Screening Strategy For Gestational Diabetes Mellitus

TABLE OF CONTENTS                                                                   Page


Abbreviations                                                                          4

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Executive Summary                                                                5


Introduction                                                                            6


Literature review                                                                                 7

Justification of the study                                                        12


Research Question                                                                  12

Hypothesis                                                                                          12

Objectives                                                                                           12

Methodology                                                                          14

Sample size determination                                                      15

Study design                                                                           16

Procedures                                                                                          16

Statistical analysis                                                                   17

Study administration                                                              18


Timeline                                                                                              18


Ethical considerations                                                             19


Application of Results                                                                        19

Budget & Budget justification.                                              20

References                                                                                          22

Appendix I consent form                                                        25

Appendix II enrolment criteria                                               29

Appendix III Data Collection Form                                       30

Appendix IV Aga Khan Screening Guidelines                      32



ACOG                        American Congress of Obstetricians and Gynaecologists

ADA               American Diabetes Association

CDA               Canadian Diabetes Association

Dr.                   Doctor

FICOG            Fellow of the Indian College of Obstetrics and Gynaecology

GDM               Gestational Diabetes Mellitus

HAPO             Hyperglycaemia & Adverse Pregnancy Outcomes.

IADPSG         International Association of Diabetes and Pregnancy Study            Groups.

IDF                 International Diabetes Federation

MD                  Doctor of Medicine

MRCP             Member of The Royal College of Physicians

NDDG            National Diabetes Data Group

OGTT              Oral Glucose Tolerance Test

ORs                 Odds Ratios

Prof.                Professor

RANZCOG    Royal Australian & New Zealand College of Obstetricians and Gynaecologists.

SPSS               Statistical package for the social sciences

WHO              World Health Organization

Yr                    Year




Gestational hyperglycaemia is associated with a higher incidence of adverse maternal and foetal outcomes than is seen in normal pregnancy. Untreated gestational diabetes mellitus (GDM) has an increased perinatal morbidity and mortality.

Morbidity related to macrosomia includes shoulder dystocia with birth injury and perinatal asphyxia in the foetus. In the mother macrosomia is a risk factor for genital tract injury, obstructed labour, uterine atony and increased risk of caesarean section.

The importance of diagnosis of GDM relates not only to potential immediate morbidities at the time of birth but long term sequelae for the child. Obesity, development of type 2 diabetes mellitus, intellectual and neurological development and mental problems are known long term sequelae. For the mother, GDM is a very strong risk factor for the development of type 2 diabetes later in life. Published studies show that after GDM, 35-60% of women develop type 2 diabetes within 10 years. (1; 2)

Therefore it is prudent that gestational diabetes is diagnosed and appropriate treatment and monitoring instituted. Diagnosis begins with screening. However, a Cochrane review published in 2011 found insufficient evidence on the best type of screening that would improve maternal and fetal health outcomes.(3)

Objectives: To compare detection rates of the universal to the selective risk factor-based screening strategy for gestational diabetes mellitus

Methodology: A prospective cross-sectional study involving 185 subjects at or less than 28 weeks gestation attending antenatal care at The Aga Khan University Hospital, Nairobi.

Recruitment of study subjects shall be consecutive as they present for booking to the antenatal clinic until a sample size of 185 is achieved.

All subjects shall have their risk factors for gestational diabetes identified and recorded at the beginning of the study.

All subjects recruited shall then undergo the 50g O’Sullivan Screening test.

At the end of the study, the detection rate of the universal screening strategy will include all participants irrespective of risk factors. The detection rate of the selective risk factor strategy will only include those identified to have risk factors for gestational diabetes mellitus.

The detection rates for both screening strategies shall then be compared.


Gestational diabetes is carbohydrate intolerance resulting in hyperglycaemia of variable severity with onset or first recognition during pregnancy. The definition applies irrespective of whether or not insulin is used for treatment or the condition persists after pregnancy. It does not exclude the possibility that the glucose intolerance may

antedate pregnancy but has been previously unrecognized.

Women who become pregnant and who are known to have diabetes mellitus which antedates pregnancy do not have gestational diabetes but have ‘diabetes mellitus and pregnancy’ and should be treated accordingly before, during, and after the pregnancy.(4)

Approximately 7% of all pregnancies are complicated by GDM. The prevalence may range from 1 to 14% of all pregnancies, depending on the population studied and the diagnostic tests employed.(5; 6)

There is, however, a paucity of data on the prevalence of GDM in Sub-Saharan Africa. The few published studies reported a prevalence of between 0 in Tanzania to 9.2% in Ethiopia.(7)

There are no published studies on screening or prevalence of gestational diabetes from Kenya.


