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NCT Number: NCT04989075

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

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)?

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Key information

Conditions

Pregnancy Complications Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Mouth Diseases Periodontal Diseases Pre-Eclampsia Stomatognathic Diseases Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital

Dakar, Senegal

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Incidence of pre-eclampsia from baseline during the pregnancy

    Time frame: 9 months of 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:

    • 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,
    • the proteinuria measured is of 2+ or more, or > 300mg/24 hours, or > 500mg/L or urinary protein/creatinine ratio > 0.034g/mmol.

Secondary outcomes

  1. Number of pathogenic bacteria in the interdental microbiota during the pregnancy

    Time frame: 3, 4, 6 and 8 months of pregnancy

    Quantitative PCR experiments will be performed and a quantitative analysis of the interdental microbiota will be made

  2. Change of bleeding on probing during the pregnancy

    Time frame: 3, 4, 6 and 8 months of pregnancy

    Quantification of the bleeding on probing of the teeth with a periodontal probe

  3. Change of pocket probing depth of teeth during the pregnancy

    Time frame: 3, 4, 6 and 8 months of pregnancy

    Quantification of the pocket probing depth of the teeth with a periodontal probe

  4. Change of clinical attachment level of teeth during the pregnancy

    Time frame: 3, 4, 6 and 8 months of pregnancy

    Quantification of the clinical attachment level of the teeth with a periodontal probe

  5. Change of gingival index of teeth during the pregnancy

    Time frame: 3, 4, 6 and 8 months of pregnancy

    Quantification of the gingival index

Sponsors and collaborators

Lead sponsor

Claude Bernard University

Other

Collaborators

  • Cheikh Anta Diop University, Senegal
  • University of Ouagadougou, Burkina Faso

Registry information

Official study title

Effect of Oral Prophylactic Measures on the Occurrence of Pre-eclampsia (OP-PE) in High-risk Pregnant Women: A Cluster-randomized Controlled Trial

Acronym: OP-PE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 4, 2021
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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