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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05182021
Other study ID # MS.21.06.1542
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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 )

Study Design


Related Conditions & MeSH terms


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
See also
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