@2024 Afarand., IRAN

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ISSN: 2251-8215    Sarem Journal of Reproductive Medicine 2019;3(1):13-17

Background
Each year, more than 10 million labor occur before 37 weeks of pregnancy, of which more than 1 million children die because of the complications of these labors[1]. One of the most important maternal factors in this regard is diagnosis of pregnant women with short cervical length or cervical failure.
Previous Studies
… [2-4]. Classical treatment of cervical disorder is cervical cerclage, in which the weak cervix is strengthened by surgery and using certain types of sutures called purse-string. …[5-7]. A meta-analysis study showed that in women with history of spontaneous prematurity, twin pregnancy, and transvaginal ultrasonography with cervical length less than 25 mm before the 24th week of gestation, cervical length measurement in transvaginal ultrasonography has a %30 reduction in the risk of prematurity below 35 weeks and %36 decrease in subsequent prenatal morbidity[8]. A history of preterm labor and twin pregnancy is one of the precautionary serclage indications and proven cervical failure is one of the indications of serclage therapy. Currently, cerclage is performed by vaginal administration in two main methods of Shirodkar and McDonald. The Mcdonald method is more conventional and more accepted. In the McDonald method, purse-strings are performed in 6-4 areas around the cervix in the anterior part of the vesicoservoir reflex and in the posterior part in recto-vaginal reflexion. However, in the Shirodkar method, as the cervix is cut from the bladder and rectum, the stiches are done near the inner hole [6, 7]. Both Shiordkar and McDonald have recommended that the location of the stiches be nearly as close to the inner hole. The McDonald cerclage and even the Shirodkar cerclage are often done in the middle third of the endocervical canal. Most studies suggest that the more the sutures are closer to the inner hole, the lower is the risk of premature or preterm birth (PTB) compared to the stitches at the level of one third or lower[8, 9]. For this reason, the modified McDonald approach is applied in Sarem Hospital in which the mucus in the vaginal and bladder lifts up with the help of the retractor to allow access to higher point of the cervical length. In this method compared to the classical McDoland method, 1.5-1 cm higher part of cervix can be stitched[5].
Aim(s)
The purpose of this study was to evaluate and compare the clinical outcomes of classical McDonald therapy with modified McDonald therapy in Sarem Women Hospital.
Research type
This analytic study is a retrospective cohort.
Research society, place and time
This research was conducted in a population of pregnant women who underwent cerclage in Sarem Women Hospital in Tehran during one year. These women were operated for a variety of reasons, including highrisk pregnancies, multiple pregnancies and cervical failure, and only cases of cerclage for congenital cervical failure were investigated in pregnant mothers with short cervical length. Cerclage in patients had been done with two groups of physicians. A group of physician were the experts in conducting cerclage with modified McDonald treatment closer to the internal cervical hole and the other group were physicians who performed cerclage with classical Mcdonold method at a lower level. Sampling method and number: A number of patients were excluded from the study due to incomplete information and a total of 105 pregnant women entered the study.
Sampling method and number

