Clinical trial NCT04152278: Chlamydia Tracomatis and Other Lower Genital Tract Infections Among Women With Unexplained Early Miscarriage
Official title: Chlamydia Tracomatis and Other Lower Genital Tract Infections Among Women With Unexplained Early Miscarriage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Early Pregnancy
Lead sponsor: Fayoum University Hospital
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study group included 300 women presenting with unexplained spontaneous miscarriage. The control group included 300 women with normal pregnancy, recruited from women attending the antenatal clinic of gestational age 8-18 weeks.

All participants were subjected to full history, careful general and abdominal examination, Cervicovaginal swabs, urine and blood sampling in addition to placental sampling from study group.

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

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.

Primary outcomes:
measure: the association of lower genital tract infection with spontaneous miscarriage
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: sahar M.Y elbaradie
Study officials:
affiliation: Fayoum University Hospital
name: sahar MY Elbaradie, a.Professor
role: PRINCIPAL_INVESTIGATOR
References: