Maternal-Fetal ExchangeMPIHHPNNCT03265704
Maternal High Blood Pressure and Newborn's Blood Profile
An observational study of Maternal-Fetal Exchange, run by Romanian Society of Anesthesia and Intensive Care at 1 site in Romania.
Trial summary
Maternal high blood pressure remodels the intrauterine environment of the fetus by altering hormonal and cellular signaling patterns and, as a result increases the risk of fetal and neonatal mortality and morbidity. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Maternal-Fetal Exchange
- What is being tested?
- AGA-PIH Study group and SGA-PIH Study group
- How many people
- 6,108 participants
- Where
- 1 siteRomania
- Study dates
- 1 Jan 2016to 25 Aug 2017
- 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 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: All newborns admitted to the Neonatology Department who met the Inclusion Criteria.
Who may be able to join
- Age: 0-28 days
- Newborns of healthy mothers;
- Newborns of mothers with Pregnancy Induced Hypertension;
- Inborn Patients;
- Written Informed Consent signed by legal guardian.
Who cannot join
- Maternal disease other than PIH;
- Syndromal, chromosomal or infectious diseases of the newborns;
- Causes other then PIH for perinatal asphyxia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maternal Pregnancy Induced Hypertension and Hematological Profile of Newborns
Maternal high blood pressure remodels the intrauterine environment of the fetus by altering hormonal and cellular signaling patterns and, as a result increases the risk of fetal and neonatal mortality and morbidity. Newborns of these mothers have an increased risk of intrauterine growth restriction, premature birth and hematological abnormalities, such as thrombocytopenia, polycythemia, and neutropenia. The purpose of the article is to review neonatal thrombocytopenia and neutropenia as a consequence of maternal high blood pressure and to establish the optimal management of these cases.
Read the detailed description
Pregnancy induced hypertension (PIH) and preeclampsia (preE) are caused by gestation and have an onset after 20 weeks of pregnancy. Although the exact etiology of PIH and preE remains unknown, two interconnected mechanisms have been identified to play an important role in the pathogenesis: dysfunction of the placental trophoblast and endothelial dysfunction within the maternal systemic vasculature. The endothelium has been identified as the target tissue of the disease. Endothelial alterations ultimately manifest as placental hypoxia and hypoplasia. The neonatal thrombocytopenia and neutropenia after pregnancy-induced hypertension is a result of inhibition of fetal bone marrow production of the myeloid lineage due to intrauterine hypoxic environment. This study aims to investigate the hematological profile in term and preterm infants born to mothers with preeclampsia. The current retrospective observational study was conducted at the Clinic of Obstetrics, Gynecology and Neonatology of the Emergency County Hospital, Timisoara over a period of three years, from January 2014 to December 2016. All inborn patient files were analyzed as anonymised limited data sets from archived records of the Neonatology Department.
- Conditions
- Maternal-Fetal Exchange
- Being tested
- AGA - Control group, SGA - Control group, AGA-PIH Study group, SGA-PIH Study group
- Keywords
- Maternal PIH, Neonatal thrombocytopenia, Neonatal neutropenia
- Medical subject headings
- Thrombocytopenia, Neonatal Alloimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGA - Control groupOther
Data processing from Patient Medical Files
SGA - Control groupOther
Data processing from Patient Medical Files
AGA-PIH Study groupOther
Monitoring PIH-related changes in the newborn
SGA-PIH Study groupOther
Monitoring PIH-related changes in the newborn
| Study group | Role | What they receive |
|---|---|---|
| AGA Neonates | AGA Control Group Appropriate for gestational age newborns of healthy mothers Receives: Other: AGA - Control group | |
| SGA Neonates | SGA - Control Group Small for gestational age newborns of healthy mothers Receives: Other: SGA - Control group | |
| AGA-PIH Neonates | AGA-PIH Study Group Appropriate for gestational age newborns of mothers with pregnancy induced hypertension Receives: Other: AGA-PIH Study group | |
| SGA-PIH Neonates | SGA-PIH Study Group Small for gestational age newborns of mothers with pregnancy induced hypertension Receives: Other: SGA-PIH Study group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematological Changes in the Newborns of Mothers with Pregnancy Induced Hypertension
Evaluating the impact of Maternal Pregnancy Induced Hypertension on fetal and neonatal hematopoiesis with focus on the myeloid lineage.
