NCT07695467

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 10, 2026

Completed
Last Updated

July 10, 2026

Status Verified

July 1, 2026

Enrollment Period

2.8 years

First QC Date

July 2, 2026

Last Update Submit

July 8, 2026

Conditions

Keywords

Hippo-YAP pathwaypreterm birthplacentamyometriummaternal bloodmiRNA-195miRNA-181cmiRNA-200amiRNA-375YAP1TAZMST1LATS1qRT-PCRimmunohistochemistry

Outcome Measures

Primary Outcomes (1)

  • 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.

    Perioperative/Periprocedural

Secondary Outcomes (1)

  • Tissue-specific expression patterns of Hippo-YAP pathway biomarkers and related microRNAs

    Perioperative/Periprocedural

Study Arms (2)

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.

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.

Other: Laboratory Biomarker Analysis

Interventions

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.

Preterm Delivery GroupTerm Delivery Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Multiple pregnancy
  • Major fetal anomaly
  • Clinical evidence of chorioamnionitis
  • Hypertensive disorders of pregnancy
  • Diabetes mellitus or gestational diabetes mellitus
  • Autoimmune disease
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sivas Cumhuriyet University Faculty of Medicine

Sivas, Kayseri Ave, 58140, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 18568457BACKGROUND
  • Goldenberg 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.

    PMID: 18177778BACKGROUND
  • Chawanpaiboon 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.

    PMID: 30389451BACKGROUND

MeSH Terms

Conditions

Premature BirthObstetric Labor, Premature

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Nazan Yurtcu, MD, PhD

    Cumhuriyet University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Obstetrics and Gynecology

Study Record Dates

First Submitted

July 2, 2026

First Posted

July 10, 2026

Study Start

June 1, 2021

Primary Completion

April 1, 2024

Study Completion

May 31, 2024

Last Updated

July 10, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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.

Locations