CN114864091A - Method, equipment and medium for evaluating cervical maturity of pregnant woman waiting for full-term labor induction - Google Patents
Method, equipment and medium for evaluating cervical maturity of pregnant woman waiting for full-term labor induction Download PDFInfo
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- G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
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- A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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- A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B8/48—Diagnostic techniques
- A61B8/485—Diagnostic techniques involving measuring strain or elastic properties
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- G—PHYSICS
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Abstract
The invention provides an evaluation method of cervical maturity of pregnant women waiting for full-term labor induction, which comprises the following steps: measuring the closed segment length (CL) of the cervical canal and/or the average strain level (IOS) of the cervical orifice region of the individual to be evaluated, and then substituting the measured strain level into a prediction model formula to perform probability calculation or scoring the CL and IOS measured values according to a critical value; and (4) integrating the evaluation results of CL and IOS to obtain the cervical maturity evaluation result. The method can evaluate the cervical state more accurately, objectively and safely, and can guide the obstetrical department to select a proper induced labor mode or an induced labor medicine clinically by taking the cervical state as an important indication. The present invention also provides an apparatus and a computer readable medium for cervical maturity assessment of a pregnant woman to be induced for term.
Description
Technical Field
The invention relates to the field of medical data analysis, in particular to an analysis and evaluation method of cervical maturity, and particularly relates to a method and equipment for evaluating the cervical maturity of a pregnant woman waiting for full-term labor induction.
Background
Cervical maturity refers to the degree to which the cervix becomes soft, shortened, effaced, and dilated before delivery. The late pregnancy induced labor is to initiate the labor process before the natural labor by means of medicines and the like to achieve the purpose of delivery, and is one of the common means for treating high-risk pregnancy in the obstetrical department. At present, the clinical methods of induced labor mainly comprise artificial rupture of membranes, intravenous drip of oxytocin and the like, and different induced labor methods are adopted according to the maturity of the cervix to a great extent.
In the prior art, the cervical maturity is mainly analyzed and evaluated in clinic and scientific research by the following methods:
1. cervical Bishop score: currently, Bishop scores are mostly adopted for the evaluation of cervical maturity clinically at home and abroad. The cervical Bishop score is a method for comprehensively evaluating the maturity of the cervix from 5 aspects of the length, the hardness, the position, the expansion degree of the uterine cervix and the position of fetal presenting fluid through vaginal examination. Because each piece of scoring element information needs to be obtained by means of direct examination of a doctor, the Bishop score is a subjective evaluation standard, and Bishop scores obtained by evaluation of different examiners for the same pregnant woman have certain difference, so that clinical treatment is influenced.
2. Ultrasonic index inspection: at present, the cervical maturity is evaluated by ultrasound in a scientific research stage, indexes comprise the length of a closed cervical segment, the expansion size of an internal cervical orifice, the distance between the dew and a perineum, the angle of a posterior cervical neck and the elasticity of the cervical, the indexes measured by the ultrasound are relatively objective, the cervical maturity can be evaluated to a certain degree, and the prediction of induced labor outcome is helped. The significance of various indexes related to the above evaluation modes on cervical maturity evaluation still has respective limitations. For example, with respect to the length of the cervical closure segment, most studies show that the length of the cervix is meaningful for evaluating the maturity of the cervix to predict the labor induction outcome, but a large number of studies suggest that the effect is comparable to or better than the Bishop score, and that the length of the cervical closure segment represents only one aspect of the cervical maturity, and the effect is limited. Regarding the size of cervical os dilation, the existing research shows whether the cervical os dilates and the degree of dilation is used as an independent index to evaluate the cervical maturity, which is not a relevant index for predicting the labor induction outcome. Regarding the distance between the dew and the perineum, the values of predicting induction of labor outcome when the dew is taken as an independent index for evaluating the maturity of the cervix are equivalent to the Bishop score and the closed segment length of the cervix, and the values of predicting induction of labor outcome are higher than the Bishop score when the dew is taken as an independent index for evaluating the maturity of the cervix. Regarding the posterior cervical angle, most researches find that the prediction effect of the posterior cervical angle is superior to that of the cervical Bishop score no matter the posterior cervical angle is used as an independent evaluation index or is used together with other ultrasonic indexes for evaluating the cervical maturity, but the prediction values of the posterior cervical angle in the researches are different, the size of the posterior cervical angle in some researches is only significant to the local prediction when the posterior cervical angle is used as a joint index in a prediction model, and the stability of the evaluation is lacked. With respect to cervical flexibility, several studies have found that cervical flexibility is more valuable for assessing cervical maturity and thereby predicting labor induction outcome as compared to cervical canal length.
There are two main ways to evaluate cervical elasticity at present: strain elastography and shear wave elastography.
