Effect of standardized education and supervision on pregnancy outcomes of women with gestational diabetes mellitus

doi:10.21203/rs.3.rs-958880/v1

Download PDF

Research Article

Effect of standardized education and supervision on pregnancy outcomes of women with gestational diabetes mellitus

https://doi.org/10.21203/rs.3.rs-958880/v1

This work is licensed under a CC BY 4.0 License

Version 1

posted

You are reading this latest preprint version

Background: To evaluate the effect of knowledge and practice education on reducing adverse pregnancy outcomes in women with gestational diabetes mellitus (GDM).

Methods: Prospective case-control studies were conducted, women with GDM who had randomly assigned into control group (168 cases) and intervention group (182 cases). In the control group, routine prenatal examination education was conducted, while in the intervention group, in addition to routine prenatal education, professional used video, WeChat public platform to regularly push knowledge and behavior education to women with GDM and supervise the implementation of actions. The pregnancy outcomes of the two groups were compared.

Results: ①fasting blood glucose ,postprandial blood glucose in two hours, glycosylated hemoglobin of the intervention group was significantly lower than that of the control group (P < 0.05); ② in the intervention group ,the TPOAb positive rate was lower and FT4 was higher than that in the control group (P > 0.05); the vaginal pH value was significantly higher than that of the control group, TSH, the weight gain during pregnancy ,the incidences of preeclampsia, polyhydramnios, preterm premature rupture of membranes, premature rupture of membranes, cesarean section, puerperal infection, amniotic fluid pollution, chorioamnionitis, macrosomia, large for gestational age infants, neonatal care, neonatal hypoglycemia, neonatal pneumonia, the detection rates of BV, Candida, mycoplasma, Streptococcus agalactiae, cleanliness III / IV, and the positive rates of hydrogen peroxide, sialidosidase, and leukocyte esterase were significantly lower than those in the control group (P < 0.05)；The rates of Trichomonas, Neisseria gonorrhoeae, Chlamydia, the incidences of oligohydramnios, FGR, placenta previa, placental abruption, fetal distress in utero, postpartum hemorrhage, preterm labor, neonatal Apgar score less than 7 in one minute, neonatal defect, neonatal death, small for gestational age, hyperbilirubinemia were lower than those in the control group (P > 0.05).

Conclusion: women with GDM supervise their self-management during pregnancy, which can effectively control the blood glucose level, maintain the vaginal microecological balance, and reduce the occurrence of adverse pregnancy outcomes.

Gestational diabetes

Standardize knowledge and action education

Diet and exercise management

Adverse pregnancy outcome

Gestational diabetes mellitus (GDM) is characterized by abnormal glucose tolerance, which is the product of increased insulin resistance during pregnancy [1]. The incidence rate of gestational diabetes mellitus is about 5.12% ~ 33.3% in China [2], and there is an upward trend. The risk factors of GDM include: family history of diabetes mellitus, obesity, old age, previous GDM history, etc [3]. There is evidence that GDM and the resulting maternal hyperglycemia are associated with adverse perinatal outcomes, and monitoring and treatment of GDM can reduce these adverse outcomes [4]. GDM pregnant women are affected by endocrine and metabolism disorders, immune status changes, sex life, poor hygiene habits and other factors, which can easily cause reproductive tract infections, and it will cause varying degrees of harm to the quality of life of pregnant women, maternal and infant health and pregnancy outcome [3]. Diet and blood glucose monitoring is the first-line therapy method for women with GDM [5]. GDM therapy is both to control diet and increase activity levels. Women with GDM of drug treatment pay more attention by doctors and researchers, the ways of diet and exercise are often ignored. Actively treat and control blood glucose to prevent complications related to pregnancy [6]. Who pregnant women do a good job of self-management to control blood glucose and maintain vaginal microecological balance can improve pregnancy outcome. However, in our clinical work, systematic and standardized knowledge and action propaganda and education are basically ignored, so the definition of successful diet and exercise attempts has not been established, and self-management ability of pregnant women with GDM is very limited. Nearly 90% of women with GDM in the absence of professional medical supervision failed the initial diet and exercise trials [7]. Restricted by the patient's compliance, follow-up conditions, remote living areas and other conditions, patients have only limited opportunities to directly interact with a doctor. Therefore, telemedicine is used for daily doctor-patient communication and feedback, to urge patients to self-manage, to monitor their blood glucose on time, to improve compliance, and to jointly improve the medical effect. The curative effect of disease management is vulnerable to the influence of patient adherence of doctor's advice [8]. We designed a prospective case-control study to explore the effects of knowledge and behavior education, standardized diet, and exercise on pregnancy outcomes in pregnant women with GDM.

