IMPACT OF GESTATIONAL DIABETES ON MATERNAL AND NEONATAL OUTCOMES: A COHORT STUDY. By Aisha Hassan Elsayed (B.Sc. Nursing)

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1 IMPACT OF GESTATIONAL DIABETES ON MATERNAL AND NEONATAL OUTCOMES: A COHORT STUDY By Aisha Hassan Elsayed (B.Sc. Nursing) Clinical Instructor /Maternity and Newborn Health Nursing Department Thesis Submitted for Partial Fulfillment of the Requirements of Master science in nursing Degree (Maternal and Newborn Health Nursing). Thesis Supervision Prof. Shadia Abdel Kader Hassan Professor of Maternal & Newborn Health Nursing Faculty of Nursing Cairo University Prof. Abdel Hamid Attia Professor of Obstetrics & Gynecology Faculty of Medicine Cairo University Dr. Hanan Fahmy Azzam Assistant Professor of maternal and Newborn Health Nursing Faculty of Nursing Cairo University Faculty of Nursing Cairo University 2012

2 APPROVAL PAGE This Thesis for Master Degree in Nursing By Aisha Hassan Has Been Approved for the Department of Maternal and Newborn Health Nursing By Prof. Shadia Abdel Kader Hassan Professor of Maternal and Newborn Health Nursing Faculty of Nursing Cairo University Prof. Abdel Hamid Attia Professor of Obstetrics & Gynecology Faculty of Medicine Cairo University Dr. Hanan Fahmy Azzam Assist. Professor of Maternal & Newborn Health Nursing Faculty of Nursing Cairo University Date

3 ACKNOWLEDGEMENT First of all I have to thank Allah, the most gracious who gave me an amazing opportunity to life and who helped me in bringing this work to light. I would like to express my gratitude and greatest indebtedness to Prof. Dr. Shadia A. Hassan, Professor of Maternal and Newborn Health Nursing, Faculty of Nursing, Cairo University, who devoted great deal of her valuable time, untiring effort, continuous guidance, providing scientific comments and encouragement to accomplish this work. I would like to express my deep thanks and appreciation to Dr. Abd El-Hamid Attia, Professor of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, for providing me with valuable knowledge and experience that helped me to conduct the practical part of this study. I have the highest respect and admiration for his personality in providing scientific comments, generous and valuable advices, insightful suggestions, continuous support and precious cooperation to accomplish this work. I would like to express my sincere thanks and appreciation to Dr. Hanan Fahmy Azzam, Assistant Professor of Maternity and Newborn Health Nursing, Faculty of Nursing, Cairo University, for her valuable guidance, support and great help in supervising this work, no words can express my feelings, respect and gratitude to her as regards her continuous encouragement and constructive criticism given to me at every stage of this work. Indeed she was a continuous source of guidance and support for me. Special thanks to all women who participated actively in this study and being appreciative and very cooperative, and tolerated me till the accomplishment of this work.

4 I found this opportunity to express my greatest appreciation to all physicians and nurses at Fetal Medicine Unit for their help. Finally, special thanks to my teachers, colleagues in the Maternal and Newborn Health Nursing Department, and in the faculty for their continuous support, help and cooperation to accomplish this work. The candidate Aisha Hassan

5 Impact of Gestational Diabetes on Maternal and Neonatal Outcome: A Cohort Study Abstract By Aisha Hassan Elsayed Gestational diabetes mellitus (GDM), a common medical complication of pregnancy, is defined as any degree of glucose intolerance with onset or first recognition during pregnancy. GDM affects 7% of all pregnancies; so, the aim of this study was to assess the impact of gestational diabetes on maternal and neonatal outcomes. A Cohort study design was utilized in this research study to assess the impact of gestational diabetes on maternal and neonatal outcome. A total sample of 200 pregnant women attending antenatal outpatient clinic at El-Manial University Hospital for follow-up were recruited for the study. Tools were used to collect data included: maternal sheet, newborn sheet, Apgar score, anthropometric measurements by the 10 th and 90 th percentile. Findings of this study indicated that, gestational diabetes is associated with, preterm labor, pregnancy induced hypertension (PIH), polyhydramnios, caesarean section, and vaginal infection the most common maternal complications. Macrosomic baby (LGA), respiratory distress, stillbirth, intrauterine fetal death, and hypoglycemia, the most common neonatal complications. The study recommended that, there is an urgent need to apply nursing care protocol for women affected with gestational diabetes mellitus to minimize maternal and neonatal complications. Key words: Gestational Diabetes, Hypoglycemia, Neonatal outcome, Maternal outcome, Cohort study, Macrosomic baby, Intrauterine fetal death. Chairperson of Thesis.