Measured: Blood profiles of newborns aged between 1-28 days were evaluated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start1 Jan 2016
- Primary completion25 Aug 2017
- Study completion25 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Maternal-Fetal ExchangeStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 6,108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Romanian Society of Anesthesia and Intensive Care
- Sponsor type
- University, hospital or other
- Collaborators
- University of Medicine and Pharmacy "Victor Babes" Timisoara, Timişoara County Emergency Clinical Hospital
- Responsible party
- Principal investigator, Alexandru Florin Rogobete, Romanian Society of Anesthesia and Intensive Care
- Investigators
- Alexandru Florin Rogobete, PhDs, Principal investigator, Romanian Society of Anesthesia and Intensive CareDorel Sandesc, Prof, Study chair, Romanian Society of Anesthesia and Intensive CareOvidiu Bedreag, Assoc Prof, Study director, Romanian Society of Anesthesia and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265704
- Sponsor's protocol ID
- 201601MP
- Acronym
- MPIHHPN
- Status last verified
- Aug 2017
- First submitted
- 26 Aug 2017
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bhat YR, Cherian CS. Neonatal thrombocytopenia associated with maternal pregnancy induced hypertension. Indian J Pediatr. 2008 Jun;75(6):571-3. doi: 10.1007/s12098-008-0110-x. Epub 2008 Aug 31.
PubMed 18759083Backes CH, Markham K, Moorehead P, Cordero L, Nankervis CA, Giannone PJ. Maternal preeclampsia and neonatal outcomes. J Pregnancy. 2011;2011:214365. doi: 10.1155/2011/214365. Epub 2011 Apr 4.
PubMed 21547086de Zegher F, Francois I, van Helvoirt M, Van den Berghe G. Clinical review 89: Small as fetus and short as child: from endogenous to exogenous growth hormone. J Clin Endocrinol Metab. 1997 Jul;82(7):2021-6. doi: 10.1210/jcem.82.7.4007. No abstract available.
PubMed 9215266Christensen RD, Yoder BA, Baer VL, Snow GL, Butler A. Early-Onset Neutropenia in Small-for-Gestational-Age Infants. Pediatrics. 2015 Nov;136(5):e1259-67. doi: 10.1542/peds.2015-1638. Epub 2015 Oct 12.
PubMed 26459642
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Pregnancy Induced Hypertension and Hematological Profile of Newborns
- ClinicalTrials.gov ID
- NCT03265704
- Acronym / sponsor ID
- MPIHHPN / 201601MP
- Conditions
- Maternal-Fetal Exchange
- Keywords
- Maternal PIH, Neonatal thrombocytopenia, Neonatal neutropenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,108 participants (actual)
- Lead sponsor
- Romanian Society of Anesthesia and Intensive CareUniversity, hospital or other
- Collaborators
- University of Medicine and Pharmacy "Victor Babes" Timisoara, Timişoara County Emergency Clinical Hospital
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 25 Aug 2017 (actual)
- Study completion
- 25 Aug 2017 (actual)
- First posted
- 29 Aug 2017 (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.
Maternal high blood pressure remodels the intrauterine environment of the fetus by altering hormonal and cellular signaling patterns and, as a result increases the risk of fetal and neonatal mortality and morbidity. Newborns of these mothers have an increased risk of intrauterine growth restriction, premature birth and hematological abnormalities, such as thrombocytopenia, polycythemia, and neutropenia. The purpose of the article is to review neonatal thrombocytopenia and neutropenia as a consequence of maternal high blood pressure and to establish the optimal management of these cases.
