cases.16
C. trachomatis preferentially infects the columnar epithelium of the eye and the respiratory and genital tracts. The infection induces an immune response but often persists for months or years in the absence of antimicrobial therapy. Serious sequelae often occur in association with repeated or persistent infections. The precise mechanism through which repeated or persistent infection elicits an inflammatory response that leads to tubal scarring and damage in the female upper genital tract is not yet clear.17 Natural human infection results in strong serological responses to the major outer membrane protein OmpA, but antibodies to outer membrane protein PorB are low or absent.18
In adults, the clinical spectrum of sexually transmitted C. trachomatis infections parallels that of gonococcal infections. Both infections have been associated with urethritis, proctitis, and conjunctivitis in both sexes; with epididymitis in men; and with mucopurulent cervicitis, acute salpingitis, bartholinitis, and the Fitz-Hugh-Curtis syndrome (perihepatitis) in women. Both infections can be associated with septic arthritis. Generally Chlamydia infections produce fewer symptoms and signs than gonococcal infections at the same anatomic site. Increasing evidence suggests that many Chlamydia infections of the genital tract, especially in women, persist for months without producing symptoms. Simultaneous infection with C. trachomatis often occurs in women with cervical gonococcal infection and in heterosexual men with gonococcal urethritis.17
Studies among male and female adults between 15 and 49 years of age in a low to middle class suburb and unmarried female plantation workers in Kenya found prevalence of Chlamydia to be 1.5 to 3.2 %19,20
Risk factors: In women include age younger than 25 years, presence or history of other sexually transmitted diseases and multiple or a new sexual partner within the last 3 months. Use of oral contraceptive pills and the presence of cervical ectopy also confer an increased risk of Chlamydia infection.17
Complications of Chlamydia infection include pelvic inflammatory disease, ectopic pregnancy, tubal factor infertility and chronic pelvic pain. Simms, et al found chlamydia in 27% of PID cases and none in women undergoing bilateral tubal ligation.21 Chlamydia infection also increases the risk of transmission of human immunodeficiency virus.22 Feist A, et al found no association between miscarriages and infection with C. Trachomatis.23 Other studies by Oakeshott, Ostaszewska-Puchalska, Sozio and Osser and their colleagues found no conclusive evidence that Chlamydia causes abortion.24,25,26,27 However. Cohen C, Sinei S, Bukusi E, et al in a study at KNH found that more frequent histories of spontaneous abortions reported by infertile women were also consistent with atypical upper genital tract infection including Chlamydia. They found antichlamydia antibodies in 34% of women with abortions.28
Diagnosis: This is based solely on laboratory tests. N. gonorrhoea and C. trachomatis are commonly asymptomatic, among men in a rural African population in Tanzania only 24 of 158 (15%) infected subjects complained of urethral discharge at the time of interview.29 Cell culture isolation has specificity of 100 % and sensitivity of 70 to 90% but is expensive and highly specialized and hence not widely available. Giemsa stain of exudates in adults with genital infection is only 40% accurate. Serological methods either complement fixation or microimmunofluorescence test are positive in 20 to 40% of sexually active women. However, most do not have a current infection. Moss and colleagues, in a study among women attending a genitourinary clinic, found that up to 50% of all chlamydia Ig G-positive cases were due to nongenital chlamydia (C. pneumoniae and C. psittaci).30 In qualitative lateral flow immunoassay, a solution extracted from a cervical swab will be applied to the test devise. If Chlamydia antigen is present in the solution, it will react with antibodies at the test region of the devise and generate a coloured line (the test line). Another coloured line will appear at the control region of the devise indicating adequate volume of specimen (the control line). Chlamydia antigen may persist even after appropriate treatment, therefore the test will be positive in cases of past infection.
The DiaspotTM Chlamydia Rapid Test Device when compare to the gold standard for detection of Chlamydia antigens on cervical swabs, Polymerase Chain Reaction, has a sensitivity of 88.5 % and specificity of 96.7 %. Its relative accuracy is 93.7 %.11
Other laboratory tests include direct smear fluorescent antibody testing that has a sensitivity of 90% and specificity of 98%. Polymerase chain reaction, ligase chain reaction and DNA probe assays for detection of C. trachomatis are more rapid and less expensive.