2.1. Research object

2.1.1. Cases source

The study object was GDM pregnant women who had undergone regular prenatal examinations and gave birth in Jinshan Branch of Shanghai Sixth People's Hospital from January 2018 to October 2020. Inclusion criteria: (1) GDM pregnant women, age ≥ 18 years old; (2) singleton pregnancy; (3) pre-pregnancy body mass index (BMI) ≤ 24.9 kg/m2; (4) voluntary participation and informed consent. Exclusion criteria: (1) Diabetes before pregnancy; (2) Gestational week of delivery < 28 weeks; (3) A diagnosis of chronic disease and pregnancy complications, and recent trauma; (4) Women with GDM required medical treatment by pregnancy progression. A total of 367 women with GDM were recruited and Excel generates random numbers for intervention group and control group. Among them, 8 cases inevitably miscarried before 28 weeks, 6 cases were treated with insulin with pregnancy progression, and 13 cases were lost to follow-up. In the end, 182 cases were included in the intervention group and 168 cases in the control group. Mean age, pre-pregnancy BMI (kg/m 2), number of pregnancies and number of births in the intervention group (30.27±3.21, 23.12±2.32, 2.45±0.36, 2.02±0.36) had no significant difference than those in the control group (29.89±3.42, 23.05±2.38, 2.39±0.48, 1.98±0.23) (P > 0.05). This study has been reviewed and approved by the Clinical Research Ethics Committee of Jinshan Branch of Shanghai Sixth People's Hospital (approval number: jszxyy201703).

2.1.2. GDM diagnostic criteria

Oral 75g glucose tolerance test (OGTT) during 24 to 28 weeks of pregnancy, blood glucose levels on an empty stomach, 1 hour and 2 hours after taking sugar are lower than 5.1 mmol/L, 10.0 mmol/L, 8.5 mmol/L, respectively, GDM is diagnosed at any point where the blood glucose level meets or exceeds the above standards [3].

2.2. Method

2.2.1. Preparation before intervention

The research team consisted of 2 obstetricians, 2 dietitian, 1 psychological consultant, and 8 nursing staff. Establish a research team, develop a unified process, and conduct training prior to intervention. The team consisted of 2 obstetricians, who performed regular antenatal examinations, introduced the risks of GDM, and conducted nutrition and exercise health education；2 dietitian to design the diet plan; 1 psychological consultant for psychological counseling; 8 clinical nursing staff, responsible for online knowledge push, WeChat group supervision of puerperia according to the diet and exercise plan implementation and answer questions, data collection and follow-up work.

2.2.2. Intervention methods

Ⅰ. control group: routine hospital obstetric examination mode was adopted: Routine health care guidance was provided for women with GDM during each antenatal examination, maternal school and paper materials were distributed to provide health education and guidance on GDM knowledge, nutrition during pregnancy, exercise, vaginal microecology knowledge and self-protection, knowledge of childbirth process and prenatal signs, neonatal nursing methods, knowledge of breastfeeding and knowledge of postpartum rehabilitation.

Ⅱ. intervention group: In addition to the practice of the control group, professionals of the research team conducted online guidance and supervision of new media, publicized education and behavior supervision by using WeChat group and "Obstetrics and Gynecology" public account. (1) Knowledge: ① GDM and vaginal micro-ecology knowledge education: teaching pregnant women about GDM vaginal micro-ecology knowledge, adverse effects on maternal and infant outcomes, and matters needing attention during pregnancy care are explained to pregnant women by means of school lectures, videos, WeChat public platform and so on. ② Dietary education: guide pregnant women to keep food diaries, self-monitoring of blood glucose, four times a day (fasting blood glucose, blood sugar 2 hours after three meals), according to results of blood sugar to monitor 2or3 days every week .and every morning monitor weight and record. Supervise pregnant women to clock in WeChat group of every day. Specialized dietitians can adjust dietary intake according to blood glucose level and weight, and develop individualized dietary programs to ensure the supply of calories and nutrients during pregnancy, and avoid the occurrence of postprandial hyperglycemia and starvation ketosis. Get your daily energy supply: 45-50% in carbohydrates, 20-25% in protein, and 30% in fats. Blood glucose control target: fasting 3.6-5.3mmol/L, 2 hours after meal blood glucose <6.7mmol/L; Weight goal: weight gain of 0.5kg/ week in the middle and late trimester. ③ Exercise guidance: ask pregnant women to do 30-60 minutes of moderate-intensity exercise 30 minutes after meal. According to personal physique and hobbies, make individual exercises, such as yoga and health exercise for pregnant women, 2-3 times a week. WeChat group punch in and supervise its implementation. ④ Vaginal micro-ecological self-management: keep the vulva clean and dry, pay attention to sexual hygiene, wear loose cotton underwear, avoid the abuse of vaginal drugs and vaginal lavage; ⑤ Perinatal guidance: during prenatal period, the pregnant women with anxiety and fear were given prenatal psychological counseling by psychological consultant to keep them happy and reduce their anxiety and other negative emotions. At the same time, the measures of prevention and rescue of perinatal adverse events were explained to the pregnant women to reduce their fear and anxiety; After delivery, the pregnant women should be aware of the high risk of GDM perinatal infants, and should be given the prevention and nursing of complications by nursing staff, such as keeping warm, oxygen inhalation and supplement of glucose water. The pregnant women should not be panic and fear, and should be instructed to breastfeed the milder pregnant women. The pregnant women with serious illness should be instructed to replace breastfeeding with artificial feeding. (2) behavior: by pregnant women of WeChat group internal clock in diet and exercise, nursing staff recorded, answering questions, regular investigation and evaluation of GDM pregnant women grasp degree, according to the medical behavior and self-management ability, and corresponding nursing care according to maternal situation, regular telephone follow-up or on-site visit to investigate and evaluate the maternal education content, to supervise its strengthen self-management, health, science and rational behavior on the importance of disease prevention and control in accordance with the doctor's advice.

