RU2746437C1 - Method for the treatment of pregnant women with isthmic-cervical insufficiency - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to obstetrics and gynecology. On the vaginal part of the cervix, a flexible loop is first applied, equipped with a lock with a retainer. Then the loop is tightened, narrowing the cervical canal to a diameter of 1 mm, while the loop is fixed in the lock. Then a fixed flexible loop is left in the vaginal cavity. After reaching full-term pregnancy or the development of regular labor in preterm labor, a flexible loop is cut off with scissors and removed from the vaginal cavity.

EFFECT: method allows simplifying technique of carrying out therapeutic measures for ischemic-cervical insufficiency (ICI), reducing complications risk associated with the correction of ICI, increasing effectiveness of treatment of pregnant women with ICI.

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Description

The invention relates to medicine, namely to obstetrics and gynecology, and can be, in particular, used for the treatment of isthmic-cervical insufficiency (ICI), which is one of the main causes of termination of pregnancy in late gestational periods.

From the practice of medicine, methods of surgical treatment of ICI are known, in which, during pregnancy, tightening sutures are surgically applied to the cervix using various modifications. Most often, a circular purse-string suture according to the MacDonald method or U-shaped stitches according to the A.I. Lyubimova and N.M. Mamedalieva (Obstetrics: national leadership / under the editorship of E.K. Ailamazyan, V.I.Kulakov, V.E. Radzinsky, G.M.Savelyeva. - M .: GEOTAR-Media, 2007. - 1200 s.).

Common disadvantages of surgical correction of ICI are: intraoperative blood loss, surgical trauma to the cervix and eruption of superimposed sutures, stimulation of uterine contractile activity, the possibility of damage to the fetal bladder, as well as a high risk of developing infectious and inflammatory complications, including with the development of a septic state.

In addition, the imposition of surgical sutures on the cervix in the treatment of ICI in a pregnant woman is carried out under general drug anesthesia, which is not quite a desirable fact in the gestational period.

In recent years, some researchers began to suggest using obstetric pessaries (Hui SY, Chor CM, Lau TK, Lao TT, Leung TY. Cerclage Pessary for Preventing Preterm Birth in Women with a Singleton Pregnancy and a Short Cervix at 20 to 24 Weeks: A Randomized Controlled Trial. Am J Perinatol 2013; 30: 283-8; Kypros H. Nicolaides, MD, Argyro Syngelaki, Ph.D., Liona C. Poon, MD, Gemma Picciarelli, MD, Natasa Tul, MD, Aikaterini Zamprakou, MD, Evdoxia Skyfta, MD, Mauro Parra-Cordero, MD, Ricardo Palma-Dias, MD, Ph.D., and Jesus Rodriguez Calvo, MD A Randomized Trial of a Cervical Pessary to Prevent Preterm Singleton Birth.N Engl J Med 2016 March 17; 374: 1044-1052).

Despite the atraumatic nature of the method, a number of authors point to a lower efficiency of the method than the imposition of surgical sutures on the cervix (Tsaregorodtseva M.V., Dikke G.B. Flexible approach: Obstetric pessaries in the prevention of miscarriage. Status Praesens. 2012; 8: 75-78).

Other disadvantages of intravaginal use of pessaries are the presence of constant abundant vaginal discharge during the period of their wearing, reflecting the quality of life of pregnant women, as well as the emergence of certain technical difficulties during its installation and extraction, requiring a certain practical skill.

At the same time, some authors note the presence of only the unloading effect from the use of pessaries (Obstetric pessaries: a differentiated approach. - A guide for doctors / Zanko S.N. [and others]. - Vitebsk, 2016. - 32 p.), While the main goal treatment of ICI is to reduce the diameter of the cervical canal and mechanical strengthening of its wall.

The possibility of imposing surgical sutures on the cervix during prolapse of the fetal bladder is indicated, while the installation of pessaries in this clinical situation is not possible (Tskhai V.B. Possibilities of surgical correction of isthmic-cervical insufficiency during prolapse of the fetal bladder // Obstetrics and gynecology. 2016; 9 : 5-11).

The aim of the present invention is to simplify techniques and improve the effectiveness of treatment of pregnant women with ICI.

The technical result is achieved by the fact that a flexible loop is first applied to the vaginal part of the cervix, equipped with a lock to fix the length of the latter, then the loop is tightened, narrowing the cervical canal to a diameter of 1 mm, at the same time the loop is fixed in the lock, after which a fixed flexible loop is left in the cavity vagina; after reaching full-term pregnancy or the development of regular labor in preterm labor, a flexible loop is cut off with scissors and removed from the vaginal cavity.