Vaccination against human Chlamydia infections is currently unavailable. However, animal trials on candidate vaccines specifically for adolescent women are ongoing. The current challenge is to develop an effective delivery vehicle for induction of a high level of immunological response. When developed, vaccines could be delivered trans-dermally via a patch, by nasal spray or vaginal cream.31,32,33,34
Treatment: Doxycycline 100 mg orally twice daily for 7 days for non-pregnant patients or azithromycin 1 g orally as a single dose can eradicate Chlamydia from the cervix. An alternate regimen is erythromycin ethylsuccinate 800 mg orally 4 times daily given for a minimum of 7 days. Patients who cannot tolerate erythromycin should consider ofloxacin 300 mg twice daily or levofloxacin 500 mg orally once daily for 7 days. Post-treatment cultures are not usually advised if doxycycline, azithromycin, or ofloxacin is taken as described above and symptoms are not present; cure rates should be higher than 95%. Retesting may be considered 3 weeks after completing treatment with erythromycin. A positive post-treatment culture is more likely to represent noncompliance by the patient or sexual partner or re-infection rather than antibiotic resistance. It is important to ensure that the sexual partner is treated, as most post-treatment re-infections occur because the sexual partner was not treated. Clinicians should advise all women with Chlamydial infection to be re-screened 3-4 months after treatment.35
Several regimens are used to treat Chlamydia infection in pregnancy. Drugs of choice are either oral erythromycin 500 mg four times a day or oral amoxicillin 500 mg three times a day both for seven days. Alternative therapies are oral erythromycin 250 mg four times a day for fourteen days or oral azithromycin 1 g single dose. Jacobson, Kacmar, Wehbeh and all their colleagues demonstrated the efficacy of azithromycin for Chlamydia infection in pregnancy.36,37,38 Adair and associates treated 106 women with erythromycin (93-percent cure) or azithromycin (88-percent cure).39 Tetracyclines are avoided because of concerns regarding fetal dental discoloration.
Ectopic pregnancy is implantation of the blastocyst anywhere else other than in the endometrial lining of the uterine cavity. 95% of these involve the fallopian tubes. Other sites of implantation are cervix, ovary, broad ligament and intra-abdominal.40
The fallopian tube lacks a submucosal layer, hence the fertilized ovum promptly burrows through the epithelium, and the zygote comes to lie within the muscular wall. At the periphery of the zygote is a capsule of rapidly proliferating trophoblast that invades and erodes the subjacent muscularis. At the same time, maternal blood vessels are opened, and blood pours into the spaces lying within the trophoblast or between it and the adjacent tissue. The tubal wall in contact with the zygote offers only slight resistance to invasion by the trophoblast, which soon burrows through it. The embryo or fetus in an ectopic pregnancy is often absent or stunted. The invading, expanding products of conception may rupture the oviduct at any of several sites. Tubal rupture in the first few weeks, the pregnancy is situated in the isthmic portion of the tube. When the fertilized ovum is implanted well within the interstitial portion, rupture usually occurs later. Rupture is usually spontaneous, but it may be caused by trauma associated with coitus or bimanual examination.40
With intraperitoneal rupture, the entire conceptus may be extruded from the tube, or if the rent is small, profuse hemorrhage may occur without extrusion. If an early conceptus is expelled essentially undamaged into the peritoneal cavity, rarely it may reimplant almost anywhere, establish adequate circulation, survive, and grow. Usually small conceptuses are resorbed. Occasionally, if larger, they may remain in the cul-de-sac for years as an encapsulated mass, or even become calcified to form a lithopedion.40
Rachael E. L., et al detected anti-Chlamydia immunoglobulin in 51% and 67% of patients with ectopic pregnancy in the United Kingdom and Trinidad respectively.10
Risk factors for tubal damage and dysfunction are associated with the occurrence of ectopic pregnancy. They include tubal corrective surgery, tubal sterilization, presence of intra-uterine contraceptive device and previous genital infection. After one previous ectopic pregnancy, the chance of recurrence is 7 to 15%.41,42 There is strong evidence linking Chlamydia infection and infertility; chlamydia antibody titers have been associated with tubal occlusion and prior ectopic pregnancy and chlamydia trachomatis seropositive serology has been found to be higher in women with ectopic pregnancy compared to controls (81% vs 63%).43,44 Frost E. and colleagues found that Chlamydia infections play a major part in salpingitis and infertility in central Africa.45 Other risk factors are multiple sexual partners, infertility and previous pelvic or abdominal surgery.46
