Very Advanced Maternal Aged Pregnants and Early Adolescent Pregnant Women

Sponsor
Siirt University (Other)
Overall Status
Completed
CT.gov ID
NCT05484869
Collaborator
(none)
297
59.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    297 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Comparison of Perinatal and Neonatal Outcomes of Very Advanced Maternal Aged Pregnants and Early Adolescent Pregnant Women
    Actual Study Start Date :
    Jan 1, 2017
    Actual Primary Completion Date :
    Dec 30, 2021
    Actual Study Completion Date :
    Dec 30, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. The maternal and perinatal outcomes 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). [1 month]

      The % of delivery type (vaginal delivery/ cesarean section) will be compared between the three groups

    2. The maternal and perinatal outcomes 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). [1 month]

      Rate and % of abortion will be compared between the three groups

    3. The maternal and perinatal outcomes 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). [1 month]

      Rate and % of neonatal death will be compared between the three groups

    4. The maternal and perinatal outcomes 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). [1 month]

      Rate and % of premature rupture of membranes (PROM) will be compared between the three groups

    5. The maternal and perinatal outcomes 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). [1 month]

      Rate and % of preterm labor will be compared between the three groups

    6. The maternal and perinatal outcomes 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). [1 month]

      Rate and % of ablatio placentae will be compared between the three groups

    7. The maternal and perinatal outcomes 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). [1 month]

      Rate and % of fetal distress will be compared between the three groups

    8. The maternal and perinatal outcomes 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). [1 month]

      Rate and % of intrauterine death will be compared between the three groups

    9. The maternal and perinatal outcomes 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). [1 month]

      Rate and % of gestational diabetes mellitus (GDM) will be compared between the three groups

    10. The maternal and perinatal outcomes 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). [1 month]

      Rate and % of preeclampsia will be compared between the three groups

    11. The maternal and perinatal outcomes 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). [1 month]

      Rate and % of surmaturation will be compared between the three groups

    12. The maternal and perinatal outcomes 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). [1 month]

      Rate and % of polyhydramnios will be compared between the three groups

    13. The maternal and perinatal outcomes 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). [1 month]

      Rate and % of oligohydramnios will be compared between the three groups

    14. The maternal and perinatal outcomes 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). [1 month]

      Rate and % of presentation anomaly will be compared between the three groups

    15. The maternal and perinatal outcomes 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). [1 month]

      Rate and % of multiple pregnancy will be compared between the three groups

    16. The maternal and perinatal outcomes 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). [1 month]

      Rate and % of intrauterine growth retardation (IUGR) will be compared between the three groups

    17. The maternal and perinatal outcomes 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). [1 month]

      Rate and % of postpartum hemorrhage will be compared between the three groups

    18. The maternal and perinatal outcomes 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). [1 month]

      Rate and % of placenta previa will be compared between the three groups

    19. The neonatal outcomes 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). [at the time of birth]

      The fetal weight (in grams) will be compared between the three groups

    20. The neonatal outcomes 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). [at the time of birth]

      % of male, female gender will be compared between the three groups

    21. The neonatal outcomes 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). [at the time of birth]

      APGAR scores in the 1st minute (by numbers) will be compared between the three groups

    22. The neonatal outcomes 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). [at the time of birth]

      APGAR scores in the 5th minute (by numbers) will be compared between the three groups

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 47 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Siirt University

    Investigators

    • Study Director: Şerif Aksin, Assoc.Prof, Siirt University Medical Faculty Obstetrics and Gynecology Departmant

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Serif Aksin, associate professor, Siirt University
    ClinicalTrials.gov Identifier:
    NCT05484869
    Other Study ID Numbers:
    • SiirtUNIVER
    First Posted:
    Aug 2, 2022
    Last Update Posted:
    Aug 2, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Serif Aksin, associate professor, Siirt University

    Study Results

    No Results Posted as of Aug 2, 2022