Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
1000 participants
Study Classification
OBSERVATIONAL
Study Start Date
2025-01-01
Study Completion Date
2026-01-20
Brief Summary
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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.
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Detailed Description
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Aims:
1. Primary aim is to investigate outcomes of pregnancies in advanced maternal age, in relation to maternal morbidity
2. Secondary aim is to investigate neonatal outcomes of pregnancies in advanced maternal age
3. Third aim is to evaluate if the pregnancy outcomes differ in relation to conception (spontaneous, IVF/ET, IVF/DO/ET or CRYO) INCLUSION CRITERIA
1\. pregnants older than 45 yrs at the time of delivery, regardless mode of conception 2. gestational age ≥24 weeks of gestation EXCLUSION CRITERIA
1. missing data relevant for the study
2. surrogacy MATERIALS AND METHODS The study will be conducted as multicentric observational study including both vaginal and cesarean section deliveries in each participating center from January 1st 2019 until December 31st, 2025 (period of seven years). In each participating center, one person will be in charge for data collection and filling the SPSS database after obtaining the approval of the local Ethic Committee. As the study is observational and all the procedures will be conducted according to the local practice, informed consent from patients is not necessary.
Following data collection and termination of the study, a single researcher will oversee the SPSS data collection for all the participating centers, checking the quality of data and submitting it for statistical analysis.
The following data will be collected for each patient:
1. maternal age at delivery
2. gravidity
3. parity
4. gestational age at delivery
5. data about conception: spontaneous, IVF, oocyte donation
6. use of cryopreserved material
7. maternal comorbidity
8. maternal pregnancy complication
9. use of prenatal diagnostics
10. mode od delivery
11. neonatal weight and AS
12. presence of fetal anomalies
13. IUGR
14. placental pathology: previa, abruption, abnormally invasive placenta
15. peripartum hemorrhage
16. ICU treatment after delivery
17. duration of postpartum hospital treatment in days
18. prolonged postpartum hospitalization peripartum major complications (hysterectomy, hematoma, relaparotomy, ligation of major blood vessels (uterine, ovarian, iliac), etc.)
1. Primary aim is to investigate outcomes of pregnancies in advanced maternal age, in relation to maternal morbidity
2. Secondary aim is to investigate neonatal outcomes of pregnancies in advanced maternal age
3. Third aim is to evaluate if the pregnancy outcomes differ in relation to conception (spontaneous, IVF/ET, IVF/DO/ET or CRYO) INCLUSION CRITERIA
1\. pregnants older than 45 yrs at the time of delivery, regardless mode of conception 2. gestational age ≥24 weeks of gestation EXCLUSION CRITERIA
1. missing data relevant for the study
2. surrogacy MATERIALS AND METHODS The study will be conducted as multicentric observational study including both vaginal and cesarean section deliveries in each participating center from January 1st 2019 until December 31st, 2025 (period of seven years). In each participating center, one person will be in charge for data collection and filling the SPSS database after obtaining the approval of the local Ethic Committee. As the study is observational and all the procedures will be conducted according to the local practice, informed consent from patients is not necessary.
Following data collection and termination of the study, a single researcher will oversee the SPSS data collection for all the participating centers, checking the quality of data and submitting it for statistical analysis.
The following data will be collected for each patient:
1. maternal age at delivery
2. gravidity
3. parity
4. gestational age at delivery
5. data about conception: spontaneous, IVF, oocyte donation
6. use of cryopreserved material
7. maternal comorbidity
8. maternal pregnancy complication
9. use of prenatal diagnostics
10. mode od delivery
11. neonatal weight and AS
12. presence of fetal anomalies
13. IUGR
14. placental pathology: previa, abruption, abnormally invasive placenta
15. peripartum hemorrhage
16. ICU treatment after delivery
17. duration of postpartum hospital treatment in days
18. prolonged postpartum hospitalization peripartum major complications (hysterectomy, hematoma, relaparotomy, ligation of major blood vessels (uterine, ovarian, iliac), etc.)
