Pregnancies Outcomes in Advanced Maternal Age Women

Not yet recruiting

• Conditions: Advanced Maternal Age Pregnancy; Delivery;Complicated;Liveborn; Complication of Labor and Delivery; Premature; Delivery Complication; Delivery Complications Affecting Fetus / Newborn; Labor Complication; Cesarean Section Complications

• Registration Number: NCT06528340
• Lead Sponsor: Centro di Ricerca Clinica Salentino

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.)

Study Timeline

• Study First Submitted: 2024-06-21
• Study First Submitted QC: 2024-07-26
• Study First Posted: 2024-07-30
• Status Verified: 2024-10
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-13
• Study Start: 2025-03-01
• Primary Completion: 2025-12-30
• Study Completion: 2026-03-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pregnancy outcomes	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 Outcome Measures

Name	Time	Method
Perinatal outcomes	1 year	The results of this study will show whether maternal age has a significant association with perinatal death.

Trial Locations

Locations (1)

Ospedale Veris delli Ponti; 🇮🇹 Scorrano, Lecce, Italy