6.3 i layer Series 1
6.3.3 BG i layer Series 1 Electrical Analysis
There was individual counselling of each woman recruited for the study, after which written consent was obtained from those who agree to participate. See details in the Appendix 1.
33
RESULTS
A total of 5 women were excluded out of the 86 recruited for the study due to development of antenatal complications capable of interfering with Amniotic fluid volume.
While 2 each developed Hypertensive disease in pregnancy and Diabetic mellitus in pregnancy, 1 had spontaneous miscarriage. Thus, a total number of 414 readings were obtained from the 81 patients who underwent more than three examinations. The age range of the study subjects was 15 to 44 years with a mean age of 28 years. The participants ranged from those that were Para zero to Six. The data were normally distributed at each gestation.
The study showed AFI rising from 20 weeks to 28 weeks and thereafter, demonstrated steady but gradual decline as pregnancy advances
Table 1 describes the descriptive data for AFI. The results were stratified by week of gestation. The 5th, 50th and 95th percentiles ranged from 6.58, 14.50
and
18.54 respectively, at 20 weeks to 5.44, 8.15 and 9.01 respectively, at 41 weeks 3 days. It is interesting to note that all the values were within 8 to 25 cm range (which is accepted and established normal range for AFI values worldwide). The maximum value of AFI in any single patient was 18.73 cm and minimum 8.2 cm in the series of low risk antenatal pregnant women studied. If 5th centile (minimum) and 95th centile (maximum) are considered as normal range, it was noted that the corresponding values too were different at different gestational age. These changes are graphically represented in Figure 1.Comparison of the mean age obtained in the study group with that of Caucasians shows statistically significant difference (P = 0.014). Also, comparison with Chama et al shows obvious statistical difference at the lower limit (5th percentile; P = 0.007, mean; P
<0.001) but no differences at the upper limit (95th percentile; P = 0.726). See Tables 3, 4, 5 and 6.
34
Figure 1: Graphical representation of AFI centiles at various gestational ages
0 5 10 15 20 25 30
20 22 24 26 28 30 32 34 36 38 40 41
AFI values (cm)
Gestational Age (Weeks)
5th percentile 50th percentile 95th percentile Mean
35
Table 1: Descriptive representation of AFI
GA
a(weeks) Mean (cm) 5
thcentile (cm) 50
thcentile(cm) 95
thcentile cm) 20 13.82 6.58 14.50 18.54
22 16.59 14.08 16.30 19.88
24 17.40 14.71 17.45 19.43
26 18.19 16.35 18.20 20.00
28 18.73 15.70 19.30 22.05
30 15.03 12.42 14.95 17.68
32 14.25 10.42 15.20 17.10
34 12.46 8.82 12.30 15.08
36 8.75 7.30 9.20 12.46
38 8.57 6.93 8.45 11.65
40 8.38 6.79 8.25 10.11
41
x8.20 5.44 8.15 9.01
GA
a: gestational age, 41
x: 41weeks and 3days
36
Table 2: Analysis of variance on AFI
GA (weeks) Mean AFI Variance
20 13.82 7.96
22 16.59 0.48
24 17.40 0.94
26 18.19 0.94
28 18.73 4.50
30 15.03 2.04
32 16.25 6.00
34 12.46 1.52
36 8.75 1.64
38 6.57 0.60
40 6.38 1.06
41
x8.20 0.54
37
Table 3: Comparative values of AFI with those of Caucasian
GA
a(wks) 50
thcentile(cm) Caucasian values (cm) Nwosu et al
20 14.50 14.30
22 16.30 16.00
24 17.45 17.30
26 18.20 18.20
28 19.30 18.70
30 14.95 19.00
32 15.20 18.80
34 12.30 18.20
36 9.20 17.30
38 8.45 16.10 13.65
40 8.25 14.50
P value =0.014
38
Table 4: Comparative values of 5
thpercentile AFI in the study group with 5
thpercentile of Chama
GAa(wks) 5th centile (cm) Chama 5th percentile (cm)
20 6.35 14.40
22 14.08 16.40
24 14.71 18.72
26 16.35 18.30
28 15.70 16.60
30 12.42 15.25
32 10.42 14.00
34 8.82 11.40
36 7.30 11.30
38 6.93 8.25
40 6.79 4.80
P value = 0.007
39
Table 5: Comparative values of mean AFI in the study group with mean of Chama
GAa(wks) Mean AFI in cm Chama mean in cm
20 13.82 17.18
22 16.59 18.54
24 17.40 20.22
26 18.19 20.39
28 18.73 19.59
30 15.03 17.65
32 16.25 16.72
34 12.46 14.61
36 8.75 13.83
38 6.57 9.71
40 6.23 8.82
P value < 0.001
40
Table 6: Comparative values of 95
thpercentile AFI in the study group with that of Chama
GA
a(wks) 95
thcentile (cm) Chama 95
thpercentile (cm)
20 18.54 20.50
22 19.88 20.10
24 19.43 21.70
26 20.00 23.40
28 22.05 23.20
30 17.68 19.87
32 17.10 18.80
34 15.08 16.70
36 12.46 16.80
38 11.65 10.80
40 10.11 12.60
P value = 0.726
41
DISCUSSION
Amniotic fluid production and regulation is a complex and dynamic process involving fetus, placenta and mother. Amniotic fluid volume gradually increases till 32-34 weeks of gestation and thereafter there is a gradual reduction till term.13, 27 The critical AFI range of 8 to 25 cm signifies fetal well-being and the variation from this range is associated with increase in fetal and maternal complications due to oligohydramnios and polyhyramnios. AFI values most especially in third trimester are proportionate to the fetal urine production, nutrients and oxygen transfer24. Hence, monitoring the AFI has become a standard of antenatal care.