Symptoms: These are pelvic and abdominal pain (95%) and amenorrhea with some degree of vaginal spotting or bleeding (60 to 80%). With rupture, the woman suddenly is stricken with severe lower abdominal pain, frequently described as sharp, stabbing, or tearing in character. Vasomotor disturbances develop, ranging from vertigo to syncope. Tenderness on abdominal and vaginal examination, especially on motion of the cervix, is demonstrable in over 75 % of women with ruptured or rupturing tubal pregnancies. This may be absent prior to rupture. Identification of non-clotting blood in the peritoneal cavity by paracentesis or culdocentesis is suggestive of a bleeding ectopic pregnancy. Absence however, does not exclude an ectopic pregnancy.47
Current serum and urine pregnancy tests that use ELISAs are sensitive to levels of chorionic gonadotrophin of 10 to 20 mIU/mL, and are positive in over 99% of ectopic pregnancies.48
In abdominal sonography, absence of a uterine pregnancy, fluid in the cul-de-sac, and an abnormal pelvic mass, ectopic pregnancy is almost diagnostic if a pregnancy test is positive.49 There has been much improvement in the early diagnosis of ectopic pregnancy using vaginal sonography which allows ultrasonic detection of a uterine gestation as early as 1 week after missed menses. When serum Î²hCG levels exceed 1000 mIU/mL, a gestational sac is seen half the time.50
Treatment: This is either surgical or medical. Surgical therapy is by laparoscopy or laparotomy. Laparoscopy is more cost-effective and has a shorter recovery time-1.3 versus 3.1 days.51 Procedures include salpingotomy, salpingostomy, salpingectomy and segmental resection and anastomoses. Medical therapy is with single or multiple dose systemic methotraxate at a dose of 50 mg/m2. The patient must be hemodynamically stable, have a pregnancy less than 6 weeks gestation and a tubal mass smaller than 4 cm in diameter. She must avoid sexual intercourse, alcohol and folic acid supplements until the ectopic pregnancy has resolved.40
Spontaneous abortion or miscarriage: This is the most common complication of pregnancy and is defined as the passing of a pregnancy prior to completion of the 20th gestational week. It implies delivery of all or any part of the products of conception, with or without a foetus weighing less than 500 g. Threatened abortion is bleeding of intrauterine origin occurring before the 20th completed week, with or without uterine contractions, without dilatation of the cervix, and without expulsion of the products of conception. Complete abortion is the expulsion of all of the products of conception before the 20th completed week of gestation, whereas incomplete abortion is the expulsion of some, but not all, of the products of conception. Inevitable abortion refers to bleeding of intrauterine origin before the 20th completed week, with dilatation of the cervix without expulsion of the products of conception. In missed abortion, the embryo or foetus dies, but the products of conception are retained in utero. In septic abortion, infection of the uterus and sometimes surrounding structures occur.53
Hemorrhage into the decidua basalis, followed by necrosis adjacent tissues causes the ovum to detach, stimulating uterine contractions that result in its expulsion. In later abortions, the retained fetus may undergo maceration - the skull bones collapse, the abdomen distends with fluid, the internal organs degenerate and skin softens and peels. Alternatively, amniotic fluid is absorbed, the fetus becomes compressed and desiccated ( fetus compressus) or resembles parchment (fetus papyraceous).54
More than 80 percent of abortions occur in the first 12 weeks of pregnancy, and at least half result from chromosomal anomalies resulting in abnormal zygote development. Various infections are uncommon causes of abortion in humans. In 2002, Oakeshott and associates reported an association between second- but not first-trimester spontaneous abortion and bacterial vaginosis.24
Iodine deficiency , antiphospholipid and antithyroid antibodies and poor glucose control in diabetes mellitus have been associated with miscarriages.54,55,56,57,58 Tobacco, alcohol and caffeine have been linked to increased risk of abortion and fetal anomalies.53 Uterine anatomical defects resulting from abnormal müllerian duct formation or fusion and cervical incompetence result in second trimester abortions.
The clinical aspects of spontaneous abortion separate into five subgroups: threatened, inevitable, complete or incomplete, missed, and recurrent abortion.