6 CONTENTS Chapter I II Introduction Introduction Significance of the study Aim of the study` Theoretical framework Review of Literature Overview on gestational diabetes Definition and incidence of gestational diabetes Pathophysiology of gestational diabetes Etiology and risk factors Effect of gestational diabetes on pregnancy outcome Page Maternal complications 23 - Pregnancy induced hypertension - Polyhydramnios - Maternal Ketoacidosis - Caesarean section - Preterm labor. - Dystocia -Vaginal infection v

7 CONTENTS (cont.) Chapter 2. Fetal and neonatal complication - Congenital Malformation - Macrosomia and large for gestational age -Intrauterine growth retardation -Intrauterine fetal death -Neonatal hypoglycemia -Hypocalcaemia - Hyperbilirubinemia - Respiratory distress syndrome Diagnosis of Gestational Diabetes Diagnostic tests -Glucose challenge test -Oral glucose tolerance test -Glycosylated Hemoglobin (HBA1C) -C-peptide Nursing Management For Women With Gestational Diabetes -Nursing assessment& history taking - Antenatal management Page vi

8 CONTENTS (cont.) Chapter - Metabolic management during pregnancy - Antepartum fetal assessment - Intrapartum management - Postpartum management -Prognosis Page III. Subjects and methods Design Sample Setting Ethical considerations Tools Pilot study Procedure Limitations of study Data management and statistical analysis IV V VI Results Discussion Summary, conclusion and recommendations References Appendices Thesis proposal Arabic summary vii

9 Table LIST OF TABLES Title Pages 1 Distribution of The Sample According to Socio-Demographic Characteristics Distribution of The Sample According To Socio-Demographic Characteristics (Cont.) Distribution of The Sample According to The Obstetric Code Distribution of The Sample According to The Complication with Previous Pregnancy. Distribution of The Sample According to Contraceptives Methods Distribution of The Sample According to Anthropometric Measurements Distribution of The Sample According to Body Mass Index Distribution of The Sample According to Complication During Current Pregnancy Distribution of The Sample According to Complication During Current Labor Distribution of The Sample According to Blood Sugar Distribution of The Sample According to Apgar Score Distribution of The Sample According to Anthropometric Measurement Distribution of The Sample According to Insulin And C-Peptide Level Distribution of The Sample According to Neonatal Complication Viii

10 { LIST OF FIGURES Figure In review In result Title 1.Suggested Theoretical Framework of the Thesis 2. Macrosomia 3. Large for gestational age Distribution of the sample According to the educational level Distribution of the sample According to mode of previous delivery Distribution of the sample According to Mode of delivery Distribution of the sample According admitted to NICU Distributions of the sample According to 10th &90th percentile Predictors that might affect of maternal outcome Predictors that might affect neonatal outcome Effect of gestational diabetes on maternal outcome Pages Effect of gestational diabetes on neonatal outcome Factors that might affect neonatal outcome con't Predictors of Measurements That Might Affected by Gestational Diabetes viiii

11 LIST OF ABBREVIATION AC ACOG ADA AGA AFI BMI CS DCCT EDD FHR GA GDM HAPO HbA1c HC HMD HPL IDMs IDF IGT IFG IUFD IUGR JOGC Abdominal circumference American college of obstetrician& gynecologists American diabetes association Appropriate for gestational age Amniotic fluid index Body mass index Cesarean section Diabetes Control and Complications Trial Expected date of delivery Fetal heart rate Gestational age Gestational diabetes mellitus Hyperglycemia and pregnancy outcome Glycosylated hemoglobin Head circumference Hyaline membrane disease Human placental lactogen Independent diabetes mellitus International Diabetes Federation Impaired Glucose Tolerance Impaired Fasting Glucose Intrauterine Fetal Death Intrauterine growth retardation Journal of Obstetrics and Gynecology Can

