|Year : 2021 | Volume
| Issue : 2 | Page : 134-142
A cross-sectional study on epidemiology and clinical profile of cleft lip and palate at a tertiary care hospital in Manipur, India
Indranil Dutta, Nilamani Sharma Guruaribam, Palin Khundongbam
Department of Plastic Surgery, Shija Hospitals and Research Institute Pvt. Ltd., Imphal, Manipur, India
|Date of Submission||12-Mar-2021|
|Date of Acceptance||03-May-2021|
|Date of Web Publication||7-Jun-2021|
Dr. Indranil Dutta
Doctors' Quarter No. 4, Shija Hospitals and Research Institute Pvt. Ltd., Imphal - 795 004, Manipu
Source of Support: None, Conflict of Interest: None
Background: Cleft lip (CL) and palate have a complex etiology with both genetics and environment playing a role. The risk factors such as folic acid deficiency, maternal age, and maternal smoking have been linked to the development of clefts. Objectives: The objective of this study is to study the different types of CL and palate with respect to age distribution, gender, caste, religion, socioeconomic status, and the clinical factors such as congenital anomalies, blood group, and the relationship with maternal addiction during pregnancy. Materials and Methods: The present study conducted among 260 patients of Manipur with primary CL, palate, and orofacial clefts of any age group. Statistical analysis of the data was performed by the descriptive statistics as mean, standard deviation, percentage/proportions, etc. For the qualitative data, the association between various variables was done by applying one-way Chi-square test at 5% (P = 0.05) level of significance. Results: Female (51.2%) children are more affected with CL and palate. Association of A +ve blood group is statistically significant. 36.2% belongs to lower middle class socioeconomic status. The proportion of consanguineous marriages was higher. 60% of mothers smoke cigarettes or consume tobacco at the time of pregnancy in association with CL and palate. Majority of the cases had left-sided CL and palate and 47.3% were Group III CL and palate. There was significant association of congenital anomalies (38.5%) among CL and palate patients. Conclusion: There is a strong association of maternal smoking or tobacco consumption, maternal alcohol consumption, consanguineous marriages, and A +ve blood group in relation to CL and palate.
Keywords: Clinical profile of cleft lip and palate, epidemiology of cleft lip and palate, maternal consumption of tobacco in cleft lip and palate
|How to cite this article:|
Dutta I, Guruaribam NS, Khundongbam P. A cross-sectional study on epidemiology and clinical profile of cleft lip and palate at a tertiary care hospital in Manipur, India. J Cleft Lip Palate Craniofac Anomal 2021;8:134-42
|How to cite this URL:|
Dutta I, Guruaribam NS, Khundongbam P. A cross-sectional study on epidemiology and clinical profile of cleft lip and palate at a tertiary care hospital in Manipur, India. J Cleft Lip Palate Craniofac Anomal [serial online] 2021 [cited 2021 Sep 28];8:134-42. Available from: https://www.jclpca.org/text.asp?2021/8/2/134/317790
| Introduction|| |
Birth defects are one of the important leading causes of child disability and mortality worldwide. Cleft lip and/or palate (CL ± P) is the most common facial birth defect which occurs in all races, both sexes and all socioeconomic groups, and their distribution varies from country to country.
The lip and palate develop separately and a child may develop CL or cleft palate (CP) or both (CLP). The cleft may possibly be single sided (unilateral) or both sided (bilateral). CP may be restricted to the soft palate or may extend to the hard palate and lip.
The incidence and prevalence of CL ± P are 1 in 600 (1:600) and 9.92 per 10,000 worldwide, respectively. The overall worldwide CL and CLP prevalence are 3.28 per 10,000 and 6.64 per 10,000. The incidence in the Asian population is reported to be around 2.0/1000 live births or higher. In India, although a national epidemiological data are not available, many studies from the different parts have reported a variation in the incidence of cleft anomaly. From various studies across India, it is estimated that the incidence of CLP in India is around 0.93–1.3.
A child with this anomaly not only suffers from poor dental development but also is deprived of breastfeeding due to improper oral seal, swallowing, and nasal regurgitation; other associated problems include hearing difficulties due to abnormalities in the palatal musculature and speech difficulties due to nasal escape and articulation problems.
It may not be the end of life but for children with cleft problems, the problem goes beyond the obvious disfigurement of face and extends to repeated infections, social stigma, and mental impairment that affect the speech, hearing, and teeth formation. These children are teased about their cleft-related features such as speech, teeth, and lip appearance and lose self-confidence.