Gestational hyperglycaemia is associated with a higher incidence of adverse maternal and foetal outcomes than is seen in normal pregnancy. Untreated GDM has an increased perinatal morbidity and mortality. Morbidity related to macrosomia includes shoulder dystocia with birth injury and perinatal asphyxia in the foetus. In the mother it causes more genital tract injury, obstructed labour, uterine atony and increased risk of caesarean section. The importance of diagnosis of GDM relates not only to potential immediate morbidities at the time of birth but long term sequelae for the child. Obesity, development of type 2 diabetes mellitus, intellectual and neurological development and mental problems are known long term sequelae. For the mother, GDM is a very strong risk factor for the development of type 2 diabetes later in life. Published studies show that after GDM, 35-60% of women develop type 2 diabetes within 10 years.(1; 8) Therefore it is prudent that gestational diabetes is diagnosed and appropriate treatment

and monitoring instituted. Diagnosis begins with screening. However, best screening strategy and test is not universally agreed upon.(9; 10)



The first study to provide solid evidence of a direct association between maternal glucose levels and pregnancy outcome, irrespective of the diagnosis of GDM, was the HAPO study (1; 2; 8)

The HAPO study was a large multinational prospective study that included 25505 women. The participants underwent a two-hour OGTT with 75 g of glucose between 24 and 32 weeks of gestation and their glycaemic levels were investigated in relation to predefined adverse pregnancy outcomes. The four predefined primary outcomes were primary caesarean delivery, clinical neonatal hypoglycaemia, and birth weight and cord serum C-peptide above the 90th percentile. Premature delivery, shoulder dystocia or birth injury, intensive neonatal care, hyperbilirubinemia, and preeclampsia were chosen as secondary outcomes. In respect to secondary outcomes, glucose levels were analyzed only as a continuous variable.

For the primary outcomes, glucose concentration was also analyzed as a categorical variable, after stratifying the women into seven categories according to the glucose values obtained during the two-hour OGTT. The frequency of the primary outcomes increased in parallel with increasing maternal glucose levels and odds ratios (ORs) were calculated for all seven glycemic categories, using as reference (OR=1) the category with the lowest glucose concentration ranges. The Odds ratios increased across the categories of maternal glycaemia and these results were statistically significant for all primary outcomes, with the exception of neonatal hypoglycaemia. Similarly, when glucose concentration was analyzed as a continuous variable, a continuous association of maternal glucose with primary and secondary outcomes was observed. Notably, these associations were detected even for low glucose levels and did not differ among the 15 centers in nine countries that participated in the study.

Even though the HAPO study indicated the need to revise the diagnostic criteria of GDM, it did not deduce any threshold glucose values that can be used in clinical practice. Therefore, even after completion of the study, screening and diagnostic methods of GDM still differ among various associations and practice guidelines.

Screening recommendations

A systematic review comparing different guidelines showed large differences between the recommendations made, mainly by international bodies, from ‘screening when clinically indicated’ to ‘universal screening’. These differences translate into a large variation in the number of screening tests, costs and translation of these guidelines into practice. (11)  These disparity has persisted over time.

The American Diabetes Association (ADA) in its 2011 position statement  on Standards of Medical Care in Diabetes ,(12) recommends for all  pregnant women not known to have diabetes, universal screening  for GDM at 24 –28 weeks of gestation, using a 75-g 2-h OGTT and the diagnostic cut points as The diagnosis of GDM is made when any of

the following plasma glucose values are


  • Fasting _92 mg/dl (5.1 mmol/l)
  • 1 h _180 mg/dl (10.0 mmol/l)
  • 2 h _153 mg/dl (8.5 mmol/l)

The American Congress of Obstetricians and Gynecologists

(ACOG) in its practice guideline number 30 to obstetricians recommends selective risk factor led  screening of all women at between 24 and 28 weeks gestation using the 50g OGTT screening test. (5)

The World Health Organization (WHO) recommends selective screening using the 75 g two-hour OGTT and the diagnostic thresholds of 126 mg/dl (7mmol/dl) and 140 mg/dl (7.77mmol/dl) for fasting and 2-hour glucose concentrations, respectively. (13).

