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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05484869
Other study ID # SiirtUNIVER
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date December 30, 2021

Study information

Verified date August 2022
Source Siirt University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 297
Est. completion date December 30, 2021
Est. primary completion date December 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years to 47 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Siirt University

References & Publications (3)

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. Review. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 1 month
Primary 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 1 month
Primary 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 1 month
Primary 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 1 month
Primary 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 1 month
Primary 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 1 month
Primary 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 1 month
Primary 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 1 month
Primary 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 1 month
Primary 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 1 month
Primary 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 1 month
Primary 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 1 month
Primary 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 1 month
Primary 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 1 month
Primary 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 1 month
Primary 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 1 month
Primary 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 1 month
Primary 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 1 month
Primary 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 1month
Primary 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 1 month
Primary 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 1 month
Primary 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 1 month
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