Pregnancy Outcomes on Advanced Maternal Age

NCT ID: NCT05182021

Last Updated: 2022-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2023-02-01

Brief Summary

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A prospective observational study of pregnancy outcomes at advanced maternal age among primigravida which include maternal ,fetal, obstetric and perinatal outcomes

Detailed Description

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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

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Advanced Maternal Age Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Case group

The case group represented by 50 primigravida women aged 35 y or more during their pregnancy or at the time of delivery

No interventions assigned to this group

Control group

The control group represented by 50 primigravida women aged 20 y : 34 y during their pregnancy or at the time of delivery

No interventions assigned to this group

Eligibility Criteria

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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 )
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rana magdy ibrahim El gharbawy

Role: PRINCIPAL_INVESTIGATOR

Obstetric and Gynecology department at mansoura university hospital

Locations

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Mansoura university hospital

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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MS.21.06.1542

Identifier Type: -

Identifier Source: org_study_id

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