Offspring of Pre-eclamptic MothersNCT05091827
Cardiovascular Risk in Infants Exposed to Pre-eclampsia in Utero
An observational study of Offspring of Pre-eclamptic Mothers, run by Walter Sisulu University.
Trial summary
An increasing number of scientific publications show that high blood pressure is being described in younger and younger children of African ancestry. It therefore makes sense to seek for the causes of this raised blood pressure in the in utero events. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Offspring of Pre-eclamptic Mothers
- How many people
- 234 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2021to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pre-eclamptic and normotensive pregnant women and their offspring.
Who may be able to join
- Pre-eclamptic or normotensive pregnant women with singleton uncomplicated ≥ 20 week old pregnancies and their offspring will be recruited for the study.
Who cannot join
- Pregnant women with chronic hypertension, type 2 diabetes, gestational diabetes, renal and cardiovascular diseases or any critical health condition will be excluded from the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment of the Cardiovascular Risk Profile of Infants Exposed to Pre-eclampsia in Utero
An increasing number of scientific publications show that high blood pressure is being described in younger and younger children of African ancestry. It therefore makes sense to seek for the causes of this raised blood pressure in the in utero events. Recent studies have attributed and increased risk to cardiovascular disease (CVD) risk factors to the gestational environment. Pre-eclampsia (PE) is associated with endothelial dysfunction and oxidative stress in the mother which may influence how the developing foetus interacts with the external environment later on in life. Indeed scientific literature suggests that the foeto-placental vascular endothelial dysfunction may cause epigenetic alteration in the intrauterine environment of the foetus which may be at the origin of chronic diseases in children, thus predisposing them to risk factors of CVD. However, very few studies in women of African ancestry have been carried out to investigate whether or not children born of pre-eclamptic mothers of African ancestry are at risk of developing CVDs. Hence, the aim of this study is to investigate the relationship between pre-eclampsia and cardiovascular risk in children born to pre-eclampsic mothers in a rural South African population. A prospective case-control control design recruiting pre-eclamptic and normotensive pregnant women and their offspring subsequently will be used. CVD risk will be accessed in the pregnant women at 30 weeks of gestation and in the offspring at birth and then six weeks later. The difference in CVD risk between children born to these two groups of women will be assessed and the correlation between maternal and offspring risks for CVDs determined. It is expected that results obtained from this project will provide information on the cardiovascular effect of in utero exposure to PE in a population of African ancestry. This knowledge will advise policy on the management of women with pre-eclampsia with a view of preventing cardiovascular diseases in the offspring. Furthermore, the project will afford the opportunity for scientific research capacity building in students in Walter Sisulu University and foster collaboration between clinical and fundamental researchers.
Read the detailed description
Study design This will be a prospective case-control study involving babies born to pre-eclamptic (cases) pregnant women as the case and babies born to normotensive mothers (control). The mothers will be recruited at the Nelson Mandela Academic Hospital, Mthatha, Eastern Cape Province of South Africa. This is a tertiary hospital to which all specialist cases are referred from the peripheral hospitals. Even though the prevalence of PE in South Africa is just over 5% nationally, 18% of all obstetric cases consulted in the Nelson Mandela Academic Hospital in Mthatha are PE cases (unpublished data). It will therefore not be a great challenge to recruit the desired number of PE patients over the study period.
Sample size calculation The study done by Amini et al, (2010) showed blood pressure (BP) differences between neonates from normotensive and pre-eclamptic mothers5. The difference in blood systolic BP (SBP) was very high (normotensive: 49.85±5.49 versus pre-eclamptic: 68.2±149). Because the SBP variance and standard deviation were very high in the pre-eclamptic group, we decided to rather use the diastolic blood pressure values (normotensive: 30.17±11.89 versus pre-eclamptic: 42.11±11.49) for sample size calculation. The software - R was used: alpha = 0.01, mean difference = 11.94 and standard = 0.05 respectively were used. The results showed that total sample size is 97 (48 cases and 49 controls). We make the assumption that not all participants would return for the follow-up. Thus we adjusted our sample size by 20% to compensate for possible loses to follow-up. Therefore the total sample will be 97 + (97x20/100) = 117 neonates. However the study will start with the recruitment of 117 pregnant women (58 pre-eclamptic women and 59 normotensive pregnant women who meet the selection criteria).
