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

Pregnancy Complications Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04989075
• Other study ID #: OP-PE
• Status: Completed
• Phase: N/A
• Start date: March 15, 2022
• Est. completion date: July 25, 2023

Study information

• Verified date: February 2023
• Source: Claude Bernard University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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)?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: July 25, 2023
• Est. primary completion date: April 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia
• Pregnancy Complications

Intervention

Other:
• Oral prophylactic intervention
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.

Locations

Country	Name	City	State
Senegal	Hospital	Dakar

Sponsors (3)

Lead Sponsor	Collaborator
Claude Bernard University	Cheikh Anta Diop University, Senegal, University of Ouagadougou, Burkina Faso

Country where clinical trial is conducted

Senegal, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	9 months of pregnancy
Secondary	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	3 months, 6 months and 8 months of pregnancy
Secondary	Change of pocket probing depth of teeth during the pregnancy	Quantification of the pocket probing depth of the teeth with a periodontal probe	3, 4, 5, 6, 7, 8 and 9 months of pregnancy
Secondary	Change of clinical attachment level of teeth during the pregnancy	Quantification of the clinical attachment level of the teeth with a periodontal probe	3, 4, 5, 6, 7, 8 and 9 months of pregnancy
Secondary	Change of gingival index of teeth during the pregnancy	Quantification of the gingival index	3, 4, 5, 6, 7, 8 and 9 months of pregnancy

External Links

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