Trials / Completed

CompletedNCT06528340

Pregnancies Outcomes in Advanced Maternal Age Women

Study of Pregnancies Outcomes in Advanced Maternal Age Women

Status: Completed
Phase: —
Study type: Observational
Enrollment: 1,000 (actual)

Sponsor: Centro di Ricerca Clinica Salentino · Network
Sex: Female
Age: 45 Years – 55 Years
Healthy volunteers: Accepted

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.

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.)

Conditions

Interventions

Type	Name	Description
PROCEDURE	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)

Timeline

Start date: 2025-01-01
Primary completion: 2025-02-28
Completion: 2026-01-20
First posted: 2024-07-30
Last updated: 2026-01-23

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT06528340. Inclusion in this directory is not an endorsement.