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Advanced Maternal Age PregnancyPOIAMANCT06528340

Pregnancies Outcomes in Advanced Maternal Age Women

An observational study of Advanced Maternal Age Pregnancy and Premature, run by Centro di Ricerca Clinica Salentino at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 55 years, women onlyHealthy volunteers can take part
What is being tested?
spontaneous delivery
Type of treatment
Surgery or procedure
How many people
1,000 participants
Where
1 siteItaly
Study dates
1 Jan 2025to 20 Jan 2026
How long will I take part?
12 Months
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 45 to 55 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

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

Who cannot join

  • missing data relevant for the study
  • surrogacy

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Ospedale Veris delli Ponti

    Scorrano, Lecce, 73020

Other trials in Italy

About this study

Official title: Study of Pregnancies Outcomes in Advanced Maternal Age Women

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.

Read the detailed description

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
  4. pregnants older than 45 yrs at the time of delivery, regardless mode of conception 2. gestational age ≥24 weeks of gestation EXCLUSION CRITERIA
  5. missing data relevant for the study
  6. 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.)
Being tested
spontaneous delivery
Keywords
Advanced maternal age, Pregnancy outcomes, Delivery, Labor, Uterine ageing, Cesarean section complications, Operative delivery complications, Female reproductive ageing
Medical subject headings
Premature Birth, Obstetric Labor Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • spontaneous deliveryProcedure or surgery

    Also called operative delivery, cesarean section

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 year

Secondary outcomes (4)

  1. Perinatal outcomes

    The results of this study will show whether maternal age has a significant association with preterm birth.

    Measured: 1 year

  2. Perinatal outcomes

    The results of this study will show whether maternal age has a significant association with low birth weight

    Measured: 1 year

  3. Perinatal outcomes

    The results of this study will show whether maternal age has a significant association with low fifth-minute Apgar score

    Measured: 1 year

  4. Perinatal outcomes

    The results of this study will show whether maternal age has a significant association with perinatal death.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2024
  2. Study start1 Jan 2025
  3. Primary completion28 Feb 2025
  4. Study completion20 Jan 2026

Resources

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
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (actual)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06528340
Sponsor's protocol ID
CER 0424
Acronym
POIAMA
Status last verified
Jan 2026
First submitted
21 Jun 2024
Last updated
23 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 18443646

  • 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.

    PubMed 30842755

  • 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.

    PubMed 34408501

  • 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.

    PubMed 25842790

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

    PubMed 26828319

  • 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.

    PubMed 38297279

  • 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.

    PubMed 26652679

  • 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.

    PubMed 29070913

  • 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.

    PubMed 17275321

  • 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.

    PubMed 36068367

  • 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.

    PubMed 15831503

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

    PubMed 17710730

  • 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.

    PubMed 38203493

  • 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.

    PubMed 32003664

  • 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.

    PubMed 28430090

Questions about this trial

What is this clinical trial studying?

An observational study of Advanced Maternal Age Pregnancy and Premature, run by Centro di Ricerca Clinica Salentino at 1 site in Italy.

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 2 inclusion and 2 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 23 Jan 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 Italy. 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?

Pregnancy outcomes (time frame: 1 year). 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 NCT06528340, which also lists 21 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 23 Jan 2026.

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