Ethical approval Ethical approval and permission to carry out the research project has been applied for from Faculty of Health Sciences Research and Ethics Committee (HRSEC) at Walter Sisulu University (WSU). When the project is approved the Provincial and District Departments of Health will be approached for clearance and approval.
Informed consent The purpose of the study will be explained thoroughly to potential participants attending the antenatal clinic in the Nelson Mandela Academic Hospital, Mthatha, Eastern Cape Province. Pregnant women who meet the selection criteria and are willing to participate in the study will be required to sign informed consent forms to participate in the study and to allow their children to participate in the study from birth.
Research Protocol Pregnant women who meet the selection criteria will be recruited between weeks 20-26 of gestation while data will be collected in week 30 of gestation. Participants will be reminded of the hospital visit for data collection in advance to enable them make all necessary preparation to spend some extra time at the hospital.
- Baseline information: Maternal demographic, obstetric and medical history will be collected from participant using a questionnaire.
- Anthropometric measurements: Height and weight will be determined as per recommendations of the NHANES, 2009-2010 recommendations24
- Confirmation of pre-eclampsia status: Hospital files will be used to confirm pre-eclampsia status.
- Blood pressure measurements: Office blood pressure will be measured as described by Putner et al., (2019)25
- Flow mediated dilatation. A Mobile Esaote MyLabTM Five portable ultrasound device (Genoa, Italy) with an Esaote Doppler probe (LA523, 12 MHz) connected to computerized software with edge detection technology (Quipu Cardiovascular Suite (CVS)™; Pisa, Italy) will be used. Endothelial function will be measured as described by Strijdom et al (2017)26
- Gestational ultrasound will be performed to determine placental morphometry, architecture and vascularization. Uterine arteries, umbilical artery and middle cerebral artery will be assessed and uterine artery mean pulsating index determined. Foetal cerebroplacental ratio and anthropometry will be calculated when possible.
- Measurement of markers of oxidative stress : Fasting blood will be collected for determination of oxidative stress in the maternal environment to which the foetus is exposed.
At birth: The Gestational age at delivery and mode of delivery will be noted. The APGAR score (1-5 minutes), will be determined, weight and height/length of the child will be measured. Cord blood will be collected for determination of titres of CVD risk as indicated below.
- Markers of endothelial function: Endocan and asymmetric dimethyl arginine (ADMA), markers of endothelial function will be assayed using ELISA kits as per manufacturers' instructions.
- Markers of oxidative stress: Lipid peroxidation, total antioxidant capacity and 8-hydoxyl-2-deoxyguanine (8-OHdG) will be determined using ELISA kits as per manufacturer's protocols.
- Lipid profile : Total cholesterol, triglyceride, LDL cholesterol and HDL cholesterol, and oxidised LDL-cholesterol will be measured as per manufacturer's protocol using colorimetric kits as per manufacturers' instructions
- Insulin Resistance: Fasting glucose, glycated haemoglobin and insulin concentrations will be determined as per manufacturer's methods. The HOMA-IR formula will be used to calculate insulin resistance from fast glucose and insulin as described by Mather et al, 1985)27.
- Renal function indices: glomerular filtration rate (GFR), creatinine and albumin will be determined using colorimetric kits as per manufacturers' instructions
- Blood pressure measurements: The oscillometric technique (Dinamap 8100) will be used for BP measurement according to the standard protocol for assessment of BP measurement in newborns by Nwankwo et al. (1997)28.
- Anthropometric measurements: All measures were done as reported by Meldere et al. (2013) 29.
- Arterial stiffness will be assessed by measuring Brachio-femoral pulse wave velocity (bfPWV) using an oscillometric device (Vicorder, Skidmore Medical) as reported by Alwan et al., 201530.
