Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06528340
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-21
Brief Title:
Pregnancies Outcomes in Advanced Maternal Age Women
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study of Pregnancies Outcomes in Advanced Maternal Age Women
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POIAMA
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 IVFET IVFDOET 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
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 IVFET IVFDOET 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None