Oral Prophylactic Measures on the Occurrence of Pre-eclampsia (OP-PE) (NCT04989075) | Clinical Trial Compass
CompletedNot Applicable
Oral Prophylactic Measures on the Occurrence of Pre-eclampsia (OP-PE)
Senegal330 participantsStarted 2022-03-15
Plain-language summary
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)?
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* pregnant woman
* women from sub-Saharan Africa
* aged from 18 to 40 years old
* nullipares at the time of the obstetrical consultation
* up to 12 weeks pregnant
* acceptance of the terms and conditions of the study
* signature of the informed consent form,
Exclusion Criteria:
* fetal distress
* congenital uterine and vaginal abnormalities
* infectious or systemic diseases such as HIV, tuberculosis, candidiasis, cancers, hemopathies
* premature termination of pregnancy for medical reasons
* diagnosis of periodontitis defined as interproximal CAL ≥1 mm at ≥2 non-adjacent teeth, or buccal/oral CAL ≥3 mm with probing depth \>3 mm at ≥2 teeth, not attributable to non-periodontitis-related causes
* history or treatment of PD
* a course of dental or orthodontic treatment
* absence of the 4 premolar-molar pairs
* less than 20 natural teeth, excluding third molars
* medication affecting the gum and/or oral mucosa
* regularly using interdental brushes and/or dental floss and/or mouthwash
* unable to answer questions or non-cooperative.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of pre-eclampsia from baseline during the pregnancy