- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05484869
Very Advanced Maternal Aged Pregnants and Early Adolescent Pregnant Women
Comparison of Perinatal and Neonatal Outcomes of 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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
1 month
|
|
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
|
1 month
|
|
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
|
1 month
|
|
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
|
1 month
|
|
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
|
1 month
|
|
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
|
1 month
|
|
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
|
1 month
|
|
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
|
1 month
|
|
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
|
1 month
|
|
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
|
1 month
|
|
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
|
1 month
|
|
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
|
1 month
|
|
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
|
1 month
|
|
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
|
1 month
|
|
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
|
1 month
|
|
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
|
1 month
|
|
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
|
1 month
|
|
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
|
1 month
|
|
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
|
1month
|
|
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
|
1 month
|
|
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
|
1 month
|
|
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
|
1 month
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SiirtUNIVER
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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