Pregnancy Outcomes on Advanced Maternal Age

• Conditions: Advanced Maternal Age Pregnancy

• Registration Number: NCT05182021
• Lead Sponsor: Mansoura University

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-06-01
• Status Verified: 2021-10
• Study First Submitted: 2021-10-13
• Study First Submitted QC: 2022-01-04
• Last Update Submitted: 2022-01-04
• Study First Posted: 2022-01-10
• Last Update Posted: 2022-01-10
• Primary Completion: 2022-06-30
• Study Completion: 2023-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

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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 )

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparing the Obstetric outcomes as Gestational diabetes mellitus between the young and the elderly group	Between June 2021 to June 2022 and may be extended if needed	Gestational 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 group	Between June 2021 to June 2022 and may be extended if needed	Detecting Anemia by measuring hemoglobin level (in gm/dl).
Comparing the Fetal outcomes of pregnancy between the young and the elderly group	Between June 2021 to June 2022 and may be extended if needed	Fetal outcomes include: - Congenital malformation \& Intra uterine fetal death (detected by anomaly scan).
Comparing the Neonatal hypoglycemia between the young and the elderly group	Between June 2021 to June 2022 and may be extended if needed	Detected by measuring neonatal blood glucose level (mg/dl).
Comparing the Obstetric outcomes as Oligohydramnios or polyhydramnios between the young and the elderly group	Between June 2021 to June 2022 and may be extended if needed	Detected by measuring (amniotic fluid index in cm) by ultrasound.
Comparing the Perinatal outcomes as Birth weight between the young and the elderly group	Between June 2021 to June 2022 and may be extended if needed	Birth weight (in gm).
Comparing the Maternal outcomes as Preterm labor between the young and the elderly group	Between June 2021 to June 2022 and may be extended if needed	Preterm labor before 37 w of pregnancy calculated from last menstrual period.
Comparing the Neonatal outcomes of pregnancy between the young and the elderly group	Between June 2021 to June 2022 and may be extended if needed	Include: * APGAR score system.; * Neonatal intensive care unit admission

Secondary Outcome Measures

Name	Time	Method
Comparing the Perinatal outcomes as Birth weight between women with spontaneous pregnancy and those using Assisted Reproductive Technique	Between June 2021 to June 2022 and may be extended if needed	Birth weight (in gm).
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	Gestational 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 Technique	Between June 2021 to June 2022 and may be extended if needed	Detected 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 Technique	Between June 2021 to June 2022 and may be extended if needed	Oligohydramnios or polyhydramnios by measuring (amniotic fluid index in cm) by ultrasound.
Comparing the Neonatal 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	Include: * APGAR score system.; * Neonatal intensive care unit admission
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	Preterm 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 Technique	Between June 2021 to June 2022 and may be extended if needed	Congenital malformation \& Intra uterine fetal death (detected by anomaly scan).
Comparing the Neonatal hypoglycemia 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	Neonatal hypoglycemia by measure neonatal blood glucose level (mg/dl).

Trial Locations

Locations (1)

Mansoura university hospital; 🇪🇬 Mansoura, Egypt