Very Advanced Maternal Aged Pregnants and Early Adolescent Pregnant Women

August 27, 2022 updated by: Serif Aksin, Siirt University

Comparison of Perinatal and Neonatal Outcomes of Very Advanced Maternal Aged Pregnants and Early Adolescent Pregnant Women

Maternal age is an important factor affecting the pregnancy process and its results. Adverse obstetric outcomes such as preterm birth, stillbirth, and infant mortality are more common in women older than 35 years and younger than 20 years compared to women aged 20-29. Adolescent pregnancies have been associated with an increased risk of adverse pregnancy outcomes such as preterm birth, low birth weight, perinatal death, and maternal mortality.

Advanced maternal age pregnancies were associated with higher rates of maternal hypertension and diabetes, and progressively worsening perinatal outcomes such as stillbirth, preterm birth, and low birth weight.

Although the investigators' region has high birth rates, as far as they have observed, the rates of early and advanced maternal age are also quite high. the investigators' aim in this study is to determine the absolute effects of early and advanced maternal age on pregnancy and to investigate the pregnancy outcomes of these mothers.

Study Overview

Status

Completed

Detailed Description

The investigators' aim in this study is to determine the absolute effects of early and advanced maternal age on pregnancy and to investigate the pregnancy outcomes of these mothers. For this purpose, the information of 90 pregnant women followed in Siirt Training and Research Hospital between 2017-2021 will be accessed through the hospital's data system. Maternal age, pregnancy history, Assisted reproductive technologies history, laboratory findings, screening test results, mode of delivery, baby birth information, pregnancy complications and complications during delivery will be recorded. In the light of the information gathered, the rates of negative effects of gestational age on pregnancy will be calculated.

Study Type

Observational

Enrollment (Actual)

297

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

Ages Eligible for Study

15 years to 47 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant on the age of 16 and below and on the age of 45 and above, control groups

Description

Inclusion Criteria:

  • Pregnants under the age of 16 and younger
  • pregnants over the age of 45 and older

Exclusion Criteria:

  • history of chronic hypertension
  • history of pre gestational diabetes
  • history of chronic diseases
  • excessive consumption of alcohol
  • smoking pregnants
  • kidney disorders

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
Early Adolescent Pregnant Women (n:80)
Perinatal and neonatal results of adolescent pregnancies of 16 years and below
Very Advanced Maternal Aged Pregnants (n:67)
Perinatal and neonatal results of pregnancies 45 years and older
Reproductive period Control Group (n:150)
Reproductive period Pregnant Between 25-35 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delivery type in pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).
Time Frame: 1 month
The % of delivery type (vaginal delivery/ cesarean section) will be compared between the three groups
1 month
Abortion ratio of pregnancies of pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).
Time Frame: 1 month
Rate and % of abortion will be compared between the three groups
1 month
Neonatal death ratio in pregnancies of pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).
Time Frame: 1 month
Rate and % of neonatal death will be compared between the three groups
1 month
Premature rupture of membranes in pregnancies of pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).
Time Frame: 1 month
Rate and % of premature rupture of membranes (PROM) will be compared between the three groups
1 month
Preterm labor ratio in pregnancies of pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).
Time Frame: 1 month
Rate and % of preterm labor will be compared between the three groups
1 month
Ablatio placentae ratio in pregnancies of pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).
Time Frame: 1 month
Rate and % of ablatio placentae will be compared between the three groups
1 month
Fetal Distress ratio in pregnancies of pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).
Time Frame: 1 month
Rate and % of fetal distress will be compared between the three groups
1 month
Intrauterine death ratio in pregnancies of pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).
Time Frame: 1 month
Rate and % of intrauterine death will be compared between the three groups
1 month
Gestational diabetes ratio in pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).
Time Frame: 1 month
Rate and % of gestational diabetes mellitus (GDM) will be compared between the three groups
1 month
Preeclampsia ratio in pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).
Time Frame: 1 month
Rate and % of preeclampsia will be compared between the three groups
1 month
Surmaturation ratio in pregnancies of pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).
Time Frame: 1 month
Rate and % of surmaturation will be compared between the three groups
1 month
Polyhydramnios ratio in pregnancies of pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).
Time Frame: 1 month
Rate and % of polyhydramnios will be compared between the three groups
1 month
Oligohydramnios ratio in pregnancies of pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).
Time Frame: 1 month
Rate and % of oligohydramnios will be compared between the three groups
1 month
Presentation anomaly ratio in pregnancies of pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).
Time Frame: 1 month
Rate and % of presentation anomaly will be compared between the three groups
1 month
Multiple pregnancy ratio in pregnancies of pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).
Time Frame: 1 month
Rate and % of multiple pregnancy will be compared between the three groups
1 month
Intrauterine growth retardation ratio in pregnancies of pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).
Time Frame: 1 month
Rate and % of intrauterine growth retardation (IUGR) will be compared between the three groups
1 month
Postpartum hemorrhage ratio in pregnancies of pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).
Time Frame: 1 month
Rate and % of postpartum hemorrhage will be compared between the three groups
1 month
Placenta previa ratio in pregnancies of pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).
Time Frame: 1 month
Rate and % of placenta previa will be compared between the three groups
1 month
Mean fetal weight of pregnancies of pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).
Time Frame: 1month
The fetal weight (in grams) will be compared between the three groups
1month
Ratio of male, female gender in pregnancies of pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).
Time Frame: 1 month
% of male, female gender will be compared between the three groups
1 month
Mean APGAR scores in the 1st minute in pregnancies of pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).
Time Frame: 1 month
APGAR scores in the 1st minute (by numbers) will be compared between the three groups
1 month
Mean APGAR scores in the 5th minute in pregnancies of pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).
Time Frame: 1 month
APGAR scores in the 5th minute (by numbers) will be compared between the three groups
1 month

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

January 1, 2017

Primary Completion (ACTUAL)

December 30, 2021

Study Completion (ACTUAL)

December 30, 2021

Study Registration Dates

First Submitted

July 22, 2022

First Submitted That Met QC Criteria

July 30, 2022

First Posted (ACTUAL)

August 2, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 1, 2022

Last Update Submitted That Met QC Criteria

August 27, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • SiirtUNIVER

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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