Clinical trial NCT04989075: Oral Prophylactic Measures on the Occurrence of Pre-eclampsia (OP-PE)
Official title: Effect of Oral Prophylactic Measures on the Occurrence of Pre-eclampsia (OP-PE) in High-risk Pregnant Women: A Cluster-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Complications
Keywords: pre-eclampsia
pregnant
periodontal disease
interdental microbiota
Lead sponsor: Claude Bernard University
Sponsor class: OTHER
Collaborators: name: Cheikh Anta Diop University, Senegal
name: University of Ouagadougou, Burkina Faso
First posted: 2021-08-04
Enrollment: 330
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This trial is designed as an two-arm parallel cluster randomized controlled trial with antenatal obstetric clinic as the unit of randomisation and an allocation ratio of 1:1
Primary purpose: PREVENTION

Brief 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)?


Eligibility criteria: Inclusion Criteria:

* pregnant woman
* women from sub-Saharan Africa
* aged from 18 to 35 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
* periodontal lesions of stage II, III (i.e., PD ≥ 4 mm, and/or CAL ≥ 4 mm), generalized (\&amp;amp;amp;gt;30% of sites)
* 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.

Primary outcomes:
measure: Incidence of pre-eclampsia from baseline during the pregnancy
timeFrame: 9 months of pregnancy
Secondary outcomes:
measure: Number of pathogenic bacteria in the interdental microbiota during the pregnancy
timeFrame: 3, 4, 6 and 8 months of pregnancy
measure: Change of bleeding on probing during the pregnancy
timeFrame: 3, 4, 6 and 8 months of pregnancy
measure: Change of pocket probing depth of teeth during the pregnancy
timeFrame: 3, 4, 6 and 8 months of pregnancy
measure: Change of clinical attachment level of teeth during the pregnancy
timeFrame: 3, 4, 6 and 8 months of pregnancy
measure: Change of gingival index of teeth during the pregnancy
timeFrame: 3, 4, 6 and 8 months of pregnancy
Other outcomes:
Locations:
city: Dakar
country: Senegal
facility: Hospital
Study officials:
affiliation: P2S, UR4129, University of Lyon
name: Florence Carrouel, Dr
role: STUDY_DIRECTOR
References:
citation: Gare J, Kanoute A, Meda N, Viennot S, Bourgeois D, Carrouel F. Periodontal Conditions and Pathogens Associated with Pre-Eclampsia: A Scoping Review. Int J Environ Res Public Health. 2021 Jul 5;18(13):7194. doi: 10.3390/ijerph18137194.