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NCT Number: NCT05484869

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.

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Key information

Conditions

Advanced Maternal Age Pregnancy Early Pregnancy

Age range

15 year–47 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

Sponsors and collaborators

Lead sponsor

Siirt University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Aug 2, 2022
Registry last updated
Sep 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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