HypoxiaNCT05817448
Hypoxia-induced Autophagy in the Pathogenesis of MAP
An observational study of Hypoxia and Autophagy, run by Assiut University.
Trial summary
To investigate the role of HIF 1α and LC3B in the pathogenesis of MAP, to evaluate the role of MMP-9 in the antenatal prediction of MAP, and to compare the expression of HIF1α, LC3B, and level MMP-9 between patients of placenta previa with MAP and patients with normal placentation. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- What is being tested?
- HIF 1α and LC3B expression and MMP-9 level
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Nov 2024
- 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 18 to 45 years
- Women only
- Adult
Study population: selected from out patient's clinic of the department of Obstetrics and Gynecology at Assiut University Hospital, Assiut, Egypt,
Who may be able to join
- Gestational age: more than 28 weeks up to 40 weeks.
- Pregnant women with at least one previous CS.
- Singleton pregnancy.
- Patient known to have placenta previa by 2D ultrasound.
- Heamodynamically stable patient.
Who cannot join
- Multiple pregnancy.
- Gestational age less than 28 weeks.
- Heamodynamically unstable patient.
- Hypertensive disorder with pregnancy.
- Gestational diabetes.
- IUGR.
- Patient with bleeding tendency or using anticoagulant.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Possible Role of Hypoxia-induced Autophagy and Matrix Metalloproteinase-9 in the Pathogenesis of Morbidly Adherent Placenta.
To investigate the role of HIF 1α and LC3B in the pathogenesis of MAP, to evaluate the role of MMP-9 in the antenatal prediction of MAP, and to compare the expression of HIF1α, LC3B, and level MMP-9 between patients of placenta previa with MAP and patients with normal placentation.
Read the detailed description
Cesarean section (CS) rate has been rising rapidly in the recent years.One of the complications of repeated CS is placenta previa, an implantation of placenta on or near internal os.
Morbidly adherent placenta (MAP), known also as placenta accreta spectrum, has histopathologic and clinical types. The placenta becomes abnormally adherent to the uterine wall, fails to separate leading to massive blood loss and possible hysterectomy. The risk of MAP in patient with placenta previa increases with repeated CS.
Theories for development of MAP include abnormal trophoblastic invasion of myometrium, abnormal decidualization, neovascularization and reduction of apoptosis of trophobalsts.
In early pregnancy: the trophoblasts invade spiral arteries and reduce blood flow to the placenta 00leading to hypoxia. Hypoxia inducible factor 1 alpha (HIF-1α), a protein involved in cellular adaptation to hypoxia, increases throughout pregnancy and contributes in the invasion of trophoblasts. Excessive invasion in MAP might prolong the hypoxia, increasing the expression of HIF1α.
Autophagy is a process for managing and removing the damaged organelles and cellular proteins in hypoxia. It supports the trophoblasts. Hypoxia induced autophagy markers such as LC3B might be enhanced by MAP.
Matrix metalloproteinase-9 (MMP-9) plays an important role in cell invasion and placental implantation. Disturbance of MMP-9 might alter the trophobalsts invasion resulting in MAP .
The investigators hypothesize that hypoxia, autophagy and invasiveness are linked to the pathophysiology of MAP, so we will assess the expression of HIF1α, LC3B to estimate their role beside MMP-9.
- Conditions
- Hypoxia, Autophagy, Placenta, Morbidly Adherent Placenta
- Being tested
- HIF 1α and LC3B expression and MMP-9 level
- Keywords
- HIF1α, hypoxia-induced autophagy, LC3B, invasion-related markers, MMP-9, Morbidly Adherent Placenta
- Medical subject headings
- Hypoxia, Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIF 1α and LC3B expression and MMP-9 levelDiagnostic test
5ml of venous blood samples will be taken from all participants at 28-40 weeks of gestation for detcetion of MMP-9 level by Enzyme-Linked Immune Sorbent Assay (ELISA) kit.
Placental tissue sample in the maternal surface will be taken during CS in placenta previa group and similar location in maternal surface will be sampled after placental delivery in control group for histopathology and immunohistochemistry for detection of HIF 1α and LC3B expression
| Study group | Role | What they receive |
|---|---|---|
| control group | 40 pregnant women with normal placentation having no pregnancy related disorders according to the physical examination and laboratory findings. Receives: Diagnostic Test: HIF 1α and LC3B expression and MMP-9 level | |
| placenta previa group | 40 pregnant women that will be diagnosed according to the ultrasound diagnostic criteria.