In the strain elastography, because external forces applied by operators are different in magnitude, an absolute value cannot be defined for the hardness of a cervix, and meanwhile, because reference tissues are lacked around the cervix, the elasticity measured by the strain elastography cannot be used as a strain ratio, so that the method is limited, and meanwhile, the measuring method is easily influenced by multiple factors such as the magnitude and the position of the force applied by the operators, the fetal activity, the respiration of pregnant women and the like, and has poor repeatability.
Shear wave elastography, the principle is that a pulse shear wave is sent by an ultrasonic probe, the hardness of a cervix is evaluated by an attenuation wave reflected by the shear wave in cervical tissue, the position of a transmitted pulse of the probe influences a measurement result, and meanwhile, although related basic research considers that the thermal effect and the mechanical effect generated by the ultrasonic shear wave are similar to normal Doppler ultrasound, the vibration effect and the pulse radiation generated by the ultrasonic shear wave at present are uncertain to the risk of a fetus.
The change trend of the cervical maturity in the whole pregnancy period has stage difference. For example, it has been found that although cervical elasticity is evaluated in patients at different gestational weeks, the elasticity of the internal cervical tissue changes significantly only after 34 weeks of gestation, indicating that the elasticity of the internal cervical tissue is more related to cervical ripening at late gestation, although the whole cervical tissue begins to soften at 20 weeks of gestation. Since the late pregnancy is faced with the option of induction of labor, the only general trend for predicting cervical maturity changes is far from adequate to provide clinical reference, but rather the need to accurately predict the progression of cervical maturity over a limited time.
In view of this, how to objectively evaluate the cervical maturity of the pregnant woman to be induced to parturite at term so as to adopt a suitable induced labor mode is an urgent problem to be solved in the clinical field at present.
Disclosure of Invention
The invention aims to: the method for evaluating the cervical maturity of the pregnant woman to be induced for delivery in term is provided, the cervical state can be evaluated more accurately, objectively and safely, and the cervical state can be used as an important index to guide the obstetrical department to select a proper induced delivery mode or an induced delivery medicine clinically.
Another object of the invention is: provided are a device, an electronic apparatus, and a medium for evaluating the cervical maturity of a pregnant woman to be induced to labor at term.
The above object of the present invention is achieved by the following technical solutions:
in a first aspect, the present invention provides a first method for evaluating the cervical maturity of a pregnant woman to be induced to labor at term, comprising: measuring the average strain level (IOS) of the endocervical region of the subject individual and substituting the measured strain level into the following formula (I) to calculate the probability of vaginal delivery within 24 hours P1;
P1＝Exp(-0.95+8.708×IOS)/[1+Exp(-0.95+8.708×IOS)] (I)。
the invention also provides a second method for evaluating the cervical maturity of the pregnant woman waiting for full-term labor induction, which comprises the following steps: measuring the closed cervical Canal Length (CL) and the average strain level (IOS) of the internal cervical region of the evaluation subject individual, and then substituting the average strain level (IOS) into the following formula (II) to calculate the probability P2 of entering the active period within 18 hours;
P2＝Exp(1.025-0.932×CL+7.310×IOS)/[1+Exp(1.025-0.932×CL+7.310×IOS)] (II)。
the invention also provides a third method for evaluating the cervical maturity of the pregnant woman waiting for full-term labor induction, which comprises the following steps: measuring the closed cervical Canal Length (CL) and the average strain level (IOS) of the internal cervical region of the evaluation subject individual, and then substituting the following formula (III) to calculate the probability P3 of entering the active period within 15 hours;
P3＝Exp(0.286-0.646×CL+6.754×IOS)/[1+Exp(0.286-0.646×CL+6.754×IOS)] (III)。
the invention also provides a fourth method for evaluating the cervical maturity of the pregnant woman waiting for full-term labor, which comprises the following steps: measuring the Closed Length (CL) of the cervical canal and the average strain level (IOS) of the internal cervical region of the individual to be evaluated; setting the evaluation critical value of the CL value to be 1.38cm, evaluating that the CL value is mature when the measured CL value is not more than 1.38cm, and otherwise evaluating that the degree of maturity is insufficient; setting the evaluation critical value of the IOS value to be 0.35, evaluating that the IOS is more mature when the measured IOS is not less than 0.35, and otherwise, evaluating that the maturity is insufficient; and (4) integrating the evaluation results of CL and IOS to obtain the cervical maturity evaluation result.
In the fourth method of the present invention, the evaluation threshold value of the CL value preferably comprises two levels, the primary level is 1.38 and the advanced level is 0.94cm, that is, the measured CL value is not more than 1.38cm and is evaluated as more mature, the measured CL value is not more than 0.94cm and is evaluated as more mature, otherwise, the evaluation of the maturity is decreased.