The genetic factors involve mutant genes, chromosomal aberrations (as trisomy 13 syndrome), and multifactorial inheritance that accounts for the majority of cases. By far the majority of cases probably have multiple etiologies involving the interaction of multiple polygenes and multiple environmental factors, collectively termed multifactorial etiology.
Among the birth defects, CL ± P have been particularly associated with maternal smoking. There is an association between blood grouping and the presence of CL and/or CP, although further studies with genetic analysis are required to clarify this relationship.
The condition in tropical countries such as India is worse due to poverty and illiteracy. The difficult mountainous region of Northern and North-Eastern India has suffered even more because of improper health facilities in the past. Due to the lack of awareness, the patients of cleft remain untreated or mistreated by some quacks.
As this is a geographically and socioeconomically different region than others, the demographic, prenatal, and clinical profile of the clefts of this region will also differ. There are no such studies so far published from this region. Thus, this study was conducted to form a clinical picture of patients specific to Manipur, India for the benefit of patients and the treating doctors.
| Materials and Methods|| |
The present study was conducted in between August 1, 2017 and January 31, 2020, among 260 CL and palate patients residing in Manipur requiring primary surgery irrespective of age. It is a hospital-based cross-sectional study. The study was approved by the Hospital Ethics Committee and Scientific Committee. All the patients gave written informed consent. All information collected was kept strictly confidential.
The study population size was 260. Statistical analysis was performed by the descriptive statistics as mean, standard deviation (SD), percentage/proportions, etc. For qualitative data association between various variables was done by applying one-way Chi-square test at 5% (P = 0.05) level of significance. Statistical analysis software, namely MICROSOFT EXCEL version 2010 and SPSS version 16 (SPSS for Windows, Version 16.0. Chicago, SPSS Inc) was used to analyze the data.
A study proforma [Appendix 1] was prepared to suit the proposed study.
Detailed history was taken in terms of age, sex, height, age, religion, caste and tribe, and socioeconomic status. Antenatal history was obtained like mother's age at the time of pregnancy, duration of pregnancy, birth order, any disease associated with pregnancy, maternal addiction in terms of smoking or tobacco consumption, for example, Ghutka, Khaini, etc., and alcohol consumption during pregnancy. Family history was obtained as mother's age of marriage and consanguinity of marriage. Family history of clefts among parents, siblings, or other first degree relatives was obtained.
Blood grouping and Rh typing were performed in all patients from the laboratory.
Classification of CL and palate was made on the basis of Agrawal's classification of CL and palate.
Socioeconomic status evaluation made on the basis of revised Modified BG Prasad SocioEconomic Classification Scale, 2016.
| Results and Observations|| |
A total of 260 cleft patients were studied in between 2017 and 2020. The mean age of the study participants is 6.1 years with a SD of 9.3 years. The minimum age is 1 month and the maximum age is 63 years. Females born with CL and palate are affected more (51.2%) as compared to males (48.8%), as showed in [Table 1]. Hindu religion (33.1%) majority of cases associated with CL and palate, followed by Christian (30%), Indigenous (20%), and Muslim (16.9%), as showed in [Table 2].
Most of the cleft patients belong to Manipuri (25.4%) followed by Naga (18.8%), Meitei-Pangal (13.8%), Kuki-Chin-Mizo (13.1%), although other groups comprised of various indigenous tribes are more in number. Mean height of our study population is 94.4 cm with SD 31.089, minimum height being 55 cm and maximum being 174 cm. Mean weight of our study population is 17.534 kg with SD 14.79, minimum weight is 2.5 kg, and maximum is 85 kg [Table 3] and [Table 4].
|Table 4: Mean and standard deviation of height (cm) and weight (kg) among study population|
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All of our study population had Rh-positive blood group. The proportions of blood groups are different significantly from expected proportions, but this pattern of blood grouping is normal in the general population except for “A” positive which is at higher end. P value is 0.001 – significant [Table 5].
Maximum number of the study population belongs to lower-middle class (36.2%) socioeconomic status [Table 6].
The proportion of consanguineous marriages was higher when compared to nonconsanguineous marriages and P = 0.001 significant [Table 7].
In our study population, the mean maternal age at the time of pregnancy is 27 years with a SD of 6 years. The maximum maternal age at the time of pregnancy is 40 years and minimum being 16 years.
Preterm pregnancy (48.8%) is more commonly associated with CL and palate [Table 8].