Detailed description
Pregnancy induced hypertension (PIH) and preeclampsia (preE) are caused by gestation and have an onset after 20 weeks of pregnancy. Although the exact etiology of PIH and preE remains unknown, two interconnected mechanisms have been identified to play an important role in the pathogenesis: dysfunction of the placental trophoblast and endothelial dysfunction within the maternal systemic vasculature. The endothelium has been identified as the target tissue of the disease. Endothelial alterations ultimately manifest as placental hypoxia and hypoplasia. The neonatal thrombocytopenia and neutropenia after pregnancy-induced hypertension is a result of inhibition of fetal bone marrow production of the myeloid lineage due to intrauterine hypoxic environment. This study aims to investigate the hematological profile in term and preterm infants born to mothers with preeclampsia. The current retrospective observational study was conducted at the Clinic of Obstetrics, Gynecology and Neonatology of the Emergency County Hospital, Timisoara over a period of three years, from January 2014 to December 2016. All inborn patient files were analyzed as anonymised limited data sets from archived records of the Neonatology Department.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AGA Neonates | – | Other: AGA - Control groupAGA Control Group Appropriate for gestational age newborns of healthy mothers |
| SGA Neonates | – | Other: SGA - Control groupSGA - Control Group Small for gestational age newborns of healthy mothers |
| AGA-PIH Neonates | – | Other: AGA-PIH Study groupAGA-PIH Study Group Appropriate for gestational age newborns of mothers with pregnancy induced hypertension |
| SGA-PIH Neonates | – | Other: SGA-PIH Study groupSGA-PIH Study Group Small for gestational age newborns of mothers with pregnancy induced hypertension |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All newborns admitted to the Neonatology Department who met the Inclusion Criteria.
Key inclusion criteria (5 listed)
- Age: 0-28 days
- Newborns of healthy mothers;
- Newborns of mothers with Pregnancy Induced Hypertension;
- Inborn Patients;
- Written Informed Consent signed by legal guardian.
Key exclusion criteria (3 listed)
- Maternal disease other than PIH;
- Syndromal, chromosomal or infectious diseases of the newborns;
- Causes other then PIH for perinatal asphyxia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGA - Control groupData processing from Patient Medical Files | Other | AGA Neonates |
| SGA - Control groupData processing from Patient Medical Files | Other | SGA Neonates |
| AGA-PIH Study groupMonitoring PIH-related changes in the newborn | Other | AGA-PIH Neonates |
| SGA-PIH Study groupMonitoring PIH-related changes in the newborn | Other | SGA-PIH Neonates |
Primary outcome
Hematological Changes in the Newborns of Mothers with Pregnancy Induced Hypertension
Time frame: Blood profiles of newborns aged between 1-28 days were evaluated.
Evaluating the impact of Maternal Pregnancy Induced Hypertension on fetal and neonatal hematopoiesis with focus on the myeloid lineage.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
- Background: PubMed 18759083Bhat YR, Cherian CS. Neonatal thrombocytopenia associated with maternal pregnancy induced hypertension. Indian J Pediatr. 2008 Jun;75(6):571-3. doi: 10.1007/s12098-008-0110-x. Epub 2008 Aug 31.
- Background: PubMed 21547086Backes CH, Markham K, Moorehead P, Cordero L, Nankervis CA, Giannone PJ. Maternal preeclampsia and neonatal outcomes. J Pregnancy. 2011;2011:214365. doi: 10.1155/2011/214365. Epub 2011 Apr 4.
- Background: PubMed 9215266de Zegher F, Francois I, van Helvoirt M, Van den Berghe G. Clinical review 89: Small as fetus and short as child: from endogenous to exogenous growth hormone. J Clin Endocrinol Metab. 1997 Jul;82(7):2021-6. doi: 10.1210/jcem.82.7.4007. No abstract available.
- Background: PubMed 26459642Christensen RD, Yoder BA, Baer VL, Snow GL, Butler A. Early-Onset Neutropenia in Small-for-Gestational-Age Infants. Pediatrics. 2015 Nov;136(5):e1259-67. doi: 10.1542/peds.2015-1638. Epub 2015 Oct 12.
- Individual participant dataSharing planned: No
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.
Alexandru Florin Rogobete, PhDs principal investigator
Romanian Society of Anesthesia and Intensive Care
Dorel Sandesc, Prof study chair
Romanian Society of Anesthesia and Intensive Care
Ovidiu Bedreag, Assoc Prof study director
Romanian Society of Anesthesia and Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maternal-Fetal Exchange, run by Romanian Society of Anesthesia and Intensive Care at 1 site in Romania.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematological Changes in the Newborns of Mothers with Pregnancy Induced Hypertension (time frame: Blood profiles of newborns aged between 1-28 days were evaluated.). 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 NCT03265704, which also lists 4 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 29 Aug 2017.