- Conditions
- Offspring of Pre-eclamptic Mothers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women with pre-eclampsia | Pre-eclamptic pregnant women with singleton uncomplicated ≥ 20 week old pregnancies will be recruited in this group of the study. | |
| Normotensive pregnant women | Normotensive pregnant women with singleton uncomplicated ≥ 20 week old pregnancies will be recruited in this group of the study | |
| Offspring of pre-eclamptic women | Both male and female offspring of pre-eclamptic women recruited in this study will be recruited into this study group. | |
| Offspring of normotensive pregnant women | Both male and female offspring of from normotensive pregnant women recruited in this study will be recruited into this study group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular risk outcomes of children exposed to pre-eclampsia in vitro.
The study will monitor both biochemical and physical risks of cardiovascular risk in exposed children during the second and third trimesters and pregnancy and up to one year after birth.
Measured: January 2022 to December 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start30 Nov 2021 (estimated)
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Offspring of Pre-eclamptic MothersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Sisulu University
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, South Africa, Medical University of Graz
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091827
- Sponsor's protocol ID
- 070/2021
- Status last verified
- Oct 2021
- First submitted
- 12 Oct 2021
- Last updated
- 25 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data collected from individual participants will be synthesize, analyzed and reported as processed data and not as individual data.
Publications
ACOG Practice Bulletin No. 202 Summary: Gestational Hypertension and Preeclampsia. Obstet Gynecol. 2019 Jan;133(1):1. doi: 10.1097/AOG.0000000000003019.
PubMed 30575668Bartsch E, Medcalf KE, Park AL, Ray JG; High Risk of Pre-eclampsia Identification Group. Clinical risk factors for pre-eclampsia determined in early pregnancy: systematic review and meta-analysis of large cohort studies. BMJ. 2016 Apr 19;353:i1753. doi: 10.1136/bmj.i1753.
PubMed 27094586Belay AS, Wudad T. Prevalence and associated factors of pre-eclampsia among pregnant women attending anti-natal care at Mettu Karl referal hospital, Ethiopia: cross-sectional study. Clin Hypertens. 2019 Jul 1;25:14. doi: 10.1186/s40885-019-0120-1. eCollection 2019.
PubMed 31304042Campos-Canas J, Romo-Palafox I, Albani-Campanario M, Hernandez-Guerrero C. An imbalance in the production of proinflammatory and anti-inflammatory cytokines is observed in whole blood cultures of preeclamptic women in comparison with healthy pregnant women. Hypertens Pregnancy. 2014 May;33(2):236-49. doi: 10.3109/10641955.2013.858744. Epub 2014 Jan 6.
PubMed 24392828Chambers JC, Fusi L, Malik IS, Haskard DO, De Swiet M, Kooner JS. Association of maternal endothelial dysfunction with preeclampsia. JAMA. 2001 Mar 28;285(12):1607-12. doi: 10.1001/jama.285.12.1607.
PubMed 11268269Corretti MC, Anderson TJ, Benjamin EJ, Celermajer D, Charbonneau F, Creager MA, Deanfield J, Drexler H, Gerhard-Herman M, Herrington D, Vallance P, Vita J, Vogel R; International Brachial Artery Reactivity Task Force. Guidelines for the ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery: a report of the International Brachial Artery Reactivity Task Force. J Am Coll Cardiol. 2002 Jan 16;39(2):257-65. doi: 10.1016/s0735-1097(01)01746-6.
PubMed 11788217Craici I, Wagner S, Garovic VD. Preeclampsia and future cardiovascular risk: formal risk factor or failed stress test? Ther Adv Cardiovasc Dis. 2008 Aug;2(4):249-59. doi: 10.1177/1753944708094227.
PubMed 19124425Friedman SA, Schiff E, Emeis JJ, Dekker GA, Sibai BM. Biochemical corroboration of endothelial involvement in severe preeclampsia. Am J Obstet Gynecol. 1995 Jan;172(1 Pt 1):202-3. doi: 10.1016/0002-9378(95)90113-2.
