Chlamydia Tracomatis and Other Lower Genital Tract Infections Among Women With Unexplained Early Miscarriage

NCT ID: NCT04152278

Last Updated: 2020-07-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2019-09-30

Brief Summary

Although one fourth of pregnant women experience at least 1 abortion, yet only 50% of causes are identified. Pregnancy loss can result from viral, bacterial, and other infections. It can reach the fetoplacental units through blood born or local spread. Lower genital tract infections- a potentially preventable infections- was suggested as a cause of spontaneous miscarriage. It was reported in 15 and 66% of early and late miscarriages respectively. These infections are also commonly encountered among apparently healthy looking pregnant women with an overall prevalence of 40-54%. If left untreated it can lead to premature rupture of the membranes, preterm birth, low birth weight, Fetal loss, neonatal ophthalmic and pulmonary damage.

Detailed Description

Abortion was defined by the World Health Organization and the National Center for Health Statistics as pregnancy termination before 20 weeks of gestational age or fetal weight smaller than 500 grams. Abortion is termed early or late if it occurs before 12 weeks or between 12 and 24 weeks of gestation respectively.

Spontaneous abortion prevalence is not exactly known as it varies according to the used method of identification. Wilcox and colleagues in 1988 reported a prevalence of 31 % of pregnancy loss after implantation and over 2/3 of them were clinically silent.

Although one fourth of pregnant women experience at least 1 abortion, yet only 50% of causes are identified. Pregnancy loss can result from viral, bacterial, and other infections. It can reach the fetoplacental units through blood born or local spread.

Lower genital tract infections- a potentially preventable infections- was suggested as a cause of spontaneous miscarriage. It was reported in 15 and 66% of early and late miscarriages respectively. These infections are also commonly encountered among apparently healthy looking pregnant women with an overall prevalence of 40-54%. If left untreated it can lead to premature rupture of the membranes, preterm birth, low birth weight, Fetal loss, neonatal ophthalmic and pulmonary damage.

The suggested mechanisms that genital tract infection can cause abortions are encountered are fetal or placental infection with production of toxic metabolites.

Some organisms like Brucella abortus, Campylobacter fetus, and Toxoplasma gondii can cause abortion in livestock. Their effects in human is unclear. Most infections were not linked to abortions except Chlamydia trachomatis, which was detected in 4% of abortuses compared with < 1 percent of controls.

Chlamydia trachomatis infection incidence was markedly increased in the last years and is responsible for many gynecological conditions as pelvic inflammatory disease and infertility and pregnancy complications as preterm birth and premature rupture of membranes but its relation to early pregnancy loss remains unrecognized.

Baud et al assumed an association between miscarriage and serologic/molecular evidence of C. trachomatis infection. This was evident by the higher prevalence of immunoglobulin G against C. trachomatis in the miscarriage group than in the control group (15.2% vs. 7.3%; p = 0.018) that remained significant after adjustment for age, origin, education, and number of sex partners (odds ratio 2.3, 95% confidence interval 1.1-4.9).

Polymicrobial infection was associated with 2 - 4fold increase in abortion. Data concerning a link between some other infections and increased abortion are conflicting. Oakeshott and coworkers (2002) reported an association between second-, but not first-, trimester miscarriage and bacterial vaginosis with a relative risk of miscarriage before 16 weeks' gestation of 1.2 (0.7 to 1.9).

The present study is designed to determine prevalence of genital tract infections and its relation to occurrence of early miscarriage in women with recent unexplained spontaneous miscarriages

Conditions

Early Pregnancy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

study group

The study group included 300 women presenting with unexplained spontaneous miscarriage or missed abortion during the first and early second trimester of pregnancy (8-16 weeks gestational age). The included women aged 18 to 45 years old.

cervicovaginal culture and qPCR for chlamydial trachomatis and wadallia chondrophila

Intervention Type: DIAGNOSTIC_TEST

three cervicovaginal swabs were obtained: one was used for a smear test of vaginal fluid pH evaluation and direct microscopy, the second swabs, cultured for aerobic and anaerobic bacteria and yeasts, the third was eluted in 2-sucrose-phosphate (2SP) based transport medium. Placental samples from the study group were cultured for aerobic and anaerobic bacteria. Placenta sample and 2SP medium were stored at -80°C until their analysis by real time PCR (qPCR)

control group

The control group included 300 women with normal pregnancy, recruited from women attending the antenatal clinic of gestational age 8-16 weeks. The included women aged 18 to 45 years old.

cervicovaginal culture and qPCR for chlamydial trachomatis and wadallia chondrophila

Intervention Type: DIAGNOSTIC_TEST

three cervicovaginal swabs were obtained: one was used for a smear test of vaginal fluid pH evaluation and direct microscopy, the second swabs, cultured for aerobic and anaerobic bacteria and yeasts, the third was eluted in 2-sucrose-phosphate (2SP) based transport medium. Placental samples from the study group were cultured for aerobic and anaerobic bacteria. Placenta sample and 2SP medium were stored at -80°C until their analysis by real time PCR (qPCR)

Interventions

cervicovaginal culture and qPCR for chlamydial trachomatis and wadallia chondrophila

three cervicovaginal swabs were obtained: one was used for a smear test of vaginal fluid pH evaluation and direct microscopy, the second swabs, cultured for aerobic and anaerobic bacteria and yeasts, the third was eluted in 2-sucrose-phosphate (2SP) based transport medium. Placental samples from the study group were cultured for aerobic and anaerobic bacteria. Placenta sample and 2SP medium were stored at -80°C until their analysis by real time PCR (qPCR)

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

placental culture and qPCR; study group only

Eligibility Criteria

Inclusion Criteria

• women with unexplained spontaneous miscarriage or missed abortion during the first and early second trimester of pregnancy (8-16 weeks gestational age).
• women with normal pregnancy, attending the antenatal clinic of gestational age 8-16 weeks.
• The included women aged 18 to 45 years old.

Exclusion Criteria

• women with miscarriage at a gestational age of more than 18 weeks,
• those with documented causes of miscarriage as fetal or uterine anomalies, antiphospholipid syndrome or endocrine factors and
• women who received recent antibiotic, antifungal or antiprotozoal treatment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fayoum University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sahar MY Elbaradie

associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

sahar MY Elbaradie, a.Professor

Role: PRINCIPAL_INVESTIGATOR

Fayoum University Hospital

Locations

sahar M.Y elbaradie

Al Fayyum, , Egypt

Countries

Egypt

Other Identifiers

fayoumUH

Identifier Type: -

Identifier Source: org_study_id