Pregnancies Outcomes in Advanced Maternal Age Women

NCT06528340 | Completed

• 1 other identifier: CER 0424
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Pregnancies occurring in advanced maternal age (AMA) have become more common over the last few decades for a variety of reasons. Prominent contributor to this trend are the significant advancement in assisted reproductive technology (ART) and the growing accessibility to egg donation. Delaying having children is generally associated with other variables, such as the availability of various forms of contraception, which have decreased the number of unintended births and given women more autonomy over when they choose to become pregnant. In addition, from a socioeconomic standpoint, greater education and career options for women are major contributors to this phenomenon. Women with postsecondary education are especially affected by this issue since they are more likely to miss out on professional opportunities, money, and social standing when they become mothers. Studies show that women with a tertiary level of education stay pregnant later in life, compared to women with a lower level of education. Moreover, severe economic volatility throughout the early adult years, delays in the establishment of partnerships and marriages, and the shift from family homes to independent living all serve to worsen the tendency. In this investigation, we will seek, with a critical eye, to evaluate the implications of a pregnant woman in AMA and her outcomes, trying to highlight all the possible complications and problems of a pregnancy in AMA, with an evaluation of a big volume of AMA women in pregnancy and at delivery.

Conditions

Advanced Maternal Age Pregnancy; Premature; Labor Complication; Delivery Complication; Delivery Complications Affecting Fetus / Newborn; Delivery;Complicated;Liveborn; Cesarean Section Complications; Complication of Labor and Delivery

Keywords

Advanced maternal age; Pregnancy outcomes; Delivery; Labor; Uterine ageing; Cesarean section complications; Operative delivery complications; Female reproductive ageing

Outcome Measures

Primary Outcomes (1)

• Pregnancy outcomes

  To investigate outcomes of pregnancies in advanced maternal age, in relation to maternal morbidity, as complications in pregnancy, gestational age at delivery, type of delivery, maternal pregnancy complications, placental pathology, peripartum hemorrages, duration of hospital stay, prolonged hospitalization, peripartum major complications, etc

  1 year

Secondary Outcomes (4)

• Perinatal outcomes

  1 year

• Perinatal outcomes

  1 year

• Perinatal outcomes

  1 year

• Perinatal outcomes

  1 year

Other Outcomes (1)

• Outcomes based on type of conception

  1 year

Interventions

spontaneous delivery PROCEDURE

The women will be followed until the birth, in which the 3 traditional 3 methods will be carried out (spontaneous, vaginal operating, abdominal operation)

Also known as: operative delivery, cesarean section

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All pregnant women in Advanced Maternal Age will be enrolled for the study, in order to better understand the outcomes of pregnancy. They are all healthy women, in spontaneous pregnancy or assisted by fertilization techniques.

You may qualify if:

• pregnants older than 45 yrs at the time of delivery, regardless mode of conception
• gestational age ≥24 weeks of gestation

You may not qualify if:

• missing data relevant for the study
• surrogacy

Sponsors & Collaborators

• Centro di Ricerca Clinica Salentino: lead

Study Sites (1)

Ospedale Veris delli Ponti

Scorrano, Lecce, 73020, Italy

Location

Related Publications (21)

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  PMID: 18443646 RESULT

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• Glick I, Kadish E, Rottenstreich M. Management of Pregnancy in Women of Advanced Maternal Age: Improving Outcomes for Mother and Baby. Int J Womens Health. 2021 Aug 10;13:751-759. doi: 10.2147/IJWH.S283216. eCollection 2021.

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• Mathews TJ, Hamilton BE. Mean Age of Mothers is on the Rise: United States, 2000-2014. NCHS Data Brief. 2016 Jan;(232):1-8.

