Risk of Chlamydia Trachomatis Infection after Induced Abortion

Geannette Green, Jayda Jones, Jerrine Morris, Chelsea Singleton

Specific Aims
The main goal of this study is to determine if there is an association between undergoing an induced abortion and contracting Chlamydia trachomatis among sexually active young women ages 15-24 in Chicago, Illinois.

Hypothesis:
Young sexually active women, ages 15-24, who undergo an induced abortion are at a greater risk of contracting Chlamydia trachomatis.

Background and Significance

Chlamydia trachomatis is a bacterium that colonizes in the cervix and urethra. 50-70% of infections go untreated because they present an asymptomatic infection. If left untreated Chlamydia Trachomatis, has detrimental effects on the female reproductive system.
Pelvic Inflammatory Disease (PID) Infertility

Literature indicates that women from age 15 through 24 are especially susceptible to colonization and infection due to increased cervical ectopy.
The visual demarcation between endocervical columnar cells and the rest of the cervix, resulting in an immature cervix.

Background and Significance

Young woman ages 15 to 24 account for 52% of all induced abortions in the country. A known complication of abortion includes sustained injury to the cervix. The occurrence of abortion as a mode of trauma to the cervix, coupled with the incomplete cervix in young women may increase the risk of developing a chlamydial infection. This is a cause for concern in adolescent and young women.

Case-Control Study Design

Cases: Those that test positive for Chlamydia Trachomatis using a Polymerase Chain Reaction Test (PCR), a type of Nucleic Acid Amplification Test (NAAT).
100% Sensitivity 99.3% Specificity

Controls: Those that test negative for Chlamydia Trachomatis . Exposed: Woman that have undergone an induced abortion (any surgical abortion in which the cervix was dilated).
Aspiration Abortion Dilation and Evacuation

Non-Exposed: Woman that have had a medical abortion, a hysterectomy abortion or have never had any type of an abortion.

Data Collection and Procedures

Investigators will recruit participants from The Adolescent Health Program of Chicago:
Five facilities in the city Public Clinics serving young adults ages 12 24 Walk-in and Appointment

Possible participants will be pre-screened for eligibility:

Woman ages 15 24 Pregnant woman will be excluded Sexually Active

Data Collection and Procedures (cont.)

Must sign consent forms:
Tulane IRB: Those participants under 18 are required to have parental consent

Cross-sectional ascertainment of the exposure status:

Interviewer administered questionnaire Medical Records

Testing for Chlamydia Trachomatis through a urine sample collected by a clinic practitioner:
Test-Retest Reliability

$20.00 compensation for participation.

Sample Size
Cases and controls will be selected independent of each other. For every one case, one control will be randomly selected from all successfully enrolled study participants that test negative for Chlamydia. CDC Abortion Surveillance Report states that woman ages 15-24 make up 47.9% of all the induced abortions in the state of Illinois. Prevalence of exposure among the target population is 0.479. [9] = 0.05 1 = 0.80

385 cases and 385 controls are needed to detect a difference in odds ratio of 1.5.

Plan of Analysis:
Collected data will be entered into a secure database and analyzed with the Statistical Analysis System (SAS). An unadjusted odds ratio (crude estimate) will be calculated A 95% confidence interval will be calculated and the appropriate p-value will be recorded.

 Pre-analysis assessments of all potential confounders and covariates. Stratified analyses will include:
stratum specific odds ratios confidence intervals to test for all potential confounders.

Plan of Analysis: (continued)

Adjustment procedures:
chi-square tests for each stratified variable to test for homogeneity among the strata. Adjust for confounders using Mantel-Haenszel Weighted Averages.

Further analysis of associations will be analyzed using logistic regression.

