Method of transvaginal cerclage of the uterus in pregnant women for emergency indications

Abstract

FIELD: medicine.SUBSTANCE: invention relates to medicine, namely obstetrics and gynecology, and can be used for transvaginal uterine circumcision for emergency indications during pregnancy from nineteen to twenty-six weeks. Two circular sutures are applied in the area of the cervix, with the proximal circular suture applied at the level of the vaginal vaults with tightening of the threads, and the distal circular suture applied in the area of the external os of the cervix at a distance of 2–3 millimeters from its edge with subsequent tightening of the threads.EFFECT: method increases the reliability of surgical correction of cervical insufficiency during emergency cerclage procedures in the presence of severe shortening of the cervical canal by achieving a strong locking effect and anatomical formation of the cervix, which provides reliable support for the fetal bladder, reduces the risk of premature rupture of the membranes in the first weeks after the intervention, statistically significantly reduces the incidence of late-term preterm births, increases the number of full-term vaginal deliveries, and improves neonatal outcomes, increasing the survival rate of newborns and reducing neonatal mortality rates.1 cl, 1 dwg, 2 ex

Description

[0001] The invention relates to the field of medicine, in particular to operative obstetrics, and can be used in pregnant women with a singleton pregnancy with cervical insufficiency (CI) for therapeutic purposes in case of shortening of the cervix length ≤ 25 mm and / or dilation of the cervical canal ≥ 10 mm (along its entire length), in an emergency (the so-called rescue cerclage) in case of shortening of the cervix to 15 mm or less), often accompanied by prolapse of the fetal membranes, as well as for prophylactic purposes in women with a history of 2 or more miscarriages or premature births in the 2nd-3rd trimester of pregnancy. The method is particularly effective when applying cerclage for emergency indications at gestational ages from 19 weeks 0 days to 26 weeks 6 days.

[0002] According to the Special Report of the Civic Chamber of the Russian Federation, "Demography 2030: How to Ensure Sustainable Population Growth in the Russian Federation," increasing the birth rate is one of our top strategic priorities. The primary objective of obstetrics in achieving this goal is to reduce perinatal mortality, 75% of which is due to premature infant mortality. The leading causes of late reproductive losses are late miscarriage and premature birth, one in three of which is due to cervical insufficiency.

[0003] The most effective method for correcting cervical insufficiency is surgery.

[0004] Today, three main methods of surgical correction of cervical insufficiency through vaginal access are most commonly used:

[0005] 1) Suturing without tissue dissection (McDonald method). A circular purse-string suture is placed at the junction of the anterior vaginal fornix and the cervix;

[0006] 2) Submucous suture with detachment of the bladder (Shirodkar method), rarely used due to high trauma;

[0007] 3) Double U-shaped submucosal suture in the area of ​​the internal os according to the method of A.I. Lyubimova, modified by N.M. Mamedalieva.

[0008] The effectiveness of these interventions, whether prophylactic or therapeutic, ranges from 70% to 80%, according to various authors. However, pregnancy outcomes with so-called emergency or rescue cerclages are statistically worse.

[0009] Therefore, the development of new surgical methods for the correction of cervical insufficiency that are effective when used for emergency indications is relevant: when the cervix is ​​shortened to 15 mm or less, often accompanied by prolapse of the fetal membranes.

[0010] The McDonald method of applying a single circular suture is well known. In this method, a circular suture is placed at the level of the vaginal fornix in the submucosal layer of the cervix. The knot is placed at 12 o'clock in the anterior vaginal fornix.

[0011] The disadvantage of this method is that the application of a single purse-string suture does not allow the formation of a cervical canal and thus makes it less effective in prolonging the gestation period.

[0012] The closest method is described in patent RU 2783974, a method for correcting isthmic-cervical insufficiency in case of prolapse of the fetal bladder, which consists of applying two circular sutures in the area of ​​the cervix.

[0013] A disadvantage of this method is that placing a second distal suture 5-8 mm from the proximal circular suture does not allow for the formation of a complete cervical canal, thereby making it less effective in prolonging the gestational period. Considering that the physiological length of the cervix during pregnancy is 35-40 mm, placing a second suture 5-8 mm from the first does not bring it closer, anatomically, to the normal formation of the cervix.

