Preterm BirthHIPPO-PTBNCT07695467
Hippo-YAP Pathway and Related miRNAs in Preterm Birth
An observational study of Preterm Birth and Pregnancy, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
This completed observational study evaluated the expression of Hippo-YAP pathway-related genes and proteins and selected microRNAs in maternal blood, placental tissue, and myometrial tissue obtained from women who underwent cesarean delivery at term or preterm gestational ages. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Preterm Birth, Pregnancy, Preterm Labor
- What is being tested?
- Laboratory Biomarker Analysis
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 31 May 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
- No healthy volunteers
- Adult
Study population: Pregnant women who underwent cesarean delivery at Sivas Cumhuriyet University Faculty of Medicine and were included in either the spontaneous preterm delivery group or the term delivery comparison group.
Who may be able to join
- cInclusion Criteria:
- Pregnant women aged 18 years or older
- Singleton pregnancy
- Women who underwent cesarean delivery
- For the preterm delivery group: spontaneous preterm labor and delivery between 24 and 34 weeks of gestation
- For the term delivery group: cesarean delivery at term gestational age without active labor
- Written informed consent for participation and collection of maternal blood, placental tissue, and myometrial tissue samples
Who cannot join
- Multiple pregnancy
- Major fetal anomaly
- Clinical evidence of chorioamnionitis
- Hypertensive disorders of pregnancy
- Diabetes mellitus or gestational diabetes mellitus
- Autoimmune disease
Show all 13Show fewer
- Chronic inflammatory disease
- Maternal systemic infection
- Placental abruption
- Premature rupture of membranes, if excluded in the original protocol
- Use of medications or presence of maternal conditions that could significantly affect inflammatory, molecular, or placental biomarker expression
- Refusal to provide informed consent
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sivas Cumhuriyet University Faculty of Medicine
Sivas, Kayseri Ave, 58140
About this study
Official title: Analysis of Hippo-YAP Pathway Genes and Proteins and Related miRNA-195, miRNA-181c, miRNA-200a, and miRNA-375 Expression in Maternal Blood, Placental Tissue, and Myometrial Tissue From Women With Term and Preterm Cesarean Delivery
This completed observational study evaluated the expression of Hippo-YAP pathway-related genes and proteins and selected microRNAs in maternal blood, placental tissue, and myometrial tissue obtained from women who underwent cesarean delivery at term or preterm gestational ages.
The study compared women with spontaneous preterm delivery and women with term delivery. Maternal blood, placental tissue, and myometrial tissue samples were analyzed using molecular, biochemical, and immunohistochemical methods to explore whether Hippo-YAP pathway activity and related miRNA expression patterns may be associated with the pathophysiology of preterm birth.
Read the detailed description
Preterm birth remains an important obstetric condition associated with neonatal morbidity and mortality. Although clinical risk factors for preterm birth are well described, the underlying molecular mechanisms are not fully understood. Inflammation, immune regulation, placental function, and myometrial activity are considered important components of the biological processes leading to preterm labor and delivery.
The Hippo-YAP signaling pathway is involved in cellular proliferation, differentiation, tissue homeostasis, immune regulation, and placental biology. Several microRNAs are also known to regulate reproductive tissues, placental function, myometrial activity, and inflammatory pathways. Based on this biological background, this study investigated the Hippo-YAP pathway and selected related microRNAs in maternal blood, placental tissue, and myometrial tissue from women with term and preterm cesarean delivery.
This was a completed observational case-control biomarker study. Participants were not assigned to any intervention. The study included two groups: women who delivered preterm and women who delivered at term. Maternal blood samples were collected before cesarean delivery. Placental tissue samples were obtained after delivery, and myometrial tissue samples were collected from the placental bed during cesarean section. Samples were stored under appropriate laboratory conditions until analysis.
The study evaluated the expression of Hippo-YAP pathway-related genes and proteins, including MST1, LATS1, YAP1, TAZ, MAP4K1, and PIK3C2B, as well as selected related microRNAs, including miRNA-195, miRNA-181c, miRNA-200a, and miRNA-375. Gene and microRNA expression analyses were performed using quantitative real-time polymerase chain reaction. Protein expression was assessed using enzyme-linked immunosorbent assay and immunohistochemistry.