In the fourth method of the present invention, the evaluation threshold of the IOS value preferably comprises two levels, the first level is 0.35 and the second level is 0.45, i.e., the measured IOS value is evaluated as being mature when not less than 0.35, and is evaluated as being more mature when not less than 0.45, otherwise the evaluation maturity is decreased.
In the fourth method of the present invention, the CL value is preferably assigned the following score: CL values greater than 2.10cm did not score; the CL value of not more than 2.10cm is 1-3 points, wherein the CL value of not more than 1.38cm is 2-3 points, and the CL value of not more than 0.94cm is 3 points.
In the fourth method of the present invention, the IOS value is preferably assigned the following score: IOS values less than 0.29 do not score; the IOS value of not less than 0.29 is 1-3 points, wherein the IOS value of not less than 0.35 is 2-3 points, and the IOS value of not less than 0.45 is 3 points.
In a further preferred fourth method of the invention, it is predicted from the total score of said CL and IOS values whether the cervix of a pregnant woman to be induced for term enters the active period within 15 hours or within 18 hours, or whether vaginal delivery is possible within 24 hours; wherein, the critical value of dividing into 2 scores predicts whether the cervix of the pregnant woman waiting for full term labor enters the active period within 15 hours or whether the vagina can deliver within 24 hours, and the critical value of dividing into 3 scores predicts whether the cervix of the pregnant woman waiting for full term labor enters the active period within 18 hours; if the total score is smaller than the critical value, the prediction result is negative, and if the total score is larger than or equal to the critical value, the prediction result is positive.
In the various methods of the present invention, the average strain level (IOS) of the cervical os is preferably measured using strain elastography, and more preferably measured using the E-Cervix technique. The principle of the E-cervix strain elastography method is that the elasticity of surrounding tissues is measured through strain force generated by internal organ activities including blood vessel pulsation, the measurement is independent of interference of factors such as operator force application and fetal activity, the measured hardness mean value in an interested range is an objective value, repeatability is high, and the E-cervix strain elastography method is a new strain imaging derivative technology and high in safety.
In the various methods of the present invention, the closed cervical Canal Length (CL) is preferably measured using a vaginal ultrasound procedure.
Although the existing Bishop scoring method can be used for evaluating the cervical maturity, the required indexes are more, and the measurement and scoring processes of the indexes are greatly influenced by subjective factors. The method of the invention is different, and only two indexes of the closed cervical segment length (CL) and the average strain level (IOS) of the internal cervical orifice area are needed for evaluating the cervical maturity of the pregnant woman to be induced to parturient at term, and the two indexes are more objective to measure, for example, CL can be obtained by clinical routine vaginal ultrasonic measurement, and IOS can be measured by a strain force elastography method (e.g. E-Cervix technology). The invention relates to an evaluation method of cervical maturity of a pregnant woman to be induced to labor in term, which is based on a queue research result of vaginal ultrasound on cervical maturity evaluation of the pregnant woman to be induced to labor in term. In the research, a patient with a premature rupture of fetal membranes in full-term single pregnancy or artificial water-breaking labor induction is scored in cervical Bishop before labor induction, and meanwhile, the closed segment length (CL) of a cervical canal, the expansion degree of an internal cervical orifice, the perineum-fetal head distance (FHPD), the angle of the posterior cervical neck (PCA) and the elasticity index of the cervix are measured through vaginal ultrasound. The cervical elasticity index includes the strain level of the cervical inner os area average (IOS) measured by the E-Cervix technique, the strain level of the cervical outer os (EOS) reflecting the texture of the cervical outer os, and IOS/EOS (r) reflecting the difference in texture of the inner and outer os. The patients were observed whether they could enter the active phase (i.e. 5cm greater opening) within 15 or 18 hours after regular contractions (10 min > 3) had been produced by breaking water in combination with oxytocin instillation, and whether vaginal delivery could be achieved within 24 hours. Analyzing the influence of the age, BMI and vaginal ultrasound measurement indexes on the outcome of the patient through logistic regression to find whether the patient can enter the active period within 15 hours or 18 hours and is only significantly related to CL (cm) and IOS indexes (P values are all less than 0.05), but is not significantly related to the age, BMI, cervical os, FHPD, PCA, EOS and R indexes (P values are all greater than 0.05); whether a patient is able to deliver within 24 hours vaginally was significantly correlated with only one index of IOS (P <0.05), but not with age, BMI, CL, cervical os, FHPD, PCA, EOS and R (P values all > 0.05).