[0014] The objective of the present invention is to develop a method for surgical correction of cervical insufficiency, which allows for greater mechanical support of the cervix and thus helps to reduce the number of premature births and improve neonatal outcomes.

[0015] The technical result is to increase the efficiency of performing cerclage, namely, to reduce the incidence of premature births and reproductive losses when performing emergency cerclage.

[0016] The technical result is achieved in that the method of transvaginal cerclage of the uterus in women in the presence of emergency indications in patients with a singleton pregnancy at a period from 19 weeks 0 days to 26 weeks 6 days includes the application of two circular sutures in the area of ​​the cervix, characterized in that the proximal circular suture is applied at the level of the vaginal fornices, gradually tightening the threads, then in the area of ​​the external os of the cervix at a distance of 2-3 millimeters from the edge of the cervix, gradually tightening the threads.

[0017] Fig. 1 shows a diagram of suturing the cervix.

[0018] The numbers indicate:

[0019] 1 - fundus of the uterus

[0020] 2 - body of the uterus

[0021] 3 - internal os

[0022] 4 - endocervix

[0023] 5 - cervical canal

[0024] 6 – vaginal vault

[0025] 7 - external os

[0026] 8 - ectocervix

[0027] 9 - vagina

[0028] 10 - cervix.

[0029] The method is as follows.

[0030] The patient is in the Trendelenburg position. Under aseptic conditions and total intravenous anesthesia, after exposing the cervix with speculums, it is grasped with bullet forceps at the 3 and 9 o'clock positions. The cervix is ​​drawn toward the vaginal introitus. Using a sterile swab soaked in 0.05% chlorhexidine aqueous solution, the fetal bladder is carefully returned to the uterine cavity. The first suture, a proximal circular purse-string, is placed at the level of the vaginal fornix in the submucosal layer of the cervix and is gradually tightened as the swab is removed. The second suture, a distal circular purse-string, is placed at the level of the external os. The knots of both sutures are positioned at the 12 o'clock position. As the second suture is tightened, the bullet forceps are removed from the cervix. The area is treated with an antiseptic solution.

[0031] Applying a "distal" circular suture to the cervix creates a strong occlusive effect on the cervix and promotes, anatomically, normal cervical development. Applying proximal and distal circular sutures to the cervix in the area of ​​the vaginal fornix and the projection of the external os provides strong support for the amniotic sac and reduces the risk of preterm labor.

[0032] The implementation of the method is confirmed by clinical examples.

[0033] Example 1. Pregnant woman S., 35 years old. Hospitalized in the Emergency Hospital, State Budgetary Institution "City Clinical Hospital No. 1" of the Ministry of Health of Chuvashia, Cheboksary. Diagnosis on admission: 23-24 weeks of pregnancy. Threatened miscarriage. OAGA (history of 6 spontaneous miscarriages at 12 to 21 weeks of pregnancy) ICI. Ultrasound on admission: Cervical circumference - 12 mm, the upper part is funnel-shaped and open to 6 mm, the length of the funnel is 16 mm. Examination with speculums: W / m 1 cm, the external os is open to 0.5 cm. Examined. On the 2nd day of hospitalization, the patient was taken to the operating room.

[0034] Sutures were applied according to the stated method. She was in the department for 7 days. Follow-up ultrasound of the cervix: cervical length (normal 25-42 mm): 34 mm, cervical width (normal 2.0-4.0 mm): 1.4 mm, cervical septum: closed. Conclusion: Signs of corrected cervical insufficiency.

[0035] There were no hospitalizations after cervical cerclage. The patient had no complaints throughout the pregnancy, cervicometry was monitored. At 37 weeks, the suture from the cervix (2 separate threads) was removed as planned. At 38 weeks, she gave birth spontaneously. Pregnancy outcome: 1 term spontaneous delivery at 38-39 weeks of pregnancy. Information about the child: alive, full-term with an Apgar score of 8 / 9 points. Gender: female. Weight 3304 g. Height 52 cm. Head circumference 33 cm. Chest circumference 32 cm. The postpartum period was uneventful.

