Pregnancy Outcomes on Advanced Maternal Age (AMA)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced Maternal Age Pregnancy

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

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt
    • Mansoura University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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

Description

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 )

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparing the Obstetric outcomes as Gestational diabetes mellitus between women with spontaneous pregnancy and those using Assisted Reproductive Technique	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 women with spontaneous pregnancy and those using Assisted Reproductive Technique	Detected 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 women with spontaneous pregnancy and those using Assisted Reproductive Technique	Oligohydramnios or polyhydramnios 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 of pregnancy between women with spontaneous pregnancy and those using Assisted Reproductive Technique	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 women with spontaneous pregnancy and those using Assisted Reproductive Technique	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 women with spontaneous pregnancy and those using Assisted Reproductive Technique	Birth weight (in gm).	Between June 2021 to June 2022 and may be extended if needed
Comparing the Neonatal hypoglycemia of pregnancy between women with spontaneous pregnancy and those using Assisted Reproductive Technique	Neonatal hypoglycemia by measure 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 women with spontaneous pregnancy and those using Assisted Reproductive Technique	Include: APGAR score system.; Neonatal intensive care unit admission	Between June 2021 to June 2022 and may be extended if needed

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Rana magdy ibrahim El gharbawy, Obstetric and Gynecology department at mansoura university hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: October 13, 2021
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (Actual): January 10, 2022

Study Record Updates

• Last Update Posted (Actual): January 10, 2022
• Last Update Submitted That Met QC Criteria: January 4, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Advanced maternal age
• Other Study ID Numbers: MS.21.06.1542

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No