[Table 9] shows that 1st born child (27.3%) is more affected with CL and palate, followed by 2nd born (21.5%), 3rd born (18.8%), 4th born (15.8%), 5th born (8.5%), 6th born (5.4%), 7th born (2.3%), and 8th born (0.4%) child.
Majority (79.2%) of the study population do not have any associated disease with pregnancy in association with CL and palate [Table 10].
The proportion of mothers who smoke cigarettes is more when compares to nonsmokers and the proportion of mothers who consume alcohol is less when compared to nonalcoholics – P = 0.001 is significant [Table 11] and [Table 12].
|Table 11: History of addiction at the time of pregnancy - Smoking or tobacco consumption distribution|
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|Table 12: History of addiction at the time of pregnancy - Alcohol consumption distribution|
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[Table 13] shows that total 28.5% of study population had CL and palate among family members, including parents (9.2%), siblings (11.9%), parents and siblings (4.6%), and 1st degree relatives (2.7%).
In our study, 41.5% of the cases had left-sided CL and palate, as shown in [Table 14].
[Table 15] shows that Group III CL and palate (47.3%) are higher in proportion as compared to other groups. Thirteen patients had orofacial (Tessier) clefts. Tessier No. 7 cleft (38.4%) is more common as compared to other rare craniofacial clefts in our study [Table 16].
|Table 15: Distribution of various cleft lip and palate groups among study population|
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There is a significant (P value 0.0002) association of congenital anomalies among CL and palate patients [Table 17].
|Table 17: Distribution of associated congenital anomalies among study population|
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| Discussions|| |
In our study, the mean age of the patients is 6.1 years with a SD of 9.3 years. The minimum age is 3 months, and the maximum age is 63 years. This coincides with the study done by Ram Kumar Sah, Dr. Rajesh Powar (2014) where the age of cleft lip and palate patients ranged from 1 day to 71 years with a mean age of 6.77 ± 8.74 years.
In our study population of total 260 patients, 51.2% were female. This coincides with the study done by Parikh and Rao where 52% of all cleft patients were girls. Thereby this demonstrates that females are affected more than males.
In our study, most of the patients belong to the Hindu religion (33.1%). There are no studies done so far regarding religion predominance, associated with CL and palate.
Most of the cleft patients belong to Manipuri (25.4%) followed by Naga (18.8%), Meitei-Pangal (13.8%), Kuki-Chin-Mizo (13.1%), and other (28.8%) groups comprised of various indigenous tribes. Manipur is having a mixed population with so many tribes in both valley and hill regions. May be that is the reason why “Other” groups of tribal are having more number of CL and palate.
The proportions of blood groups differ significantly from expected proportions, but this pattern of blood grouping is normal in the general population except for A positive which is significantly at higher end. O +ve blood group (47.3%), A +ve (21.5%), B +ve (20.4%), and AB +ve (10.8%) have been observed. These findings correspond with Jamilian et al. who found that congenital oral clefts are most frequent in participants with blood group A which may be considered as a factor of risk of developing this condition. They observed 42.2% of the patients suffering from oral clefts were participants with blood group A +ve and O +ve being 31%.
In our study, 36.2% of the patient's per capita income in between Rs. 952 and 1903. The per capita monthly income in 28.9% cases was in between Rs. 1904 and 3172, 27.3% cases were Rs. ≤951, 4.6% cases were in between Rs. 3173 and 6345 and 3.1% cases were ≥Rs. 6346. This corresponds with the similar study done by Jyoti Dvivedi, Sanjay Dvivedi (2012) who observed the monthly family per capita earning in CL and palate patients in most of the cases, 60.58% was below 1000 rupees, 21.15% were between 1000 and 1999 rupees, 0.65% was in the range of 2000–2999 rupees, and 17.62% cases were above 3000 per month.
The proportion of consanguineous marriages (60.4%) was higher when compared to nonconsanguineous marriages (39.6%) in association with CL and palate. This coincides with a study done by Jamilian et al., where they concluded that children born of a consanguineous marriage (33.7%) were strongly associated with increased risk of CL and palate.
In our study, preterm pregnancy (48.8%) was higher in proportion as compared to term pregnancy (36.9%) and postterm pregnancy (14.2%) in association with CL and palate. Jamilian et al. in their study also concluded that 33.7% had preterm pregnancy in association with CL and palate but statistically not significant.
In our study population, the mean maternal age at the time of pregnancy is 27 years with a SD of 6 years. This corresponds to the similar study done by Jamilian et al. who concluded a significantly higher incidence of CL/P in mothers whose age were in between 21 and 34 years.