On the basis of obtaining the correlation index through single-factor analysis, on one hand, a prediction model formula is established according to logistic regression, so that the first, second and third cervical maturity evaluation methods can be obtained, and can be used for evaluating the change of the cervical maturity within 24 hours, 18 hours and 15 hours respectively. On the other hand, ROC curve analysis is carried out on two correlation indexes of CL and IOS respectively, an optimal critical value for predicting the junction area is found, the optimal critical value of CL is not more than 1.38cm, the optimal critical value of cervical IOS is not less than 0.35, and a cervical maturity scoring system is established by further taking the median of upper and lower sections as a demarcation point according to the optimal critical values of CL and cervical IOS, so that the fourth cervical maturity evaluation method is obtained.
In a second aspect, the present invention also provides an apparatus for evaluating the cervical maturity of a pregnant woman waiting for full term labor, comprising:
the data acquisition module is used for receiving actual measurement data of the closed segment length (CL) of the cervical canal of the individual to be evaluated and actual measurement data of the average strain level (IOS) of the cervical internal orifice area;
the calculation evaluation module is used for evaluating the cervical maturity based on the actually measured data received by the data acquisition module;
the evaluation is probability calculation based on a prediction model formula or scoring evaluation based on a scoring system;
the probability calculation based on the predictive model formula is to calculate the probability P1 of the vagina delivering within 24 hours, the probability P2 of entering the active period within 18 hours or the probability P3 of entering the active period within 15 hours of the cervix; the calculation formulas of P1, P2 and P3 are as follows:
P1＝Exp(-0.95+8.708×IOS)/[1+Exp(-0.95+8.708×IOS)] (I)；
P2＝Exp(1.025-0.932×CL+7.310×IOS)/[1+Exp(1.025-0.932×CL+7.310×IOS)] (II)；
P3＝Exp(0.286-0.646×CL+6.754×IOS)/[1+Exp(0.286-0.646×CL+6.754×IOS)] (III)；
the scoring evaluation based on the scoring system comprises the following steps: giving a higher score to CL measured data not greater than 1.38cm and giving a lower score to CL measured data greater than 1.38 cm; giving a higher score for the IOS measured value not less than 0.35, and giving a lower score for the IOS measured value less than 0.35; and (4) integrating the evaluation results of CL and IOS to obtain the cervical maturity evaluation result.
The invention also provides a user terminal for evaluating the cervical maturity of the pregnant woman to be induced to parturite at term, which comprises a memory and a processor, wherein the memory is used for storing a cervical maturity evaluation program, and the processor runs the cervical maturity evaluation program to enable the user terminal to execute any one of the cervical maturity evaluation methods of the pregnant woman to be induced to parturite at term.
The present invention also provides a computer readable storage medium, on which a cervical maturity evaluation program is stored, which when executed by a processor implements any one of the methods for evaluating the cervical maturity of a pregnant woman waiting for full-term labor of the present invention.
Compared with the prior art, in the evaluation method, the variables participating in the model are ultrasonic objective measured values, the operation is simple and convenient, the repeatability is high, the prediction value of the induced labor outcome is obviously higher than that of the traditional Bishop score, and simultaneously compared with vaginal examination, the comfort degree of a patient on vaginal ultrasonic examination is higher, and the acceptance degree is higher. In addition, only 2 ultrasonic indexes need to be measured in the model, and results can be obtained quickly. In the preferred scheme of the invention, cervical maturity is evaluated by measuring the cervical closed section length by vaginal ultrasound and measuring the cervical elasticity by an E-Cervix technology, and a mode which is objective, has strong repeatability and can comprehensively evaluate the cervical maturity is hopefully provided for clinic, so that labor induction outcome is predicted and clinical labor induction mode selection is guided.
Drawings
FIG. 1 is a ROC curve for different evaluation methods ending with a 15 hour successful entry into the active period.
FIG. 2 is a ROC curve for different evaluation methods ending with 18 hour successful entry into the active period.
FIG. 3 is a ROC curve for different assessment methods with 24 hour successful vaginal delivery as outcome.
Detailed Description
The invention provides a cervical maturity evaluation method for pregnant women waiting for full-term labor induction, and the conclusion obtained by evaluation only reflects one physiological indication and is used as one of reference indexes for making a clinical treatment scheme and selecting a clinical treatment means.
The method of the invention is roughly divided into two categories, one is to use different regression equations to calculate the probability that the cervix enters the active period in different time, and the other is to use a simple and easy scoring system to evaluate the maturity of the cervix. Two indicators of the length CL (cm) of the cervical closure zone and/or the cervical IOS are used in the various methods of the present invention. Wherein the length CL (cm) of the cervical closure segment can be obtained by vaginal ultrasound measurement; the cervical IOS is preferably measured by the E-Cervix technique.
