Pregnancy Outcomes on Advanced Maternal Age
AMA
The Effect of Advanced Maternal Age on Pregnancy Outcomes: A Prospective Study
1 other identifier
observational
100
1 country
1
Brief Summary
A prospective observational study of pregnancy outcomes at advanced maternal age among primigravida which include maternal ,fetal, obstetric and perinatal outcomes
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2021
CompletedFirst Submitted
Initial submission to the registry
October 13, 2021
CompletedFirst Posted
Study publicly available on registry
January 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2023
CompletedJanuary 10, 2022
October 1, 2021
1.1 years
October 13, 2021
January 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Comparing the Obstetric outcomes as Gestational diabetes mellitus between the young and the elderly group
Gestational diabetes mellitus by using oral glucose tolerance test between 24 : 28 weeks of pregnancy (in mg/dl),
Between June 2021 to June 2022 and may be extended if needed
Comparing the Obstetric outcomes as Anemia between the young and the elderly group
Detecting Anemia by measuring hemoglobin level (in gm/dl).
Between June 2021 to June 2022 and may be extended if needed
Comparing the Obstetric outcomes as Oligohydramnios or polyhydramnios between the young and the elderly group
Detected by measuring (amniotic fluid index in cm) by ultrasound.
Between June 2021 to June 2022 and may be extended if needed
Comparing the Maternal outcomes as Preterm labor between the young and the elderly group
Preterm labor before 37 w of pregnancy calculated from last menstrual period.
Between June 2021 to June 2022 and may be extended if needed
Comparing the Fetal outcomes of pregnancy between the young and the elderly group
Fetal outcomes include: \- Congenital malformation \& Intra uterine fetal death (detected by anomaly scan).
Between June 2021 to June 2022 and may be extended if needed
Comparing the Perinatal outcomes as Birth weight between the young and the elderly group
Birth weight (in gm).
Between June 2021 to June 2022 and may be extended if needed
Comparing the Neonatal hypoglycemia between the young and the elderly group
Detected by measuring neonatal blood glucose level (mg/dl).
Between June 2021 to June 2022 and may be extended if needed
Comparing the Neonatal outcomes of pregnancy between the young and the elderly group
Include: * APGAR score system. * Neonatal intensive care unit admission
Between June 2021 to June 2022 and may be extended if needed
Secondary Outcomes (8)
Comparing the Obstetric outcomes as Gestational diabetes mellitus between women with spontaneous pregnancy and those using Assisted Reproductive Technique
Between June 2021 to June 2022 and may be extended if needed
Comparing the Obstetric outcomes as Anemia between women with spontaneous pregnancy and those using Assisted Reproductive Technique
Between June 2021 to June 2022 and may be extended if needed
Comparing the Obstetric outcomes as Oligohydramnios or polyhydramnios between women with spontaneous pregnancy and those using Assisted Reproductive Technique
Between June 2021 to June 2022 and may be extended if needed
Comparing the Maternal outcomes of pregnancy between women with spontaneous pregnancy and those using Assisted Reproductive Technique
Between June 2021 to June 2022 and may be extended if needed
Comparing the Fetal outcomes of pregnancy between women with spontaneous pregnancy and those using Assisted Reproductive Technique
Between June 2021 to June 2022 and may be extended if needed
- +3 more secondary outcomes
Study Arms (2)
Case group
The case group represented by 50 primigravida women aged 35 y or more during their pregnancy or at the time of delivery
Control group
The control group represented by 50 primigravida women aged 20 y : 34 y during their pregnancy or at the time of delivery
Eligibility Criteria
The control group will be presented by 50 women aged 20-34 years during their pregnancy and the case group will be presented by 50 women aged 35 years or more during their pregnancy or at the time of delivery
You may qualify if:
- all primigravida women aged 20 to 34 years in control group and aged 35years or more in case group who seeking for antenatal care in mansoura university hospital and who accept study protocol
You may not qualify if:
- multipara
- women aged less than 20 years
- women with any medical disorder ( anti phospholipid syndrome , chronic hypertension ,Diabetes, autoimmune disease and thrombosis embolic disease )
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mansoura university hospital
Al Mansurah, Egypt
Study Officials
- PRINCIPAL INVESTIGATOR
Rana magdy ibrahim El gharbawy
Obstetric and Gynecology department at mansoura university hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2021
First Posted
January 10, 2022
Study Start
June 1, 2021
Primary Completion
June 30, 2022
Study Completion
February 1, 2023
Last Updated
January 10, 2022
Record last verified: 2021-10