[0036] Example 2. Pregnant woman F., 36 years old. Hospitalized in the Emergency Hospital, State Budgetary Institution "City Clinical Hospital No. 1" of the Ministry of Health of Chuvashia, Cheboksary. Diagnosis on admission: 22-23 weeks of pregnancy. Threatened miscarriage. Cervical insufficiency. Prolapse of the fetal bladder. Ultrasound on admission: Cervical diameter - 7 mm, fetal bladder along the entire length of the cervix up to 15 mm. Examination with speculums: cervical diameter 1 cm, external os dilated to 1.5 cm, prolapsed fetal bladder, intact. Examined. On the 2nd day of hospitalization, she was taken to the operating room.

[0037] Sutures were applied according to the stated method. She was in the department for 7 days. Follow-up ultrasound of the cervix: CC length (normal 25-42 mm): 17.9 mm, CC width (normal 2.0-4.0 mm): 1.8 mm, VMZ area dilated to 3.7 mm. Conclusion: Signs of corrected cervical insufficiency.

[0038] There were no hospitalizations after cervical cerclage. The patient had no complaints throughout the pregnancy, and cervicometry was monitored. At 37 weeks, the suture from the cervix (2 separate threads) was removed as planned. At 39 weeks, the child gave birth spontaneously. Pregnancy outcome: Term spontaneous labor 5 at 39 weeks of pregnancy. Information about the child: alive, full-term, with an Apgar score of 8 / 9 points. Gender: female. Weight: 3438 g. Height 50 cm. Head circumference 33 cm. Chest circumference 33 cm. The postpartum period was uneventful.

[0039] The effectiveness of the claimed method is confirmed by studies conducted at the perinatal center of the City Clinical Hospital No. 1 of the Ministry of Health of the Chechen Republic, Cheboksary, aimed at comparing the effectiveness of using a double suture according to the claimed method and a circular single suture according to McDonald on the cervix in reducing the incidence of premature birth and reproductive losses during emergency cerclage.

[0040] This study is a retrospective analysis of the medical records of 215 pregnant women hospitalized at the Perinatal Center of the State Budgetary Institution "City Clinical Hospital No. 1" of the Chuvash Ministry of Health with a diagnosis of cervical insufficiency (CI). Patients underwent emergency cervical cerclage between 19 and 27 weeks of pregnancy. The effectiveness of a single McDonald cervical suture (Group 1, 102 patients) and a double suture using the proposed method (Group 2, 113 patients) was compared. Pregnancy and neonatal outcomes, as well as surgical complications, were assessed.

[0041] The incidence of preterm births before 32 weeks of gestation is comparable in the study groups. However, at 32-37 weeks of gestation, the incidence of preterm births statistically significantly increases in the group of patients who underwent single suture repair using the McDonald method (38.2% vs. 18.6%, p=0.002). The incidence of term births is significantly higher in the group of patients who underwent two sutures (66.4% vs. 46.1%, p=0.002). Most patients in both groups delivered vaginally (85.3% vs. 89.4%, p>0.05), and regardless of the method of delivery, the pregnancy ended in live birth (99% vs. 100%, p>0.05). Fetal weight was 3087 g and 3117 g in the first and second groups, respectively. Premature rupture of membranes (PROM) within the first two weeks after cervical cerclage was observed in 4.9% and 2.65% of cases, respectively.

[0042] Double cervical cerclage is a more effective method for surgical correction of cervical insufficiency when performing cerclage for emergency indications, i.e., when the cervical canal length is ≤ 15 mm. This method is associated with a statistically significant reduction in the rate of preterm births between 32 and 37 weeks, while the rate of term births is significantly higher. In more cases, births occur vaginally and, regardless of the method of delivery, result in a live birth. Neonatal survival beyond 28 days is higher, and neonatal mortality is correspondingly 1.7 times lower.

Claims

A method of transvaginal cerclage of the uterus for emergency indications at 19-26 weeks of pregnancy, which includes the application of two circular sutures in the area of ​​the cervix, characterized in that the proximal circular suture is applied at the level of the vaginal fornices, tightening the threads, then in the area of ​​the external os of the cervix at a distance of 2-3 millimeters from the edge of the cervix, the distal circular suture is applied, tightening the threads.

Images