Introduction
Congenital anomalies are a common cause of long-term disability in children, which has become an important medical issue [1]. Cleft lip (CL), cleft palate (CP), and cleft lip and palate (CLP) are common congenital anomalies. CP occurs in the secondary palate (soft and hard palate). Its occurrence may be unilateral, bilateral, complete, or incomplete. This abnormality can occur alone or along with CL or other syndromes [2]. The development of the lip and palate involves the events that need coordination; therefore, the occurrence of CL and CP is more common than the occurrence of each one alone. Veau et al. classified CL and CP into four main groups: soft palate cleft, hard palate cleft, unilateral CLP, and bilateral CLP [3].

Methods
This is a retrospective cross-sectional study on the data of babies born in Kamali, Imam Ali, Maryam, and Ghaem hospitals in Karaj, Iran, from March 2014 to February 2019. The sampling method was simple random method. The sample size was determined 3837 according to the study by Haseli et al. [17] who reported the ratio of CP as 0.001, and considering the accuracy of 0.001, which increased to 4000 by taking into account the possible dropout. In this regard, 1000 cases were selected from each hospital using a simple random method. The obtained data were analyzed in SPSS software version .24 using descriptive statistics (mean, standard deviation, frequency, and percentage) and chi-square test. P<0.05 was considered statistically significant.

Results
Of 91,563 live births, 46 had CL, CP, or CLP, with an overall prevalence of 0.5 per 1000 live births.
Out of 46 cases with clefts, 12(26.08%) had CL, 24(52.17%) had CP, and 10(21.73%) had CLP (Figure 1).

The chi-square test results showed a significant difference in the prevalence of clefts in terms of type, where CP had the highest prevalence.
Among mothers of newborns with clefts, 27(58.69%) had first pregnancy, 11(23.91%) second pregnancy, 6(13.04%) third pregnancy, and 2 (4.34%) fourth or more pregnancies. Regarding the gender of the newborns with clefts, 26(56.52%) were boys and 20(43.47%) were girls. Also, regarding the blood group of mothers of newborns with clefts, 36.95% had blood group A; 15.21%, blood group B;17.39%, blood group AB; and 30.43%, blood group O (Table 1).


Three mothers had Rhesus (Rh) negative and the rest had Rh positive. None of the mothers had a history of alcohol or smoking. Only one mother had a history of opium use.
In assessing the number of children, 67.39% of mothers had one child, 21.73% had two children, and 10.86% had three children. A significant difference in the prevalence of clefts in terms of the number of children; the families with one child had the highest percentage of clefts. In assessing the weight of the baby, 10.86% had a weight <2500 g, 28.26% had a weight of 2500-3000 g, and 60.86% had a weight >3000 g. There was a significant difference in the prevalence of clefts in terms of infant weight, where babies above 3000 g experienced the highest percentage of clefts (Table 1).

Conclusion
Cleft lips and cleft palates are some of the congenital anomalies with low prevalence. These anomalies not only endanger the child’s health but also cause many economic, psychological and social problems for families. Identifying the factors related to the development of these anomalies can have a very important contribution to reducing the problems of families. Based on the results of this research, during a 5-year period from 2014 to 2019, 46 cases of clefts were recorded in 91,563 live births. 
The overall prevalence was 0.5 per 1000 live births. This is lower than the prevalence reported by Ghafari et al. (2.22 per 1000 live births) and Kayanifar (1.9 per 1000 live births), Hasli (1.24 per 1000 live births), Namdar et al. (1.2 per 1000 live births) [13, 16, 17, 20], but is close to the reports of Jalilevand (0.485 per 1000 live births), Jahanbin (0.69 per 1000 live births) and Farhadian (0.83 per 1000 live births) [21-23].
 In terms of the type of clefts, the highest prevalence was related to CP (52.17%), followed by CL (26.08%) and CLP ( 21.73%). In this study, the prevalence of clefts was higher in male babies, babies with mothers aged 20-30 years, babies with mothers having first pregnancy, babies with maternal blood group A, babies with parents having cousin marriage, babies with a head circumference of 32-37 cm and a weight of 2500-3000 g. To reduce the prevalence of clefts, it is recommended to increase the awareness of families to reduce cousin marriages and emphasize more on the use of complementary medicines for pregnant mothers.

Ethical Considerations
Compliance with ethical guidelines
The ethical approval of this study was obtained from the Research Ethics Committee of Alborz University of Medical Sciences (code: IR.ABZUMS.REC.1399.252).

Funding
This article was extracted from the thesis of Seyed Mostafa Mortazavi. This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

Authors' contributions
Conceptualization, design, drafting the manuscript, editing & review: Faraz Farahi Araghi; Acquisition and interpretation of data: All authors; Statistical analysis and supervision: Seyed Mostafa Mortazavi.

Conflicts of interest
The authors declare no conflict of interest.

Acknowledgments
The authors would like to thank the participants for their cooperation.


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