An interventional study of Oral prophylactic intervention in Pregnancy Complications, sponsored by Claude Bernard University. Completed at 1 site in Senegal. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-30.
Sponsored by Claude Bernard University · Not applicable, Interventional, and Prevention
Pre-eclampsia (PE) remains a major source of maternal and perinatal morbidity and mortality especially in low- and middle-income settings. PE, a pregnancy-specific hypertensive disorder, characterized by the development of placental endothelial dysfunction resulting in, among the most common diagnostic features, concomitant hypertension and proteinuria that may evolve into organs with fluctuating clinical specificities. Current studies indicate that periodontal disorders during pregnancy and particularly periodontal pathogens may be related to the risk of PE. Standard oral hygiene methods, based mainly on the joint use of toothbrushes and interdental brushes, reduce periodontal inflammatory risk, modulate of the dysbiotic oral microbiome. The purpose of the present study is to compare the PE outcomes in high-risk pregnant women receiving oral prophylactic measures to a control group. One specific question is addressed as follows according to the PICO principles: In high-risk pregnant women (Population), does oral prophylactic measures (Intervention) have a beneficial effect on PE parameters (Outcome) compared to pregnant women without any specific oral prophylactic measures (Control)?
916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.
This study's enrollment of 330 is above the median of 110 across 480 interventional studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →Claude Bernard University is the lead sponsor of 31 studies on the registry; 4 are open to participants now.
Compared within Pre-Eclampsia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pregnancy Complications. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The control group will continue its usual oral hygiene practice.
For the study group, the oral prophylactic intervention will consist of provision of specfic package including soft-bristled manual toothbrush, toothpaste, and a kit of calibrated interdental brushes (IDBs)(Curaprox CPS; Curaden) of sizes corresponding to the diameter of their interdental spaces. The participants will be instructed to brush their teeeth twice-daily and to realise a daily interdental brushing until delivery. The instructions for the use of the toothbrush and IDBs comprised verbal instructions supported by practical demonstration. The first use of the material will be conducted under the supervision of a qualified public health professor.
Other: Oral prophylactic intervention
The oral prophylactic intervention will consist of the provision of specific package including a soft-bristled manual toothbrush, toothpaste, and a kit of calibrated interdental brushes (IDBs)(Curaprox CPS; Curaden) of sizes corresponding to the diameter of their interdental spaces. The participants will be instructed to brush their teeeth twice-daily and to realise a daily interdental brushing until delivery. The instructions for the use of the toothbrush and IDBs comprised verbal instructions supported by practical demonstration. The first use of the material will be conducted under the supervision of a qualified public health professor.
Incidence of pre-eclampsia from baseline during the pregnancy
To determine if pregnant women suffer from pre-eclampsia, several indices are measured (diastolic or systolic pressure and proteinuria or urinary protein/creatinine ratio). The combination of the results of pressure and proteinuria permits to classify of a woman as suffering from pre-eclampsia if: 1. the diastolic pressure is higher than 90 mm Hg on two 4 hours intervals, or \> 110 mm Hg once, or systolic pressure \> 140 mm Hg on two 4 hours intervals, or \> 160 mm Hg once, after 20 weeks of gestation and, 2. the proteinuria measured is of 2+ or more, or \> 300mg/24 hours, or \> 500mg/L or urinary protein/creatinine ratio \> 0.034g/mmol.
Time frame: 9 months of pregnancy
Number of pathogenic bacteria in the interdental microbiota during the pregnancy
Quantitative PCR experiments will be performed and a quantitative analysis of the interdental microbiota will be made
Time frame: 3, 4, 6 and 8 months of pregnancy
Change of bleeding on probing during the pregnancy
Quantification of the bleeding on probing of the teeth with a periodontal probe
Time frame: 3, 4, 6 and 8 months of pregnancy
Change of pocket probing depth of teeth during the pregnancy
Quantification of the pocket probing depth of the teeth with a periodontal probe
Time frame: 3, 4, 6 and 8 months of pregnancy
Change of clinical attachment level of teeth during the pregnancy
Quantification of the clinical attachment level of the teeth with a periodontal probe
Time frame: 3, 4, 6 and 8 months of pregnancy
Change of gingival index of teeth during the pregnancy
Quantification of the gingival index
Time frame: 3, 4, 6 and 8 months of pregnancy
Plan to share: No
Ran from Mar 2022 to primary completion in Apr 2023, 13 months.
Of 171 non-industry interventional studies with no phase under Pre-Eclampsia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's 13 months is below that.
Counting every sponsor, half of 176 studies reached it within 24 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Claude Bernard University