Then according to the histopathological examination, placenta previa group will be subdivided into 2 groups, placenta previa with MAP and placenta previa without MAP Receives: Diagnostic Test: HIF 1α and LC3B expression and MMP-9 level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the expression of HIF 1α and LC3B by immunohistochemistry and the level of MMP-9
To explore the mechanism of abnormal trophoblasts invasion in MAP.
Measured: 28-40 weeks of gestation.
Secondary outcomes (1)
Measure MMP-9 concentration in the maternal plasma
To verify its usefulness as an antenatal predictor of MAP
Measured: 28-40 weeks of gestation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study startSep 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nermeen Bahaa El Dien Mohamed Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817448
- Sponsor's protocol ID
- hypoxia in MAP
- Status last verified
- May 2023
- First submitted
- 5 Apr 2023
- Last updated
- 24 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Morfaw F, Fundoh M, Bartoszko J, Mbuagbaw L, Thabane L. Using tocolysis in pregnant women with symptomatic placenta praevia does not significantly improve prenatal, perinatal, neonatal and maternal outcomes: a systematic review and meta-analysis. Syst Rev. 2018 Dec 27;7(1):249. doi: 10.1186/s13643-018-0923-2.
PubMed 30591076Shainker SA, Silver RM, Modest AM, Hacker MR, Hecht JL, Salahuddin S, Dillon ST, Ciampa EJ, D'Alton ME, Otu HH, Abuhamad AZ, Einerson BD, Branch DW, Wylie BJ, Libermann TA, Karumanchi SA. Placenta accreta spectrum: biomarker discovery using plasma proteomics. Am J Obstet Gynecol. 2020 Sep;223(3):433.e1-433.e14. doi: 10.1016/j.ajog.2020.03.019. Epub 2020 Mar 19.
PubMed 32199927Morlando M, Collins S. Placenta Accreta Spectrum Disorders: Challenges, Risks, and Management Strategies. Int J Womens Health. 2020 Nov 10;12:1033-1045. doi: 10.2147/IJWH.S224191. eCollection 2020.
PubMed 33204176Faraji A, Akbarzadeh-Jahromi M, Bahrami S, Gharamani S, Raeisi Shahraki H, Kasraeian M, Vafaei H, Zare M, Asadi N. Predictive value of vascular endothelial growth factor and placenta growth factor for placenta accreta spectrum. J Obstet Gynaecol. 2022 Jul;42(5):900-905. doi: 10.1080/01443615.2021.1955337. Epub 2021 Sep 24.
PubMed 34558384Seno K, Tanikawa N, Takahashi H, Ohkuchi A, Suzuki H, Matsubara S, Iwata H, Kuwayama T, Shirasuna K. Oxygen concentration modulates cellular senescence and autophagy in human trophoblast cells. Am J Reprod Immunol. 2018 Jun;79(6):e12826. doi: 10.1111/aji.12826. Epub 2018 Feb 15.
PubMed 29446169Parrish AR. Matrix Metalloproteinases in Kidney Disease: Role in Pathogenesis and Potential as a Therapeutic Target. Prog Mol Biol Transl Sci. 2017;148:31-65. doi: 10.1016/bs.pmbts.2017.03.001. Epub 2017 May 4.
PubMed 28662825Chen Y, Wang L, Bao J, Sha X, Cui L, Huang Q, Gu C, Li X, Liu H. Persistent hypoxia induced autophagy leading to invasiveness of trophoblasts in placenta accreta. J Matern Fetal Neonatal Med. 2021 Apr;34(8):1297-1303. doi: 10.1080/14767058.2019.1635582. Epub 2019 Jul 3.
PubMed 31269830Nakashima A, Tsuda S, Kusabiraki T, Aoki A, Ushijima A, Shima T, Cheng SB, Sharma S, Saito S. Current Understanding of Autophagy in Pregnancy. Int J Mol Sci. 2019 May 11;20(9):2342. doi: 10.3390/ijms20092342.