2.2.3. Self-management behavior assessment after intervention

Two groups of patients before delivery Summary of Diabetes Self Care Activities (SDSCA) [9] evaluation, for general diet, special diet, exercise, blood glucose monitoring, foot care, medicine and other six dimensions, the total score of each dimension is the total score of the scale. The lowest score was 0 and the highest was 77. The score was positively correlated with good self-management behavior. SDSCA score of the study group (55.68±11.37) was significantly higher than that of the control group (41.95±12.98) (P<0.05).

2.2.4. Vaginal microecological detection

In the third trimester (28 weeks to delivery) of the two groups of patients, vaginal secretions were collected from the posterior vaginal domes with sterile cotton swabs. The 6-way examination indexes of vaginal secretions included: pH value, hydrogen peroxide, Leukocyteestetrase (LE), neuraminidase (NA), N-acetyl- D-glucosaminidase (NAG), And prolineaminopeptidase (PA); According to the results of vaginal secretions, bacterial vaginosis (BV), vulvovaginal vodiasis (VVC), trichomonas vaginitis (TV), group B Hemolytic Streptococcus (GBS). Diagnostic criteria for BV were as follows: vaginal pH > 4.5, positive amine test, and vaginal secretions with a fish-like stench. VVC diagnostic criteria: 10% KOH hanging drop method, spore and pseudomycelium observed under the light microscope; Diagnostic criteria of TV: Trichomonas were observed under optical microscope by smear method. After culture on GBS color plate, drug sensitivity test was carried out by automatic bacterial identification drug sensitivity analyzer. Cervical secretions were collected to detect ureaplasma urealyticum (UU), Chlamydia (CT) and Neisseria gonorrhoeae. Other types of vaginitis refer to the infection of Neisseria gonorrhoeae, Mycoplasma or Chlamydia, that is, PCR method is used to detect DNA of Neisseria gonorrhoeae, Mycoplasma or Chlamydia [10]. Sexual activity, vaginal irrigation and medication are prohibited within 48 hours before sample collection.

2.3 Evaluation index

(1) In one month before delivery in 2 groups: Fasting blood glucose (FPG),2-hour postprandial blood glucose (PG-2h), Glycosylated hemoglobin (HbAlc)；

(2) In the third trimester (28 weeks to delivery) in 2 groups: Thyroid peroxidase antibody (TPOAb), Free thyroxine (FT4), Thyrotropic hormone (TSH)；

(3) In the third trimester (28 weeks ~ delivery) in 2 groups: vaginal pH value, cleanliness, Bacterial vaginosis (BV), Vulvovaginal candidiasis (VVC), Group B Streptococcus (GBS) and Functional detection ； Ureaplasma urealyticum (UU), Chlamydia (CT) and Neisseria gonorrhoeae.

(4) The pregnant women in two groups had adverse pregnancy outcomes: The weight gain during pregnancy, Preeclampsia (PE), Polyhydramnios, Preterm premature rupture of membranes (PPROM), Premature rupture of membranes (PROM), Cesarean section, Puerperal infection, Amniotic fluid pollution, Chorioamnionitis, Oligohydramnios, FGR, Placenta previa, Placental abruption, Fetal distress in utero, Postpartum hemorrhage, Premature delivery.

(5) Neonatal adverse outcomes in both groups: Macrosomia, large for gestational age (LGA), Neonatal care, Neonatal hypoglycemia, Neonatal pneumonia, Preterm labor, Neonatal Apgar score less than 7 in one minute, Neonatal defect, Neonatal death, Small for gestational age (SGA), Hyperbilirubinemia.

2.4. Statistical analysis

The data were analyzed by SPSS 22.0. The measurement data in accordance with normal distribution were represented by x ± s, and the comparison between groups was performed by two independent samples t test; Counting data were expressed by frequency and rate (%), and X² test was used for comparison between groups. P<0.05 for the difference was statistically significant.

3.1. Ccomparison of blood glucose and glycosylated hemoglobin between the two groups within one month before delivery

The fasting blood glucose and 2-hour postprandial blood glucose of the intervention group were within the normal range, while the fasting blood glucose and 2-hour postprandial blood glucose of the control group were higher than the normal range, and the difference between the two groups was statistically significant (P < 0.05); The mean value of glycosylated hemoglobin in the two groups were in normal reaction, the intervention group was lower than the control group, the difference was statistically significant (P < 0.05); See Table 1 for details.

Table 1

Comparison of two groups of blood glucose and glycosylated hemoglobin index (nmol/L, %, x±s)

Group	Cases	FPG(mmol/L)	2hPG(mmol/L)	HbAlc(%)
Intervention group	182	4.83 ±0.63	6.31 ±0.86	5. 26 ±0. 65
Control group	168	5.61 ±0.75	7.12 ±0.95	6. 26 ±0. 94
T	/	15.1164	11.9964	16.6182
P	/	0.000	0.000	0.000

3.2. The levels of TPOAb, FT4 and TSH in the third trimester (28 weeks to delivery) were compared between the two groups

The positive rate of TPOAb in the study group was lower than that in the control group, and the level of FT4 in the intervention group was higher than that in the control group, but there was no significant difference (P > 0.05); Thyroid stimulating hormone (TSH) level was lower than that of the control group (P < 0.05), and was shown in Table 2.

