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Instructions for use GINIPRAL® (GINIPRAL)

During the use of GINIPRAL®, you should monitor the mother's pulse and blood pressure, as well as the fetal heartbeat. It is recommended to record an ECG before and during treatment. Patients with hypersensitivity to sympathomimetics should use GINIPRAL® in small doses prescribed individually, under constant medical supervision.

If there is a significant increase in the mother's heart rate (more than 130 beats/min) and/or a significant decrease in blood pressure, the dose should be reduced; if there are complaints of difficulty breathing, pain in the heart, or if signs of heart failure appear, the use of GINIPRAL® should be stopped immediately.

Pregnant women with diabetes should monitor carbohydrate metabolism, because the use of GINIPRAL®, especially in the initial stage of treatment, may cause an increase in blood sugar levels. If childbirth occurs immediately after a course of treatment with GINIPRAL®, it is necessary to take into account the possibility of hypoglycemia and acidosis in newborns due to the transplacental penetration of acidic metabolic products (lactic and ketonic acids).

In some cases, the simultaneous use of glucocorticosteroids during GINIPRAL® infusions may cause pulmonary edema. Therefore, during infusion therapy, constant careful clinical monitoring of patients is necessary. This is especially important during combined treatment with corticosteroids in patients with concomitant diseases that contribute to fluid retention (kidney disease). Strict limitation of excess fluid intake is necessary. The risk of possible development of pulmonary edema requires limiting the volume of infusions as much as possible, as well as using dilution solutions that do not contain electrolytes. You should limit your salt intake from food. Before starting tocolytic therapy, it is necessary to take potassium supplements, because with hypokalemia, the effect of sympathomimetics on the myocardium is enhanced. The simultaneous use of certain narcotic drugs (halothane) and sympathomimetics can lead to cardiac arrhythmias. Taking GINIPRAL® must be stopped before using halothane for anesthesia. With prolonged tocolytic therapy, it is necessary to monitor the condition of the fetoplacental complex and ensure that there is no placental abruption. Clinical symptoms of premature placental abruption can be smoothed out with tocolytic therapy. When the membranes rupture and when the cervix is dilated by more than 2-3 cm, the effectiveness of tocolytic therapy is low.

During tocolytic treatment with beta-agonists, the symptoms of concomitant dystrophic myotonia may intensify. In such cases, the use of diphenylhydantoin (phenytoin) drugs is recommended.

Tactics for managing premature pregnancy with premature rupture of membranes

Digest of the Academy of Obstetrics and Gynecology No. 1/2016

According to the WHO definition, preterm birth is defined as a birth that occurs during pregnancy from 22 to 36 weeks and 6 days (154,259 days), starting from the first day of the last normal menstrual period with a regular menstrual cycle, and the fetal body weight ranges from 500 to 2500 g.

The relevance of the problem of managing preterm labor due to premature rupture of membranes (PROM) is beyond doubt. PPO, according to various authors, accompanies 35%-60% of all premature births, which end in the birth of a premature baby. in turn, premature babies account for 60%-70% of neonatal mortality. Significant advances in world medicine and pharmacology achieved over the past 30 years have not affected the prevalence of preterm birth with preterm birth. their frequency remains almost stable, ranging from 5% to 12%, and has no tendency to decrease. Premature births between 28 and 34 weeks account for 27% - 32% of all premature births and are less studied than, for example, early preterm births between 22 and 28 weeks.

Despite the fact that the fetal lungs are still immature at this stage of gestation, individually selected expectant management of labor and prevention of fetal respiratory distress syndrome (RDS) contribute to their accelerated maturation. The three leading causes of neonatal mortality are associated with preterm pregnancy: prematurity, sepsis, and pulmonary hypoplasia. The mortality rate of newborns with intrauterine infection resulting in sepsis is four times higher. The risk to the mother is primarily associated with chorioamnionitis (13-60%). There has been a proven connection between ascending infection from the lower genital tract and PROM. Every third patient with prostate cancer during premature pregnancy has positive culture results of the genital tract; moreover, studies have proven the possibility of bacteria penetrating through intact membranes. So, perinatal morbidity in this group of patients remains high and requires expensive nursing of children in intensive care conditions using modern technologies. The most controversial question remains about the timing of prolongation of the anhydrous interval. on the one hand, prolongation of premature pregnancy increases the gestational age of the fetus, on the other hand, the risk of infectious complications in the fetus due to severe oligohydramnios, as well as in the mother, increases with the subsequent development of chorioamnionitis and septic conditions. therefore, cases of long-term prolongation of premature pregnancy with PROM are unreasonably rare.