PubMed 7847535Leiva A, Pardo F, Ramirez MA, Farias M, Casanello P, Sobrevia L. Fetoplacental vascular endothelial dysfunction as an early phenomenon in the programming of human adult diseases in subjects born from gestational diabetes mellitus or obesity in pregnancy. Exp Diabetes Res. 2011;2011:349286. doi: 10.1155/2011/349286. Epub 2011 Nov 24.
PubMed 22144986Lowe DT. Nitric oxide dysfunction in the pathophysiology of preeclampsia. Nitric Oxide. 2000 Aug;4(4):441-58. doi: 10.1006/niox.2000.0296.
PubMed 10944429Maynard SE, Min JY, Merchan J, Lim KH, Li J, Mondal S, Libermann TA, Morgan JP, Sellke FW, Stillman IE, Epstein FH, Sukhatme VP, Karumanchi SA. Excess placental soluble fms-like tyrosine kinase 1 (sFlt1) may contribute to endothelial dysfunction, hypertension, and proteinuria in preeclampsia. J Clin Invest. 2003 Mar;111(5):649-58. doi: 10.1172/JCI17189.
PubMed 12618519Meeme A, Buga GA, Mammen M, Namugowa A. Endothelial dysfunction and arterial stiffness in pre-eclampsia demonstrated by the EndoPAT method. Cardiovasc J Afr. 2017 Jan/Feb 23;28(1):23-29. doi: 10.5830/CVJA-2016-047. Epub 2016 May 19.
PubMed 27196639Mol BWJ, Roberts CT, Thangaratinam S, Magee LA, de Groot CJM, Hofmeyr GJ. Pre-eclampsia. Lancet. 2016 Mar 5;387(10022):999-1011. doi: 10.1016/S0140-6736(15)00070-7. Epub 2015 Sep 2.
PubMed 26342729Nakimuli A, Chazara O, Byamugisha J, Elliott AM, Kaleebu P, Mirembe F, Moffett A. Pregnancy, parturition and preeclampsia in women of African ancestry. Am J Obstet Gynecol. 2014 Jun;210(6):510-520.e1. doi: 10.1016/j.ajog.2013.10.879. Epub 2013 Oct 30.
PubMed 24184340Noori M, Donald AE, Angelakopoulou A, Hingorani AD, Williams DJ. Prospective study of placental angiogenic factors and maternal vascular function before and after preeclampsia and gestational hypertension. Circulation. 2010 Aug 3;122(5):478-87. doi: 10.1161/CIRCULATIONAHA.109.895458. Epub 2010 Jul 19.
PubMed 20644016
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Cardiovascular Risk Profile of Infants Exposed to Pre-eclampsia in Utero
- ClinicalTrials.gov ID
- NCT05091827
- Acronym / sponsor ID
- 070/2021
- Conditions
- Offspring of Pre-eclamptic Mothers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Walter Sisulu UniversityUniversity, hospital or other
- Collaborators
- Medical Research Council, South Africa, Medical University of Graz
- Study start
- 30 Nov 2021 (estimated)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An increasing number of scientific publications show that high blood pressure is being described in younger and younger children of African ancestry. It therefore makes sense to seek for the causes of this raised blood pressure in the in utero events. Recent studies have attributed and increased risk to cardiovascular disease (CVD) risk factors to the gestational environment. Pre-eclampsia (PE) is associated with endothelial dysfunction and oxidative stress in the mother which may influence how the developing foetus interacts with the external environment later on in life. Indeed scientific literature suggests that the foeto-placental vascular endothelial dysfunction may cause epigenetic alteration in the intrauterine environment of the foetus which may be at the origin of chronic diseases in children, thus predisposing them to risk factors of CVD. However, very few studies in women of African ancestry have been carried out to investigate whether or not children born of pre-eclamptic mothers of African ancestry are at risk of developing CVDs. Hence, the aim of this study is to investigate the relationship between pre-eclampsia and cardiovascular risk in children born to pre-eclampsic mothers in a rural South African population. A prospective case-control control design recruiting pre-eclamptic and normotensive pregnant women and their offspring subsequently will be used. CVD risk will be accessed in the pregnant women at 30 weeks of gestation and in the offspring at birth and then six weeks later. The difference in CVD risk between children born to these two groups of women will be assessed and the correlation between maternal and offspring risks for CVDs determined. It is expected that results obtained from this project will provide information on the cardiovascular effect of in utero exposure to PE in a population of African ancestry. This knowledge will advise policy on the management of women with pre-eclampsia with a view of preventing cardiovascular diseases in the offspring. Furthermore, the project will afford the opportunity for scientific research capacity building in students in Walter Sisulu University and foster collaboration between clinical and fundamental researchers.
