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Pregnancy Outcomes on Advanced Maternal Age

The Effect of Advanced Maternal Age on Pregnancy Outcomes: A Prospective Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05182021
Acronym
AMA
Enrollment
100
Registered
2022-01-10
Start date
2021-06-01
Completion date
2023-02-01
Last updated
2022-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Maternal Age Pregnancy

Keywords

Advanced maternal age

Brief summary

A prospective observational study of pregnancy outcomes at advanced maternal age among primigravida which include maternal ,fetal, obstetric and perinatal outcomes

Detailed description

The investigator will have 2 groups of primigravida , the first group will be presented by 50 women aged 35 y or more and the second group will be presented by 50 women aged 20 y to 34 y The first group will be also divided into 2 subgroups : group (1A ) aged 35 y to 40 y and group (1B) aged above 40 y The investigator will compare the outcomes between the two group , also comparing the outcomes between women with spontaneous pregnancy and those using ART ( Assisted Reproductive Technology ) The participants will undergo routine investigations at the first antenatal visit and a monthly ultrasound examination until delivery The participants will be screened for gestational diabetes mellitus using oral glucose tolerance test between 24 :34 weeks of pregnancy The participants will be screened for gestational hypertension after 20 weeks of pregnancy Obstetric outcomes will be recorded regarding pregnancy induced hypertension, gestational diabetes mellitus , anemia, antepartum hemorrhage, obstetric shock and intrapartum hemorrhage Maternal outcomes will be recorded regarding mode of delivery ,time of delivery ,preterm labor ,obstructed labor and prolonged labor Fetal outcomes will be recorded regarding congenital malformation ,intra uterine growth retardation ,intra uterine fetal death and still birth Perinatal outcomes will be recorded regarded birth weight ,birth asphyxia , neonatal hypoglycemia ,hyperbilirubinemia and ICU admission

Interventions

None listed

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* multipara * women aged less than 20 years * women with any medical disorder ( anti phospholipid syndrome , chronic hypertension ,Diabetes, autoimmune disease and thrombosis embolic disease )

Design outcomes

Primary

MeasureTime frameDescription
Comparing the Neonatal outcomes of pregnancy between the young and the elderly groupBetween June 2021 to June 2022 and may be extended if neededInclude: * APGAR score system. * Neonatal intensive care unit admission
Comparing the Obstetric outcomes as Gestational diabetes mellitus between the young and the elderly groupBetween June 2021 to June 2022 and may be extended if neededGestational diabetes mellitus by using oral glucose tolerance test between 24 : 28 weeks of pregnancy (in mg/dl),
Comparing the Obstetric outcomes as Anemia between the young and the elderly groupBetween June 2021 to June 2022 and may be extended if neededDetecting Anemia by measuring hemoglobin level (in gm/dl).
Comparing the Obstetric outcomes as Oligohydramnios or polyhydramnios between the young and the elderly groupBetween June 2021 to June 2022 and may be extended if neededDetected by measuring (amniotic fluid index in cm) by ultrasound.
Comparing the Maternal outcomes as Preterm labor between the young and the elderly groupBetween June 2021 to June 2022 and may be extended if neededPreterm labor before 37 w of pregnancy calculated from last menstrual period.
Comparing the Fetal outcomes of pregnancy between the young and the elderly groupBetween June 2021 to June 2022 and may be extended if neededFetal outcomes include: \- Congenital malformation & Intra uterine fetal death (detected by anomaly scan).
Comparing the Perinatal outcomes as Birth weight between the young and the elderly groupBetween June 2021 to June 2022 and may be extended if neededBirth weight (in gm).
Comparing the Neonatal hypoglycemia between the young and the elderly groupBetween June 2021 to June 2022 and may be extended if neededDetected by measuring neonatal blood glucose level (mg/dl).

Secondary

MeasureTime frameDescription
Comparing the Obstetric outcomes as Gestational diabetes mellitus between women with spontaneous pregnancy and those using Assisted Reproductive TechniqueBetween June 2021 to June 2022 and may be extended if neededGestational diabetes mellitus by using oral glucose tolerance test between 24 : 28 weeks of pregnancy (in mg/dl),
Comparing the Obstetric outcomes as Anemia between women with spontaneous pregnancy and those using Assisted Reproductive TechniqueBetween June 2021 to June 2022 and may be extended if neededDetected by measuring hemoglobin level (in gm/dl).
Comparing the Obstetric outcomes as Oligohydramnios or polyhydramnios between women with spontaneous pregnancy and those using Assisted Reproductive TechniqueBetween June 2021 to June 2022 and may be extended if neededOligohydramnios or polyhydramnios by measuring (amniotic fluid index in cm) by ultrasound.
Comparing the Maternal outcomes of pregnancy between women with spontaneous pregnancy and those using Assisted Reproductive TechniqueBetween June 2021 to June 2022 and may be extended if neededPreterm labor before 37 w of pregnancy calculated from last menstrual period.
Comparing the Fetal outcomes of pregnancy between women with spontaneous pregnancy and those using Assisted Reproductive TechniqueBetween June 2021 to June 2022 and may be extended if neededCongenital malformation & Intra uterine fetal death (detected by anomaly scan).
Comparing the Perinatal outcomes as Birth weight between women with spontaneous pregnancy and those using Assisted Reproductive TechniqueBetween June 2021 to June 2022 and may be extended if neededBirth weight (in gm).
Comparing the Neonatal hypoglycemia of pregnancy between women with spontaneous pregnancy and those using Assisted Reproductive TechniqueBetween June 2021 to June 2022 and may be extended if neededNeonatal hypoglycemia by measure neonatal blood glucose level (mg/dl).
Comparing the Neonatal outcomes of pregnancy between women with spontaneous pregnancy and those using Assisted Reproductive TechniqueBetween June 2021 to June 2022 and may be extended if neededInclude: * APGAR score system. * Neonatal intensive care unit admission

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026