Cardiovascular DiseasesNCT00005208
Regulation of Placental Vascular Reactivity in Pregnancy-induced Hypertension
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To elucidate the role of an imbalance in vasodilator prostacyclin (PGI2) and vasoconstrictor thromboxane (TxA2) in pregnancy-induced hypertension Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Hypertension
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1987to Jul 1992
- 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To elucidate the role of an imbalance in vasodilator prostacyclin (PGI2) and vasoconstrictor thromboxane (TxA2) in pregnancy-induced hypertension
Read the detailed description
BACKGROUND:
Pregnancy-induced hypertension (PIH) is associated with increased fetal and neonatal morbidity and mortality possibly resulting from hypoxia in utero. The primary pathology of PIH involves a reduction in uteroplacental blood flow but modern imaging techniques have now shown that increased impedance of the fetal-placental circulation and hence reduced blood flow can also be found in PIH. This may represent a direct effect of hypoxia or be a fetal adaptation to increase placental oxygen extraction to relieve hypoxia. The fetal-placental circulation is regulated by humoral agents and vascular pressure. An imbalance of vasodilator prostacyclin (PGI2) and vasoconstrictor thromboxane (TxA2) production is reported to underlie the vasoconstriction seen in PIH.
The study resulted from the 1986 release of a Request for Applications for Research on Hypertension in Pregnancy by the National Heart, Lung, and Blood Institute and the National Institute of Child Health and Human Development.
DESIGN NARRATIVE:
The fetal-placental circulations of perfused human placental cotyledons from normotensive and pregnancy-induced hypertensive pregnancies were used to determine if an imbalance in PGI2/TxA2 production existed and its relationship to the responses of the fetal-placental circulation to vasoconstriction. Studies were also conducted on the effects of hypocalcemia and hypomagnesemia, hypoxia, and drugs.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Hypertension, Pre-Eclampsia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startSep 1987
- Study completionJul 1992
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- 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
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005208
- Sponsor's protocol ID
- 1087
- Other IDs
- R01HL040029
- Status last verified
- May 2000
- First submitted
- 25 May 2000
- Last updated
- 29 Feb 2016
- Results posted
- No
Publications
Myatt L, Brewer AS, Brockman DE. The comparative effects of big endothelin-1, endothelin-1, and endothelin-3 in the human fetal-placental circulation. Am J Obstet Gynecol. 1992 Dec;167(6):1651-6. doi: 10.1016/0002-9378(92)91756-z.
PubMed 1471681Myatt L. Control of vascular resistance in the human placenta. Placenta. 1992 Jul-Aug;13(4):329-41. doi: 10.1016/0143-4004(92)90057-z. No abstract available.
PubMed 1438081Eis AW, Mitchell MD, Myatt L. Endothelin transfer and endothelin effects on water transfer in human fetal membranes. Obstet Gynecol. 1992 Mar;79(3):411-5. doi: 10.1097/00006250-199203000-00017.
PubMed 1738524Myatt L, Brewer AS, Langdon G, Brockman DE. Attenuation of the vasoconstrictor effects of thromboxane and endothelin by nitric oxide in the human fetal-placental circulation. Am J Obstet Gynecol. 1992 Jan;166(1 Pt 1):224-30. doi: 10.1016/0002-9378(92)91863-6.
PubMed 1733199Myatt L, Langdon G, Brewer AS, Brockman DE. Endothelin-1-induced vasoconstriction is not mediated by thromboxane release and action in the human fetal-placental circulation. Am J Obstet Gynecol. 1991 Dec;165(6 Pt 1):1717-22. doi: 10.1016/0002-9378(91)90021-i.
PubMed 1750466Jacobson RL, Brewer A, Eis A, Siddiqi TA, Myatt L. Transfer of aspirin across the perfused human placental cotyledon. Am J Obstet Gynecol. 1991 Oct;165(4 Pt 1):939-44. doi: 10.1016/0002-9378(91)90444-v.
PubMed 1951559Myatt L, Brewer A, Brockman DE. The action of nitric oxide in the perfused human fetal-placental circulation. Am J Obstet Gynecol. 1991 Feb;164(2):687-92. doi: 10.1016/s0002-9378(11)80047-5.
PubMed 1899534Myatt L, Brockman DE, Langdon G, Pollock JS. Constitutive calcium-dependent isoform of nitric oxide synthase in the human placental villous vascular tree. Placenta. 1993 Jul-Aug;14(4):373-83. doi: 10.1016/s0143-4004(05)80459-x.