Most of the CL and palate patients in our study was 1st born child (27.3%) and least was 8th born child (0.4%). Similarly, Métneki et al. concluded that 57.6% were thev1st born child in association with CL and palate.
In our study, 20.8% of the study population had disease associated with pregnancy with respect to CL and palate. Majority (79.2%) of the study population did not have any disease associated with pregnancy. This coincides with the similar study conducted by Métneki et al. which concluded that 21.4% of the study population had disease associated with pregnancy in relation to CL and palate.
Sixty percent of the mothers having a history of smoking or tobacco consuming at the time of pregnancy is strongly associated (P < 0.001) with CL and palate. Similar study done by Chung et al., found that cigarette smoking during pregnancy was significantly associated with a risk of having a newborn with CL and palate.
The proportion of mothers who consume alcohol is less (16.2%) when compared to nonalcoholics (83.8%) in association with CL and palate. This coincides with the similar study done by Collett et al. where they showed 3.1% of their study population associated with maternal alcohol consumption in relation to CL and palate.
We found that 28.5% of the study population had a history of family members having CL and palate. Similarly, Zhou et al. have shown a history of family members having clefts occurred in 6.84% of patients. Jamilian et al. concluded that 10.7% of CL and palate cases having clefts among family members.
In our study, 41.5% of the cases had left-sided CL and palate. Similarly, Nagalo et al. concluded that among CL and palate cases left side (49.2%) were the most affected.
We found that majority (47.3%) of the cases were Group III CL and palate. This coincides with the similar study done by Nagalo et al., where they found most common type of cleft was CL and palate (49.7%).
In our study, 5% of the cases had Tessier clefts. Of these 38.4% cases had Tessier No. 7 clefts. This is supported by similar study done by Kalantar-Hormozi et al., which concluded that 8.29% patients were identified with rare craniofacial/Tessier clefts.
In our study, there was significant association of congenital anomalies (38.5%) among CL and palate patients. Similarly, Nagalo et al. concluded that 21.1% of CL and palate cases were associated with other congenital malformations.
| Conclusion|| |
This study concludes that there is a strong association of maternal smoking or tobacco consumption, maternal alcohol consumption, consanguineous marriages, and A +ve blood group in relation to CL and palate.
People should be aware of maternal smoking or tobacco consumption mostly in forms of Pan, maternal alcohol consumption. People should be advised to avoid consanguineous marriage. Government (health sector) should develop strategies in health sector for awareness, identification, and treatment of cleft deformities.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| Appendix|| |
Appendix 1: Proforma of Research Work
Sl. no.-............................................................................. Date of evaluation: ____/___/_____
- Patient Information:
□ Patient ID No.:
□ Date of Birth: ______/_____/________(dd/mm/yyyy)
□ Age: ______month(s)__________year(s)
□ Gender: Male/Female/Third Gender (Unknown)
□ Religion: Hindu/Muslim/Christian/Indigenous
□ Caste and Tribe: Manipuri/Naga/Kuki-chin-mizo/Meitei-pangal/Others.
□ Patient Height: __________cms.
□ Patient Weight: ________kgs.
□ Blood Group: A/B/AB/O Rh: Positive/Negative.
□ Name of Hospital: Shija Hospitals and Research Institute Pvt. Ltd.
- Parent/Guardian Information:
□ Relationship with patient: Mother/Father/Others(________________)
□ Socio-economic status: Upper/Upper Middle/Middle/Lower Middle/Lower class.
- Family and Antenatal History:
□ Type of marriage: Consanguineous/Non- consanguineous
□ Age of marriage:
□ Duration of pregnancy: ______months. (Preterm/Term/Post-term)
□ Birth order:
□ Age of mother at the time of pregnancy:
□ Any disease associated with pregnancy: Yes/No/Don't know
□ History of smoking during pregnancy: Yes/No/Don't know
□ History of consume alcohol during pregnancy: Yes/No/Don't know
□ History of cleft lip, cleft palate, or cleft involving face in patients parents: Yes/No/Don't know
□ History of cleft lip, cleft palate, or cleft involving face in patients siblings- brother/sister: Yes/No/Don't know
□ History of cleft lip, cleft palate, or cleft involving face in patients any other first degree relatives: Yes/No/Don't know
□ Lip: Non-cleft/Complete cleft/Incomplete cleft
Left side/Right side/Midline cleft
□ Alveolus: Non-cleft/Complete cleft/Incomplete cleft
Left side/Right side/Midline cleft
□ Hard Palate: Non-cleft/Complete cleft/Incomplete cleft
Left side/Right side/Midline cleft
□ Soft Palate: Non-cleft/Complete cleft
Incomplete cleft/submucous cleft
Final diagnosis – cleft lip and palate – left/right, group I/Ia/II/III, P (Incomplete)/S (Submucous)
□ Any associated congenital anomaly: Yes/No
Participation Information Sheet
Title of the study: “A CROSS-SECTIONAL STUDY ON EPIDEMIOLOGY AND CLINICAL PROFILE OF CLEFT LIP AND PALATE IN A TERTIARY CARE HOSPITAL IN MANIPUR, INDIA”.
