This was a hospital-based prospective cohort study to investigate the abnormal umbilical Doppler: incidence and neonatal outcomes along with the diagnostic efficacy of umbilical Doppler among women with hypertensive disorders in pregnancy at KCMC-zonal referral hospital in the northern part of Tanzania between August 2022 to March 2023. The AUD was detected by screening hypertensive pregnant women who attended ANC at the obstetrics/gynecology clinic and those admitted to the maternity ward through the labor ward at KCMC. Umbilical artery Doppler indices were RI, PI, and S/D and they were considered abnormal if their values were above the 95^th percentile of the respective gestation age. This design was appropriate to determine the incidence of AUD and the neonatal outcome among women with HDP in the specified study frame in a given period.

This study was conducted at KCMC zonal consultancy referral hospital, located at Moshi municipal council in Northern Tanzania. The site was purposively selected because of having screening capacity, and the number of women who attended ANC and those admitted for obstetrics care was high per day which was a good site for this study. Knowing that this is the zonal consultancy referral hospital with an average of 3000 women admitted per month, and about half of these women were referred from other facilities for which the majority of them presented with a high risk of pregnancy-related complications including HDP, so the hypertensive disorders cases could be easily reached.

Women with hypertensive disorders in pregnancy attended ANC and those admitted in the maternity ward through the labor ward at KCMC hospital in Obstetrics and Gynecology department during the study period.

This was a hospital-based prospective cohort study to investigate the abnormal umbilical Doppler: incidence and neonatal outcomes along with the diagnostic efficacy of umbilical Doppler among women with hypertensive disorders in pregnancy at KCMC-zonal referral hospital in the northern part of Tanzania between August 2022 to March 2023. The AUD was detected by screening pregnant women who attended ANC at the obstetrics/gynecology clinic and those admitted to the maternity ward through the labor ward at KCMC as shown in Appendix I. Umbilical artery Doppler indices were RI, PI, and S/D and they were considered abnormal if their values were above the 95^th percentile of the respective gestation age. This design was appropriate to determine the incidence of AUD and the neonatal outcome among women with HDP in the specified study frame in a given period.

This study was conducted at KCMC zonal consultancy referral hospital, located at Moshi municipal council in Northern Tanzania. The site was purposively selected because of having screening capacity, and the number of women who attended ANC and those admitted for obstetrics care was high per day which was a good site for this study. Knowing that this is the zonal consultancy referral hospital with an average of 3000 women admitted per month, and about half of these women were referred from other facilities for which the majority of them presented with a high risk of pregnancy-related complications including HDP, so the hypertensive disorders cases could be easily reached (Appendix II).

All statistical calculations were coded and entered using the statistical package SPSS (Statistical Package for the Social Sciences) version 25 and Stata 17.

Data were statistically described in terms of mean, standard deviation (± SD), median, and range for qualitative data or frequencies (number of cases) and percentages for categorical data.

Comparison of numerical variables between the study groups was done using the student t-test for independent samples when normally distributed and the Mann-Whitney U test for independent samples when not normally distributed.

For comparing categorical data, Chi-square (χ²) test was performed. When the expected frequency is  <5, Fisher’s exact test was used instead.

The test of sensitivity, specificity, and positive and negative predictive values (PPV and NPV) was used.

Multivariate logistic regression analysis was used to determine the association between AUD and neonatal outcomes.

For all tests, P values less than 0.05 was considered statistically significant.

Ethical approval to conduct this study no PG106/2022 was obtained from KCMU College and Research Ethics Review Committee. Permission to carry out this study was obtained from the Executive Director of the KCMC together with Head of the obstetrics and gynecology and radiology departments. Written and verbal informed consent were obtained from the study participants. Participants were given unique identification numbers to ensure privacy and confidentiality.

During the study period from August 2022 to March 2023, there were a total of 119 enrolled hypertensive pregnant women. We excluded 3 (2.52%) women who lost follow-up, 3 (2.50%) with critical conditions who were admitted to ICU and could not be taken to the radiology department for Doppler assessment, 1 (0.88%) who missed some of the Doppler indices the remaining 112 were included in the analysis as shown in Figure 1 .