12 LGA LMP L/S MNT NDDG NICU OGCT OGTT PIH PG PROM RDS SGA SMBG WHO Large for gestational age Last menstrual period Lecithin/sphnigomylin Medical nutrition therapy National Diabetes Data Group Neonatal intensive care unit Oral glucose challenge test Oral glucose tolerance test Pregnancy induced hypertension Phosphatidyglycerol Premature rupture of membrane Respiratory distress syndrome Small for gestational age Self-monitoring of blood glucose World of health organization

13 1 CHAPTER I Introduction Gestational diabetes mellitus (GDM) is one of the most common medical complications of pregnancy. It is defined as carbohydrate intolerance of variable degrees, with an onset or first recognition occurring during pregnancy;started during second half of pregnancy. It usually begins in the fifth or sixth month of pregnancy (between the 24th &28th weeks), and disappears after delivery of the infant. GDM is a condition in which women without previously diagnosed diabetes exhibit high blood glucose levels during pregnancy. (American Diabetes Association, 2004&Moore et al., 2005). The GDM generally has few symptoms and it is most commonly diagnosed by screening during third trimester. No specific cause has been identified but, it represents an insulin resistance state, possibly due to the placental production of progesterone, cortisol, prolactin and other hormones which interfere with normal glucose metabolism. Insulin resistance usually appears in the second trimester of pregnancy and increases as the pregnancyadvances. Thus, as the pregnancy progresses, more insulin is required to maintain normal blood glucose levels. Most women are able to meet the increased demand for insulin. While women with GDM are unable to produce sufficient insulin to cope with the increased demand(buchanan & Xiang, 2005).

14 2 Sachdev, (2011) reported that, any woman can develop GDM during pregnancy but, certain factors increase the risk for developing it. As: overweight or obese (body mass index [BMI] 30), age (25-35 years or older), family history of diabetes mellitus and previous macrosomic baby (weight is 4kg). Worldwide statistics reported that, the prevalence of GDM is 3-10 % of all pregnant women, represented as ( case) the United States each year (American Diabetes Association, 2007). In relation to the prevalence of GDM in Arabic world it represents 20% in the united Arab Emirate (UAE), %.in Iran; very high prevalence rates were observed in Saudi Arabia (12.5%), Bahrain (13.5%) medium to high levels were observed in different studies in Iran and 7.2%, in Japan (Hossein-Nezhad, 2007). Diabetes during pregnancy increases neonatal and maternal morbidity and mortality. Recent evidence has clarified the relationship of maternal glycemia to fetal and neonatal outcomes and demonstratedthat, appropriate detection and treatment to improve outcomes. Maternal complications associated with GDM included: preeclampsia which occurs more often in the woman with diabetes than in unaffected population; and urinary tract infections, which are more common possibly because glucose rich urine provides a good medium for bacterial growth(cunningham et al., 2001). Other effects included: hydramnios which may result from fetal hyperglycemia and consequently fetal dieresis, premature rupture of membrane, which may be caused by over distention of the uterus by hydramnios, and preterm labor which may be due to poor glycemic control, and polyhydramnios (Yogev, Xenakis,& Langer, 2004).

