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

Primary Purpose

Pregnancy Complications

Status
Recruiting
Phase
Not Applicable
Locations
Senegal
Study Type
Interventional
Intervention
Oral prophylactic intervention
Sponsored by
Claude Bernard University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy Complications focused on measuring pre-eclampsia, pregnant, periodontal disease, interdental microbiota

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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 (>30% of sites)
  • history or treatment of PD
  • a course of dental or orthodontic treatment
  • 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.

Sites / Locations

  • HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Oral prophylactic intervention

Arm Description

The control group will continue its usual oral hygiene practice.

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.

Outcomes

Primary Outcome Measures

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: 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 Outcome Measures

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
Change of pocket probing depth of teeth during the pregnancy
Quantification of the pocket probing depth of the teeth with a periodontal probe
Change of clinical attachment level of teeth during the pregnancy
Quantification of the clinical attachment level of the teeth with a periodontal probe
Change of gingival index of teeth during the pregnancy
Quantification of the gingival index

Full Information

First Posted
July 19, 2021
Last Updated
May 1, 2023
Sponsor
Claude Bernard University
Collaborators
Cheikh Anta Diop University, Senegal, University of Ouagadougou, Burkina Faso
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1. Study Identification

Unique Protocol Identification Number
NCT04989075
Brief Title
Oral Prophylactic Measures on the Occurrence of Pre-eclampsia (OP-PE)
Acronym
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
April 15, 2023 (Actual)
Study Completion Date
September 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Claude Bernard University
Collaborators
Cheikh Anta Diop University, Senegal, University of Ouagadougou, Burkina Faso

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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)?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Complications
Keywords
pre-eclampsia, pregnant, periodontal disease, interdental microbiota

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
880 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will continue its usual oral hygiene practice.
Arm Title
Oral prophylactic intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Oral prophylactic intervention
Intervention Description
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 Outcome Measure Information:
Title
Incidence of pre-eclampsia from baseline during the pregnancy
Description
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.
Time Frame
9 months of pregnancy
Secondary Outcome Measure Information:
Title
Number of pathogenic bacteria in the interdental microbiota during the pregnancy
Description
Quantitative PCR experiments will be performed and a quantitative analysis of the interdental microbiota will be made
Time Frame
3 months, 6 months and 8 months of pregnancy
Title
Change of pocket probing depth of teeth during the pregnancy
Description
Quantification of the pocket probing depth of the teeth with a periodontal probe
Time Frame
3, 4, 5, 6, 7, 8 and 9 months of pregnancy
Title
Change of clinical attachment level of teeth during the pregnancy
Description
Quantification of the clinical attachment level of the teeth with a periodontal probe
Time Frame
3, 4, 5, 6, 7, 8 and 9 months of pregnancy
Title
Change of gingival index of teeth during the pregnancy
Description
Quantification of the gingival index
Time Frame
3, 4, 5, 6, 7, 8 and 9 months of pregnancy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 (>30% of sites) history or treatment of PD a course of dental or orthodontic treatment 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Florence Carrouel
Phone
0478785745
Ext
+33
Email
florence.carrouel@univ-lyon1.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Denis Bourgeois
Phone
0478785745
Ext
+33
Email
denis.bourgeois@univ-lyon1.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florence Carrouel, Dr
Organizational Affiliation
P2S, UR4129, University of Lyon
Official's Role
Study Director
Facility Information:
Facility Name
Hospital
City
Dakar
Country
Senegal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aida Kanoute

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34281133
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.
Results Reference
background
Links:
URL
https://doi.org/10.3390/ijerph18137194
Description
Article

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

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