Cyclin-dependent Kinase Inhibitor 2A (Placental Senescence Marker) on Labor-related Signals

NCT05864066 | Unknown

• 1 other identifier: P16 INK4a and PR
• Study Type: observational
• Target: 81
• Locations: 0 countries
• Sites: N/A

Brief Summary

Onset of labor in human is initiated by progesterone withdrawal. Over many decades researchers had proposed hypotheses to explain the functional withdrawal of progesterone. These hypotheses were through the sequestration of active progesterone by corticosteroid-binding globulin, a decrease in active progesterone metabolite levels and changes in the ratio of progesterone receptor (PR) isoforms (nuclear progesterone receptors A (nPRA) and nuclear progesterone receptors B (nPRB)). Progesterone performs its action non-genomically through binding to membrane receptors and genomically via binding to nPRs. PRA is the less active or inactive form of progesterone receptors and shorter in amino acid sequence than PRB, the active form of the receptors.

Conditions

Preterm Labor

Outcome Measures

Primary Outcomes (1)

• P16 INK4a

  1.Evaluating the role of cyclin-dependent kinase inhibitor 2A (P16 INK4a) placental senescence marker to predict time of labor.

  one year

Secondary Outcomes (1)

• PR

  one year

Study Arms (3)

1

Women in preterm delivery with GA \< 36 weeks.

2

Women not in labor undergoing elective C-section with GA between 36 and 40 weeks.

3

Women following spontaneous labor (without being induced) with GA between 36 and 40 weeks.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pregnant women who will come for termination of pregnancy

You may qualify if:

• Pregnant women who will come for termination of pregnancy by caesarean section or vaginal delivery.
• Gestational age is between 28 to \< 37 weeks for preterm labor and 37 to 40 weeks for term labor.
• The age range of women is between18- 40 years.

You may not qualify if:

• Acute or chronic infectious diseases or other chronic illness
• Autoimmune diseases
• PE complicated with Eclampsia, DIC or HELP syndrome
• Congenital anomaly of the uterus
• History of trauma
• Twins pregnancy
• Congenital anomalies of the fetus
• Fetal growth restriction

Sponsors & Collaborators

• Assiut University: lead

Related Publications (8)

• Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

  PMID: 17695343 BACKGROUND

• Grazul-Bilska AT, Thammasiri J, Kraisoon A, Reyaz A, Bass CS, Kaminski SL, Navanukraw C, Redmer DA. Expression of progesterone receptor protein in the ovine uterus during the estrous cycle: Effects of nutrition, arginine and FSH. Theriogenology. 2018 Mar 1;108:7-15. doi: 10.1016/j.theriogenology.2017.11.008. Epub 2017 Nov 20.

  PMID: 29175682 BACKGROUND

• Jacobsen BM, Horwitz KB. Progesterone receptors, their isoforms and progesterone regulated transcription. Mol Cell Endocrinol. 2012 Jun 24;357(1-2):18-29. doi: 10.1016/j.mce.2011.09.016. Epub 2011 Sep 17.

  PMID: 21952082 BACKGROUND

• Kidus F, Woldemichael K, Hiko D. Predictors of neonatal mortality in Assosa zone, Western Ethiopia: a matched case control study. BMC Pregnancy Childbirth. 2019 Mar 29;19(1):108. doi: 10.1186/s12884-019-2243-5.

  PMID: 30925903 BACKGROUND

• Kowalik MK, Rekawiecki R, Kotwica J. Expression of membrane progestin receptors (mPRs) in the bovine corpus luteum during the estrous cycle and first trimester of pregnancy. Domest Anim Endocrinol. 2018 Apr;63:69-76. doi: 10.1016/j.domaniend.2017.12.004. Epub 2018 Jan 11.

  PMID: 29413904 BACKGROUND

• Kumari R, Jat P. Mechanisms of Cellular Senescence: Cell Cycle Arrest and Senescence Associated Secretory Phenotype. Front Cell Dev Biol. 2021 Mar 29;9:645593. doi: 10.3389/fcell.2021.645593. eCollection 2021.

  PMID: 33855023 BACKGROUND

• Martin JA, Hamilton BE, Osterman MJK, Driscoll AK. Births: Final Data for 2018. Natl Vital Stat Rep. 2019 Nov;68(13):1-47.

  PMID: 32501202 BACKGROUND

• Menon R, Bonney EA, Condon J, Mesiano S, Taylor RN. Novel concepts on pregnancy clocks and alarms: redundancy and synergy in human parturition. Hum Reprod Update. 2016 Sep;22(5):535-60. doi: 10.1093/humupd/dmw022. Epub 2016 Jun 30.

  PMID: 27363410 BACKGROUND

MeSH Terms

Conditions

Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Fatma El-Sayed Moustafa, Assistant lecturer

CONTACT

01094045199; fatma.taha.elsayed@gmail.com

Mahmoud Raafat Abdel-fadeil, professor

CONTACT

0201001644429; mrafadeil@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 18, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: February 1, 2025
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share