Clinical trial NCT06528340: Pregnancies Outcomes in Advanced Maternal Age Women
Official title: Study of Pregnancies Outcomes in Advanced Maternal Age Women
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: 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
Keywords: Advanced maternal age
Pregnancy outcomes
Delivery
Labor
Uterine ageing
Cesarean section complications
Operative delivery complications
Female reproductive ageing
Lead sponsor: Centro di Ricerca Clinica Salentino
Sponsor class: NETWORK
First posted: 2024-07-30
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.)

Eligibility criteria: 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

Primary outcomes:
measure: Pregnancy outcomes
timeFrame: 1 year
Secondary outcomes:
measure: Perinatal outcomes
timeFrame: 1 year
measure: Perinatal outcomes
timeFrame: 1 year
measure: Perinatal outcomes
timeFrame: 1 year
measure: Perinatal outcomes
timeFrame: 1 year
Other outcomes:
measure: Outcomes based on type of conception
timeFrame: 1 year
Locations:
city: Scorrano
country: Italy
facility: Ospedale Veris delli Ponti
state: Lecce
Study officials:
affiliation: Ospedale Veris delli Ponti, Scorrano, Le
name: ANDREA TINELLI, MD
role: STUDY_CHAIR
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