The International Diabetes Federation (IDF) global guidelines recommend that women who are at high risk (history of previous GDM) should undergo an OGTT as soon as possible. For all other women the OGTT should be performed between the 26th and 28th week of gestation. In both cases, a one-stage procedure with the 75 g OGTT is preferred. (10)

The CDA (Canadian Diabetes Association) guideline recommends universal screening of all pregnant women between 24-28 weeks using the 50g GCT. The CDA also recommends that women with multiple risk factors undergo first-trimester screening using the 50g GCT and reassessment in the subsequent trimesters if initial results are negative. It further suggests that in populations at high risk of GDM, a single 75 g OGTT can be used as a definitive screen.(14)

UK NICE guidelines recommend that screening for gestational diabetes using fasting plasma glucose, random blood glucose, glucose challenge test and urinalysis for glucose should not be undertaken. The 2 hr 75g oral glucose tolerance test (OGTT) should be used to test for gestational diabetes and diagnosis made using the criteria defined by the World Health Organization. (15)

The RCOG in a 2011 opinion paper has recommended a review of the current selective screening by NICE following the HAPO study findings and the IADPSG recommendations. (16)

The Scottish Intercollegiate Guidelines Network (SIGN) recommend a selective screening approach using the 75g OGTT.  (16)

The RANZCOG guidelines recommend Universal Screening at 26 to 28 weeks. Choice of 50g GCT or 75g OGTT is left to the attending clinician. (17)


Due to the lack of uniform diagnostic criteria for more than 40 years, there has been no global consensus about the appropriate screening or diagnostic test, whether it should be applied selectively or to all pregnant women and about the diagnostic thresholds. There has been both short term and long term benefits of screening and treating maternal hyperglycemia in the HAPO study and the Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS). (18) IADPSG has hence offered recommendations. (19)

IADPSG recommendations

The IADPSG was formed “as an umbrella organization to facilitate collaboration between the various regional and national groups that have a primary or significant focus on diabetes and pregnancy” In 2010, the IADPSG proposed a new set of diagnostic criteria for GDM, The overall strategy recommended by the IADPSG Consensus

Panel for detection and diagnosis of hyperglycemic

disorders in pregnancy is in two discrete phases. The first is the detection of women with overt diabetes not previously diagnosed or treated outside of pregnancy. Universal early testing in populations with a high prevalence of type 2 diabetes is recommended, especially if metabolic testing in this age group is not commonly performed outside of pregnancy. The second phase is a 75-g OGTT at 24–28 weeks’ gestation in all women not previously found to have overt diabetes or GDM. (19)



Universal vs. Selective Screening Strategy


The two main strategies to screening are ‘universal’ where all pregnant women undergo a screening test for GDM; and a selective approach where only those women at high risk are screened. The main risk factors are maternal age, high body mass index, family history and cigarette smoking. The different screening strategies used around the world to identify women with GDM include identifying women based on their risk factors then conducting a urinalysis for glycosuria, a random blood sugar, fasting blood sugar, oral glycemic challenge or oral glucose tolerance tests. (20; 21)

A Cochrane review in 2010 reviewed four trials involving 3972 women recommended further research to determine the most appropriate screening strategy for GDM.(22)


Gaps in the screening of gestational diabetes and postpartum follow up have been identified. This was in a study that estimated the screening rate and prevalence of gestational diabetes mellitus (GDM) and the

screening rate and prevalence of postpartum diabetes, in a large, national sample of pregnant women. It concluded that many women may not be receiving GDM screening during pregnancy and postpartum diabetes screening rates after pregnancy remain low.(23)


Various studies have demonstrated benefits of universal screening over selective screening. The HAPO and ACHOIS studies are the most recent and are expected to greatly influence screening strategies around the world. (1; 9; 18)


An observational study at the University of Michigan assessing suitability of Selective screening over universal screening found that 10 to 11 % of women with risk factors and 4% of women with GDM would be missed by the selective strategy.(24)


An audit of pregnancies complicated by diabetes from a centre in United Arab Emirates five years apart with selective versus Universal screening, confirmed the influence of ethnic background on the prevalence of gestational diabetes in a multiethnic and multicultural society. Universal screening was shown to a be a better screening policy in that set up that had a high prevalence of Type II diabetes with a 66.7% increase in prevalence over 5 years. (25)