  PMID: 26828319 RESULT

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• Baird DT, Collins J, Egozcue J, Evers LH, Gianaroli L, Leridon H, Sunde A, Templeton A, Van Steirteghem A, Cohen J, Crosignani PG, Devroey P, Diedrich K, Fauser BC, Fraser L, Glasier A, Liebaers I, Mautone G, Penney G, Tarlatzis B; ESHRE Capri Workshop Group. Fertility and ageing. Hum Reprod Update. 2005 May-Jun;11(3):261-76. doi: 10.1093/humupd/dmi006. Epub 2005 Apr 14.

  PMID: 15831503 RESULT

• Hall JE. Neuroendocrine changes with reproductive aging in women. Semin Reprod Med. 2007 Sep;25(5):344-51. doi: 10.1055/s-2007-984740.

  PMID: 17710730 RESULT

• Tinelli A, Andjic M, Morciano A, Pecorella G, Malvasi A, D'Amato A, Sparic R. Uterine Aging and Reproduction: Dealing with a Puzzle Biologic Topic. Int J Mol Sci. 2023 Dec 25;25(1):322. doi: 10.3390/ijms25010322.

  PMID: 38203493 RESULT

• Kosmas IP, Malvasi A, Vergara D, Mynbaev OA, Sparic R, Tinelli A. Adrenergic and Cholinergic Uterine Innervation and the Impact on Reproduction in Aged Women. Curr Pharm Des. 2020;26(3):358-362. doi: 10.2174/1381612826666200128092256.

  PMID: 32003664 RESULT

• Tinelli A. Editorial (Thematic Issue: Uterine Innervation and Clinical Features in Obstetrics & Gynecology). Curr Protein Pept Sci. 2017;18(2):106-107. doi: 10.2174/138920371802161215213813. No abstract available.

  PMID: 28430090 RESULT

• Tinelli A, Malvasi A, Rahimi S, Negro R, Vergara D, Martignago R, Pellegrino M, Cavallotti C. Age-related pelvic floor modifications and prolapse risk factors in postmenopausal women. Menopause. 2010 Jan-Feb;17(1):204-12. doi: 10.1097/gme.0b013e3181b0c2ae.

  PMID: 19629013 RESULT

• Tinelli A, Vergara D, Ma Y, Malvasi A. Dystocia, Uterine Healing and Uterine Innervation: An Unexplored Intersection. Curr Protein Pept Sci. 2020;21(5):440-442. doi: 10.2174/1389203720666190717115744. No abstract available.

  PMID: 32268856 RESULT

• Frick AP. Advanced maternal age and adverse pregnancy outcomes. Best Pract Res Clin Obstet Gynaecol. 2021 Jan;70:92-100. doi: 10.1016/j.bpobgyn.2020.07.005. Epub 2020 Jul 15.

  PMID: 32741623 RESULT

• Radon-Pokracka M, Adrianowicz B, Plonka M, Danil P, Nowak M, Huras H. Evaluation of Pregnancy Outcomes at Advanced Maternal Age. Open Access Maced J Med Sci. 2019 Jun 30;7(12):1951-1956. doi: 10.3889/oamjms.2019.587. eCollection 2019 Jun 30.

  PMID: 31406535 RESULT

• Kahveci B, Melekoglu R, Evruke IC, Cetin C. The effect of advanced maternal age on perinatal outcomes in nulliparous singleton pregnancies. BMC Pregnancy Childbirth. 2018 Aug 22;18(1):343. doi: 10.1186/s12884-018-1984-x.

  PMID: 30134873 RESULT

• Kenny LC, Lavender T, McNamee R, O'Neill SM, Mills T, Khashan AS. Advanced maternal age and adverse pregnancy outcome: evidence from a large contemporary cohort. PLoS One. 2013;8(2):e56583. doi: 10.1371/journal.pone.0056583. Epub 2013 Feb 20.

  PMID: 23437176 RESULT

MeSH Terms

Conditions

Premature Birth; Obstetric Labor Complications

Interventions

Cesarean Section

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• ANDREA TINELLI, MD

  Ospedale Veris delli Ponti, Scorrano, Le

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: July 30, 2024
• Study Start: January 1, 2025
• Primary Completion: February 28, 2025
• Study Completion: January 20, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

IT (1)