15 3 In addition, large fetal size increasesthe likelihood of cesarean birth, which increases the risk for postpartum hemorrhage. Also, infant's head may enter the birth canal but the shoulders will be too large due to macrosomic baby, causing dystocia. Shoulder dystocia occurs in 1% 2% of pregnancies, which necessitates the use of special procedures to deliver the baby. These procedures can cause nerve damage, fractured bones or rarely, brain damage to the neonate. The challenges of delivering a macrosomic baby can also lead to birth canal injuries and large episiotomy for the mother (ACOG, 2005; Cunningham et al., 2005). The GDM is also associated with neonatal complications including large for gestational age. Neonatal macrosomia has been defined in several different ways, included birth weight of g or greater than 90 th percentile for gestational age after correcting for neonatal sex and ethnicity. Macrosomia affects 1-10% of all pregnancies. Macrocosmic babies can cause problems during delivery because of their size (Martin et al., 2006). Furthermore, newborn of women with GDM may develop hypoglycemia immediately after birth. Hypoglycemia is the most common metabolic problem in neonates; a blood glucose value of less than 40 mg/dl represents hypoglycemia. This occurs because the neonate's body is still producing extra insulin to process the extra sugar that was in his blood in utero (Hilarie, 2002). In addition, premature baby and Respiratory distress syndrome (RDS) is occurring as a result of GDM that require medical interventions until the lungs are improved. Fetal hyperinsulinemia retards cortisol production, which is necessary for synthesis of surfactant needed to keep the newborn's alveoli open, thereby increasing the risk for respiratory distress syndrome. Also, after delivery, some neonates may develop polycythemia, up to 50% have low levels of serum calcium [Hypocalcaemia

16 4 (<7 mg/100 ml)], and approximately 25% have hyperbilirubinemia (Roberts, 2004; &Donovan, 2010). The diagnostic test for GDM is screening with 50 g oral glucose challenge test (OGCT) followed by 100 g oral glucose tolerance test (OGTT). The oral glucose tolerance test at 24 to 28 week of gestation, which requires the woman to fast overnight and two to four blood samples to be taken over a two to three hour period. The oral glucose load differs (75gm or 100gm) according to which organizations' criteria are utilized to perform and interpret the test results (Vidaeff et al., 2003). The World Health Organization and Australian Diabetes in Pregnancy Society recommend that, a 75gram oral glucose tolerance test load;one or more abnormal results are considered diagnostic for GDM. The Hyperglycemia and Adverse Pregnancy Outcomes (HAPO) is a large prospective study on GDM.In which the researcher adopted the 75gram oral glucose tolerance test for Diagnosis and Classification of Hyperglycemia in Pregnancy (Crowther et al., 2005; HAPO Study Cooperative Research Group, 2008& HAPO, 2009). The ideal outcome of every pregnancy is a healthy newborn and women. Nurses can be pivotal in realizing this outcome for women with GDM by implementing measures to minimize maternal and neonatal complications. Nursing management of GDM emphasizes regular monitoring of blood sugar levels, eating a carefully controlled diet prescribed by a health care professional and regular exercise appropriate to pregnancy. If these measures do not adequately control glucose levels, some women may need insulin injections until blood glucose levels return to normal after delivery. Prompt treatment of diabetes can reverse high glucose levels in the blood and minimize or eliminate possible complications such as;preeclampsia,

17 5 premature birth, respiratory distress syndrome, and macrosomic baby (Alwan, Tuffnell &West, 2009). The diet should provide the calories and nutrients needed for maternal and fetal health, avoid ketosis, and promote appropriate weight gain. Calories should be distributed in a way similar to that for preexisting diabetes. Simple sugars found in concentrated sweets should be eliminated from the diet. Based on a non obese prepregnancy weight, an average of 30kcal/kg/day is recommended. Calories restriction to 25kcal/kg each day may be recommended for the obese woman. Calories should be divided among three meals and at least three snacks (ACOG, 2001; Franz, 2002; and Moore, 2004).Crowther, et al.,(2005)showed that, the rate of serious Perinatal conducted a randomized clinical trial to determine whether treatment of women with gestational diabetes mellitus reduced the risk of perinatal complications. Complications were significantly lower among the infants of the women in the intervention group than among the infants of the women in the routine-care group. Physical exercise program should be recommended by a physician taking intoaccount each woman's' risk factors. Avery and Walker, 2001, reported that, significant declines in blood glucose level were observed during low- and moderateintensity exercise compared to rest. If monitoring reveals failing in the control of glucose levels with these measures, or if there is evidence of complications like excessive fetal growth, treatment with insulin might become necessary. The most common therapeutic regimen involves premeal fast-acting insulin to blunt sharp glucose rises after meals. Care needs to be taken to avoid low blood sugar levels (hypoglycemia) due to excessive insulin injections (ACOG, 2001; and ADA, 2004).