Table 2

Comparison of TPOAb positive between the two groups [n (%)], FT4, TSH (pmol/L, mIU/L, x ±s)

Group	Cases	TPOAb positive	FT4(pmol/L)	TSH(mIU/L)
Intervention group	182	10(5.49)	17.59±2.58	2.65±0.69
Control group	168	11(6.55)	17.28±2.45	3.57±0.98
T/ X²	/	0.172	1.653	14.578
P	/	0.679	0.099	0.000

3.3. The effect of comparison of vaginal microorganism in the third trimester (28 weeks to delivery) between the two groups (details in Table 3)

Table 3

Comparison of vaginitis factors between the two groups (n,%)

Group	Cases	Vaginal pH	Vaginal BV (+)	Candida	Trichomonad	GBS(+)	Cleanliness III
Intervention group	182	4.11±0.19	7(3.85)	16(8.79)	2(1.10)	13(7.14)	24(13.19)
Control group	168	3.79±0.23	16(9.52)	33(19.64)	3(1.79)	23(13.69)	43(25.60)
T/ X²	/	20.362	4.587	8.544	0.293	4.059	8.690
P	/	0.000	0.032	0.003	0.589	0.044	0.003

Table 3 continued

Group	Cleanliness IV	Mycoplasma	Chlamydia	Neisseria gonorrhoeae	Leucocyte esterase	Sialyl glycosidase	Hydrogen peroxide
Intervention group	15(8.24)	34(18.68)	2(1.10)	1(0.55)	107(58.79)	55(30.22)	130(71.43)
Control group	30(17.86)	63(37.50)	4(2.38)	2(1.19)	133(79.17)	78(46.43)	139(82.74)
T/ c²	7.209	15.443	0.852	0.422	16.829	9.742	6.282
P	0.007	0.000	0.356	0.516	0.000	0.002	0.012

The incidences of BV, Candida, mycoplasma, Streptococcus agalactiae, cleanliness III / IV and the positive incidences of hydrogen peroxide, sialidosidase and leukocyte esterase of the intervention group were significantly lower than those of the control group (P<0.05) (Fig. 1); The vaginal pH value of the intervention group was significantly higher than that of the control group (P<0.05);The incidences of Trichomonas, Neisseria gonorrhoeae and chlamydia were lower than those in the control group, but the difference was not statistically significant 7 (P>0.05).

3.4. The effect of comparison of adverse outcomes of pregnant women between the two groups (details in Table 4)

Table 4

comparison of adverse outcomes of pregnant women [Kg, n (%)]

Group	Cases	Weight gain during pregnancy	Fetal distress	Preeclampsia	FGR	Oligohydramnios	Puerperal infection	Polyhydramnios
Intervention group	182	13.89±6.82	7(3.85)	12(6.59)	3(1.65)	7(3.85)	24(13.19)	10(5.49)
Control group	168	16.37±2.43	11(6.55)	22(13.10)	4(2.39)	10(5.95)	43(25.60)	19(11.31)
T/ X²	/	6.4852	1.307	4.211	0.239	0.839	8.690	3.887
P	/	0.000	0.253	0.040	0.625	0.360	0.003	0.049

Table 4 continued

Group	Postpartum hemorrhage	Placenta previa	Premature rupture of membranes	Preterm premature rupture of membranes	Placental abruption	Amniotic fluid pollution	Chorionic villitis	Cesarean section
Intervention group	11(6.04)	5(2.75)	14(7.70)	6(3.30)	1(0.55)	9(4.95)	40(21.98)	57(31.32)
Control group	15(8.93)	6(3.57)	25(14.88)	14(8.33)	2(1.19)	22(13.10)	58(34.52)	71(42.26)
T/ X²	1.057	0.195	4.560	4.113	0.422	7.188	6.821	4.510
P	0.304	0.659	0.033	0.043	0.516	0.007	0.009	0.034

Preeclampsia, polyhydramnios, preterm premature rupture of membranes,premature rupture of membranes, puerperal infection, amniotic fluid pollution, chorioamnionitis and cesarean section in the intervention group were significantly lower than those in the control group (P < 0.05) (Fig. 2); Weight gain during prengancy were significantly lower than that in the control group (P < 0.05);The incidences of oligohydramnios, FGR, placenta previa, placental abruption, fetal distress and postpartum hemorrhage were lower than those in the control group, but there was no statistical difference (P > 0.05).

3.5. The effect of comparison of the incidence of adverse neonatal outcomes between the two groups (details in Table 5)

Table 5

Comparison of incidence of adverse neonatal outcomes [n (%)]

Group	Cases	Premature delivery	Macroso mia	Small for gestational age infants	1 minute Apgar < 7 points	Neonatal care
Intervention group	182	10(5.49)	19(10.44)	4(2.20)	3(1.65)	10(5.49)
Control group	168	16(9.52)	37(22.02)	4(2.38)	6(3.57)	23(13.69)
T/ X²	/	2.062	8.723	0.526	1.290	6.872
P	/	0.151	0.003	0.468	0.256	0.009

Table 5 continued

Group	Hyperbiliru binemia	Hypoglyc emia	Neonatal defects	Large for gestational age infants	Neonatal death	Neonatal pneumonia
Intervention group	21(11.54)	15(8.24)	3(1.65)	13(7.14)	1(0.55)	9(4.95)
Control group	23(13.69)	35(20.83)	5(2.97)	31(18.45)	1(0.60)	22(13.10)
T/ X²	0.368	10.761	0.690	10.166	0.003	7.188
P	0.544	0.001	0.406	0.001	0.955	0.007

The incidence of macrosomia, gestational age, neonatal care, neonatal hypoglycemia and neonatal pneumonia in the intervention group were significantly lower than those in the control group (P < 0.05) (Fig. 3); The incidence of premature delivery, Apgar score less than 7 in one minute, neonatal defect, neonatal death, small for gestational age and hyperbilirubinemia in the neonatal group were lower than those in the control group, with no statistical difference (P > 0.05).