The primary objective was to compare Hippo-YAP pathway-related gene, protein, and microRNA expression patterns between preterm and term delivery groups. Secondary objectives included evaluating expression patterns across maternal blood, placental tissue, and myometrial tissue and exploring whether these molecular differences may contribute to understanding the biological mechanisms involved in preterm birth.
The study was approved by the Sivas Cumhuriyet University Clinical Research Ethics Committee. Written informed consent was obtained from participating women. The project was supported by the Scientific and Technological Research Council of Türkiye (TUBITAK), project number 121S414, and the immunohistochemistry experiments were additionally supported by a complementary research grant, project number T-2022-954-D7.
This study was retrospectively registered after completion of participant enrollment, sample collection, and laboratory analyses for transparency.
- Conditions
- Preterm Birth, Pregnancy, Preterm Labor
- Being tested
- Laboratory Biomarker Analysis
- Keywords
- Hippo-YAP pathway, preterm birth, placenta, myometrium, maternal blood, miRNA-195, miRNA-181c, miRNA-200a, miRNA-375, YAP1, TAZ, MST1, LATS1, qRT-PCR, immunohistochemistry
- Medical subject headings
- Premature Birth, Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Laboratory analysis of maternal blood, placental tissue, and myometrial tissue samples for Hippo-YAP pathway-related gene, protein, and microRNA expression. No treatment or clinical intervention was assigned to participants.
| Study group | Role | What they receive |
|---|---|---|
| Preterm Delivery Group | Women who underwent cesarean delivery between 24 and 34 weeks of gestation after spontaneous preterm labor. Maternal blood, placental tissue, and myometrial tissue samples were collected for molecular, biochemical, and immunohistochemical analyses. Receives: Other: Laboratory Biomarker Analysis | |
| Term Delivery Group | Women who underwent cesarean delivery after 39 weeks of gestation without active labor. Maternal blood, placental tissue, and myometrial tissue samples were collected as the term delivery comparison group. Receives: Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression levels of Hippo-YAP pathway-related genes, proteins, and selected microRNAs
Expression levels of Hippo-YAP pathway-related genes and proteins, including MST1, LATS1, YAP1, TAZ, MAP4K1, and PIK3C2B, and selected microRNAs, including miRNA-195, miRNA-181c, miRNA-200a, and miRNA-375, were compared between women with preterm delivery and women with term delivery using maternal blood, placental tissue, and myometrial tissue samples.
Measured: Perioperative/Periprocedural
Secondary outcomes (1)
Tissue-specific expression patterns of Hippo-YAP pathway biomarkers and related microRNAs
Expression patterns of Hippo-YAP pathway-related genes, proteins, and selected microRNAs were evaluated across maternal blood, placental tissue, and myometrial tissue samples to explore tissue-specific molecular differences between preterm and term delivery groups.
Measured: Perioperative/Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start1 Jun 2021
- Primary completion1 Apr 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Nazan Yurtcu MD, Cumhuriyet University
- Investigators
- Nazan Yurtcu, MD, PhD, Principal investigator, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695467
- Sponsor's protocol ID
- TUBITAK-121S414
- Other IDs
- 121S414, T-2022-954
- Acronym
- HIPPO-PTB
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because no prospective data-sharing consent for public individual-level data sharing was obtained, and the dataset includes sensitive maternal clinical information and biological sample-related laboratory data.
Publications
Menon R. Spontaneous preterm birth, a clinical dilemma: etiologic, pathophysiologic and genetic heterogeneities and racial disparity. Acta Obstet Gynecol Scand. 2008;87(6):590-600. doi: 10.1080/00016340802005126.
PubMed 18568457Goldenberg RL, Culhane JF, Iams JD, Romero R. Epidemiology and causes of preterm birth. Lancet. 2008 Jan 5;371(9606):75-84. doi: 10.1016/S0140-6736(08)60074-4.