PubMed 31083536Nakashima A, Aoki A, Kusabiraki T, Cheng SB, Sharma S, Saito S. Autophagy regulation in preeclampsia: Pros and cons. J Reprod Immunol. 2017 Sep;123:17-23. doi: 10.1016/j.jri.2017.08.006. Epub 2017 Aug 26.
PubMed 28869810El-Hussieny M, Mohammed EM, Zenhom NM, Refaie MM, Okasha AM, Tawab MAE. Possible Role of TGF-beta1, MMP-2, E-CAD, beta-Catenin and Antioxidants in Pathogenesis of Placenta Accreta. Fetal Pediatr Pathol. 2021 Jun;40(3):222-232. doi: 10.1080/15513815.2020.1843574. Epub 2020 Nov 11.
PubMed 33172328Gao F, Zhou C, Qiu W, Wu H, Li J, Peng J, Qiu M, Liang C, Gao J, Luo S. Total flavonoids from Semen Cuscutae target MMP9 and promote invasion of EVT cells via Notch/AKT/MAPK signaling pathways. Sci Rep. 2018 Nov 26;8(1):17342. doi: 10.1038/s41598-018-35732-6.
PubMed 30478366Fratelli N, Prefumo F, Maggi C, Cavalli C, Sciarrone A, Garofalo A, Viora E, Vergani P, Ornaghi S, Betti M, Vaglio Tessitore I, Cavaliere AF, Buongiorno S, Vidiri A, Fabbri E, Ferrazzi E, Maggi V, Cetin I, Frusca T, Ghi T, Kaihura C, Di Pasquo E, Stampalija T, Belcaro C, Quadrifoglio M, Veneziano M, Mecacci F, Simeone S, Locatelli A, Consonni S, Chianchiano N, Labate F, Cromi A, Bertucci E, Facchinetti F, Fichera A, Granata D, D'Antonio F, Foti F, Avagliano L, Bulfamante GP, Cali G; ADoPAD (Antenatal Diagnosis of Placental Adhesion Disorders) Working Group. Third-trimester ultrasound for antenatal diagnosis of placenta accreta spectrum in women with placenta previa: results from the ADoPAD study. Ultrasound Obstet Gynecol. 2022 Sep;60(3):381-389. doi: 10.1002/uog.24889.
PubMed 35247287world health organisation. Rising rates suggest increasing numbers of medically unnecessary, potentially harmful procedures 2021 [cited 16 june 2021
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Possible Role of Hypoxia-induced Autophagy and Matrix Metalloproteinase-9 in the Pathogenesis of Morbidly Adherent Placenta.
- ClinicalTrials.gov ID
- NCT05817448
- Acronym / sponsor ID
- hypoxia in MAP
- Conditions
- Hypoxia, Autophagy, Placenta, Morbidly Adherent Placenta
- Keywords
- HIF1α, hypoxia-induced autophagy, LC3B, invasion-related markers, MMP-9, Morbidly Adherent Placenta
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 18 Apr 2023 (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.
To investigate the role of HIF 1α and LC3B in the pathogenesis of MAP, to evaluate the role of MMP-9 in the antenatal prediction of MAP, and to compare the expression of HIF1α, LC3B, and level MMP-9 between patients of placenta previa with MAP and patients with normal placentation.
Detailed description
Cesarean section (CS) rate has been rising rapidly in the recent years.One of the complications of repeated CS is placenta previa, an implantation of placenta on or near internal os.
Morbidly adherent placenta (MAP), known also as placenta accreta spectrum, has histopathologic and clinical types. The placenta becomes abnormally adherent to the uterine wall, fails to separate leading to massive blood loss and possible hysterectomy. The risk of MAP in patient with placenta previa increases with repeated CS.
Theories for development of MAP include abnormal trophoblastic invasion of myometrium, abnormal decidualization, neovascularization and reduction of apoptosis of trophobalsts.
In early pregnancy: the trophoblasts invade spiral arteries and reduce blood flow to the placenta 00leading to hypoxia. Hypoxia inducible factor 1 alpha (HIF-1α), a protein involved in cellular adaptation to hypoxia, increases throughout pregnancy and contributes in the invasion of trophoblasts. Excessive invasion in MAP might prolong the hypoxia, increasing the expression of HIF1α.