Used devices&materials
McDonald Modified Surgical Procedure: in this method, in addition to observing the notes regarding the Trendelenberg position during operation, using a wet sterile gas with a forceps to lift the embryonic veins into the uterus, it is attempted to reach the highest level of cervical height. By using the upper retractor, as much as possible, the bladder with the vaginal mucus are lifted to be out of reach and not damaged in the sutures (damage or possible entry into the bladder is controlled with the help of a catheter). Then, the first and second stitches are carefully done to suture in the upper of front of right anterolateral and the left anterolateral parts respectively (2 and 10 o’clock) so that the half-circle around the anatomical level of the bladder can be made and the stitches be done without entering the bladder. At the bottom, also, in the lefthand posterolateral corner and then the right posterolateral position (at 7 and 5 o'clock) are stitched to be away from the anatomical location of the intestine (control of this area is also done with the help of a rectal touch during stitching). Finally, by touching the amount of stiffening of the stitches, or using a boogie of 6 to 8 (to prevent necrosis due to non-perforation in the too stiffened area of stiches), the knot is about in the area higher than 3 o’clock, and the end to the thread with a visible length (about 2 cm) is cut off to facilitate the work of opening the cerclage suture. In this way, the cerclage, despite the bladder groove location and the absence of damage to the bladder and rectum, compared with the common types of cerclage is at the highest level and closer to the inner hole (Fig. 1). Information regarding cervical length before cerclage, history of previous surgery, gestational age duringcerclage, number of labors, number of abortion in previous history of patients, and history of cervical failure was gathered. Also, the incidence of preterm delivery or death, gestational age at birth of premature or dead infant, gestational age at the time of preterm premature rupture of membranes, gestational age at the time of vaginal bleeding, postoperative cervical length and the increase in the length of cervix after the operation were investigated as post-cervical outcomes. Information was collected from patients' files that had undergone a cerclage operation during the last year from the hospital archives and telephone contacts with patients were provided to complete the information. Data were analyzed using SPSS 22 and GraphPad Prism 6 and through student t-test, Fisher exact, and chisquare tests.
Findings by Text
Modified McDonald cerclage and classical Mcdonald cerclage methods were used for %65.7)69) and%34.3)36) of patients respectively. In general, %5.2 ,%7.1 ,%9.3 ,%16.9, and %41.5 had preterm rupture, bleeding, pre-term labor, vaginal infection and abortion respectively. The history of previous surgery was %11.0, which not significantly different between the two treatment groups (p>0.05). The highest and lowest McDonald gestational age were 15 weeks (%15.3) and 23 weeks (%0.8). In general, %41.5 had history of abortion which was %39.0 in the classical cerclagic group and %42.9 in the modified group that this difference was not significant (p=0.420). The mean age of patients was not significantly different between the classical cerclage group and modified cerclage group (p=0.148, Table 1).Comparison of the two groups in terms of preterm labor, premature rupture of membranes, and the cervical length, showed no significant difference in these issues. In the modified cerclage method, the cerclage had been done at the higher gestational age (p=0.0001). However, total complications were the same in both methods (Table 1). Also, gravid 1 had the highest prevalence of gravid among mothers with a prevalence of %49.2. There was no significant difference between the two groups in terms of gravid prevalence and term and preterm labors (Table 2).Absolute and relative frequency (numbers in parenthesis are percentages) of gravidity and prevalence of preterm labor in patients studied in two groups of classical and modified McDonald cerclage operation in Sarem Hospital in Tehran (n=105). Cervical length was significant in both groups before and after operation. In addition, the increase in cervical length in cerclage with Modified McDonald Method was significantly higher compared to the classical method (p=0.0257; Table 1).
Main comparison to the similar studies
…[4, 10].In this study, the modified McDonald method was carried out at higher gestational age compared to the classical method. Considering the similarity of the results of both groups regarding the ratio of preterm and term labors, premature rupture of membranes, and upper gestational age at the time of McDonald operation, we find that the modified cerclage method has had a better result. Other studies have also shown that the higher cerclage height i.e. the higher distance of cerclage from the outer hole (usually more than 2 cm) has a better effect on the results of cerclage[2, 5, 11]. However, in some studies, it was concluded that cerclage size had the least correlation with the gestational age at labor[8].
Suggestions
Although in terms of frequency, the cases of preterm labor in classical method was higher, it is suggested that this issue be examined with a larger sample size in order to provide more consistent conclusion of the outcome of pregnancy. Also, to achiever more reliable results, RCT study and randomization of groups are recommended with appropriate (more) sample size.
Limitations
Relatively, people with a shorter cervical length participated in the modified cerclage method that this shift in certain individuals with higher gestational age may be non-random.
Conclusions
Conducting cerclage therapy with McDonald therapy at higher gestational age and increasing the cervical length after cerclage show superiority of this method. However, this method is not different from the classical McDonald method in terms of the results of preterm labor.
Acknowledgments
Non-declared by the authors.
Conflict of interest
Non-declared by the authors.
Ethical Permissions
Non-declared by the authors.
Funding Sources
Non-declared by the authors.

TABLES and CHARTS

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