Detailed description
Study design This will be a prospective case-control study involving babies born to pre-eclamptic (cases) pregnant women as the case and babies born to normotensive mothers (control). The mothers will be recruited at the Nelson Mandela Academic Hospital, Mthatha, Eastern Cape Province of South Africa. This is a tertiary hospital to which all specialist cases are referred from the peripheral hospitals. Even though the prevalence of PE in South Africa is just over 5% nationally, 18% of all obstetric cases consulted in the Nelson Mandela Academic Hospital in Mthatha are PE cases (unpublished data). It will therefore not be a great challenge to recruit the desired number of PE patients over the study period.
Sample size calculation The study done by Amini et al, (2010) showed blood pressure (BP) differences between neonates from normotensive and pre-eclamptic mothers5. The difference in blood systolic BP (SBP) was very high (normotensive: 49.85±5.49 versus pre-eclamptic: 68.2±149). Because the SBP variance and standard deviation were very high in the pre-eclamptic group, we decided to rather use the diastolic blood pressure values (normotensive: 30.17±11.89 versus pre-eclamptic: 42.11±11.49) for sample size calculation. The software - R was used: alpha = 0.01, mean difference = 11.94 and standard = 0.05 respectively were used. The results showed that total sample size is 97 (48 cases and 49 controls). We make the assumption that not all participants would return for the follow-up. Thus we adjusted our sample size by 20% to compensate for possible loses to follow-up. Therefore the total sample will be 97 + (97x20/100) = 117 neonates. However the study will start with the recruitment of 117 pregnant women (58 pre-eclamptic women and 59 normotensive pregnant women who meet the selection criteria).
Ethical approval Ethical approval and permission to carry out the research project has been applied for from Faculty of Health Sciences Research and Ethics Committee (HRSEC) at Walter Sisulu University (WSU). When the project is approved the Provincial and District Departments of Health will be approached for clearance and approval.
Informed consent The purpose of the study will be explained thoroughly to potential participants attending the antenatal clinic in the Nelson Mandela Academic Hospital, Mthatha, Eastern Cape Province. Pregnant women who meet the selection criteria and are willing to participate in the study will be required to sign informed consent forms to participate in the study and to allow their children to participate in the study from birth.
Research Protocol Pregnant women who meet the selection criteria will be recruited between weeks 20-26 of gestation while data will be collected in week 30 of gestation. Participants will be reminded of the hospital visit for data collection in advance to enable them make all necessary preparation to spend some extra time at the hospital.
- Baseline information: Maternal demographic, obstetric and medical history will be collected from participant using a questionnaire.
- Anthropometric measurements: Height and weight will be determined as per recommendations of the NHANES, 2009-2010 recommendations24
- Confirmation of pre-eclampsia status: Hospital files will be used to confirm pre-eclampsia status.
- Blood pressure measurements: Office blood pressure will be measured as described by Putner et al., (2019)25
- Flow mediated dilatation. A Mobile Esaote MyLabTM Five portable ultrasound device (Genoa, Italy) with an Esaote Doppler probe (LA523, 12 MHz) connected to computerized software with edge detection technology (Quipu Cardiovascular Suite (CVS)™; Pisa, Italy) will be used. Endothelial function will be measured as described by Strijdom et al (2017)26
- Gestational ultrasound will be performed to determine placental morphometry, architecture and vascularization. Uterine arteries, umbilical artery and middle cerebral artery will be assessed and uterine artery mean pulsating index determined. Foetal cerebroplacental ratio and anthropometry will be calculated when possible.
