Advanced Maternal Age PregnancyAMANCT05182021
Pregnancy Outcomes on Advanced Maternal Age
An observational study of Advanced Maternal Age Pregnancy, run by Mansoura University at 1 site in Egypt.
Trial summary
A prospective observational study of pregnancy outcomes at advanced maternal age among primigravida which include maternal ,fetal, obstetric and perinatal outcomes Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Advanced Maternal Age Pregnancy
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 1 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- multipara
- women aged less than 20 years
- women with any medical disorder ( anti phospholipid syndrome , chronic hypertension ,Diabetes, autoimmune disease and thrombosis embolic disease )
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Advanced Maternal Age Pregnancy
- Keywords
- Advanced maternal age
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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),
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: Between June 2021 to June 2022 and may be extended if needed
Secondary outcomes (8)
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),
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: Between June 2021 to June 2022 and may be extended if needed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start1 Jun 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Maternal Age PregnancyStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rana magdy ibrahim El gharbawy, Principal investigator, Obstetric and Gynecology department at mansoura university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182021
- Sponsor's protocol ID
- MS.21.06.1542
- Acronym
- AMA
- Status last verified
- Oct 2021
- First submitted
- 13 Oct 2021
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Advanced Maternal Age on Pregnancy Outcomes: A Prospective Study
- ClinicalTrials.gov ID
- NCT05182021
- Acronym / sponsor ID
- AMA / MS.21.06.1542
- Conditions
- Advanced Maternal Age Pregnancy
- Keywords
- Advanced maternal age
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- multipara
- women aged less than 20 years
- women with any medical disorder ( anti phospholipid syndrome , chronic hypertension ,Diabetes, autoimmune disease and thrombosis embolic disease )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparing the Obstetric outcomes as Gestational diabetes mellitus between the young and the elderly group
Time frame: Between June 2021 to June 2022 and may be extended if needed
Gestational diabetes mellitus by using oral glucose tolerance test between 24 : 28 weeks of pregnancy (in mg/dl),
Comparing the Obstetric outcomes as Anemia between the young and the elderly group
Time frame: Between June 2021 to June 2022 and may be extended if needed
Detecting Anemia by measuring hemoglobin level (in gm/dl).
Comparing the Obstetric outcomes as Oligohydramnios or polyhydramnios between the young and the elderly group
Time frame: Between June 2021 to June 2022 and may be extended if needed
Detected by measuring (amniotic fluid index in cm) by ultrasound.
Comparing the Maternal outcomes as Preterm labor between the young and the elderly group
Time frame: Between June 2021 to June 2022 and may be extended if needed
Preterm labor before 37 w of pregnancy calculated from last menstrual period.
Comparing the Fetal outcomes of pregnancy between the young and the elderly group
Time frame: Between June 2021 to June 2022 and may be extended if needed
Fetal outcomes include: - Congenital malformation \& Intra uterine fetal death (detected by anomaly scan).
Comparing the Perinatal outcomes as Birth weight between the young and the elderly group
Time frame: Between June 2021 to June 2022 and may be extended if needed
Birth weight (in gm).
Comparing the Neonatal hypoglycemia between the young and the elderly group
Time frame: Between June 2021 to June 2022 and may be extended if needed
Detected by measuring neonatal blood glucose level (mg/dl).
Comparing the Neonatal outcomes of pregnancy between the young and the elderly group
Time frame: Between June 2021 to June 2022 and may be extended if needed
Include: * APGAR score system. * Neonatal intensive care unit admission
8 secondary outcomes
Comparing the Obstetric outcomes as Gestational diabetes mellitus between women with spontaneous pregnancy and those using Assisted Reproductive Technique
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Between June 2021 to June 2022 and may be extended if needed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rana magdy ibrahim El gharbawy principal investigator
Obstetric and Gynecology department at mansoura university hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Maternal Age Pregnancy, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing the Obstetric outcomes as Gestational diabetes mellitus between the young and the elderly group (time frame: Between June 2021 to June 2022 and may be extended if needed). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2022.