18 6 Furthermore, nursing counseling about testing to identify fetal compromise may begin as early as 28 weeks of gestation if the woman has poor glycemic control or by 34 weeks of gestation. The surveillance testing often includes "kick count" ultrasonograghy for fetal growth and amniotic fluid volume, biophysical profile, nonstress test, contraction stress test, or amniocentesis for fetal lung maturity (Moore, 2004). Significance of the Study The GDMis fast becoming a major health problem in developing countries undergoing rapid changes in lifestyle, dietary habits and body mass index. Both maternal and neonatal mortality and morbidity resulting from GDM can be prevented by proper antenatal supervision and institutional care, facilities that exist in our tertiary care units and even in most of the primary health centers. The major obstacles to be crossed in Egypt include lack of education and socio-cultural taboos leading to improper and substandard antenatal care, failure of screening of high risk pregnancies and their referral to the appropriate health facilities at the proper time. (Randhawa, Moin & Shoaib, 2003). Moreover, if GDM is not properly treated, there is an increased risk of adverse maternal complications (preeclampsia, recurrent vulvo-vaginal infections, increased incidence of operative deliveries, obstructed labor & development of diabetes mellitus later in life), fetal complications (macrosomia, polyhydromnios, preterm labor, respiratory distress, unexplained intrauterine fetal death & traumatic delivery) and neonatal complications (hypoglycemia, jaundice, polycythemia, tetany, hypocalcaemia, hypomagnesaemia( Tamas, &Kerenyi, 2001).

19 7 In Egypt, from clinical observation GDM is a significant phenomenon and the commonest complications during pregnancy. It is associated with maternal and neonatal complications. At the same time there were scattered nursing researches related to assessing the impact of gestational diabetes on maternal and neonatal outcomes. The nurse as an important member in caring for women experiencing gestational diabetes should be aware of its impact on maternal and neonatal outcomes; so she can contribute to improve the quality of the nursing care given to those women. Aim of the Study The aim of this study wasto assess the impact of gestational diabetes on maternal and neonatal outcomes. Research Question What is the impact of gestational diabetes on maternal and neonatal outcomes? Theoretical Framework The proposed theoretical model in this study represents the impact of gestational diabetes on maternal and neonatal outcomes. Concepts are mainly derived from the Neuman theory. Neuman Theory "Systems Model" (1972, 1989,& 1993) reflected general systems, theory that is the nature of living open systems. The theory states that all the elements are in interaction in a complex organization. It described adjustment as the process by which the organism satisfies his needs (many needs exist and each may disturb client balance or stability). Neuman added that, adjustment is a dynamic and continuous process. She concluded that, when the stabilizing process fails, the

20 8 organism will be unable to satisfy his needs, so, illness may develop, and if compensatory process fails completely, death may occur. She also described stress as a non-specific response of the body to any demand on it. Additionally, she reported that, stress increases the demand for readjustment and adaptation to a problem, whereas stressors are tension-producing stimuli, which may cause disequilibrium (situational or maturational crisis). According to Neuman, nurses deal with clients as a whole. Nursing clients are people who are anticipating stress or who are dealing with stress (Neuman,& Young, 1972). Nurses focus their attention on responses that could be labeled stressful and these responses are then within the domain of nursing. The nurse diagnoses the level of stability, internal and external environmental stressors, and the effect of stressors on client's system stability. Levels of stability can be determined through the analyses of lines of defense, lines of resistance, basic structure energy resources or survival factors, and five interacting dynamic variables: physiological, psychological, sociocultural, developmental, and spiritual(neuman, 2001). Stressors attempt to penetrate the flexible and normal line of defense and the results are positive or negative responses. How a client system responds to stress is determined by resistance demonstrated through lines of defense and by the dynamic relationship of five variable areas. The five variable areas are: physiology, which describes bodily structure and function; psychological, which is related to mental process and relationships; socio-culture, which related to social and cultural functions; developmental, referring to life development processes; and spiritual, referring to spiritual life system (Neuman, 1989).