The first cervical maturity evaluation method for the pregnant women waiting for full-term labor can be any one of the following methods:
the first method comprises the following steps: measuring the average strain level (IOS) of the endocervical region of a pregnant woman to be induced to give birth in term by using the E-Cervix technique, and then substituting the measured strain level (IOS) into the following formula (I) to calculate the probability P1 of vaginal delivery within 24 hours;
P1＝Exp(-0.95+8.708×IOS)/[1+Exp(-0.95+8.708×IOS)] (I)。
and the second method comprises the following steps: measuring the Closed Length (CL) of a cervical canal of a pregnant woman to be induced to labor in a full term by using a vaginal ultrasound method, measuring the average strain level (IOS) of the internal cervical region of the pregnant woman to be induced to labor in the full term by using an E-Cervix technology, and then substituting the average strain level (IOS) into the following formula (II) to calculate the probability P2 of entering an active period within 18 hours;
P2＝Exp(1.025-0.932×CL+7.310×IOS)/[1+Exp(1.025-0.932×CL+7.310×IOS)] (II)。
alternatively, the first and second electrodes may be,
and the third is that: measuring the Closed Length (CL) of a cervical canal of a pregnant woman to be induced to labor in a full term by using a vaginal ultrasound method, measuring the average strain level (IOS) of the internal cervical region of the pregnant woman to be induced to labor in the full term by using an E-Cervix technology, and then substituting the average strain level (IOS) into the following formula (III) to calculate the probability P3 of entering an active period within 15 hours;
P3＝Exp(0.286-0.646×CL+6.754×IOS)/[1+Exp(0.286-0.646×CL+6.754×IOS)] (III)。
the method for evaluating the cervical maturity of the second kind of pregnant women waiting for full-term labor comprises the following steps: measuring the Closed Length (CL) of the cervical canal of the pregnant woman to be induced to labor in term by a vaginal ultrasound method, measuring the average strain level (IOS) of the internal cervical region of the pregnant woman to be induced to labor in term by an E-Cervix technology, and respectively assigning scores to the measured CL value and IOS value according to the following standards: CL values greater than 2.10cm did not score; the CL value of not more than 2.10cm is 1 to 3 points, wherein the CL value of not more than 1.38cm is 2 to 3 points, and the CL value of not more than 0.94cm is 3 points; IOS values less than 0.29 do not score; the IOS value of not less than 0.29 is 1-3 points, wherein the IOS value of not less than 0.35 is 2-3 points, and the IOS value of not less than 0.45 is 3 points; calculating the total score of the CL value and the IOS value, predicting whether the cervix of the pregnant woman to be induced for term enters an active period within 15 hours or whether vaginal delivery can be carried out within 24 hours by using a critical value which is divided into 2 total scores, and predicting whether the cervix of the pregnant woman to be induced for term enters an active period within 18 hours by using a critical value which is divided into 3 total scores; the total score is less than the threshold value, the prediction result is negative, and the total score is greater than or equal to the threshold value, the prediction result is positive.
Example 1
The cervical maturity of the pregnant woman induced to labor at term is evaluated by adopting a prediction model formula, and the method specifically comprises the following steps:
the evaluation subjects were some cases of premature rupture of fetal membranes in full-term single pregnancy or induced labor by artificial water-breaking, and the basic conditions are shown in the following table 1:
TABLE 1 basic conditions of labor-induced pregnant women to be evaluated at term
| Cases of disease | BMI | Days of pregnancy | Cases of disease | BMI | Days of pregnancy |
| 1 | 27.41 | 276 | 11 | 22.66 | 261 |
| 2 | 24.07 | 280 | 12 | 23.71 | 273 |
| 3 | 27.73 | 280 | 13 | 23.88 | 281 |
| 4 | 29.41 | 278 | 14 | 26.45 | 278 |
| 5 | 33.28 | 278 | 15 | 28.34 | 287 |
| 6 | 23.88 | 276 | 16 | 28.77 | 280 |
| 7 | 26.95 | 277 | 17 | 28.58 | 272 |
| 8 | 28.89 | 280 | 18 | 27.34 | 278 |
| 9 | 46.71 | 279 | 19 | 26.53 | 287 |
| 10 | 24.39 | 264 | 20 | 35.30 | 280 |
In the case of premature rupture of fetal membranes in full-term single pregnancy or artificial water breaking induced labor, the closed segment length (CL) of the cervical canal is measured by vaginal ultrasound before induced labor, and the average strain level (IOS) of the internal cervical region is measured by an E-Cervix technology.
