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

NCT04152278 | Completed

• 1 other identifier: fayoumUH
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Pregnancy

Outcome Measures

Primary Outcomes (1)

• the association of lower genital tract infection with spontaneous miscarriage

  relation between genital tract infection and miscarriage

  one year

Study Arms (2)

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.

Diagnostic Test: cervicovaginal culture and qPCR for chlamydial trachomatis and wadallia chondrophila

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.

Diagnostic Test: cervicovaginal culture and qPCR for chlamydial trachomatis and wadallia chondrophila

Interventions

cervicovaginal culture and qPCR for chlamydial trachomatis and wadallia chondrophila 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)

Also known as: placental culture and qPCR, study group only

control group; study group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

sahar M.Y elbaradie

Al Fayyum, Egypt

Location

Biospecimen

Retention: NONE RETAINED

cervicovaginal swabs, serum samples and placental tissues

Study Officials

• sahar MY Elbaradie, a.Professor

  Fayoum University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate Professor

Study Record Dates

• First Submitted: November 2, 2019
• First Posted: November 5, 2019
• Study Start: September 1, 2017
• Primary Completion: August 30, 2019
• Study Completion: September 30, 2019
• Last Updated: July 23, 2020

Record last verified: 2020-07

Locations

EG (1)