A study in Argentina in 2008 involving 1702 women comparing selective versus universal screening concluded in favour of universal screening. Selective screening yielded 4% prevalence while universal screening 9% .Due this disparity, universal screening was recommended in their population. Thus, all non-hyperglycaemic 24–28-week pregnant women should be tested for GDM with an OGTT, and particular attention must be paid to MG women with risk factors for GDM: if negative at 24–28 weeks, they may be retested at 32 weeks.’(26)


A randomized study conducted at The National Maternity Hospital, Dublin Ireland showed a GDM prevalence of 2.7% using universal screening compared to 1.45% in the risk factor group. Universal screening also facilitated earlier diagnosis and an improved pregnancy outcome.(27)


A comparative analysis in Australia showed benefits of universal screening over selective screening.(28)


A French observational study with end points of fetal and maternal outcomes demonstrated better outcomes with universal rather than selective screening.(29)



Current practice at The Aga Khan University Hospital Clinic is Selective. Patient’s risk factors are assessed at the booking clinic and clients found to have two or more risk factors are subjected to the 50g O’ Sullivan test with a follow up 75g OGTT for clients with an abnormal O’ Sullivan test. (30)

The prevalence of type II diabetes in Kenya is estimated at between 4.2% and 12% (31) There are no publications to shows estimates of the prevalence of gestational diabetes. It is expected to mirror that of type II diabetes in a population.

At the Aga Khan University Hospital, we still find a number of women at term and the immediate post partum who are diabetic, have impaired glucose tolerance or have foetal macrosomia. The effects of missed diagnosis are likely to be associated with increased morbidity. This raises the possibility that the practice of selective screening of gestational diabetes in the antenatal period based on risk factors identified by history taking does not always diagnose all cases of gestational diabetes.


There is therefore a need to estimate the prevalence of a positive screening test, the prevalence of gestational diabetes, the most significant risk factors in the patients attending our clinic, the most appropriate screening practice for our population.


This study shall aim to provide answers to the questions above. This may influence policies and screening guidelines.



Research Question


Is the detection rate of an abnormal 50g oral glucose challenge test higher with universal screening strategy compared to selective screening strategy?


Null Hypothesis


Detection rates of an abnormal 50g OGTT are higher with Universal screening strategy compared to selective screening strategy.


Broad Objective


To compare the detection rate of universal screening of gestational diabetes using the 50g Glucose Challenge Test to that of selective screening based on risk factors.

Specific Objectives

  1. To compare detection rates of Universal versus Selective risk factor based screening strategy for gestational diabetes mellitus in the local population.


  1. To determine the prevalence of an abnormal screening test for gestational diabetes mellitus.


  1. To identify risk factors most predictive of gestational diabetes in our population.



The study will be based at the Aga Khan University Hospital, Nairobi, which is a 254-bed private tertiary institution under the Aga Khan Health Services. It is located in the North-Western part of Nairobi.

The hospital serves residents of Nairobi and is a referral centre whose catchment includes other parts of the country and the entire East and Central Africa region. It is a teaching hospital offering courses in postgraduate medical education and advanced nursing. Patients who attend for antenatal follow-up are a heterogeneous representation from a cosmopolitan population.

The department of Obstetrics and Gynaecology runs several specialized outpatient clinics including antenatal clinics. On average there are forty new antenatal bookings per week.



Reference population

The target population will include all pregnant women attending the antenatal clinic at the Aga Khan university Hospital, Nairobi over the study period.

Sample population

The sample population will comprise pregnant women booking for antenatal follow-up at or before 28 weeks gestation during the study period

Study population

This will comprise all the pregnant women eligible and recruited for the study.



Consecutive recruitment as women enrol into the antenatal clinic for booking and regular follow-up. Recruitment shall be conducted after the antenatal consultation is completed.



In Limpopo province of South Africa and using the 2hr OGTT, The prevalence of gestational impaired glucose tolerance (GIGT) and gestational diabetes mellitus (GDM) was 8.8% (7.3% GIGT; 1.5% GDM)(7) The prevalence of gestational diabetes in the low risk population is between 0.1 and 2.8%.(32) ) Studies comparing the two screening strategies show an approximate doubling of prevalence with Universal compared to Selective screening strategy. (25; 27)


A sample size of 185 will be required to achieve a 5% alpha error with a 10% width of the confidence interval.