In threatened abortion, the cervix remains closed and bleeding is slight while inevitable abortions present as abdominal or back pain and bleeding with an open cervix. In an incomplete abortion, the products of conception have partially passed from the uterine cavity. If less than 10 weeks of gestation, the fetus and placenta are usually passed together while in those greater than 10 weeks, they may be passed separately, with a portion of the products retained in the uterine cavity. Cramps are usually present and bleeding is persistent and is often severe. Complete abortion is identified by passage of the entire conceptus. Slight bleeding may continue for a short time, but pain ceases after pregnancy has traversed the cervix. Missed abortion implies that the pregnancy has been retained following death of the fetus. Normal progestogen production by the placenta may continue while estrogen levels fall, which may reduce uterine contractility. A blighted ovum or anembryonic pregnancy represents a failed development of the embryo so that only a gestational sac is present.53
Laboratory tests: These include complete blood count and pregnancy tests. If significant bleeding has occurred, the patient will be anemic. Both the white blood cell count and the sedimentation rate may be elevated even without infection. Falling or abnormally rising plasma levels of Î²hCG are diagnostic of an abnormal pregnancy, either a blighted ovum, spontaneous abortion or ectopic pregnancy.53
Transvaginal ultrasound: This is helpful in documenting intrauterine pregnancies as early as 4-5 weeks' gestation. Fetal heart motion should be seen in embryos at least 5-6 weeks gestation. 53
Management: In threatened abortion, bed rest and pelvic rest are recommended while for inevitable or incomplete abortion, evacuation of the uterus by D&C should be considered. Grouping and cross-match for possible blood transfusion and determination of Rhesus status should be obtained. For complete abortion , the patient should be observed for further bleeding and products of conception should be examined.53
Treatment of septic abortion involves hospitalization and intravenous antibiotic therapy. A D&C should be performed, and a hysterectomy may be necessary if the infection does not respond to treatment.53
A study by A. Kaaria showed that patients seen at KNH with abortion were in the same socio-economic class as those with ectopic pregnancy unlike those attending antenatal clinic who are in a higher class.59 Hence women with abortion are a better control group than antenatal clinic attendants.
The prevalence of Chlamydia infection is higher among patients of ectopic pregnancy than those with intrauterine pregnancy (presenting with incomplete abortion).
Current local guidelines on the management of ectopic pregnancy do not include treatment of Chlamydia infection and this is not common practice. Previous studies on STI among patients presenting with ectopic pregnancy have not focussed on Chlamydia and none has used rapid immunoassays such as DiaspotTM the current gold standard of Chlamydia diagnosis. Previous studies have also compared patients with ectopic to patients with on going pregnancies. However this may cause bias as STIs are likely to lead to miscarriages of intrauterine pregnancies. Therefore patients seeking abortion services are an ideal comparison group. This study will be the first done in the Kenyan setting where prevalence of undiagnosed STIs is high.
To describe and compare the prevalence of Chlamydia infection in patients with ectopic pregnancy and abortion at the Kenyatta National Hospital.
Describe and compare obstetric, sexuality, clinical and socio-demographic characteristics of patients presenting ectopic pregnancy and abortion at KNH.
Describe and compare prevalence of Chlamydia infection among patients with ectopic pregnancy and abortion at KNH.
Determine obstetric and socio-demographic factors associated with Chlamydia infection.
This will be a case control study. An endocervical swab will be taken from a patient with ectopic pregnancy the day after emergency surgery. Rapid immunoassay test for antichlamydial antibodies Ig G and Ig M will be done on the sample and a questionnaire on socio-demographic profiles will be filled post-operatively. On the same day, a patient with abortion of the same age plus or minus 5 years as the ectopic pregnancy patient will be recruited. A similar sample will be taken for testing and questionnaire filled. Doxycycline 100 mg twice daily for a week will be given to all patients with positive antibody tests.
The study will be done at the KNH acute gynaecological ward. KNH serves the population within and around the city and it is the national referral hospital. It also serves as the university teaching hospital for the College of Health Sciences of the University of Nairobi and the Kenya Medical Training College. Several medical specialties are catered for and the Department of Obstetrics and Gynaecology is one of them.
The obstetrics unit consists of four antenatal/postnatal wards, a labour ward, maternity operating theatre, antenatal and post natal clinics while the gynaecology unit consists of a screening room (number 7) in the A + E department and acute and elective gynaecological wards - 1 D and 1 B respectively. Gynaecological surgeries are done at the main theatres as well as Trauma theatres at the A + E department.
The Ob/Gyn department is organized into three firms. Each firm is headed by a senior consultant obstetrician and gynaecologist with a team of consultants, senior registrars, senior house officers, interns, nurses and paramedical staff. The senior medical staff is both from KNH and UoN.