The results of the tests for each case are shown in table 2 below:
TABLE 2 actual CL and IOS test results for each case
| Cases of disease | CL | IOS average value | Cases of disease | CL | IOS average value |
| 1 | 0.61 | 0.587 | 11 | 3.51 | 0.345 |
| 2 | 0.73 | 0.460 | 12 | 3.51 | 0.397 |
| 3 | 0.70 | 0.510 | 13 | 2.36 | 0.293 |
| 4 | 1.27 | 0.643 | 14 | 1.30 | 0.293 |
| 5 | 0.80 | 0.520 | 15 | 2.27 | 0.283 |
| 6 | 2.91 | 0.500 | 16 | 1.56 | 0.210 |
| 7 | 1.65 | 0.357 | 17 | 1.40 | 0.193 |
| 8 | 1.68 | 0.287 | 18 | 2.66 | 0.190 |
| 9 | 2.19 | 0.287 | 19 | 0.95 | 0.533 |
| 10 | 2.50 | 0.313 | 20 | 0.66 | 0.550 |
The IOS mean in Table 2 refers to the mean of three IOS measurements in the same case by the E-Cervix technique.
Then substituting the following formulas I-III to calculate the probability P1 of the patient delivering vagina within 24 hours, the probability P2 of the patient's cervix entering the active period within 18 hours, or the probability P3 of the patient's cervix entering the active period within 15 hours:
P1＝Exp(-0.95+8.708×IOS)/[1+Exp(-0.95+8.708×IOS)] (I)；
P2＝Exp(1.025-0.932×CL+7.310×IOS)/[1+Exp(1.025-0.932×CL+7.310×IOS)] (II)；
P3＝Exp(0.286-0.646×CL+6.754×IOS)/[1+Exp(0.286-0.646×CL+6.754×IOS)] (III)。
the calculation results are shown in table 3 below:
TABLE 3 calculation of probability of different outcomes for each case
| Cases of disease | P1 | P2 | P3 | Cases of disease | P1 | P2 | P3 |
| 1 | 0.98461 | 0.99138 | 0.97924 | 11 | 0.88635 | 0.56880 | 0.58640 |
| 2 | 0.95502 | 0.97605 | 0.94887 | 12 | 0.92442 | 0.65805 | 0.66776 |
| 3 | 0.97043 | 0.98371 | 0.96367 | 13 | 0.83259 | 0.72525 | 0.67760 |
| 4 | 0.99055 | 0.98949 | 0.97834 | 14 | 0.83259 | 0.87634 | 0.80647 |
| 5 | 0.97282 | 0.98339 | 0.96377 | 15 | 0.82010 | 0.72739 | 0.67554 |
| 6 | 0.96782 | 0.87749 | 0.85612 | 16 | 0.70650 | 0.75154 | 0.66742 |
| 7 | 0.89619 | 0.89042 | 0.83603 | 17 | 0.67553 | 0.75659 | 0.66536 |
| 8 | 0.82434 | 0.82570 | 0.75710 | 18 | 0.66913 | 0.48397 | 0.46285 |
| 9 | 0.82434 | 0.74655 | 0.69158 | 19 | 0.97573 | 0.98268 | 0.96353 |
| 10 | 0.85548 | 0.72838 | 0.68728 | 20 | 0.97894 | 0.98823 | 0.97272 |
The true outcome of each case is shown in table 4 below:
TABLE 4 true outcome of each case
As can be seen from tables 3 and 4, the probability result calculated by the above formula in this embodiment has high consistency with the true outcome, so the outcome predicted by the probability result in this embodiment can provide a strong reference for clinical selection of a suitable labor induction mode.
In the embodiment, the ultrasonic measurement of the length of the cervical closed section has a unified standard clinically, and the accuracy and the stability of the ultrasonic measurement can be ensured. The E-Cervix technology is used for measuring the elasticity of the Cervix according to the stress generated by the pulsation of the uterine artery, is not easily influenced by an operator, and is high in accuracy because the radius of the ultrasonic interesting range of the IOS is set to be a semicircle of 1 cm. In addition, in the research, the elasticity of the Cervix uteri of the patient is measured by 2-3 sonographers through an E-Cervix technology every time, and Friedman inspection of related variables proves that no obvious difference exists among multiple measurements, which shows that the method has high stability, and finally, the accuracy of the method is improved by taking the average value of the multiple measurements.
Example 2.
The cervical maturity of the pregnant woman induced to labor at term is evaluated by adopting a scoring system, and the method specifically comprises the following steps:
for the cases listed in table 1, the detection values of the indices listed in table 2 were obtained by the same detection method as in example 1, the measured CL value and IOS value were scored according to the scoring criteria in table 5 below, and the respective scores of the CL value and IOS value were obtained, and the two were added to calculate the total score. The scoring results are shown in table 6.