Gestational diabetes mellitus (GDM) is one of the common complications of pregnancy. Improper control of blood glucose level can have a negative impact on maternal and infant outcomes. The 2008 "study on hyperglycemia and adverse pregnancy outcomes (HAPO)" found that GDM not only increased the risk of perinatal adverse outcomes such as macrosomia, respiratory ditress, neonatal hypoglycemia and shoulder difficulty [11], but also increased the risk of maternal and neonatal long-term metabolic diseases [12]. Therefore, it is necessary to pay attention to the maternal and infant safety of pregnant women with perinatal GDM. So about diet, exercise and self-monitoring of blood glucose-first-line treatment clinical management of women with GDM -should get more attention. Patients on the standard diet, exercise, blood sugar monitoring compliance and strict glycemic control is considered and decided to pregnancy outcome aspect plays a key role [6]. According to the report, through the social software platform, instant messaging, application or telephone to GDM women telemedicine may improve patients' compliance [13]. Our results further confirmed that the health education and supervise their self-management on maternal and infant outcomes have improved significantly. This study investigated the clinical significance of dietary and exercise intervention, microecological protection, obesity control and other health education and self-management for maternal and infant outcomes in women with GDM.

The fasting blood glucose and 2-hour postprandial blood glucose in the intervention group were within the normal range one month before delivery, while the fasting blood glucose and 2-hour postprandial blood glucose in the control group were higher than the normal range; The mean value of glycosylated hemoglobin in the two groups was normal, and the intervention group was significantly lower than the control group; Studies have shown that diet, exercise and weight management intervention consultation before 20 weeks of gestation can reduce the risk of GDM of these high-risk pregnant women by 39% [14]. This study suggests that the standard supervision of diet and exercise self-management in pregnant women with GDM can better control the blood glucose level. Studies have shown that using a mobile device management of a pregnant woman GDM can improve the qualified rate of monitoring compliance and glucose, which is consistent with our results [15]. Ming et al. study on telemedicine for gestational diabetes mellitus showed a decrease in HbA1c levels, which is consistent with the results of our study [16].

In this study, TPOAb positive rate was slightly lower and FT4 level was slightly higher in the intervention group in the third trimester of pregnancy; TSH level was significantly lower than that of the control group. According to the 2011 ATA guidelines, pregnant women with type 1 diabetes are prone to hypothyroidism [17]. In 2014, China's "guidelines for the diagnosis and treatment of gestational diabetes mellitus" carried out thyroid function test for pregnant women with gestational diabetes mellitus when necessary to understand the thyroid function of pregnant women with GDM [18]. There was no significant difference in the positive rate of thyroid dysfunction and TPOAb between pregnant women with GDM and those with normal blood glucose [19]. Some scholars have also reported that when TSH level during pregnancy is basically normal, FT4 content is related to the degree of impaired glucose tolerance. The more impaired glucose tolerance is, the less insulin secretion will be caused, which will lead to the disorder of glucose metabolism and affect the secretion of thyroxine [20]. This study suggests that standardized educational behavior management has a good protective effect on thyroid function in women with GDM.

The female vagina microbial flora, anatomical structure, endocrine regulation function and immune system constitute the female vagina micro ecosystem. More secretions during pregnancy, reduced local immunity, more prone to flora imbalance [21]. Freitas et al. conducted a cross-sectional study on 182 pregnant women and 310 non pregnant women in Canada, and found that the diversity of lactobacilli in vaginal microbiota decreased and the prevalence rate was higher during pregnancy [22]. The increase of blood glucose and hormone levels in patients with GDM leads to the imbalance of vaginal microecology, the decrease of the number of Lactobacillus in vagina, which is easy to lead to the breeding of abnormal pathogens and the increase of vaginal infectious diseases [23]. Prospective study found that the most common vaginitis was Candida vaginitis, followed by bacterial vaginitis and mycoplasma infection [24]. The increase of glycogen in vaginal epithelial cells of GDM pregnant women is easy for Candida to adhere, colonize and grow [25]. The influencing factors of vaginal microecology of pregnant women include vaginal flushing, sexual behavior and menstrual cycle, etc [26]. Intervention group in this study through standard missionary vaginal microecological GDM pregnant women after the content and method of self-protection BV, candida, mycoplasma detection rate, cleanliness, non-dairy streptococcus III/IV degree ratio and hydrogen peroxide, saliva acid glycosides enzyme, leukocyte esterase positive rate was significantly lower than the control group, trichomoniasis, Neisseria gonorrhoeae, chlamydia infection rate is lower than the control group. This is consistent with the results of Dunn A. B. et al. Good personal protection and early recovery of normal vaginal microecology can eliminate all kinds of pathogenic vaginitis [27].