- Measurement of markers of oxidative stress : Fasting blood will be collected for determination of oxidative stress in the maternal environment to which the foetus is exposed.
At birth: The Gestational age at delivery and mode of delivery will be noted. The APGAR score (1-5 minutes), will be determined, weight and height/length of the child will be measured. Cord blood will be collected for determination of titres of CVD risk as indicated below.
- Markers of endothelial function: Endocan and asymmetric dimethyl arginine (ADMA), markers of endothelial function will be assayed using ELISA kits as per manufacturers' instructions.
- Markers of oxidative stress: Lipid peroxidation, total antioxidant capacity and 8-hydoxyl-2-deoxyguanine (8-OHdG) will be determined using ELISA kits as per manufacturer's protocols.
- Lipid profile : Total cholesterol, triglyceride, LDL cholesterol and HDL cholesterol, and oxidised LDL-cholesterol will be measured as per manufacturer's protocol using colorimetric kits as per manufacturers' instructions
- Insulin Resistance: Fasting glucose, glycated haemoglobin and insulin concentrations will be determined as per manufacturer's methods. The HOMA-IR formula will be used to calculate insulin resistance from fast glucose and insulin as described by Mather et al, 1985)27.
- Renal function indices: glomerular filtration rate (GFR), creatinine and albumin will be determined using colorimetric kits as per manufacturers' instructions
- Blood pressure measurements: The oscillometric technique (Dinamap 8100) will be used for BP measurement according to the standard protocol for assessment of BP measurement in newborns by Nwankwo et al. (1997)28.
- Anthropometric measurements: All measures were done as reported by Meldere et al. (2013) 29.
- Arterial stiffness will be assessed by measuring Brachio-femoral pulse wave velocity (bfPWV) using an oscillometric device (Vicorder, Skidmore Medical) as reported by Alwan et al., 201530.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with pre-eclampsia | – | –Pre-eclamptic pregnant women with singleton uncomplicated ≥ 20 week old pregnancies will be recruited in this group of the study. |
| Normotensive pregnant women | – | –Normotensive pregnant women with singleton uncomplicated ≥ 20 week old pregnancies will be recruited in this group of the study |
| Offspring of pre-eclamptic women | – | –Both male and female offspring of pre-eclamptic women recruited in this study will be recruited into this study group. |
| Offspring of normotensive pregnant women | – | –Both male and female offspring of from normotensive pregnant women recruited in this study will be recruited into this study group. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pre-eclamptic and normotensive pregnant women and their offspring.
Key inclusion criteria (1 listed)
- Pre-eclamptic or normotensive pregnant women with singleton uncomplicated ≥ 20 week old pregnancies and their offspring will be recruited for the study.
Key exclusion criteria (1 listed)
- Pregnant women with chronic hypertension, type 2 diabetes, gestational diabetes, renal and cardiovascular diseases or any critical health condition will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiovascular risk outcomes of children exposed to pre-eclampsia in vitro.
Time frame: January 2022 to December 2023
The study will monitor both biochemical and physical risks of cardiovascular risk in exposed children during the second and third trimesters and pregnancy and up to one year after birth.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Background: PubMed 30575668ACOG Practice Bulletin No. 202 Summary: Gestational Hypertension and Preeclampsia. Obstet Gynecol. 2019 Jan;133(1):1. doi: 10.1097/AOG.0000000000003019.
- Background: PubMed 27094586Bartsch E, Medcalf KE, Park AL, Ray JG; High Risk of Pre-eclampsia Identification Group. Clinical risk factors for pre-eclampsia determined in early pregnancy: systematic review and meta-analysis of large cohort studies. BMJ. 2016 Apr 19;353:i1753. doi: 10.1136/bmj.i1753.