Conditions
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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
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Interventions
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spontaneous delivery
The women will be followed until the birth, in which the 3 traditional 3 methods will be carried out (spontaneous, vaginal operating, abdominal operation)
Intervention Type
PROCEDURE
Other Intervention Names
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operative delivery
cesarean section
Eligibility Criteria
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Inclusion Criteria
1. pregnants older than 45 yrs at the time of delivery, regardless mode of conception
2. gestational age ≥24 weeks of gestation
2. gestational age ≥24 weeks of gestation
Exclusion Criteria
1. missing data relevant for the study
2. surrogacy
2. surrogacy
Minimum Eligible Age
45 Years
Maximum Eligible Age
55 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
Yes
Sponsors
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Centro di Ricerca Clinica Salentino
NETWORK
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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ANDREA TINELLI, MD
Role: STUDY_CHAIR
Ospedale Veris delli Ponti, Scorrano, Le
Locations
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Ospedale Veris delli Ponti
Scorrano, Lecce, Italy
Site Status
Countries
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Italy
References
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Broekmans FJ, Knauff EA, te Velde ER, Macklon NS, Fauser BC. Female reproductive ageing: current knowledge and future trends. Trends Endocrinol Metab. 2007 Mar;18(2):58-65. doi: 10.1016/j.tem.2007.01.004. Epub 2007 Feb 1.
Reference Type
RESULT
Charalambous C, Webster A, Schuh M. Aneuploidy in mammalian oocytes and the impact of maternal ageing. Nat Rev Mol Cell Biol. 2023 Jan;24(1):27-44. doi: 10.1038/s41580-022-00517-3. Epub 2022 Sep 6.
Reference Type
RESULT
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
RESULT
Friese C, Becker G, Nachtigall RD. Older Motherhood and the Changing Life Course in the Era of Assisted Reproductive Technologies. J Aging Stud. 2008 Jan;22(1):65-73. doi: 10.1016/j.jaging.2007.05.009.
Reference Type
RESULT
Ubaldi FM, Cimadomo D, Vaiarelli A, Fabozzi G, Venturella R, Maggiulli R, Mazzilli R, Ferrero S, Palagiano A, Rienzi L. Advanced Maternal Age in IVF: Still a Challenge? The Present and the Future of Its Treatment. Front Endocrinol (Lausanne). 2019 Feb 20;10:94. doi: 10.3389/fendo.2019.00094. eCollection 2019.
Reference Type
RESULT
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.
Reference Type
RESULT
Traisrisilp K, Tongsong T. Pregnancy outcomes of mothers with very advanced maternal age (40 years or more). J Med Assoc Thai. 2015 Feb;98(2):117-22.
Reference Type
RESULT
Mathews TJ, Hamilton BE. Mean Age of Mothers is on the Rise: United States, 2000-2014. NCHS Data Brief. 2016 Jan;(232):1-8.
Reference Type
RESULT
Zhu C, Zhang S, Shen L, Ye L, Zhan M, Cai S, Huang J, Wang Z, Chen H. Changes in the characteristics and outcomes of high-risk pregnant women who delivered prior to and after China's universal two-child policy: a real-world retrospective study, 2010-2021. BMC Public Health. 2024 Jan 31;24(1):336. doi: 10.1186/s12889-024-17810-9.
Reference Type
RESULT
Goisis A. How Are Children of Older Mothers Doing? Evidence from the United Kingdom. Biodemography Soc Biol. 2015;61(3):231-51. doi: 10.1080/19485565.2014.1001887.
Reference Type
RESULT
Myrskyla M, Barclay K, Goisis A. Advantages of later motherhood. Gynakologe. 2017;50(10):767-772. doi: 10.1007/s00129-017-4124-1. Epub 2017 Aug 29.
Reference Type
RESULT
Other Identifiers
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CER 0424
Identifier Type: -
Identifier Source: org_study_id
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