Clinical trial NCT05182021: Pregnancy Outcomes on Advanced Maternal Age
Official title: The Effect of Advanced Maternal Age on Pregnancy Outcomes: A Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Advanced Maternal Age Pregnancy
Keywords: Advanced maternal age
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-01-10
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

Eligibility criteria: 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 )

Primary outcomes:
measure: Comparing the Obstetric outcomes as Gestational diabetes mellitus between the young and the elderly group
timeFrame: Between June 2021 to June 2022 and may be extended if needed
measure: Comparing the Obstetric outcomes as Anemia between the young and the elderly group
timeFrame: Between June 2021 to June 2022 and may be extended if needed
measure: Comparing the Obstetric outcomes as Oligohydramnios or polyhydramnios between the young and the elderly group
timeFrame: Between June 2021 to June 2022 and may be extended if needed
measure: Comparing the Maternal outcomes as Preterm labor between the young and the elderly group
timeFrame: Between June 2021 to June 2022 and may be extended if needed
measure: Comparing the Fetal outcomes of pregnancy between the young and the elderly group
timeFrame: Between June 2021 to June 2022 and may be extended if needed
measure: Comparing the Perinatal outcomes as Birth weight between the young and the elderly group
timeFrame: Between June 2021 to June 2022 and may be extended if needed
measure: Comparing the Neonatal hypoglycemia between the young and the elderly group
timeFrame: Between June 2021 to June 2022 and may be extended if needed
measure: Comparing the Neonatal outcomes of pregnancy between the young and the elderly group
timeFrame: Between June 2021 to June 2022 and may be extended if needed
Secondary outcomes:
measure: Comparing the Obstetric outcomes as Gestational diabetes mellitus between women with spontaneous pregnancy and those using Assisted Reproductive Technique
timeFrame: Between June 2021 to June 2022 and may be extended if needed
measure: Comparing the Obstetric outcomes as Anemia between women with spontaneous pregnancy and those using Assisted Reproductive Technique
timeFrame: Between June 2021 to June 2022 and may be extended if needed
measure: Comparing the Obstetric outcomes as Oligohydramnios or polyhydramnios between women with spontaneous pregnancy and those using Assisted Reproductive Technique
timeFrame: Between June 2021 to June 2022 and may be extended if needed
measure: Comparing the Maternal outcomes of pregnancy between women with spontaneous pregnancy and those using Assisted Reproductive Technique
timeFrame: Between June 2021 to June 2022 and may be extended if needed
measure: Comparing the Fetal outcomes of pregnancy between women with spontaneous pregnancy and those using Assisted Reproductive Technique
timeFrame: Between June 2021 to June 2022 and may be extended if needed
measure: Comparing the Perinatal outcomes as Birth weight between women with spontaneous pregnancy and those using Assisted Reproductive Technique
timeFrame: Between June 2021 to June 2022 and may be extended if needed
measure: Comparing the Neonatal hypoglycemia of pregnancy between women with spontaneous pregnancy and those using Assisted Reproductive Technique
timeFrame: Between June 2021 to June 2022 and may be extended if needed
measure: Comparing the Neonatal outcomes of pregnancy between women with spontaneous pregnancy and those using Assisted Reproductive Technique
timeFrame: Between June 2021 to June 2022 and may be extended if needed
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university hospital
Study officials:
affiliation: Obstetric and Gynecology department at mansoura university hospital
name: Rana magdy ibrahim El gharbawy
role: PRINCIPAL_INVESTIGATOR
References: