Oral Prophylactic Measures on the Occurrence of Pre-eclampsia (OP-PE)

NCT04989075 | Completed DMC

• 1 other identifier: OP-PE
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

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)?

Conditions

Pregnancy Complications

Keywords

pre-eclampsia; pregnant; periodontal disease; interdental microbiota

Outcome Measures

Primary Outcomes (1)

• 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.

  9 months of pregnancy

Secondary Outcomes (5)

• Number of pathogenic bacteria in the interdental microbiota during the pregnancy

  3, 4, 6 and 8 months of pregnancy

• Change of bleeding on probing during the pregnancy

  3, 4, 6 and 8 months of pregnancy

• Change of pocket probing depth of teeth during the pregnancy

  3, 4, 6 and 8 months of pregnancy

• Change of clinical attachment level of teeth during the pregnancy

  3, 4, 6 and 8 months of pregnancy

• Change of gingival index of teeth during the pregnancy

  3, 4, 6 and 8 months of pregnancy

Study Arms (2)

Control group

NO INTERVENTION

The control group will continue its usual oral hygiene practice.

Oral prophylactic intervention

EXPERIMENTAL

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

Interventions

Oral prophylactic intervention OTHER

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.

Oral prophylactic intervention

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Claude Bernard University: lead
• Cheikh Anta Diop University, Senegal: collaborator
• University of Ouagadougou, Burkina Faso: collaborator

Study Sites (1)

Hospital

Dakar, Senegal

Location

Related Publications (2)

• 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.

  PMID: 34281133 BACKGROUND

• Carrouel F, Kanoute A, Faye D, Mazur M, Perrier H, Vitiello F, Ardan R, Clement C, Lan R, Bourgeois D. Impact of Interdental Brushing on Pregnancy-Associated Gingivitis: A Secondary Analysis of a Randomised Controlled Trial. J Clin Periodontol. 2026 Jan 20. doi: 10.1111/jcpe.70085. Online ahead of print.

  PMID: 41558746 DERIVED

MeSH Terms

Conditions

Pregnancy Complications; Pre-Eclampsia; Periodontal Diseases

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension, Pregnancy-Induced; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Florence Carrouel, Dr

  P2S, UR4129, University of Lyon

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 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

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: August 4, 2021
• Study Start: March 15, 2022
• Primary Completion: April 15, 2023
• Study Completion: July 25, 2023
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)