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CompletedNCT05484869Updated Sep 1, 2022

Very Advanced Maternal Aged Pregnants and Early Adolescent Pregnant Women

An observational study in Advanced Maternal Age Pregnancy and Early Pregnancy, sponsored by Siirt University. Completed. Open to female participants aged 15 Years to 47 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-01.

Sponsored by Siirt University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
297
Ages
15 Years to 47 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Advanced Maternal Age Pregnancy
  • Early Pregnancy

Keywords

  • age
  • pregnancy
  • adolescent
  • perinatal
  • neonatal
03

In context

Lead sponsor

Siirt University is the lead sponsor of 16 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 47 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • history of chronic hypertension
  • history of pre gestational diabetes
  • history of chronic diseases
  • excessive consumption of alcohol
  • smoking pregnants
  • kidney disorders
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
297 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

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).

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

    Time frame: 1 month

  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).

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

    Time frame: 1 month

  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).

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

    Time frame: 1 month

  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).

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

    Time frame: 1 month

  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).

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

    Time frame: 1 month

  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).

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

    Time frame: 1 month

  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).

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

    Time frame: 1 month

  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).

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

    Time frame: 1 month

  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).

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

    Time frame: 1 month

  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).

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

    Time frame: 1 month

  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).

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

    Time frame: 1 month

  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).

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

    Time frame: 1 month

  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).

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

    Time frame: 1 month

  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).

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

    Time frame: 1 month

  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).

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

    Time frame: 1 month

  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).

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

    Time frame: 1 month

  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).

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

    Time frame: 1 month

  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).

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

    Time frame: 1 month

  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).

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

    Time frame: 1month

  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).

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

    Time frame: 1 month

  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).

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

    Time frame: 1 month

  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).

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

    Time frame: 1 month

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Brown W, Ahmed S, Roche N, Sonneveldt E, Darmstadt GL. Impact of family planning programs in reducing high-risk births due to younger and older maternal age, short birth intervals, and high parity. Semin Perinatol. 2015 Aug;39(5):338-44. doi: 10.1053/j.semperi.2015.06.006. Epub 2015 Jul 10. PubMed 26169538 ↗
  • Malabarey OT, Balayla J, Klam SL, Shrim A, Abenhaim HA. Pregnancies in young adolescent mothers: a population-based study on 37 million births. J Pediatr Adolesc Gynecol. 2012 Apr;25(2):98-102. doi: 10.1016/j.jpag.2011.09.004. Epub 2011 Nov 16. PubMed 22088316 ↗
  • Traisrisilp K, Tongsong T. Pregnancy outcomes of mothers with very advanced maternal age (40 years or more). J Med Assoc Thai. 2015 Feb;98(2):117-22. PubMed 25842790 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05484869
Lead sponsor
Siirt University
Responsible party
Serif Aksin (associate professor, Siirt University) — Principal investigator
First posted
Aug 2, 2022
Start date
Jan 1, 2017
Primary completion
Dec 30, 2021
Completion
Dec 30, 2021
Last update
Sep 1, 2022

Study contacts

Şerif Aksin, Assoc.Prof
study director · Siirt University Medical Faculty Obstetrics and Gynecology Departmant

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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