The formula illustrated below will be used to determine the sample size that will enable a comparison between 2 proportions.


  • Formula




  • where n = the sample size required
  • p1 = outcome at baseline
  • p2 = estimated proportion after intervention
  • Z1-α=critical value for level of significance
  • Zb =critical value for desired power


P1=9%, P2=19% (Considering an increase of 10% in prevalence as significant)


N= (1.96+0.84)2 (0.09(1-0.09) + 0.19(1-0.19)



= ( 2.82) (0.09(0.91)) + 0.19(0.81)


= (7.84) (0.0819 + 0.1539)


=7.84 x 0.2358




= 184.8672


N = 185



The study will be of a cross sectional design.




The study will be undertaken at the Aga Khan University Hospital antenatal clinic during the booking visits on Tuesday, Thursday and Friday every week for the period of the study. Patients shall be informed of the study and their consent requested after they have completed their clinic consultation.

Enrolled women will be booked for the 50g Oral Glucose Tolerance Test between 24 and 28 Weeks. The Cost of the screening test shall be met by the study budget.

All subjects shall have their risk factors for gestational diabetes identified and recorded at the beginning of the study.

All subjects recruited shall then undergo the 50g O’Sullivan Screening test. Those subjects found to have an abnormal screening test shall be referred for a diagnostic test, the 75g OGTT for which they shall meet the cost of the test. Those diagnosed as having gestational diabetes shall be followed up at the Combined Physician-Obstetrician-Dietician clinic, the One Stop Medical-ANC Clinic.

At the end of the study, the detection rate of the universal screening strategy will include all participants. The detection rate of the selective risk factor strategy will only include those identified to have risk factors for gestational diabetes mellitus.

The detection rates for both screening strategies shall then be compared.





All pregnant women attending the antenatal clinic at the Aga Khan University Hospital, Nairobi and;

  1. Willing to participate in the study having completed a fully signed informed consent form (appendix I)
  2. Those at or less than 28 weeks gestational age at bookingExclusion


  1. Clients who decline to give consent to participate in the study.
  2. Clients who are found at the booking visit to have a gestational age above 28 weeks
  3. Clients with chronic illnesses or medication that may influence glucose metabolism.
  4. Women known to have diabetes mellitus




FLOW CHART: Statistical analysis shall constitute the whole recruited sample and a subgroup of patients identified to be at risk as per the Aga Khan Screening Guidelines.













Calculation of detection rates:


For All Subjects (Universal Screening Strategy)

For The At Risk Group (Selective Screening Strategy)



Data management and analysis


Data generated from the study will be stored in a departmental computer under password protection and backed up on an external hard drive. The hard drive will be under the safe custody of the principal investigator. Each entry shall be under the enrolment study number so as to protect the privacy of the study participants. The data collection questionnaires will be filed and stored in a safe cabinet where verification of results can be done whenever necessary.


The primary data will be captured as MS Excel spreadsheets SPSS version 17.0 will be used for data analysis and the statistics presented as proportions and in graphical and tabular format as appropriate.


For continuous variables of normal distribution, the Student’s t-test shall be used to compare the groups and discrete data shall be compared using chi-square analysis and Fischer’s exact test where applicable. A probability < 0.05 shall be considered statistically significant. The Sensitivity, Specificity, NPV and PPV of both screening strategies shall be calculated & compared with each other.

The statistician will offer guidance during data entry, analysis and presentation of the final statistics.





The principal investigator will have the sole responsibility to brief the target population about the study, recruit those who will be willing to participate in the study and take their consent. He will further collect the blood samples or liaise with the laboratory to have samples collected and have them clearly labelled and delivered for analysis within 24 hours from the time of collection. The principal investigator will ensure all forms in the study  are fully filled by entering both laboratory data and patient information. All data entered shall be checked for completeness and accuracy  by the principal investigator as soon as is practically possible.

The supervisor will offer guidance to the principal investigator as the study proceeds as appropriate.