- Background: PubMed 31304042Belay AS, Wudad T. Prevalence and associated factors of pre-eclampsia among pregnant women attending anti-natal care at Mettu Karl referal hospital, Ethiopia: cross-sectional study. Clin Hypertens. 2019 Jul 1;25:14. doi: 10.1186/s40885-019-0120-1. eCollection 2019.
- Background: PubMed 24392828Campos-Canas J, Romo-Palafox I, Albani-Campanario M, Hernandez-Guerrero C. An imbalance in the production of proinflammatory and anti-inflammatory cytokines is observed in whole blood cultures of preeclamptic women in comparison with healthy pregnant women. Hypertens Pregnancy. 2014 May;33(2):236-49. doi: 10.3109/10641955.2013.858744. Epub 2014 Jan 6.
- Background: PubMed 11268269Chambers JC, Fusi L, Malik IS, Haskard DO, De Swiet M, Kooner JS. Association of maternal endothelial dysfunction with preeclampsia. JAMA. 2001 Mar 28;285(12):1607-12. doi: 10.1001/jama.285.12.1607.
- Background: PubMed 11788217Corretti MC, Anderson TJ, Benjamin EJ, Celermajer D, Charbonneau F, Creager MA, Deanfield J, Drexler H, Gerhard-Herman M, Herrington D, Vallance P, Vita J, Vogel R; International Brachial Artery Reactivity Task Force. Guidelines for the ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery: a report of the International Brachial Artery Reactivity Task Force. J Am Coll Cardiol. 2002 Jan 16;39(2):257-65. doi: 10.1016/s0735-1097(01)01746-6.
- Background: PubMed 19124425Craici I, Wagner S, Garovic VD. Preeclampsia and future cardiovascular risk: formal risk factor or failed stress test? Ther Adv Cardiovasc Dis. 2008 Aug;2(4):249-59. doi: 10.1177/1753944708094227.
- Background: PubMed 7847535Friedman SA, Schiff E, Emeis JJ, Dekker GA, Sibai BM. Biochemical corroboration of endothelial involvement in severe preeclampsia. Am J Obstet Gynecol. 1995 Jan;172(1 Pt 1):202-3. doi: 10.1016/0002-9378(95)90113-2.
- Background: PubMed 22144986Leiva A, Pardo F, Ramirez MA, Farias M, Casanello P, Sobrevia L. Fetoplacental vascular endothelial dysfunction as an early phenomenon in the programming of human adult diseases in subjects born from gestational diabetes mellitus or obesity in pregnancy. Exp Diabetes Res. 2011;2011:349286. doi: 10.1155/2011/349286. Epub 2011 Nov 24.
- Background: PubMed 10944429Lowe DT. Nitric oxide dysfunction in the pathophysiology of preeclampsia. Nitric Oxide. 2000 Aug;4(4):441-58. doi: 10.1006/niox.2000.0296.
- Background: PubMed 12618519Maynard SE, Min JY, Merchan J, Lim KH, Li J, Mondal S, Libermann TA, Morgan JP, Sellke FW, Stillman IE, Epstein FH, Sukhatme VP, Karumanchi SA. Excess placental soluble fms-like tyrosine kinase 1 (sFlt1) may contribute to endothelial dysfunction, hypertension, and proteinuria in preeclampsia. J Clin Invest. 2003 Mar;111(5):649-58. doi: 10.1172/JCI17189.
- Background: PubMed 27196639Meeme A, Buga GA, Mammen M, Namugowa A. Endothelial dysfunction and arterial stiffness in pre-eclampsia demonstrated by the EndoPAT method. Cardiovasc J Afr. 2017 Jan/Feb 23;28(1):23-29. doi: 10.5830/CVJA-2016-047. Epub 2016 May 19.
- Individual participant dataSharing planned: No. Data collected from individual participants will be synthesize, analyzed and reported as processed data and not as individual data.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Offspring of Pre-eclamptic Mothers, run by Walter Sisulu University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benedicta Nkeh-Chungag, PhD (+27475021989 ext. 2454, bnkehchungag@wsu.ac.za), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular risk outcomes of children exposed to pre-eclampsia in vitro. (time frame: January 2022 to December 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05091827, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.