Most of the patients were aged 31years and above 50 (44.64%) 16 (32.00%) presented with abnormal umbilical Doppler while 34 (68.00%) presented with normal umbilical Doppler study, the least patients were of age less than 20 years 13 (11.61%) and the mean age was (Mean ± SD) (29.16 ± 6.248) as shown in Table 1 .

The overall incidence of abnormal umbilical Doppler among 112 participants was 38 (33.93%) while that of normal umbilical Doppler was 74 (66.07%) in which the characteristics of indices were higher with abnormal RI 37 (33.04%), followed by abnormal PI and S/D both 31 (27.68%) each and the least being the absence of EDF 8 (7.14%) (see Table 2 ).

EDF-end diastolic flow; PI-pulsitility index; RI-resistive index; S/D-systole/diastole ratio.

Low birth weight was in 21 (18.75%) of which 13 (61.90%) were from women with abnormal umbilical Doppler and only 8 (38.10%) had normal umbilical Doppler.

Among 112 patients only 8 (7.14%) delivered neonates with low Apgar scores of less than 7 in 5^th minute for which 4 (3.57%) were from the group of abnormal umbilical Doppler study.

Neonatal ICU admission was found to be 18 (16.07%) of which 13 (72.22%) were neonates from women with abnormal umbilical Doppler findings and only 5 (27.78%) were from the control group.

Early neonatal death was in 6 (5.36%) for which only 2 (33.33%) out of 4 (66.67%) were from women with abnormal umbilical Doppler.

The group with abnormal umbilical artery Doppler had a 4.29 times probability of getting neonates of low birth weight compared to the normal Doppler group. After adjusting for other variables, the adjusted odds ratio (aOR) remained the same at 4.52. The crude odds ratio (cOR) and adjusted odds ratio (aOR) were statistically significant with p values of 0.004 and 0.005, respectively. This suggests that abnormal umbilical artery Doppler measurements are independently associated with an increased risk of low birth weight, even after accounting for other variables.

There was no significant difference in the probability of having a low Apgar score between the abnormal Doppler group and the normal Doppler group. The crude odds ratio (cOR) and adjusted odds ratio (aOR) were not statistically significant. This suggests that Doppler measurements of the umbilical artery are not associated with an increased risk of low Apgar scores.

There was no significant association between umbilical artery Doppler measurements and neonatal death. The crude odds ratio (cOR) and adjusted odds ratio (aOR) were not statistically significant.

The group with abnormal umbilical artery Doppler was 7.18 times more likely to be admitted to the ICU compared to the normal Doppler group. After adjustment for other variables, the adjusted odds ratio (aOR) increased to 9.71, indicating a strong association. The crude odds ratio (cOR) and adjusted odds ratio (aOR) were statistically significant with p values of 0.001 and 0.000 respectively as shown in Table 3 .

From this study we found 61.90% of cases with low birth weight are correctly identified based on the abnormal Doppler findings and 72.50% of cases without low birth weight are correctly identified based on normal Doppler findings.

72.2% of cases with ICU admission are correctly identified based on the abnormal Doppler findings and 73.4% of cases without ICU admission are correctly identified based on normal Doppler findings (see Table 4 ).

cOR = crude odds ratio, aOR = adjusted odds ratio P value = probability value CI = confidence interval. The neonatal outcomes were adjusted for use of steroids, smoking, parity and alcohol consumption.

PID: ………………….

Greetings! Yusuph Mwidibo, a student of Kilimajar Christian Medical University College, conducting research entitled “Abnormal umbilical Doppler: incidence and neonatal outcomes among hypertensive disorders in pregnancy at KCMC-Ahospital based prospective cohort study.”.

Purpose of the study: The purpose of this observational study is to determine the incidence and neonatal outcomes of abnormal umbilical Doppler in hypertensive disorders in pregnancy.