The Ministry of Health of the Russian Federation has developed protocols for the management of premature birth, including preterm birth, which regulate the actions of obstetrician-gynecologists in all medical institutions in Moscow. Thus, the diagnosis of prpo has a number of features. In most cases, the diagnosis is obvious due to thin, clear vaginal discharge. however, if prpo is suspected, vaginal examination should be avoided unless there are signs of active labor, as it significantly increases the risk of spreading the infection and is unlikely to determine the tactics for further management of pregnancy and childbirth.

If the rupture of the membranes occurred long ago, diagnosis may be difficult. In this case, the algorithm of medical measures is as follows:

Offer the pregnant woman a sterile pad and assess the nature and amount of discharge after 1 hour;
Inspect on a chair with sterile mirrors; fluid flowing from the cervical canal or located in the posterior fornix confirms the diagnosis;
Take a smear of amniotic fluid, with a false negative rate of more than 20%;
Use disposable test systems, so-called amniotests, based on the determination of the non-phosphorylated form of protein-1 associated with insulin-like growth factor or placental α-microglobulin-1;
An ultrasound scan of oligohydramnios in combination with an indication of fluid leakage from the vagina confirms the diagnosis of protrusion.

The likelihood of developing spontaneous labor with PROM is directly dependent on the gestational age: the shorter the period, the longer the period before the development of regular labor. within the first day after birth, spontaneous labor begins in 26% of cases with a fetal weight of 500-1000 grams, in 51% with a fetal weight of 1000-2500 grams, in 81% with a fetal weight of more than 2500 grams.

Prolonging pregnancy up to 22 weeks is not advisable due to the unfavorable prognosis for the fetus and the high frequency of purulent-septic complications in the mother. termination of pregnancy is recommended.

With a gestational age of 22-24 weeks, the prognosis is also unfavorable. Parents should be aware that babies born before 24 weeks are unlikely to survive, and those who do are unlikely to be healthy.

The choice of management tactics for preterm pregnancy must be formalized in the form of informed consent from the patient.

When a patient is admitted to a hospital of the 1st and 2nd groups with suspected prostate cancer in a pregnancy up to 34 weeks, transfer to a 3rd level obstetric hospital is recommended. in the gestation period up to 34 weeks, expectant management is indicated, which involves monitoring the patient in the ward of the pregnancy pathology department with keeping a special observation sheet in the birth history with recording every 4 hours of the body temperature and pulse of the pregnant woman, fetal heart rate, the nature of discharge from the genital tract and labor activity .

The scope of laboratory examinations for preterm pregnancy and premature pregnancy includes culture of discharge from the cervical canal for β-hemolytic streptococcus, flora and sensitivity to antibiotics during the first speculum examination; complete blood count with leukocyte formula once every 2-3 days in the absence of clinical signs of infection; determination of c-reactive protein in the blood as a predictor of chorioamnionitis.

Assessment of the fetal condition includes ultrasound, Doppler, CTG at least once every 2-3 days.

Pharmacological interventions for PROM and preterm pregnancy include tocolysis, fetal RDS prophylaxis, and antibiotic therapy. tocolysis is indicated for a period of no more than 48 hours for transfer to a perinatal center and a course of corticosteroids. Prophylactic use of tocolytics is ineffective. Antibiotic prophylaxis should begin immediately after the diagnosis of prostate cancer and continue until the birth of the child (in case of delayed delivery, it may be limited to 7-10 days).

Antibiotic prescription regimens:

erythromycin per os no 0.5 g every 6 hours to 10 days
ampicillin per os no 0.5 g every 6 hours up to 10 days
if hemolytic streptococcus is detected in microbiological cultures, penicillin 1.5 g IM every 4 hours.
NB! amoxicillin + clavulanic acid should not be prescribed due to the increased risk of necrotizing enterocolitis.

Schemes for the prevention of fetal RDS:

24 mg betamethasone (12 mg IM every 24 hours) or
24 mg dexamethasone (6 mg IM every 12 hours).

Expectant management of preterm birth in preterm birth is contraindicated in cases of chorioamnionitis, pregnancy complications requiring urgent delivery, severe gestosis, placental abruption, bleeding with placenta previa, and decompensated conditions of the mother and fetus.

