Very Advanced Maternal Aged Pregnants and Early Adolescent Pregnant Women

Early Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05484869
• Other study ID #: SiirtUNIVER
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Advanced Maternal Age Pregnancy
• Early Pregnancy

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