Possible Confounders
Variables will be organized categorically in the following manner:
Age: (15-19) and (20-24) Number of Sexual Partners in the Previous Year: (1-2) (3-4) and (>=5) Methods of contraception: (Natural) (Barrier) (NonBarrier) and (None) Race: (Caucasian) (African American) (Hispanic) and (Other) Years of Education: (<7) (8 12) (13 15) and (>=16) Heavy Alcohol Consumption: (Yes) and (No) Number of previous induced abortions: (1) (2) and (>=3)

Threats to Validity
Selection Bias
Threat: Convenience sampling
a non probability sample is taken from a specific population as opposed to taking a probability sample from the general population. there is a possibility that findings will not be applicable to the target population (all woman ages 15 24).

To equalize this bias, the same participant selection methods will be applied to both cases and controls from each clinic being used as a testing site. Threat: Assessing exposure before outcome investigators will not determine a participants exposure status until reliable Chlamydia trachomatis test results are obtained.

Threats to Validity
External Validity
Threat: Generalizability
all participants will be selected from Chicago.

Chlamydia acquisition and abortion occur via biological pathways; therefore, they will affect subjects similarly regardless of the location of our source population.

Information Bias
Threat: Recall Bias
Interviewer questionnaires will be administered

completed respondent questionnaires will be compared to medical records of all study participants.

Threat: Misclassification PCR testing, with high sensitivity and specificity, will be used in order to avoid information bias

Threats to Validity
Threat: Temporal Bias
If the participant had a long-term undiagnosed case of Chlamydia prior to the induced abortion, temporal bias could occur and bias the calculated measure of association.

only incident cases will be included in this study If a participants medical history does not indicate antibiotic treatment (azithromycin or doxycycline) at the time of their induced abortion, they will be excluded from the study.

Ethical Precautions:
Must inform the study participants of why the study is being conducted and what organization is conducting the study.

Participants under 18 must give personal assent and obtain parental consent.
Each patient will be assigned a unique identification number. Only approved staff will have access to each participants information. Patient treatment and counseling will be provided by the Adolescent Health Program of Chicago

Study Limitations
Parental Consent Exposure Status
the number of abortions in past history is not being assessed as a factor of exposure status classification.

There is no temporal time limit placed on past abortion history.

Possible increase in recruitment period

Literature Citations
1. 2. 3. 4. 5. 6. 7. 8. 9. Centers for Disease Control and Prevention, Division of STD Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. Chlamydia. Sexually Transmitted Disease Surveillance, 2006: Special Focus Profiles: Adolescents and Young Adults. November 2007. Centers for Disease Control and Prevention. CDC Fact Sheet: Chlamydia. December 2007. Carey AJ, Beagley KW. Chlamydia trachomatis, a Hidden Epidemic: Effects on Female Reproduction and Options for Treatment. American Journal of Reproductive Immunology. 2010. Hillard, PJA MD. Behavioral Correlates of Biologic Maturity of the Cervix in Adolescents. Journal of Adolescent Health. February 2009; 44(2):97-98. The Center for Bio-Ethical Reform. Abortion Facts. 2008. Available at: http://www.abortionno.org/Resources/fastfacts.html. Accessed April 13, 2010. Planned Parenthood. In-Clinic Abortion Procedures. 2010. Available at: http://www.plannedparenthood.org/health-topics/abortion/in-clinic-abortion-procedures4359.htm. Accessed April 12, 2010. WESTERGAARD, L MD; PHILIPSEN, T MD; SCHEIBEL, J MD. Significance of Cervical Chlamydia trachomatis Infection in Postabortal Pelvic Inflammatory Disease. American College of Obstetrics and Gynecology. September 1982; 60(3) Quinn TC, Gaydos C, Shepard M et al. Epidemiologic and Microbiologic Correlates of Chlamydia trachomatis Infection in Sexual Partnerships. JAMA. December 4, 1996; 276:21 Pazol K, Gamble SB, Parker WY, Cook DA, Zane SB, Hamdan S. Abortion Surveillance-United States, 2006. Surveillance Summaries MMWR. November 27, 2009; 58(SS08);1-35

Questions and Comments