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Completed

NCT Number: NCT06528340

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.

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Key information

Conditions

Advanced Maternal Age Pregnancy Cesarean Section Complications Complication of Labor and Delivery Delivery Complication Delivery Complications Affecting Fetus / Newborn Delivery;Complicated;Liveborn Female Urogenital Diseases and Pregnancy Complications Labor Complication Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Premature Birth Urogenital Diseases

Age range

45 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Ospedale Veris delli Ponti

Scorrano, Lecce, 73020, Italy

About this study

Aims:

  • Primary aim is to investigate outcomes of pregnancies in advanced maternal age, in relation to maternal morbidity
  • Secondary aim is to investigate neonatal outcomes of pregnancies in advanced maternal age
  • Third aim is to evaluate if the pregnancy outcomes differ in relation to conception (spontaneous, IVF/ET, IVF/DO/ET or CRYO) INCLUSION CRITERIA
  • pregnants older than 45 yrs at the time of delivery, regardless mode of conception 2. gestational age ≥24 weeks of gestation EXCLUSION CRITERIA
  • missing data relevant for the study
  • 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:

  • maternal age at delivery
  • gravidity
  • parity
  • gestational age at delivery
  • data about conception: spontaneous, IVF, oocyte donation
  • use of cryopreserved material
  • maternal comorbidity
  • maternal pregnancy complication
  • use of prenatal diagnostics
  • mode od delivery
  • neonatal weight and AS
  • presence of fetal anomalies
  • IUGR
  • placental pathology: previa, abruption, abnormally invasive placenta
  • peripartum hemorrhage
  • ICU treatment after delivery
  • duration of postpartum hospital treatment in days
  • prolonged postpartum hospitalization peripartum major complications (hysterectomy, hematoma, relaparotomy, ligation of major blood vessels (uterine, ovarian, iliac), etc.)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • missing data relevant for the study
  • surrogacy

Treatment and study plan

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)

Other names: operative delivery, cesarean section

Primary outcomes

  1. 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

Secondary outcomes

  1. Perinatal outcomes

    Time frame: 1 year

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

  2. Perinatal outcomes

    Time frame: 1 year

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

  3. 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

  4. Perinatal outcomes

    Time frame: 1 year

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

Other outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Centro di Ricerca Clinica Salentino

Network

Registry information

Official study title

Study of Pregnancies Outcomes in Advanced Maternal Age Women

Acronym: POIAMA

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 30, 2024
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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