Early PregnancyNCT04152278
Chlamydia Tracomatis and Other Lower Genital Tract Infections Among Women With Unexplained Early Miscarriage
An observational study of Early Pregnancy, run by Fayoum University Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Early Pregnancy
- What is being tested?
- cervicovaginal culture and qPCR for chlamydial trachomatis and wadallia chondrophila
- How many people
- 600 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2017to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- cervicovaginal culture and qPCR for chlamydial trachomatis and wadallia chondrophila
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervicovaginal culture and qPCR for chlamydial trachomatis and wadallia chondrophilaDiagnostic test
Also called placental culture and qPCR, study group only
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: cervicovaginal culture and qPCR for chlamydial trachomatis and wadallia chondrophila |
What is being measured
The primary outcome is the main question the study is designed to answer.
the association of lower genital tract infection with spontaneous miscarriage
relation between genital tract infection and miscarriage
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start1 Sep 2017
- Primary completion30 Aug 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahar MY Elbaradie, Fayoum University Hospital
- Investigators
- sahar MY Elbaradie, a.Professor, Principal investigator, Fayoum University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152278
- Sponsor's protocol ID
- fayoumUH
- Status last verified
- Jul 2020
- First submitted
- 2 Nov 2019
- Last updated
- 23 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chlamydia Tracomatis and Other Lower Genital Tract Infections Among Women With Unexplained Early Miscarriage
- ClinicalTrials.gov ID
- NCT04152278
- Acronym / sponsor ID
- fayoumUH
- Conditions
- Early Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 5 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | Diagnostic Test: cervicovaginal culture and qPCR for chlamydial trachomatis and wadallia chondrophilaThe 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. |
| control group | – | Diagnostic Test: cervicovaginal culture and qPCR for chlamydial trachomatis and wadallia chondrophilaThe 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cervicovaginal culture and qPCR for chlamydial trachomatis and wadallia chondrophilaAlso: placental culture and qPCR, study group onlythree 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) | Diagnostic test | control group, study group |
Primary outcome
the association of lower genital tract infection with spontaneous miscarriage
Time frame: one year
relation between genital tract infection and miscarriage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sahar MY Elbaradie, a.Professor principal investigator
Fayoum University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Pregnancy, run by Fayoum University Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the association of lower genital tract infection with spontaneous miscarriage (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.