When maternal GDM, vaginal microecology and immunosuppression lead to the decline of maternal resistance, which leads to premature rupture of membranes and other complications [28]. In this study, the incidence of premature rupture of membranes (PPROM), premature rupture of membranes (PROM), puerperal infection, amniotic fluid contamination and chorionic amniotis in the intervention group were significantly lower than those in the control group. The results indicate that standardized education and behavior supervision can improve the adverse pregnancy outcomes.

The incidence rate of preeclampsia is higher in pregnant women with various types of diabetes mellitus [29]. Studies have shown that the occurrence of GDM can have adverse effects on pregnant women and newborns, such as pregnancy induced hypertension, polyhydramnios, cesarean section, infection, macrosomia, premature infants, neonatal hypoglycemia, premature rupture of membranes and other pregnancy complications and adverse pregnancy outcomes significantly increased; In addition, it also increased the risk of maternal and infant diabetes [30]. The risk of cesarean section and vaginal delivery is increased, and the risk of fetal macrosomia and shoulder dystocia is increased [31]. In our study, the incidence of pregnancy weight gain, preeclampsia, hyperhydramniotic fluid and cesarean section of pregnant women with GDM in the study group was significantly lower than that in the control group after standardized diet and exercise intervention. The incidence of oligohydramnios, FGR, placenta previa, placental abruption and postpartum hemorrhage were lower than those in the control group. It is further suggested that standardized knowledge and behavior education and behavior supervision can improve the adverse pregnancy outcomes. Lower weight gain is associated with lower incidence of preeclampsia in GDM women [32].

Other studies have shown that the teratogenic rate of GDM pregnant women is 7-10 times higher than that of normal women [33]. Macrosomia has been proved to be the main adverse outcome of GDM patients [34]. Macrosomia is usually defined as gestational age, birth weight over 90 percentile or 4000 grams [35]. Maternal hyperglycemia, maternal obesity, gestational age at delivery, maternal pre pregnancy BMI, hypertension and smoking all have effects on macrosomia [36-37]. GDM is also a risk factor for birth defects [38]. An observational study recruited pregnant women from 2002 to 2010 and reported that the birth defect rate of type 2 diabetes group was higher than that of the general population [39]. Another observation using the Swedish medical birth registration database found that the birth defects rate of PGDM patients was higher than that of GDM patients, but the incidence rate of birth defects in GDM patients was similar to that of in population [40]. Compared with women without a history of diabetes, women with GDM have higher BMI and older age. Obesity and maternal age may also be associated with birth defects. In our study, the incidence of macrosomia in the intervention group was significantly lower than that in the control group; The incidence of intrauterine distress, premature delivery, 1 minute Apgar score less than 7, neonatal defects, neonatal death, small for gestational age, and hyperbilirubinemia were lower than those in the control group. The results show that standardized education and behavior supervision can reduce the occurrence of neonatal adverse events.

Hypoglycemia is a common neonatal complication of GDM mothers. The study found that neonatal hypoglycemia of gestational diabetes mellitus maternal delivery occurs earlier, often within 4 hours after birth, and the high-risk period is the first 1-2 hours after birth [41]. In our study, the incidence of neonatal monitoring care, neonatal hypoglycemia and neonatal pneumonia in pregnant women with GDM after standardized diet and exercise intervention was significantly lower than that in the control group. It is further indicated that knowledge and action education can improve the adverse outcomes of neonates.

In conclusion, the results suggest that standardized management of GDM pregnant women during pregnancy and strict control of diet and exercise can effectively control the target of blood glucose, improve thyroid function and vaginal microecology, and significantly reduce the adverse pregnancy outcomes of mothers and children.

The professional health educators in this study can not only promote health education, but also understand the questions about health education of women with GDM by setting up WeChat group, and provide answers. At the same time, the establishment of WeChat group allows the puerpera to share experience and exchange in the group, and it is easier to get the follow-up focus of health education, which provides interaction and reference.

That based on the research results suggest that specifications of prenatal care are effective to actively improve the women with GDM, this shows that the remote mobile medical management can make the pregnant women as soon as possible control diet, exercise and blood sugar management awareness, get into the habit of self-management, can reduce the occurrence of maternal and infant adverse events. We hope that the combination of online management method can be further research and promotion, improve the efficiency of disease management research, discusses the remote intervention women with GDM knowledge management mode. The purpose of this study is to explore a standardized knowledge and behavior management model for women with GDM, so as to provide valuable data for future GDM guidelines and health promotion plans. At the same time, health education and clinical practice to improve self-management of women with GDM will be the focus of future research.

Ethics approval and consent to participate

This study was approved by the Ethics Committee of Jinshan Branch of Shanghai Sixth People's Hospital (approval number: jszxyy201703). Written informed consent was obtained from the parents for publication of clinical details, clinical images, and videos.

Consent to publish

Not Applicable

Availability of data and materials

The datasets supporting the conclusions of this article are included within the manuscript. The demanders may contact the corresponding author.

Competing interest

The authors declare that there is no competing interest.

Funding

This research supported by Shanghai Jinshan Health Committee (grant No: JSKJ - kTMS -2017 - 11) and research fund for medical consortium construction of Shanghai Sixth People’s Hospital Medical Group (grant No: 02.2Y02.07.023).

Author contributions

YZ finished the conception, design, and implementation of the project, and prepared the manuscript. GG assisted in the conception and design of the project, provided technical assistance. All authors approved the final manuscript and agreed to be accountable for all aspects of the work.