The antenatal clinic is located at the hospitals outpatient department (clinic no. 18). Each firm has its own specific ANC and gynaecology clinic follow-up day i.e. Tuesday, Wednesday and Thursday. Monday has traditionally been reserved for antenatal booking; however antenatal booking is now done on any clinic day.
The acute gynaecological ward admits patients from A+E department and gynaecology clinic for all three firms. Each day at least one patient with ectopic pregnancy is admitted while three with incomplete abortion are treated by manual vacuum aspiration.
Study population/Study period
The study population will include patients presenting with ectopic pregnancies and abortions at KNH, from October 2010 to December 2010. The principal investigator will recruit patients with ectopic pregnancy from Sunday to Saturday and those with incomplete abortion on the same day. With an average of one ectopic per day, the sample size shall be achieved in two months.
The sample size was calculated using the following formula [Fleiss JL Statistical Methods for Rates and Proportions (2nd edition). Wiley:New York, 1981.],
Factor under consideration "prevalence of chlamydia"
1ST GROUP "Ectopic Pregnancies"
2ND GROUP "Abortions"
Parameter Symbol Value
"Prevalence of chlamydia" in "Ectopic Pregnancies" group p1 67.0%
"Prevalence of chlamydia" in "Abortions" group p2 34.0%
p1 - p2 d 0.33
Odds Ratio OR 3.94
Proportion of participants expected in "Ectopic Pregnancies" m1 50.0%
Proportion of participants expected in "Abortions" group m2 50.0%
Ratio of ("Ectopic Pregnancies":"Abortions") sizes r 1.00
P corrected p-bar 0.505
Power 1-Î² 80%
Confidence level 1-Î± 95%
Number of subjects required for "Ectopic Pregnancies" n1' 35
Number of subjects required for "Abortions" group n2' 35
Continuity correction for n1' n1 41
Continuity correction for n2' n2 41
Sample size 82
Patients operated at KNH for ectopic pregnancy
Women presenting with abortion at KNH.
Those who consent.
Women with other causes of bleeding in pregnancy e.g.
-placenta previa / abruptio
-malignancies like cervical carcinoma
Those who decline to give consent.
A pre-coded questionnaire will be used.
Recruitment will be done at the acute gynaecological ward KNH on all days of the week. The principal investigator will recruit participants from among patients who have undergone surgery for ectopic pregnancy. Upon written consent, an endocervical swab will be taken and put in an extraction tube that has 5 drops of reagent A. The bottom of the tube will be compressed and the swab rotated 15 times. After 2 minutes, 220 microliters of reagent B will be added into the tube, the bottom compressed and the swab rotated 15 times. After 1 minute, the swab will be withdrawn while squeezing the tube and a dropper tip fitted to the top of the extraction tube. 3 full drops of the solution will be added to the DiaspotTM Chlamydia Rapid Test Device and the result read after 10 minutes. The appearance of 2 distinct coloured lines indicates a positive result while 1 coloured line in the control line region denotes a negative result. If the control line fails to appear, this is an invalid test and may be due to an inadequate specimen volume or incorrect procedure technique. A coded questionnaire will then be administered. On the same day, an abortion patient in the same age group as the ectopic pregnancy patient will be recruited upon written consent. A similar specimen will be subjected to the rapid test and a similar questionnaire filled. All patients with a positive chlamydia test will receive oral doxycycline 100 mg twice daily for a week.
Data collection and management
Data will be collected using a coded questionnaire. A biostatistician will carry out data entry and analysis. All the information will subsequently be entered into the computer and analyzed using Statistical Package for Social Sciences (SPSS 12) for Windows. Data analysis will involve descriptive statistics like cross tabulation, frequency ranges and mean. Chi-square will be used for proportions and p-value for significance.
Presence of anti-chlamydia antibodies does not mean there is an ongoing active Chlamydia infection. Despite this, all patients with positive serology will be put on doxycycline 100 mg twice daily for one week.
Approval for the study will be sought from the ethical and research committee of KNH.
Voluntary informed consent will be obtained from every participant prior to collection of blood and administration of the chlamydia rapid strip test and of the questionnaire.
Results of chlamydia rapid test will be availed to participants. Participants with positive results will be treated immediately.
Data and information will be treated with confidentiality. The participant's names and in-/outpatient number will not appear on the questionnaire. A serial number will be used.
Results of the study will be used for academic purposes and for improvement of the standard of care.
Results of the study will be availed to KNH.