Name of Investigator: Dr. Indranil Dutta.
Name of Guide: Prof. Dr. G. Nilamani Sharma.
Name of Co- Guide: Dr. Kh. Palin Singh.
Introduction: Myself, Dr. Indranil Dutta, DNB Plastic Surgery (Direct 6 years course) resident, in Shija Hospitals and Research Institute, Langol, Imphal West, Manipur, India, is collecting data for the study called: “A CROSS-SECTIONAL STUDY ON EPIDEMIOLOGY AND CLINICAL PROFILE OF CLEFT LIP AND PALATE IN A TERTIARY CARE HOSPITAL IN MANIPUR, INDIA”. You are hereby requested for participation in this study. This consent form will give you information about this study to participate in it. Therefore, you or your parents or guardians are requested to read this form or I will read it for your parents or guardians in his/her understandable language. If you are willing to participate in this study, you or your parent/guardian need to put today's date and sign the consent form.
Purpose of this study: The objective of this study is to determine epidemiology and clinical profile of cleft lip and cleft palate in a tertiary care hospital in Manipur, India.
Procedure of the study: If you or your parents/guardians agree to participate in this study, I shall ask you or your parents/guardians some questions about you, your present complaints, family history etc., The interview will last about 10-15 minutes. Your parents/guardians may choose not to answer certain questions if you don't want to. General and systemic examinations will be performed.
Eligibility: 1. Patient presenting with cleft lip, cleft alveolus, cleft palate, or both cleft lip and palate, craniofacial and oro-facial cleft are included in the study.
2. All patients irrespective of age are included in the study.
Risk and benefit for participating in the study: None beyond the scope of the operative procedure.
Cost to participant: Nil.
Participation in the study: You may decide not to take part in the study or can withdraw from the study at any time. You will continue to receive the medical services and routine medical care.
Confidentiality: Your personal information will be kept confidential. This information will not be given to anybody else without your permission. However, collective data without identifiers will be presented and may be published. If you ever have any questions regarding this study, or in case of research related inquiries, you can contact any time to Dr. Indranil Dutta, DNB Plastic Surgery (Direct 6 years course) resident, in Shija Hospitals and Research Institute, Langol, Imphal West, Manipur, India. Contact no.: (+91) 7642006045/9007056736.e-mail id: [email protected]
Shija Hospitals and Research Institute
(An ISO 9001:2008 Certified Hospital)
INFORMED CONSENT FORM
Patient identification number for this trial ______________
Title of the project: A CROSS-SECTIONAL STUDY ON EPIDEMIOLOGY AND CLINICAL PROFILE OF CLEFT LIP AND PALATE IN A TERTIARY CARE HOSPITAL IN MANIPUR, INDIA.
Name of the Principal Investigator: Dr. Indranil Dutta
Contact no.: (+91)7642006045/9007056736. e-mail-id: [email protected]
- I have received the information sheet on the above study and have read and/or understood the written information.
- I have been given the chance to discuss the study and ask questions.
- I give consent to take part in the study and I am aware that my participation is voluntary.
- I understand that I may withdraw at any time without affecting my future care.
- I understand that the information collected about me from my participation in this research and sections of any of my medical notes may be looked at by responsible persons (ethics committee members/regulatory authorities). I give access to these individuals to have access to my records.
- I understand and I will receive a copy of the patient information sheet and the informed consent form.
I agree to take part in the above study.
Date and time-
Signature/Thumb Impression of patient's parent/guardian:
Name of Parent/Guardian:
Name of Participant:
This is to certify that above consent has been obtained in my presence.
Signature of Principal Investigator:
Dr. Indranil Dutta
DNB Trainee, Department of Plastic Surgery,
Shija Hospitals and Research Institute Pvt. Ltd.
Signature of Impartial Witness:
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8], [Table 9], [Table 10], [Table 11], [Table 12], [Table 13], [Table 14], [Table 15], [Table 16], [Table 17]