Acknowledgements

We are grateful to all our study participants who willingly volunteered to participate in this study and sincerely provided these valuable data. We are very grateful to all the research assistants for their role in the data collection.

Gestational diabetes mellitus. ACOG Practice Bulletin No. 190. American College of Obstetricians and Gynecologists. Obstet. Gynecol. 2018; 131: e49-e64.
Gao C, Sun X, Lu L, Liu F, Yuan J. Prevalence of gestational diabetes mellitus in mainland China: A systematic review and meta-analysis. J. Diabetes Investig. 2019; 10(1):154-162.
Xie X, Kong BH. Obstetrics and Gynecology 9th Edition. Beijing: People's Medical Publishing House, 2018:107.
Association AD. 13. Management of Diabetes in Pregnancy: Standards of Medical Care in Diabetes-2018. Diabetes Care. 2018; 41(Suppl 1): S137-143.
Committee on Practice Bulletins—Obstetrics. ACOG practice bulletin no. 190: gestational diabetes mellitus. Obstet. Gynecol. 2018;131.
Hartling L, Dryden DM, Guthrie A, Muise M, Vandermeer B, Donovan L. Benefits and harms of treating gestational diabetes mellitus: a systematic review and meta-analysis for the U.S. preventive services task force and the national institutes of health office of medical applications of research. Ann. Internal. Med. 2013; 159:123–129.
Lockwood, Charles J., Jay D. Iams, and Michael F. Greene. Creasy and Resnik's maternal-fetal medicine: principles and practice. Philadelphia: Elsevier Health Sciences, 2013.
Cosson E, Baz B, Gary F, Pharisien I, Nguyen MT, Sandre-Banon D, et al. Poor reliability and poor adherence to self-monitoring of blood glucose are common in women with gestational diabetes mellitus and may be associated with poor pregnancy outcomes. Diabetes Care. 2017; 40(9):1181-1186.
Fan Pengxia. Improving the knowledge, belief and practice of pregnant women with diabetes mellitus. Chinese Women and Children Health Research, 2015,26(5):949-952.
Point-of-care abstracts from the 2017 American association for clinical chemistry meeting (reprintes with permission). Point care,2018,17(1):23-45.
HAPO Study Cooperative Research Group. Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study: associations with neonatal anthropometrics. Diabetes, 2009, 58(2):453-459.
Lowe WJ, Scholtens DM, Kuang A, et al. Hyperglycemia and Adverse Pregnancy Outcome Follow‑up Study (HAPO FUS): Maternal Gestational Diabetes Mellitus and Childhood Glucose Metabolism. Diabetes Care, 2019, 42(3):372‑380.
Mackillop L, Hirst JE, Bartlett KJ, Birks JS, Clifton L, Farmer AJ, et al. Comparing the efficacy of a mobile phone-based blood glucose management system with standard clinic care in women with gestational diabetes: randomized controlled trial. JMIR mHealth and uHealth, 2018;6(3): e71.
Koivusalo SB, Rönö K, Klemetti MM, et al. Gestational diabetes mellitus can be prevented by lifestyle intervention: the finnish gestational diabetes prevention study (radiel): A randomized controlled trial. Diabetes Care, 2016,39(1):24-30.
Miremberg H, Ben-Ari T , Betzer T , Raphaeli H, Gasnier R, Barda G, et al. The impact of a daily smartphone-based feedback system among women with gestational diabetes on compliance, glycemic control, satisfaction, and pregnancy outcome: a randomized controlled trial. Am. J. Obstet. Gynecol., 2018;218(4):e1-e7.
Ming WK, Mackillop LH, Farmer AJ, Loerup L, Bartlett K, Levy JC et al. Telemedicine technologies for diabetes in preg-nancy: a systematic review and meta-analysis. J Med Internet Res. 2016,18(11): e290.
Stagnaro-Green A, Abalovich M, Alexander E, et al. Guidelines of the American Thyroid Association for the diagnosis and management of thyroid disease during pregnancy and postpartum. Thyroid. 2011; 21(10):1081-1125.
Obstetrics Division, Chinese Society of Obstetrics and Gynecology, Chinese Society of Perinatal Medicine, Pregnancy and Diabetes Cooperative Group. Guidelines for the Diagnosis and Treatment of Gestational Diabetes Mellitus. 2014; 49(8): 561-569.
Agarwal MM, Dhatt GS, Punnose J, et al. Thyroid function abnormalities and antithyroid antibody prevalence in pregnant women at high risk for gestational diabetes mellitus. Gynecol. Endocrinol., 2006; 22(5):261-266.
Weetman AP. Graves’ disease. N Engl. J. Med. 2000;343(17):1236–1248.
Achilles SL,Austin MN,Meyn LA,et al. Impact of contraceptive initiation on vaginal microbiota. Am. J. Obstet. Gynecol. 2018;218(6): 622.e1-e10.
Freitas AC, Chaban B, Bocking A, Rocco M, Yang S, Hill JE, Money DM. The vaginal microbiome of pregnant women is less rich and diverse, with lower prevalence of Mollicutes, compared to non-pregnant women. Scientific Reports. 2017;7(1):9212-9212.
Margarita V, Fiori PL, Rappelli P. Impact of Symbiosis Between Trichomonas vaginalis and Mycoplasma hominis on Vaginal Dysbiosis: A Mini Review. Frontiers in Cellular and Infection Microbiology, 2020;10:179.
Datcu R. Characterization of the vaginal microflora in health and disease．Dan. Med. J. 2014(61): B4830．
Hirji I, Andersson SW, Guo Z, Hammar N, Gomez-Caminero A. Incidence of genital infection among patients with type 2 diabetes in the UK General Practice Research Database. J. Diabetes and Its Complications, 2012;26(6):501-505.
Jafarzadeh L, Motamedi A, Behradmanesh M, Hashemi R. A Comparison of serum levels of 25-hydroxy vitamin d in pregnant women at risk for gestational diabetes mellitus and women without risk factors. Materia Socio Medica. 2015;27(5):318–322.
Dunn AB, Hanson L, VandeVusse L, Leslie S. Through the Microbial Looking Glass: Premature Labor, Preeclampsia, and Gestational Diabetes: A Scoping Review. J. Perinat 1 Neonatal Nurs. 2019;33(1); 35-51.
Li YY,Kong CW,To W. Pathogens in preterm prelabour rupture of membranes and erythromycin for antibiotic prophylaxis: a retrospective analysis. Hong Kong Med. J. 2019;25 (4):287-294.
Garmendia ML, Mondschein S, Montiel B, Kusanovic JP. Trends and predictors of gestational diabetes mellitus in Chile. Int. J. Gynaecol. Obstet. 2019; 148(2): 210-218.
Group of Obstetrics of Society of Gynecology, and Obstetrics, Gestational Diabetes Cooperation Group of Perinatal Medicine Branch, Chinese Medical Association. Guidelines for diagnosis and treatment of pregnancy associated with diabetes (2014). Chinese Journal of Obstetrics and Gynecology. 2014; 49(8):561-569.
Catalano PM, Ehrenberg HM. The short-and long-term implications of maternal obesity on the mother and her offspring. British Journal of Obstetrics and Gynaecology. 2006;113(10):1126-1133.
Risk of pre-eclampsia in women taking metformin: a systematic review and meta-analysis. Diabetic medicine: A journal of the British Diabetic Association, 2018.
Fang YN,Wang Q,Zhang GH,et al. On application of traditional Chinese medicine constitution in “preventive treatment of disease”. Journal of Traditional Chinese Medicine. 2020;61(7):581-585.
Mitanchez D. Foetal and neonatal complications in gestational diabetes: perinatal mortality, congenital malformations, macrosomia, shoulder dystocia, birth injuries, neonatal complications. Diabetes Metab. 2010(36):617-627.
Kc K, Shakya S, Zhang H. Gestational diabetes mellitus and macrosomia: a literature review. Ann. Nutr. Metab. 2015;66(Suppl 2):14-20.
Ehrenberg HM, Mercer BM, Catalano PM. The influence of obesity and diabetes on the prevalence of macrosomia. Am. J. Obstet. Gynecol. 2004(191):964-968.
Yogev Y, Langer O. Pregnancy outcome in obese and morbidly obese gestational diabetic women. Eur. J. Obstet. Gynecol. Reprod. Biol. 2008(137):21-26.
Schaefer-Graf UM, Buchanan TA, Xiang A, Songster G, Montoro M, et al. Patterns of congenital anomalies and relationship to initial maternal fasting glucose levels in pregnancies complicated by type 2 and gestational diabetes. Am. J. Obste.t Gynecol. 2000(182):313-320.
Callec R, Perdriolle-Galet E, Sery GA, Morel O. Type 2 diabetes in pregnancy: Rates of fetal malformations and level of preconception care. J. Obstet. Gynaecol. 2014(34):648-649.
Aberg A, Westbom L, Kallen B. Congenital malformations among infants whose mothers had gestational diabetes or preexisting diabetes. Early Hum. Dev. 2001(61):85-95.
Huang XX, Jiang XM, Lin Y, et al. The dynamic changes of blood glucose and the influencing factors of hypoglycemia in neonates of gestational diabetes mellitus mothers within 48 hours after birth. Chinese Journal of Evidence-Based Pediatrics. 2017;12(5): 342-346.

