Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A prospective observational study of pregnancy outcomes at advanced maternal age among primigravida which include maternal ,fetal, obstetric and perinatal outcomes
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
Not provided
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Pregnant women
Not provided
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
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rana magdy ibrahim El gharbawy | Obstetric and Gynecology department at mansoura university hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura university hospital | Al Mansurah | Egypt |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 25, 2021 | Oct 28, 2021 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
| 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:
| 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:
| Between June 2021 to June 2022 and may be extended if needed |