Pregnancy Outcomes on Advanced Maternal Age

Advanced Maternal Age Pregnancy Clinical Trial

— AMA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05182021
• Other study ID #: MS.21.06.1542
• Status: Active, not recruiting
• Start date: June 1, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: October 2021
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: February 1, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

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 )

Related Conditions & MeSH terms

• Advanced Maternal Age Pregnancy

Locations

Country	Name	City	State
Egypt	Mansoura university hospital	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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