In this study, the gestation specific percentage values of amniotic fluid index have been formulated for the uncomplicated pregnant Abuja women. While various studies34, 76 recorded their peak AFI values at 26th week of gestation, the peak mean AFI value in the present study was recorded at the 28th week of gestation. Igbinidu and colleagues reported similar findings2. Salahuddin et al observed peak AFI values amongst Japanese women at 30 weeks gestation, Birang arrived at a peak mean AFI value at 27weeks gestation in an Iranian population. The difference in these findings may be due to racial and environmental factors78,
79, a reason which is buttressed by the fact that previous studies carried out in the southern Nigeria and northern Nigeria were at variance. Also, the transient drop in the AFI values reported by few studies2, 35 from Nigeria were not observed in this study. This observation is similar to virtually all other studies.
The results of this study compared with 14.3cm – 19cm at 20 -30 weeks and 18.8 – 14.5cm at 32 weeks – 40 weeks for Caucasian population by Nwosu et al31, are significantly different (P = 0.014). The lowest (5th centile) and median (50th centiles) values of AFI from this study also differ statistically from those of Chama however, not statistically different
42
from values obtained at upper limits (P = 0.726), most probably due to the reason stated above.
Also, a wide variation of “normal” AFI values within the same gestational week throughout pregnancy was observed. A feature that is common to most studies of amniotic fluid index. This finding is not surprising though, as Brace and Wolf13 had documented a wide variation in amniotic fluid volume at each gestational week in their study.
This study has determined the curves of normal amniotic fluid values for each gestational age and defined lower and upper limits of normal. The values obtained from this study therefore can serve as a preliminary normogram for quantitatively assessing AFV across this locality. However, it is important to recognise that due to small sample size a larger multicentre studies are needed for proving more accurate estimates of normal range in Nigerian population.
In conclusion therefore, it appears that due to racial and climatic factors, AFI differs from population to population. The reference range of AFI used in clinical practice should therefore be based on data obtained from local population. The values obtained in this study may assist the Obstetrician in this environment in adequately assessing amniotic fluid volume in pregnancy and improving feto-maternal care, thus reducing perinatal morbidity and mortality.
Limitations:
The single centre was recognise as limitation of this study, thus a large multicentre studies are needed for proving more accurate estimate of the normal range in Nigerian women
43
Recommendations:
1. The reference range of AFI values used in clinical practice should be based on data obtained from the local population due to ethnic and racial variations in amniotic fluid index
2. There should be a National multicentre study to determine the reference AFI for Nigeria
44
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53
APPENDIX 1: CONSENT FORM
Introduction: You have been selected to participate in a hospital based study of amniotic fluid index in normal pregnant women at University of Abuja Teaching Hospital, Abuja. The study is premised on the assumption that there is need to establish values of amniotic fluid index for normal pregnancy in our population.
Voluntary nature of participation: Participation in the study is completely voluntary. Thus, although you have been selected you are free to participate in the study or to decide otherwise. If you decide to participate, you are free to withdraw from the study at any stage without any reprisal whatsoever.
Study procedure: There will be ultrasonic examination and measurements of volume of liquor. This will be done after consent has been obtained. A questionnaire will also be administered to you during the course of study and it shall be seeking information on your personal data (excluding your name), acceptance and perception of the procedure.
Risks: Apart from the little discomfort that you may feel during positioning for examination, the procedure is entirely non-invasive. However, possible risks though rare, associated with the procedure include heat, cavitation (pocket of gas in organs e.g lung and intestine) and acoustic streaming (jet of fluid). However, these risks are rare at six examinations being proposed for this study.
Confidentiality: All information gathered as well as the outcome of the procedure will be treated with utmost confidentiality, and will not be use against you in any form. Also, data presented from this information will not in any way reveal the individual participants.
Feedbacks: The researcher will be at hand every time to answer question(s) you may have concerning the study. Similarly, the researcher will be available in the hospital to answer any
54
questions or deal with any problems that may arise from the study. You can also reach the researcher on 08030415232 or at the Department of Obstetrics and Gynaecology, UATH, Abuja.
Response: I have read and understood the above (or had someone read and explained the entire study to me). Also, all gray areas have been clarified. I fully understood the nature, risks and benefit of the study and hereby consent to participate in it.
Thank you very much for agreeing to participate in this clinical trial.
... ... ... ...
Name and signature of participant Name and signature of witness
Date... Date...
...
Name and signature of Researcher
Date...
55
APPENDIX 2: QUESTIONNAIRE
Please Information given will be treated with utmost confidentiality. Tick the appropriate box or list.
1. Age in years (as at last birthday)...
2. Marital status: Single Married Widowed Divorced
3. Highest level of education completed...
4. Occupation...
5. Religion...
6. Ethnic group.... ...
7. Last menstrual period...
8. Have had ultrasound scan done before in this pregnancy yes Yes No
9. If yes, when is your USS EDD...
56
APPENDIX 3: PROFORMA
A longitudinal study of amniotic fluid index in normal pregnancy at University of Abuja Teaching Hospital, Abuja.
Serial number... Date...
Section A: Bio-data
1. Hospital number...
2. Age (Last birthday)...
3. Parity: Nulliparous ( ) Multipara ( ) 4. Gestational age at booking in weeks ( ) 5. Is pregnancy booked before: Yes ( ) No( )
6. If Question 5 is yes, where and at what gestation...
Section B: Identification of confounding factors
Hypertensive disorder of pregnancy
Diabetes
Intrauterine growth restriction
Sickle cell disease
Poor obstetrics history
Oligohydramnious
Haemoglobinopathy
Others (specify)...