The method is illustrated in Fig., Where: Fig. 1-flexible loop with a lock; figure 2 - narrowing of the cervical canal; where: 1- loop; 2- cervix.

In the proposed invention, a loop is used that has the necessary plasticity and strength, has a convenient lock for its reliable fixation and, after use, is easily cut off with scissors. This loop refers to medical devices, which some authors use for devascularization of the uterus during cesarean section and myomectomy (S.P. Sinchikhin, A.E. Sarbasova, O.B. Mamiev, L.V. Stepanyan / Transient uterine ischemia in cesarean section operations in young women // Reproductive health of children and adolescents - 2017, No. 6 - P.52-59; S.P.Sinchikhin, O.B. Mamiev, S.G. Magakyan / Algorithm for treatment and prophylactic tactics patients with uterine myoma // Gynecology-2015, Vol. 17, No. 3- P.4-6).

It should be noted that the tension of the tightening loop is quite moderate and contributes, on the one hand, to the necessary narrowing of the cervical canal, and on the other hand, it does not lead to a complete cessation of blood flow in the tissues of the cervix (to prevent the development of trophic changes). It is important to emphasize that with the help of a flexible tightening loop, it is possible to create the required diameter of the cervical canal for any expansion.

Distinctive features of the proposed method are the ease of implementation, which does not require high qualifications of the doctor, the possibility of quick manipulation without general and local anesthesia, the absence of any surgical procedures associated with punctures of soft tissues and the risk of their infection, as well as traumatic damage to the fetal bladder.

An additional advantage of the developed method is that it can also be used with a prolapsing fetal bladder. In this case, the risk of its damage will be significantly lower than with surgical correction of ICI. In this clinical situation, before imposing a plastic loop, it is first necessary to fill the prolapsing part of the fetal bladder into the uterine cavity, and then mechanically reduce the dilated diameter of the cervical canal according to the technique we have developed, which is technically a simpler manipulation than surgical sutures on the cervix.

The practical significance of the proposed method lies in the absence of blood loss, reduction in the time of manipulation and prevention of the development of gestational complications after correction of ICI. The used plastic hinge with a lock has a low cost.

In general, the application of the developed method makes it possible to achieve the set goal: to simplify techniques and increase the efficiency of ICI treatment. With this method, no pain relievers are used, no anesthesia is used, there is no need for a long stay for a pregnant patient in an obstetric hospital.

The proposed method was successfully tested in 2017-2019 at the clinical bases of the Department of Obstetrics and Gynecology of the Medical Faculty of the Astrakhan State Medical University

In general, 150 pregnant patients were under observation, who were diagnosed with isthmic-cervical insufficiency (ICI) at 14-18 weeks of gestation and subsequently treated for this pathological condition. The criteria for the diagnosis of ICI were: shortening of the cervix less than 25-20 mm and opening of the internal pharynx more than 1.0 mm according to ultrasound examination (US) with an interval of 2 weeks; softening and shortening of the vaginal part of the cervix, found during gynecological examination. In some patients, prolapse of the fetal bladder into the cervical canal was noted. The observed pregnant women were divided into three groups, each of which consisted of 50 people. Treatment of pregnant women was carried out in terms of 15-18 weeks of gestation after the diagnosis of ICI.

Before the correction of ICI in all groups, local sanitation of the vagina was carried out with suppositories containing an antiseptic (chlorhexidine) for 5-7 days.

The first group was formed by pregnant women with ICI, in whom we used the method of treatment developed by us (narrowing of the dilated cervical canal with a flexible loop with a fixing lock). The second group consisted of pregnant women in whom surgical correction of the ICI was performed (U-shaped stitches were applied to the cervix according to the method of A.I. Lyubimova-N.M. Mamedalieva). The third group was formed by pregnant women with the initial stage of ICI, in whom obstetric pessaries were used. Patients between groups were comparable in age, reproductive behavior, somatic pathology, and obstetric and gynecological history.

Criteria for inclusion in the study groups: diagnosed ICI, singleton pregnancy.

Exclusion criteria: absence of criteria for the diagnosis of ICI, multiple pregnancy, spotting from the uterine cavity.

The results of prospective observation showed the following (Tables 1-3).