Download PDF

Version 1

posted

You are reading this latest preprint version

Effect of standardized education and supervision on pregnancy outcomes of women with gestational diabetes mellitus

Status:

Version 1

Abstract

Figures

1. Introduction

2. Materials and Methods

2.1. Research object

2.1.1. Cases source

2.1.2. GDM diagnostic criteria

2.2. Method

2.2.1. Preparation before intervention

2.2.2. Intervention methods

2.2.3. Self-management behavior assessment after intervention

2.2.4. Vaginal microecological detection

2.3 Evaluation index

2.4. Statistical analysis

3. Results

3.1. Ccomparison of blood glucose and glycosylated hemoglobin between the two groups within one month before delivery

3.2. The levels of TPOAb, FT4 and TSH in the third trimester (28 weeks to delivery) were compared between the two groups

3.3. The effect of comparison of vaginal microorganism in the third trimester (28 weeks to delivery) between the two groups (details in Table 3)

3.4. The effect of comparison of adverse outcomes of pregnant women between the two groups (details in Table 4)

3.5. The effect of comparison of the incidence of adverse neonatal outcomes between the two groups (details in Table 5)

4. Discussion

5. Conclusions

Declarations

Ethics approval and consent to participate

Consent to publish

Availability of data and materials

Competing interest

Funding

Author contributions

Acknowledgements

References

Status:

Version 1