Pregnancies Outcomes in Advanced Maternal Age Women (POIAMA)

January 22, 2026 updated by: Centro di Ricerca Clinica Salentino

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

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.)

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lecce
      • Scorrano, Lecce, Italy, 73020
        • Ospedale Veris Delli Ponti

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy outcomes
Time Frame: 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perinatal outcomes
Time Frame: 1 year
The results of this study will show whether maternal age has a significant association with preterm birth.
1 year
Perinatal outcomes
Time Frame: 1 year
The results of this study will show whether maternal age has a significant association with low birth weight
1 year
Perinatal outcomes
Time Frame: 1 year
The results of this study will show whether maternal age has a significant association with low fifth-minute Apgar score
1 year
Perinatal outcomes
Time Frame: 1 year
The results of this study will show whether maternal age has a significant association with perinatal death.
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Outcomes based on type of conception
Time Frame: 1 year
To evaluate if the pregnancy outcomes in AMA women differ in relation to conception (if spontaneous, or by IVF/ET, by IVF/DO/ET or by CRYO).
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro di Ricerca Clinica Salentino

Investigators

  • Study Chair: ANDREA TINELLI, MD, Ospedale Veris delli Ponti, Scorrano, Le

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Actual)

February 28, 2025

Study Completion (Actual)

January 20, 2026

Study Registration Dates

First Submitted

June 21, 2024

First Submitted That Met QC Criteria

July 26, 2024

First Posted (Actual)

July 30, 2024

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CER 0424

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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