TABLE 5
| 0 point (min) | 1 minute (1) | 2 is divided into | 3 points of | |
| Length of cervical closure segment (cm) | >2.10cm | ≤2.10cm | ≤1.38cm | ≤0.94cm |
| Cervical IOS | <0.29 | ≥0.29 | ≥0.35 | ≥0.45 |
Table 6.
| Cases of disease | CL score | IOS scoring | Total score | Cases of disease | CL score | IOS scoring | Total score |
| 1 | 3 | 3 | 6 | 11 | 0 | 1 | 1 |
| 2 | 3 | 3 | 6 | 12 | 0 | 2 | 2 |
| 3 | 3 | 3 | 6 | 13 | 0 | 1 | 1 |
| 4 | 2 | 3 | 5 | 14 | 2 | 1 | 3 |
| 5 | 3 | 3 | 6 | 15 | 0 | 0 | 0 |
| 6 | 0 | 3 | 3 | 16 | 1 | 0 | 1 |
| 7 | 1 | 2 | 3 | 17 | 1 | 0 | 1 |
| 8 | 1 | 0 | 1 | 18 | 0 | 0 | 0 |
| 9 | 0 | 0 | 0 | 19 | 2 | 3 | 5 |
| 10 | 0 | 1 | 1 | 20 | 3 | 3 | 6 |
Predicting whether the cervix of the pregnant woman to be induced for labor in term enters an active period within 15 hours or whether the cervix can be delivered in vagina within 24 hours by using a critical value divided into 2 total scores, and predicting whether the cervix of the pregnant woman to be induced for labor in term enters an active period within 18 hours by using a critical value divided into 3 total scores; the total score is less than the threshold value, the prediction result is negative, and the total score is greater than or equal to the threshold value, the prediction result is positive.
The real outcome of the above cases is shown in table 4, and it can be seen that the result predicted by using the scoring system shown in table 5 in this embodiment substantially matches the real outcome, so the outcome predicted according to the scoring result of this embodiment can provide a strong reference for clinically selecting a suitable labor induction manner.
Comparative example 1.
Patients who had a premature rupture of fetal membranes in full term single-gestation or who had been induced to break water artificially (the patient population was the same as in examples 1 and 2) were scored prior to induction using the current Bishop scoring method and were predicted to enter the active phase within 15 hours and 18 hours and to be able to give vaginal delivery within 24 hours at a cut-off value of 6 as a total score.
The scoring results are shown in table 7:
TABLE 7 Bishop scoring results and true outcome
As can be seen from table 7 above, there is a significant difference between the predicted result and the actual outcome of the conventional Bishop scoring method.
ROC curve analysis was performed on the probability values predicted by the prediction model of example 1 and the scoring results of comparative example 1, and found that: in all three outcomes of example 1, the logistic regression models AUC were greater than 0.7, indicating a higher predictive value for each outcome, while the Bishop score AUC was less than 0.7, indicating a low predictive value for the Bishop score in these three outcomes, particularly with a P >0.05 for the Bishop score at the outcome of a successful vaginal delivery within 24 hours. Thus, it can be shown that the predictive value of the logistic regression model for outcome is higher in each outcome of example 1. The results of the ROC curve analysis are shown in Table 8:
TABLE 8 predicted Effect of Bishop scores and logistic regression models for different outcomes
ROC curve analysis was performed on the scoring results of example 2 and comparative example 1 above to find: as shown in fig. 1, fig. 2 and fig. 3, for the same pregnant woman waiting for labor induction at term, it is predicted whether the cervix enters the active period within 15 hours and 18 hours, and whether the woman can deliver the vagina within 24 hours, if the existing Bishop scoring method is adopted, the areas under the curve (AUC) are respectively 0.670, 0.691 and 0.685, and if the scoring method of the embodiment 2 of the present invention is adopted, the areas under the curve (AUC) are respectively 0.781, 0.831 and 0.853 (which are respectively higher than the corresponding areas of the Bishop method, the difference is significant, and P is less than 0.001).
Claims (10)
1. A method for evaluating the cervical maturity of a pregnant woman to be induced to give birth at term comprises the following steps: the closed cervical Canal Length (CL) and the average strain level (IOS) of the cervical orifice region of the subject to be evaluated were measured and then substituted into the following formulas (I) to (III) to calculate the probability P1 of vaginal childbirth within 24 hours of the subject, the probability P2 of entry of the subject's cervix into the active stage within 18 hours, or the probability P3 of entry of the subject's cervix into the active stage within 15 hours:
P1＝Exp(-0.95+8.708×IOS)/[1+Exp(-0.95+8.708×IOS)] (I)；
P2＝Exp(1.025-0.932×CL+7.310×IOS)/[1+Exp(1.025-0.932×CL+7.310×IOS)] (II)；
alternatively, the first and second electrodes may be,
P3＝Exp(0.286-0.646×CL+6.754×IOS)/[1+Exp(0.286-0.646×CL+6.754×IOS)] (III)。
2. a method for evaluating the cervical maturity of a pregnant woman to be induced to give birth at term comprises the following steps: measuring the Closed Length (CL) of the cervical canal and the average strain level (IOS) of the internal cervical region of the individual to be evaluated; setting the evaluation critical value of the CL value to be 1.38cm, evaluating that the CL value is mature when the measured CL value is not more than 1.38cm, and otherwise evaluating that the degree of maturity is insufficient; setting the evaluation critical value of the IOS value to be 0.35, evaluating that the IOS is more mature when the measured IOS is not less than 0.35, and otherwise, evaluating that the maturity is insufficient; and (4) integrating the evaluation results of CL and IOS to obtain the cervical maturity evaluation result.
