Pregnancy Outcomes on Advanced Maternal Age (AMA)

January 4, 2022 updated by: Mansoura University

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt
        • Mansoura University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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),
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
Time Frame: Between June 2021 to June 2022 and may be extended if needed
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
Time Frame: Between June 2021 to June 2022 and may be extended if needed
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
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.
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
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).
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
Time Frame: Between June 2021 to June 2022 and may be extended if needed
Birth weight (in gm).
Between June 2021 to June 2022 and may be extended if needed
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).
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
Time Frame: Between June 2021 to June 2022 and may be extended if needed

Include:

  • APGAR score system.
  • Neonatal intensive care unit admission
Between June 2021 to June 2022 and may be extended if needed

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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 women with spontaneous pregnancy and those using Assisted Reproductive Technique
Time Frame: Between June 2021 to June 2022 and may be extended if needed
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
Time Frame: Between June 2021 to June 2022 and may be extended if needed
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
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.
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
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
Time Frame: Between June 2021 to June 2022 and may be extended if needed
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
Time Frame: Between June 2021 to June 2022 and may be extended if needed
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
Time Frame: Between June 2021 to June 2022 and may be extended if needed

Include:

  • APGAR score system.
  • Neonatal intensive care unit admission
Between June 2021 to June 2022 and may be extended if needed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mansoura University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rana magdy ibrahim El gharbawy, Obstetric and Gynecology department at mansoura university hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 10, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MS.21.06.1542

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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