What participation involves

If you agree to participate in this study, you will be required to answer questions about Nutrition assessment and associated factors. Do not hesitate because in this assessment there are no RIGHT or WRONG answers. You can stop involving yourself in this study at any time, even if you have already given your consent. Refusal to participate or withdrawal from the study will not involve penalty or loss of your role in the facility.

Confidentiality You are strongly assured of the confidentiality of the information collected from you and that it will only be used for the purpose of this study and anonymity will highly be observed when collecting data and compiling reports. All of the information that you provide for the study will be kept completely confidential. We record your responses, but the questionnaire will not have your name on it, and your responses to our questions are identified only by a number, never by name.

Risks: No anticipated risk or harm that may result from participating in this study.

Right of participation in the study: Your participation is absolutely voluntary and there is no penalty for refusing to participate.

Benefits: Although there are no direct benefits to you from participating in this survey, we hope that the survey will help to come up with interventions that will be useful for reducing the effects of morbidity and serious harm related to hypertensive disorders of pregnancy.

Contact Person: If you have questions or concerns after we are finished, you may contact the principal investigator via email: mwidiboy@gmail.com; or mobile: +255 759 798 267

Kindly provide us with your consent. If you agree to participate in this study, please sign this consent form. I have read and understood the contents of this form and I have been given a satisfactory explanation with all my questions answered. I therefore consent to participate in this study.

Signature of the participant …………………… Date…………………

Signature of research assistant……………… Date …………………

1.0 DEMOGRAPHIC AND OBSTETRIC HISTORY

1.1 Age of the participant (years): __________________

1.2 Current residence: ☐ Rural ☐Urban ☐Semi urban

1.3 Marital Status: ☐ Married ☐ Single ☐ Widowed ☐ Divorced

1.4 Occupation: ☐ Housewife ☐ Farmer ☐ Service business ☐ others

1.5 Education level: ☐ None ☐ Secondary ☐ Primary ☐ Higher

1.6 Referred patient: ☐ Yes ☐ No

If Yes: Referred from: ☐ Home ☐ District hospital ☐ regional hospital

1.7 Referred during labor: ☐ Admitted in labor ☐ Admitted before ☐ labor

1.8 Alcohol consumption: ☐ Yes ☐ No

1.9 Smoker: ☐ Yes ☐ No

1.10 Physical activity during pregnancies: ☐ Yes ☐ No

1.11 Number of antenatal visits: _________________________

1.12 History of abortion: _____________________________

1.13 Number of births/pregnancies: ____________________________

1.14 Number births (parity): ________________________________

1.15 Number of live children: ______________________________

1.16 MUAC: ____________________________

1.17. list of medications used during this pregnancy……………………………

1.18. umbilical artery Doppler indices with its corresponding gestational age………………..

1.19. interpretation of each umbilical artery Doppler index whether normal/abnormal……………………………….

2.0 OBSTETRIC EXAMINATION

2.1 Gestation age at admission (wks): ____________

2.2. BP (mmHg): __________________

2.3 urine Dipstick: _______________

2.4 Urine color: _______________

2.5 Albumin deposits: _______________

2.6 Hemoglobin: _______________

2.7 Blood urea: _______________

2.8 sugar: _______________

2.9 serum createnine: _______________

2.10 Complaints during admission (put a tick if applied):

2.11 Blood pressure during pregnancy (if any): _____ (mmHg)

2.12 Proteinuria: ______

2.13 Diseases and complications during present pregnancy

_______________________________________________________________________________________________________

3.0 DOPPLER AND OTHER CLINICAL INVESTIGATIONS

3.1 Fetal distress: __________________

3.2 Fetal heart rate during labor: __________________

DOPPLER ASSESSMENTS

3.3 Umbilical artery Doppler: __________________

3.4 Doppler ultrasound of umbilical artery

4.0 NEONATAL OUTCOME

4.1 Mode of delivery

4.2 Birth weight of the baby delivered: _______________

4.3 Apgar score: ____________

4.4 Small for gestational age

4.5 Neonate status

4.6 If born alive, admission to ICU

4.7 Any other complications during child birth:

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4.8 Other neonatal outcome: _____________________________________