3. The method of claim 2, wherein: the evaluation threshold value of the CL-value includes two levels, the primary level is 1.38, the advanced level is 0.94cm, namely, the CL-value is measured to be more mature when the CL-value is not more than 1.38cm, the CL-value is measured to be more mature when the CL-value is not more than 0.94cm, and the CL-value is inversely evaluated to be less mature.
4. The method of claim 2, wherein: the evaluation critical value of the IOS value comprises two levels, the primary level is 0.35, the advanced level is 0.45, namely, the measured IOS value is evaluated as being mature when not less than 0.35, the evaluation is evaluated as being more mature when not less than 0.45, and otherwise, the evaluation maturity is gradually reduced.
5. The method of claim 2, wherein: the CL values were assigned the following scores: CL values greater than 2.10cm did not score; the CL value of not more than 2.10cm is 1 to 3 points, wherein the CL value of not more than 1.38cm is 2 to 3 points, and the CL value of not more than 0.94cm is 3 points; assigning the IOS value the following score: IOS values less than 0.29 do not score; the IOS value of not less than 0.29 is 1-3 points, wherein the IOS value of not less than 0.35 is 2-3 points, and the IOS value of not less than 0.45 is 3 points.
6. The method of claim 5, wherein: adding the CL value score and the IOS value score to obtain a total score, and predicting whether the cervix of the pregnant woman to be induced for term enters an active period within 15 hours or 18 hours or whether vaginal delivery can be carried out within 24 hours according to the total score; wherein, the critical value of dividing into 2 points is used for predicting whether the cervix of the pregnant woman to be induced into labor in term enters the active period within 15 hours or whether the cervix can be delivered in vagina within 24 hours, and the critical value of dividing into 3 points is used for predicting whether the cervix of the pregnant woman to be induced into labor in term enters the active period within 18 hours; if the total score is smaller than the critical value, the prediction result is negative, and if the total score is larger than or equal to the critical value, the prediction result is positive.
7. The method of any one of claims 1-6, wherein: the average strain level (IOS) of the cervical internal orifice area is obtained by detecting by a strain elastography method, and is further preferably obtained by measuring by an E-Cervix technology; the closed section length (CL) of the cervical canal is obtained by adopting vaginal ultrasonic measurement.
8. An apparatus for evaluating the cervical maturity of a pregnant woman to be induced to give birth at term, comprising:
the data acquisition module is used for receiving actual measurement data of the closed segment length (CL) of the cervical canal of the individual to be evaluated and actual measurement data of the average strain level (IOS) of the cervical internal orifice area;
the calculation evaluation module is used for evaluating the cervical maturity based on the actually measured data received by the data acquisition module;
the evaluation is probability calculation based on a prediction model formula or scoring evaluation based on a scoring system;
the probability calculation based on the prediction model formula is to calculate the probability P1 of vaginal delivery within 24 hours, the probability P2 of the cervix entering the active period within 18 hours, or the probability P3 of the cervix entering the active period within 15 hours; the calculation formulas of P1, P2 and P3 are as follows:
P1＝Exp(-0.95+8.708×IOS)/[1+Exp(-0.95+8.708×IOS)] (I)；
P2＝Exp(1.025-0.932×CL+7.310×IOS)/[1+Exp(1.025-0.932×CL+7.310×IOS)] (II)；
P3＝Exp(0.286-0.646×CL+6.754×IOS)/[1+Exp(0.286-0.646×CL+6.754×IOS)] (III)；
the scoring evaluation based on the scoring system comprises the following steps: giving a higher score to CL measured data not greater than 1.38cm and giving a lower score to CL measured data greater than 1.38 cm; giving a higher score for the IOS measured value not less than 0.35, and giving a lower score for the IOS measured value less than 0.35; and (4) integrating the evaluation results of CL and IOS to obtain the cervical maturity evaluation result.
9. A user terminal for cervical maturity evaluation of a pregnant woman to be induced for full term, comprising a memory for storing a cervical maturity evaluation program and a processor for executing the cervical maturity evaluation program to cause the user terminal to perform the cervical maturity evaluation method of the pregnant woman to be induced for full term of any one of claims 1-6.
10. A computer-readable storage medium having stored thereon a cervical maturity evaluation program which, when executed by a processor, implements the method of cervical maturity evaluation of a pregnant woman waiting for full term labor as set forth in any one of claims 1 to 6.
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