Clinical trial NCT05484869: Very Advanced Maternal Aged Pregnants and Early Adolescent Pregnant Women
Official title: Comparison of Perinatal and Neonatal Outcomes of Very Advanced Maternal Aged Pregnants and Early Adolescent Pregnant Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Maternal Age Pregnancy
Early Pregnancy
Keywords: age
pregnancy
adolescent
perinatal
neonatal
Lead sponsor: Siirt University
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 297
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 47
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: 1 month
measure: 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).
timeFrame: 1 month
measure: 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).
timeFrame: 1 month
measure: 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).
timeFrame: 1 month
measure: 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).
timeFrame: 1 month
measure: 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).
timeFrame: 1 month
measure: 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).
timeFrame: 1 month
measure: 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).
timeFrame: 1 month
measure: 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).
timeFrame: 1 month
measure: 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).
timeFrame: 1 month
measure: 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).
timeFrame: 1 month
measure: 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).
timeFrame: 1 month
measure: 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).
timeFrame: 1 month
measure: 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).
timeFrame: 1 month
measure: 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).
timeFrame: 1 month
measure: 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).
timeFrame: 1 month
measure: 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).
timeFrame: 1 month
measure: 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).
timeFrame: 1 month
measure: 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).
timeFrame: 1month
measure: 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).
timeFrame: 1 month
measure: 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).
timeFrame: 1 month
measure: 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).
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Siirt University Medical Faculty Obstetrics and Gynecology Departmant
name: Şerif Aksin, Assoc.Prof
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.