Autophagy is a process for managing and removing the damaged organelles and cellular proteins in hypoxia. It supports the trophoblasts. Hypoxia induced autophagy markers such as LC3B might be enhanced by MAP.
Matrix metalloproteinase-9 (MMP-9) plays an important role in cell invasion and placental implantation. Disturbance of MMP-9 might alter the trophobalsts invasion resulting in MAP .
The investigators hypothesize that hypoxia, autophagy and invasiveness are linked to the pathophysiology of MAP, so we will assess the expression of HIF1α, LC3B to estimate their role beside MMP-9.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | Diagnostic Test: HIF 1α and LC3B expression and MMP-9 level40 pregnant women with normal placentation having no pregnancy related disorders according to the physical examination and laboratory findings. |
| placenta previa group | – | Diagnostic Test: HIF 1α and LC3B expression and MMP-9 level40 pregnant women that will be diagnosed according to the ultrasound diagnostic criteria. Then according to the histopathological examination, placenta previa group will be subdivided into 2 groups, placenta previa with MAP and placenta previa without MAP |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- selected from out patient's clinic of the department of Obstetrics and Gynecology at Assiut University Hospital, Assiut, Egypt,
Key inclusion criteria (5 listed)
- Gestational age: more than 28 weeks up to 40 weeks.
- Pregnant women with at least one previous CS.
- Singleton pregnancy.
- Patient known to have placenta previa by 2D ultrasound.
- Heamodynamically stable patient.
Key exclusion criteria (7 listed)
- Multiple pregnancy.
- Gestational age less than 28 weeks.
- Heamodynamically unstable patient.
- Hypertensive disorder with pregnancy.
- Gestational diabetes.
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 |
|---|---|---|
| HIF 1α and LC3B expression and MMP-9 level5ml of venous blood samples will be taken from all participants at 28-40 weeks of gestation for detcetion of MMP-9 level by Enzyme-Linked Immune Sorbent Assay (ELISA) kit. Placental tissue sample in the maternal surface will be taken during CS in placenta previa group and similar location in maternal surface will be sampled after placental delivery in control group for histopathology and immunohistochemistry for detection of HIF 1α and LC3B expression | Diagnostic test | control group, placenta previa group |
Primary outcome
Compare the expression of HIF 1α and LC3B by immunohistochemistry and the level of MMP-9
Time frame: 28-40 weeks of gestation.
To explore the mechanism of abnormal trophoblasts invasion in MAP.
1 secondary outcome
Measure MMP-9 concentration in the maternal plasma
Time frame: 28-40 weeks of gestation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Background: PubMed 30591076Morfaw F, Fundoh M, Bartoszko J, Mbuagbaw L, Thabane L. Using tocolysis in pregnant women with symptomatic placenta praevia does not significantly improve prenatal, perinatal, neonatal and maternal outcomes: a systematic review and meta-analysis. Syst Rev. 2018 Dec 27;7(1):249. doi: 10.1186/s13643-018-0923-2.
- Background: PubMed 32199927Shainker SA, Silver RM, Modest AM, Hacker MR, Hecht JL, Salahuddin S, Dillon ST, Ciampa EJ, D'Alton ME, Otu HH, Abuhamad AZ, Einerson BD, Branch DW, Wylie BJ, Libermann TA, Karumanchi SA. Placenta accreta spectrum: biomarker discovery using plasma proteomics. Am J Obstet Gynecol. 2020 Sep;223(3):433.e1-433.e14. doi: 10.1016/j.ajog.2020.03.019. Epub 2020 Mar 19.
- Background: PubMed 33204176Morlando M, Collins S. Placenta Accreta Spectrum Disorders: Challenges, Risks, and Management Strategies. Int J Womens Health. 2020 Nov 10;12:1033-1045. doi: 10.2147/IJWH.S224191. eCollection 2020.
- Background: PubMed 34558384Faraji A, Akbarzadeh-Jahromi M, Bahrami S, Gharamani S, Raeisi Shahraki H, Kasraeian M, Vafaei H, Zare M, Asadi N. Predictive value of vascular endothelial growth factor and placenta growth factor for placenta accreta spectrum. J Obstet Gynaecol. 2022 Jul;42(5):900-905. doi: 10.1080/01443615.2021.1955337. Epub 2021 Sep 24.