The most pressing maternal complication associated with preterm pregnancy is chorioamnionitis. clinically, signs of chorioamnionitis should be considered maternal fever above 38°C, fetal tachycardia > 160 beats/min, maternal tachycardia > 100 beats/min, vaginal discharge with a putrid odor, increased uterine tone. leukocytosis (> 18 × 109 ml) and neutrophil shift of the leukocyte formula have low predictive value for confirming the presence of infection. it is necessary to determine these indicators over time (once every 1–2 days). Chorioamnionitis is an absolute indication for rapid delivery and is not a contraindication to cesarean section. in the absence of active labor, the method of choice for delivery is cesarean section. if chorioamnionitis is suspected, therapy with broad-spectrum antibiotics or a combination of drugs should be started, taking into account the need to target all groups of pathogens (gram-positive, gram-negative aerobes; anaerobes). the indication for discontinuation of antibacterial therapy is normal body temperature within 2 days. PPO is not an indication for emergency delivery.

In pregnancy more than 34 weeks, long-term (more than 12-24 hours) expectant management is not indicated, as it increases the risk of intrauterine infection and umbilical cord compression, which negatively affects the outcome of childbirth for the fetus. But the decision to intervene should be made on the basis of a comprehensive clinical assessment of the situation after obtaining the informed consent of the patient.

Let us consider the indicators of premature births with PROM in the 3rd obstetric department of City Clinical Hospital No. 29 for 2015. 29.3% of all births 3 Ao were premature. 50% of preterm births were in patients with PROM, of which early births occurred in 5% of women, at 28-34 in 42%, and 52% in patients at 34-36 weeks of gestation, which is most favorable for perinatal outcomes. Moreover, 55% of caesarean sections were performed at 28-34 weeks. The protocol for the management of pregnant women with a prognosis of 29 gkB complies with the standards adopted in Moscow, namely: antibacterial therapy - penicillin group drugs from the moment of admission, a course of RDS prophylaxis (24 mg dexamethasone), acute tocolysis (ginipral 48 hours), tocolysis in maintenance regime was found to be ineffective. We analyzed the timing of spontaneous birth in patients with prognosis. Thus, birth occurred on the 3rd day and 1 week of a long anhydrous interval in 37 and 33% of patients. 11% of pregnant women gave birth a day after the rupture of amniotic fluid. in 6% of patients, birth occurred during a one-week water-free interval, in 3% - during a three-week period. while 66% of children were admitted to the neonatal intensive care unit, but 33% were admitted to the 2nd neonatal unit. 55% of children from mothers with prognosis and a long anhydrous interval were born at 28-34 weeks of gestation, and then transferred to the second stage of nursing. at 34-36 weeks - 38% of children. early preterm birth in patients with PROM occurred in 6%, with an unfavorable outcome.

So, premature birth remains a pressing medical and social problem, as well as a public health priority. Correct management of premature pregnancy, wisely chosen timing and methods of delivery in case of premature rupture of membranes will improve the rates of perinatal and maternal morbidity.

Elena Viktorovna Karpova , Obstetrician-gynecologist, Candidate of Medical Sciences

Elena Evgenievna Komarova , Obstetrician-gynecologist, Candidate of Medical Sciences, Head of the 3rd obstetric department of City Clinical Hospital No. 29, doctor of the highest category

results

The mean gestational age at delivery was 41 weeks + 0 days in the induction group and 41 weeks + 2 days in the expectant group.

In the induction of labor group, 15 of 900 women (1.7%) had adverse perinatal outcomes, compared with 28 of 901 women (3.1%) in the expectant group (absolute risk difference, −1.4%, 95% CI −2.9%-0.0%, P=0.22 for non-inferiority).
11 (1.2%) infants in the labor induction group and 23 (2.6%) in the second group had Apgar scores <7 at 5 minutes (relative risk, 0.48; 95% CI, 0.23-0. 98).
No infants in the induction of labor group and 3 (0.3%) in the expectant group had Apgar scores <4 at 5 minutes.
There were no neonatal deaths recorded.
Three infants (0.3%) in the induction group and 8 (0.9%) in the expectant group were admitted to the intensive care unit (relative risk, 0.38; 95% CI, 0.10 to 1.41).
There were no statistically significant differences between groups in adverse maternal outcomes or cesarean section rates.

How to use the drug

Ginipral, which is used for women at 40 weeks and during labor, is hexoprenaline. The element is considered a strong selective beta2-agonist, which exhibits a pronounced tocolytic effect. The main indication for the use of such a substance is considered to be the need for urgent relief of contractions, for example, the state of fetal suffocation, when performing a manual turn, which is located transverse to the birth canal, when prolapse of the umbilical cord and other complications are detected.

In emergency surgery options for artificial resolution of labor, the medicine can relax the uterus. Ginipral for uterine tone is used with a dropper during pregnancy. At the same time, the drug slows down early contractions and prevents the resolution of labor in the early stages. A medicine from the tocolytic group prepares the uterus for suturing the cervix to hold it in a closed position and promotes recovery after manipulation.

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