PubMed 7504255
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of Placental Vascular Reactivity in Pregnancy-induced Hypertension
- ClinicalTrials.gov ID
- NCT00005208
- Acronym / sponsor ID
- 1087
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1987
- Study completion
- Jul 1992 (actual)
- First posted
- 26 May 2000 (estimated)
- 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.
To elucidate the role of an imbalance in vasodilator prostacyclin (PGI2) and vasoconstrictor thromboxane (TxA2) in pregnancy-induced hypertension
Detailed description
BACKGROUND:
Pregnancy-induced hypertension (PIH) is associated with increased fetal and neonatal morbidity and mortality possibly resulting from hypoxia in utero. The primary pathology of PIH involves a reduction in uteroplacental blood flow but modern imaging techniques have now shown that increased impedance of the fetal-placental circulation and hence reduced blood flow can also be found in PIH. This may represent a direct effect of hypoxia or be a fetal adaptation to increase placental oxygen extraction to relieve hypoxia. The fetal-placental circulation is regulated by humoral agents and vascular pressure. An imbalance of vasodilator prostacyclin (PGI2) and vasoconstrictor thromboxane (TxA2) production is reported to underlie the vasoconstriction seen in PIH.
The study resulted from the 1986 release of a Request for Applications for Research on Hypertension in Pregnancy by the National Heart, Lung, and Blood Institute and the National Institute of Child Health and Human Development.
DESIGN NARRATIVE:
The fetal-placental circulations of perfused human placental cotyledons from normotensive and pregnancy-induced hypertensive pregnancies were used to determine if an imbalance in PGI2/TxA2 production existed and its relationship to the responses of the fetal-placental circulation to vasoconstriction. Studies were also conducted on the effects of hypocalcemia and hypomagnesemia, hypoxia, and drugs.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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
Not reported in the source record.
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 Feb 2016.
- Background: PubMed 1471681Myatt L, Brewer AS, Brockman DE. The comparative effects of big endothelin-1, endothelin-1, and endothelin-3 in the human fetal-placental circulation. Am J Obstet Gynecol. 1992 Dec;167(6):1651-6. doi: 10.1016/0002-9378(92)91756-z.
- Background: PubMed 1438081Myatt L. Control of vascular resistance in the human placenta. Placenta. 1992 Jul-Aug;13(4):329-41. doi: 10.1016/0143-4004(92)90057-z. No abstract available.
- Background: PubMed 1738524Eis AW, Mitchell MD, Myatt L. Endothelin transfer and endothelin effects on water transfer in human fetal membranes. Obstet Gynecol. 1992 Mar;79(3):411-5. doi: 10.1097/00006250-199203000-00017.
- Background: PubMed 1733199Myatt L, Brewer AS, Langdon G, Brockman DE. Attenuation of the vasoconstrictor effects of thromboxane and endothelin by nitric oxide in the human fetal-placental circulation. Am J Obstet Gynecol. 1992 Jan;166(1 Pt 1):224-30. doi: 10.1016/0002-9378(92)91863-6.
- Background: PubMed 1750466Myatt L, Langdon G, Brewer AS, Brockman DE. Endothelin-1-induced vasoconstriction is not mediated by thromboxane release and action in the human fetal-placental circulation. Am J Obstet Gynecol. 1991 Dec;165(6 Pt 1):1717-22. doi: 10.1016/0002-9378(91)90021-i.
- Background: PubMed 1951559Jacobson RL, Brewer A, Eis A, Siddiqi TA, Myatt L. Transfer of aspirin across the perfused human placental cotyledon. Am J Obstet Gynecol. 1991 Oct;165(4 Pt 1):939-44. doi: 10.1016/0002-9378(91)90444-v.
- Background: PubMed 1899534Myatt L, Brewer A, Brockman DE. The action of nitric oxide in the perfused human fetal-placental circulation. Am J Obstet Gynecol. 1991 Feb;164(2):687-92. doi: 10.1016/s0002-9378(11)80047-5.
- Background: PubMed 7504255Myatt L, Brockman DE, Langdon G, Pollock JS. Constitutive calcium-dependent isoform of nitric oxide synthase in the human placental villous vascular tree. Placenta. 1993 Jul-Aug;14(4):373-83. doi: 10.1016/s0143-4004(05)80459-x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 Feb 2016. 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?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005208, which also lists 8 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 Feb 2016.