- Background: PubMed 29446169Seno K, Tanikawa N, Takahashi H, Ohkuchi A, Suzuki H, Matsubara S, Iwata H, Kuwayama T, Shirasuna K. Oxygen concentration modulates cellular senescence and autophagy in human trophoblast cells. Am J Reprod Immunol. 2018 Jun;79(6):e12826. doi: 10.1111/aji.12826. Epub 2018 Feb 15.
- Background: PubMed 28662825Parrish AR. Matrix Metalloproteinases in Kidney Disease: Role in Pathogenesis and Potential as a Therapeutic Target. Prog Mol Biol Transl Sci. 2017;148:31-65. doi: 10.1016/bs.pmbts.2017.03.001. Epub 2017 May 4.
- Background: PubMed 31269830Chen Y, Wang L, Bao J, Sha X, Cui L, Huang Q, Gu C, Li X, Liu H. Persistent hypoxia induced autophagy leading to invasiveness of trophoblasts in placenta accreta. J Matern Fetal Neonatal Med. 2021 Apr;34(8):1297-1303. doi: 10.1080/14767058.2019.1635582. Epub 2019 Jul 3.
- Background: PubMed 31083536Nakashima A, Tsuda S, Kusabiraki T, Aoki A, Ushijima A, Shima T, Cheng SB, Sharma S, Saito S. Current Understanding of Autophagy in Pregnancy. Int J Mol Sci. 2019 May 11;20(9):2342. doi: 10.3390/ijms20092342.
- Background: PubMed 28869810Nakashima A, Aoki A, Kusabiraki T, Cheng SB, Sharma S, Saito S. Autophagy regulation in preeclampsia: Pros and cons. J Reprod Immunol. 2017 Sep;123:17-23. doi: 10.1016/j.jri.2017.08.006. Epub 2017 Aug 26.
- Background: PubMed 33172328El-Hussieny M, Mohammed EM, Zenhom NM, Refaie MM, Okasha AM, Tawab MAE. Possible Role of TGF-beta1, MMP-2, E-CAD, beta-Catenin and Antioxidants in Pathogenesis of Placenta Accreta. Fetal Pediatr Pathol. 2021 Jun;40(3):222-232. doi: 10.1080/15513815.2020.1843574. Epub 2020 Nov 11.
- Background: PubMed 30478366Gao F, Zhou C, Qiu W, Wu H, Li J, Peng J, Qiu M, Liang C, Gao J, Luo S. Total flavonoids from Semen Cuscutae target MMP9 and promote invasion of EVT cells via Notch/AKT/MAPK signaling pathways. Sci Rep. 2018 Nov 26;8(1):17342. doi: 10.1038/s41598-018-35732-6.
- Background: PubMed 35247287Fratelli N, Prefumo F, Maggi C, Cavalli C, Sciarrone A, Garofalo A, Viora E, Vergani P, Ornaghi S, Betti M, Vaglio Tessitore I, Cavaliere AF, Buongiorno S, Vidiri A, Fabbri E, Ferrazzi E, Maggi V, Cetin I, Frusca T, Ghi T, Kaihura C, Di Pasquo E, Stampalija T, Belcaro C, Quadrifoglio M, Veneziano M, Mecacci F, Simeone S, Locatelli A, Consonni S, Chianchiano N, Labate F, Cromi A, Bertucci E, Facchinetti F, Fichera A, Granata D, D'Antonio F, Foti F, Avagliano L, Bulfamante GP, Cali G; ADoPAD (Antenatal Diagnosis of Placental Adhesion Disorders) Working Group. Third-trimester ultrasound for antenatal diagnosis of placenta accreta spectrum in women with placenta previa: results from the ADoPAD study. Ultrasound Obstet Gynecol. 2022 Sep;60(3):381-389. doi: 10.1002/uog.24889.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxia and Autophagy, run by Assiut 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 5 inclusion and 7 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 24 May 2023. 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 Nermeen Bahaa ElDien Mohamed Ahmed, dr (01011126294, nermeenbahaa11@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the expression of HIF 1α and LC3B by immunohistochemistry and the level of MMP-9 (time frame: 28-40 weeks of gestation.). 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 NCT05817448, which also lists 13 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 24 May 2023.