The main complications after correction of cervical incompetence (Table 1) were infectious and inflammatory changes in the vagina and cervix, which were observed in patients of all groups. However, these changes in patients of group 1 were 4 times less than in women of group 2, and 2.3 times less than in pregnant women of group 3.

The imposition of surgical sutures in pregnant women of the 2nd group was complicated by the development of bleeding in 2 patients and eruption of sutures in 3 women, which required local surgical hemostasis and repeated surgical manipulation. In addition, deformity of the cervix and impaired trophism of soft tissues in 3 patients of this group made it impossible for them to have a vaginal delivery.

It should be noted that in 2 patients from group 3, after removing the pessary at full-term, trophic changes in the cervix in the form of pressure ulcers were observed, which was probably associated with its displacement if the rules of use or administration were not followed. However, these changes in the cervix were quickly applied to successful local therapy and were not an obstacle to labor through the vaginal birth canal.

Hypertensive contractions of the uterus after the installation of a plastic loop on the cervix and a pessary were observed only in 1 patient from groups 1 and 3, while after the imposition of surgical sutures, increased uterine tone, which required long-term tocolytic therapy, was observed in patients of group 2. 5 times more often than in pregnant women of other groups (Table 2). Further observation of pregnant women showed that clinical signs of threatened abortion at various gestational periods were observed in 10 (20%), 27 (54%) and 13 (26%) patients in groups, respectively (Table 2).

Full-term delivery was completed in 44 (88%), 34 (68%) and 42 (84)% of patients by group, respectively (Table 3). Termination of pregnancy before 22 weeks of gestation, due to uncorrected uterine contractile activity, was observed in patients from all groups, however, this pregnancy outcome was less common in patients of groups 1 and 3 in comparison with patients in group 2. At the same time, special attention is paid to the fact that the most favorable pregnancy outcomes were recorded in the 1st group, i.e. in patients in whom the method developed by us was used to correct ICI.

Thus, the use of this method of ICI correction is technically simple and clinically effective, as well as cost-effective in view of preventing possible complications. It is important that with this method of treatment there is no drug load on the pregnant woman and her fetus.

The implementation of the proposed method is illustrated by the following clinical example.

Example. Re-pregnant L., 36 years old, at 14 weeks of gestation, consulted a antenatal clinic with complaints of constant aching pains in the lower abdomen for 3 days. History: vaginal delivery and two artificial abortions.

An ultrasound examination performed cervicometry, in which it was found that the length of the cervical canal was 24 mm (with a norm of 14 weeks - 36-37 mm). Repeated cervicometry after 2 weeks showed a decrease in the length of the cervix to 22 mm, despite the ongoing therapy, which was aimed at stabilizing the normal tone of the uterus and the hormonal background of the pregnant patient. Taking into account the data of ultrasound examination, the diagnosis was made: Pregnancy 14-16 weeks. Isthmico-cervical insufficiency.

The patient was offered the correction of isthmico-cervical insufficiency according to the technique developed by us, in which a flexible loop is applied to the vaginal part of the cervix, after which the cervical tissue is tightened in the loop of the loop with fixation in the lock.

After obtaining written consent, the patient underwent the above manipulation.

Observation of the pregnant woman during the gestational period showed no development of any complications of the gestational period. According to the results of cervicometry, the average indicators of the length of the cervix during the subsequent (after the correction of ICI) period were 26 ± 1.5 mm.

At the age of 37 weeks of pregnancy in an obstetric hospital with the onset of labor, the flexible loop located on the cervix was cut off with scissors and removed from the vagina without any technical difficulties. Urgent labor through the vaginal birth canal passed without complications, and on the 3rd day of the postpartum period, the patient was discharged from the obstetric hospital.

Summarizing the data presented in general, it should be noted that when using the method we propose, it is achieved:

- simplification of techniques during the treatment of ICI;

- reducing the risk of complications associated with the correction of ICI;

- reducing the cost of medical services;

- increasing the effectiveness of treatment of pregnant women with ICI.

Claims (1)

A method of treating pregnant women with isthmic-cervical insufficiency by narrowing the cervical canal, characterized in that a flexible loop equipped with a lock with a retainer is first applied to the vaginal part of the cervix, then the loop is tightened, narrowing the cervical canal to a diameter of 1 mm, at the same time the loop is fixed in the lock , after which a fixed flexible loop is left in the vaginal cavity; after reaching full-term pregnancy or the development of regular labor in preterm labor, a flexible loop is cut off with scissors and removed from the vaginal cavity.

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