  Proposal development Ethical and budget approval Data collection Data analysis Result presentation


May-June 2011




July – Dec 2011      


January– February 2012        


March 2012








  1. The investigators will seek ethical approval from the institutions’ ethics review committee to carry out the study at the Aga Khan University Hospital antenatal clinic.
  2. Research participants will be requested to voluntarily enrol for the study after a comprehensive explanation of the intention of the study
  3. Those who decline participation will be accorded similar antenatal treatment and care as those who enrol in the study according to the standards at the Aga Khan University hospital.
  4. All participants will have their identity protected by assigning them study numbers, and only the research team can access their information.
  5. The primary doctor in the antenatal clinic will have access the laboratory reports of the study participants therefore those with glucose intolerance or gestational diabetes will receive appropriate treatment as per the department policy.





The actual detection rates of our screening strategy at our unit shall be known. This information is vital for public health education and institutional policy making on management of gestational diabetes.

This may be extended to other institutions in the region. The results of the study shall be disseminated via clinical meetings in our hospital, scientific conferences and via peer reviewed scientific journals.


BUDGET SUMMARY: Request for funding to the Research Support Unit as follows;


 LABORATORY INPUTS No. of Tests Price per packet Patients No. of packets Total cost

185 Patients & 15 Controls

400 1,750.70 200 8 28,011.20
GLUCOSE500g (Total=12,950g) 400 167.00 200 26 4,325.30
NEEDLESG21 100`S / NEEDLES G22 100’S 400 755.00 200 4 6,040.00
VACUTAINER HOLDER N/A 6.10 200 2 12.20
VACUTAINER TUBES SODIUM FLUORIDE OXALATE 4 ML 100`S 400 1,045.00 200   4,180.00
LAB MISCELLANEOUS         10,000.00
TOTAL LAB BUDGET         52,568.70



ITEM Unit cost (KSh.) Number of units Total (KSh.)


Printing paper 255 5     1,275
Box files 150 5        750
Biro pens 10 20        200
Pencils 20 10        200
Erasers 9.50 5          47.50
Stickers 500 1        500
TOTAL     2972.50



laboratory 15,000
antenatal clinic 15,000
TOTAL 30,000




laboratory inputs 52,568.70
stationery 2,972.50
research assistants 30,000





A Total of KSh. 85,541.20 shall be required to conduct this study.


Subsidised costs of doing the O’Sullivan test has been sought from the main laboratory. 185 subjects shall eventually be tested. The blood sugar levels are taken twice, an initial level and 1 hour later hence a total of 370 tests. A control of 30 tests was advised by the laboratory management hence all inputs are calculated using 400 where applicable.

The Costs of the inputs in table 1 are at buying price as quoted from the Materials Management Department (MMD) of the hospital who shall provide all the laboratory inputs.

Research assistants, i.e. the nurse in charge of diabetic education shall be requested to assist with recruitment of subjects. A lab technologist shall assist with laboratory analysis of samples. For this, both shall receive KSh. 15,000 each at the completion of the study as appreciation.

Patients requiring the Diagnostic 75gOGTT shall meet the cost themselves since this study is only evaluating the screening test, 50g OGTT.


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  32. Appendix 1

Informed consent for pregnant women attending the prenatal clinic.


This document is to be read to or by each prospective participant in a language she understands.


Principal investigator: Dr. Francis Githae

Supervisors: Dr. Evan Sequeira, Dr. Nancy Kunyiha & Prof. William Stones.


I am Dr. Francis Githae working for the Aga Khan University Hospital as a resident in the Obstetrics and Gynaecology department. I am conducting a research study to determine whether or not universal screening strategy for diabetes in pregnancy is better than selective screening strategy.


You are being requested to participate as part of a group of 185 pregnant women attending the prenatal clinic. The collection of information and samples will happen over a six months period after which the study shall be terminated, results analysed and recommendations on screening of gestational diabetes made.




This is an observational study, which means that with the exception of taking two 5ml blood samples from your forearm vein before and after a glucose load, we will not perform additional medical procedures, nor will you be given any experimental medicines during your care. Your care during pregnancy will not be changed if you agree to participate in this study. If for any reason you feel you cannot participate in the study or you wish to withdraw even after giving your consent, your decision will not affect the standard of antenatal care that you should receive as this study is a research and not part of your current routine care.


The reason we are performing this study is because we would like to obtain information that would be useful in screening for diabetes in pregnancy. This is a condition that may complicate pregnancy and the newborn if undetected and untreated.



The following is a description of the samples and information we would like to collect as part of this study.

