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Pregnancy ComplicationsOP-PENCT04989075

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

A study testing Oral prophylactic intervention in people with Pregnancy Complications, run by Claude Bernard University at 1 site in Senegal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy Complications
What is being tested?
Oral prophylactic intervention
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
330 participants
Where
1 siteSenegal
Study dates
15 Mar 2022to 25 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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,

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Senegal1 site

  • Hospital

    Dakar

Other trials in Senegal

About this study

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

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)?

Being tested
Oral prophylactic intervention
Keywords
pre-eclampsia, pregnant, periodontal disease, interdental microbiota
Medical subject headings
Pregnancy Complications, Pre-Eclampsia, Periodontal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral prophylactic interventionOther

    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.

Study groups in NCT04989075
Study groupRoleWhat they receive
Control groupNo interventionThe control group will continue its usual oral hygiene practice.
Oral prophylactic interventionExperimentalFor 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.
Receives: Other: Oral prophylactic intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 9 months of pregnancy

Secondary outcomes (5)

  1. 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

    Measured: 3, 4, 6 and 8 months of pregnancy

  2. Change of bleeding on probing during the pregnancy

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

    Measured: 3, 4, 6 and 8 months of pregnancy

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

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

    Measured: 3, 4, 6 and 8 months of pregnancy

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

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

    Measured: 3, 4, 6 and 8 months of pregnancy

  5. Change of gingival index of teeth during the pregnancy

    Quantification of the gingival index

    Measured: 3, 4, 6 and 8 months of pregnancy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2021
  2. Study start15 Mar 2022
  3. Primary completion15 Apr 2023
  4. Study completion25 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
330 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04989075
Sponsor's protocol ID
OP-PE
Acronym
OP-PE
Status last verified
Jul 2025
First submitted
19 Jul 2021
Last updated
30 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34281133

  • 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 Apr;53(4):539-549. doi: 10.1111/jcpe.70085. Epub 2026 Jan 20.

    PubMed 41558746

Questions about this trial

What is this clinical trial studying?

A study testing Oral prophylactic intervention in people with Pregnancy Complications, run by Claude Bernard University at 1 site in Senegal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Senegal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of pre-eclampsia from baseline during the pregnancy (time frame: 9 months of pregnancy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04989075, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.

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