Effect of oral health on occurence of low birth weight children in females with previous history of preterm low birth weight child.

Not Applicable

• Conditions: Health Condition 1: null- PeriodontitisPreterm Low Birth Weight

• Registration Number: CTRI/2018/01/011480
• Lead Sponsor: Dr Ashish Jain

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 202

Inclusion Criteria

All participants displaying:

1. >20 teeth, excluding third molars

2. 18-35 years of age or older

3.With a singleton pregnancy

4.Bearing their second offspring

would be included in this study.

After an oral examination, the patients would be asked to enroll in an oral health care programme as per the needs of the individual patient. The patient refusing to undergo the oral health care programme will be asked for their consent for participation into the study and will be included after obtaining a written informed consent. During the course of study, any subject opting for the treatment will be provided the required dental care and will be excluded from the study.

All the participating women would be monitored by standard of care principles at the Department of Obstetrics and Gynaecology, Government Medical College and Hospital, Chandigarh

Exclusion Criteria

Since the outcome of the study is dependent on presence of disease; obstetrical, medical and dental reasons for exclusion will be taken into account which will include:

A.Obstetrical reasons:

1.Women with Congenital uterine malformations, congenital vaginal malformations, fetal malformation, multifetal gestation and cervical incompetence, and/or any other known cause of premature labor.

2.Chronic diseases (severe anaemia , hepatic in sufficiency , diabetes, hypertension, epilepsy, cardiac disease, lung disease, epilepsy, renal disease, or a positive test for human immunodeficiency virus) or any cause that commands termination of pregnancy for fetal/maternal indication.

3.Poor dating or unknown dates would be excluded.

B.Medical reasons:

Women with-

1.History of infective endocarditis which could have required antibiotic prophylaxis preceding a PDL examination.

2.Congenital heart disease.

3.Chronic regimen of aspirin or non-steroidal anti-inflammatory drugs (NSAIDs), chronic use of medications that cause gingival enlargement such as phenytoin, cyclosporine A, or calcium channel antagonists.

4.Chronic smokers and alcoholics would be excluded.

C.Dental reasons:

Women with-

1.Receipt of orthodontic treatment, dental prophylaxis, or periodontal dental treatment within the previous six months.

2.Extensive tooth decay

Presence of acute dental or periodontal disease, or likely to have <18 remaining teeth would be excluded.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the effect of periodontal status on incidence of PTLBW children in females with history of PTLBW.Timepoint: At beginning of 6th month or 7th month samples will be collected which will be analyzed and results will be related to the incidence of preterm birth after delivery.

Secondary Outcome Measures

Name	Time	Method
1.Correlation of the periodontal clinical parameters with the incidence of PTLBW children in the pregnant women with history of PTLBW, during gestation. <br/ ><br>2.Correlation of the microbiological parameters with the incidence of PTLBW children in the pregnant women with history of PTLBW, during gestation. <br/ ><br>3.Correlation of the immunological parameters with the incidence of PTLBW children in the pregnant women with history of PTLBW, during gestation. <br/ ><br>Timepoint: After Delivery