PubMed 18177778Chawanpaiboon S, Vogel JP, Moller AB, Lumbiganon P, Petzold M, Hogan D, Landoulsi S, Jampathong N, Kongwattanakul K, Laopaiboon M, Lewis C, Rattanakanokchai S, Teng DN, Thinkhamrop J, Watananirun K, Zhang J, Zhou W, Gulmezoglu AM. Global, regional, and national estimates of levels of preterm birth in 2014: a systematic review and modelling analysis. Lancet Glob Health. 2019 Jan;7(1):e37-e46. doi: 10.1016/S2214-109X(18)30451-0. Epub 2018 Oct 30.
PubMed 30389451
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Hippo-YAP Pathway Genes and Proteins and Related miRNA-195, miRNA-181c, miRNA-200a, and miRNA-375 Expression in Maternal Blood, Placental Tissue, and Myometrial Tissue From Women With Term and Preterm Cesarean Delivery
- ClinicalTrials.gov ID
- NCT07695467
- Acronym / sponsor ID
- HIPPO-PTB / TUBITAK-121S414
- Conditions
- Preterm Birth, Pregnancy, Preterm Labor
- Keywords
- Hippo-YAP pathway, preterm birth, placenta, myometrium, maternal blood, miRNA-195, miRNA-181c, miRNA-200a
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 10 Jul 2026 (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.
This completed observational study evaluated the expression of Hippo-YAP pathway-related genes and proteins and selected microRNAs in maternal blood, placental tissue, and myometrial tissue obtained from women who underwent cesarean delivery at term or preterm gestational ages.
The study compared women with spontaneous preterm delivery and women with term delivery. Maternal blood, placental tissue, and myometrial tissue samples were analyzed using molecular, biochemical, and immunohistochemical methods to explore whether Hippo-YAP pathway activity and related miRNA expression patterns may be associated with the pathophysiology of preterm birth.
Detailed description
Preterm birth remains an important obstetric condition associated with neonatal morbidity and mortality. Although clinical risk factors for preterm birth are well described, the underlying molecular mechanisms are not fully understood. Inflammation, immune regulation, placental function, and myometrial activity are considered important components of the biological processes leading to preterm labor and delivery.
The Hippo-YAP signaling pathway is involved in cellular proliferation, differentiation, tissue homeostasis, immune regulation, and placental biology. Several microRNAs are also known to regulate reproductive tissues, placental function, myometrial activity, and inflammatory pathways. Based on this biological background, this study investigated the Hippo-YAP pathway and selected related microRNAs in maternal blood, placental tissue, and myometrial tissue from women with term and preterm cesarean delivery.
This was a completed observational case-control biomarker study. Participants were not assigned to any intervention. The study included two groups: women who delivered preterm and women who delivered at term. Maternal blood samples were collected before cesarean delivery. Placental tissue samples were obtained after delivery, and myometrial tissue samples were collected from the placental bed during cesarean section. Samples were stored under appropriate laboratory conditions until analysis.
The study evaluated the expression of Hippo-YAP pathway-related genes and proteins, including MST1, LATS1, YAP1, TAZ, MAP4K1, and PIK3C2B, as well as selected related microRNAs, including miRNA-195, miRNA-181c, miRNA-200a, and miRNA-375. Gene and microRNA expression analyses were performed using quantitative real-time polymerase chain reaction. Protein expression was assessed using enzyme-linked immunosorbent assay and immunohistochemistry.
The primary objective was to compare Hippo-YAP pathway-related gene, protein, and microRNA expression patterns between preterm and term delivery groups. Secondary objectives included evaluating expression patterns across maternal blood, placental tissue, and myometrial tissue and exploring whether these molecular differences may contribute to understanding the biological mechanisms involved in preterm birth.
The study was approved by the Sivas Cumhuriyet University Clinical Research Ethics Committee. Written informed consent was obtained from participating women. The project was supported by the Scientific and Technological Research Council of Türkiye (TUBITAK), project number 121S414, and the immunohistochemistry experiments were additionally supported by a complementary research grant, project number T-2022-954-D7.