If you agree to participate, you will be requested  to go to the lab and have a 50 gram oral glucose given to you and 2 blood samples of 5mls each, for blood sugar testing taken from your forearm veins before administration of the glucose and at 1 hour after taking the glucose.

Your medical care will be the one routinely performed at this institution. Incase your screening test is positive, you shall be sent for a diagnostic test (The 75g OGTT) for which you shall meet the cost as would have been the case out of the study. If the 75g OGTT is diagnostic for diabetes in pregnancy, you shall be followed up in our existing combined Physician-Obsterician-Dietician clinic.


Risks and discomforts


You are not expected to have any additional risks by participating in this study. The collection of blood may result in some discomfort at the needle site.



Participating in this study will not be of direct benefit to you. The knowledge obtained by this project will improve our understanding of the prediction of diabetes in pregnancy. Incase your screening test is positive, you shall benefit from early referral for definitive diagnosis and improved outcome of the pregnancy upon follow up.




You will receive no compensation for participating in this study. In case new protocols are developed as a result of this study, you will not receive monetary or other benefits from the development of such protocols.





Any information you provide during the study will be kept strictly confidential. Your full name will not appear on any study document and only the principal investigator will have access to the information you provide. I shall take full responsibility for your confidentiality.


Right to withdraw.


You are free to choose whether or not you wish to participate. If for any reason, you are not eligible for the study, or decide not to participate, you will receive normal care and standard treatment and medication before, during and after delivery. You will suffer neither penalties nor loss of any benefits should you decide not to participate.


Who to contact


If you have any questions you may ask now or later in pregnancy. If you wish to ask questions later, you may contact the responsible doctor caring for you at the time of your routine prenatal care. You can also reach me (Dr. Francis Githae) through Tel. 0721913815 or 0203662179, Dr. Sequeira through 0203662733 or Dr. Nancy Kunyiha Tel. 0203662798


Your Contacts


You will be requested to provide your telephone and email contact. This shall only be used to remind you of your test booking and for any relevant follow up as found important by the Principal Investigator.


This proposal has been reviewed and approved by the Aga Khan University Hospital research committee, whose task is to make sure that research participants are protected from harm.






 Certificate of Consent for Women to Sign





Participant’s name……………………………………………………………………………………………………….




I have (been) read the information sheet concerning this study and I understand what is required of me if I take part in the study. All my questions and doubts have been answered by you. I agree to take part in this study.




Participant’s signature……………………………………………..Date…………………………………………….


If not able to sign: print name of Independent Witness, date and signature of Witness (if possible, this person should be selected by the participant and should have no connection to the research team)


Witness name………………………………………………………………………………………………………….


Witness signature………………………………………………..Date……………………………………………


Name of researcher…………………………………………………………


Researcher’s signature………………………………………….Date………………………..






Appendix II: criteria for enrolment to the study


Universal versus selected screening for gestational diabetes


Participant’s eligible for participating in this study should fulfil all of the following criteria:


  1. Be 28 weeks gestation or less by best estimated date or first trimester scanning.
  2. Consent to participate in the study
  3. Not suffering from any chronic medical condition or on medication likely to influence glucose metabolism.
  4. Not known diabetics
















Appendix III: Data Collection Questionnaire



Patient Identifier:

FILE NUMBER            


Patient Contacts:

Tel No or email……………………………………………………………………………….



Age (yrs):…………….



Gravidy: Para…….+………






Risk factor history: please tick

Polycystic Ovarian Syndrome  
Previous Gestational diabetes  
Previous impaired glucose tolerance  
Previous  baby >4kg  
Previous unexplained fetal death  
Previous fetal anomalies  





Family history:


Type 2 diabetes in one or several first

Degree relatives.



IF YES Specify who…………………………………………





O’Sullivan Test Results:


Fasting Blood Glucose (mmol/L)  
1 hr post 50g glucose load  


O’Sullivan Test Results Classification: Please Tick


Impaired Glucose Tolerance  
No impaired Glucose Tolerance  




The patients with Impaired Glucose Tolerance shall be offered an OGTT( at patient’s cost).


OGTT Results:


Impaired Glucose Tolerance  



Participants with Normoglycaemia shall be discharged from follow up and continue with regular antenatal care.


Participants with Impaired Glucose Tolerance and Diabetes shall be referred to our multidisciplinary clinic for care.

Appendix IV The Current Screening Guidelines at The Aga Khan University Hospital Nairobi. (see attached PDF document)



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