This study was retrospectively registered after completion of participant enrollment, sample collection, and laboratory analyses for transparency.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preterm Delivery Group | – | Other: Laboratory Biomarker AnalysisWomen who underwent cesarean delivery between 24 and 34 weeks of gestation after spontaneous preterm labor. Maternal blood, placental tissue, and myometrial tissue samples were collected for molecular, biochemical, and immunohistochemical analyses. |
| Term Delivery Group | – | Other: Laboratory Biomarker AnalysisWomen who underwent cesarean delivery after 39 weeks of gestation without active labor. Maternal blood, placental tissue, and myometrial tissue samples were collected as the term delivery comparison group. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women who underwent cesarean delivery at Sivas Cumhuriyet University Faculty of Medicine and were included in either the spontaneous preterm delivery group or the term delivery comparison group.
Key inclusion criteria (7 listed)
- cInclusion Criteria:
- Pregnant women aged 18 years or older
- Singleton pregnancy
- Women who underwent cesarean delivery
- For the preterm delivery group: spontaneous preterm labor and delivery between 24 and 34 weeks of gestation
Key exclusion criteria (13 listed)
- Multiple pregnancy
- Major fetal anomaly
- Clinical evidence of chorioamnionitis
- Hypertensive disorders of pregnancy
- Diabetes mellitus or gestational diabetes mellitus
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 |
|---|---|---|
| Laboratory Biomarker AnalysisLaboratory analysis of maternal blood, placental tissue, and myometrial tissue samples for Hippo-YAP pathway-related gene, protein, and microRNA expression. No treatment or clinical intervention was assigned to participants. | Other | Preterm Delivery Group, Term Delivery Group |
Primary outcome
Expression levels of Hippo-YAP pathway-related genes, proteins, and selected microRNAs
Time frame: Perioperative/Periprocedural
Expression levels of Hippo-YAP pathway-related genes and proteins, including MST1, LATS1, YAP1, TAZ, MAP4K1, and PIK3C2B, and selected microRNAs, including miRNA-195, miRNA-181c, miRNA-200a, and miRNA-375, were compared between women with preterm delivery and women with term delivery using maternal blood, placental tissue, and myometrial tissue samples.
1 secondary outcome
Tissue-specific expression patterns of Hippo-YAP pathway biomarkers and related microRNAs
Time frame: Perioperative/Periprocedural
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 10 Jul 2026.
- Background: PubMed 18568457Menon R. Spontaneous preterm birth, a clinical dilemma: etiologic, pathophysiologic and genetic heterogeneities and racial disparity. Acta Obstet Gynecol Scand. 2008;87(6):590-600. doi: 10.1080/00016340802005126.
- Background: PubMed 18177778Goldenberg RL, Culhane JF, Iams JD, Romero R. Epidemiology and causes of preterm birth. Lancet. 2008 Jan 5;371(9606):75-84. doi: 10.1016/S0140-6736(08)60074-4.
- Background: PubMed 30389451Chawanpaiboon S, Vogel JP, Moller AB, Lumbiganon P, Petzold M, Hogan D, Landoulsi S, Jampathong N, Kongwattanakul K, Laopaiboon M, Lewis C, Rattanakanokchai S, Teng DN, Thinkhamrop J, Watananirun K, Zhang J, Zhou W, Gulmezoglu AM. Global, regional, and national estimates of levels of preterm birth in 2014: a systematic review and modelling analysis. Lancet Glob Health. 2019 Jan;7(1):e37-e46. doi: 10.1016/S2214-109X(18)30451-0. Epub 2018 Oct 30.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because no prospective data-sharing consent for public individual-level data sharing was obtained, and the dataset includes sensitive maternal clinical information and biological sample-related laboratory data.
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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.
Nazan Yurtcu, MD, PhD principal investigator
Cumhuriyet University
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 Preterm Birth and Pregnancy, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
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 7 inclusion and 13 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 10 Jul 2026. 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 Turkey (Türkiye). 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?
Expression levels of Hippo-YAP pathway-related genes, proteins, and selected microRNAs (time frame: Perioperative/Periprocedural). 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 NCT07695467, which also lists 3 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 10 Jul 2026.