Very Advanced Maternal Aged Pregnants and Early Adolescent Pregnant Women

NCT05484869 | Completed

• 1 other identifier: SiirtUNIVER
• Study Type: observational
• Target: 297
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Advanced Maternal Age Pregnancy; Early Pregnancy

Keywords

age; pregnancy; adolescent; perinatal; neonatal

Outcome Measures

Primary Outcomes (22)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (3)

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

Eligibility Criteria

• Age: 15 Years - 47 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Siirt University: lead

Related 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.

  PMID: 26169538 BACKGROUND

• 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.

  PMID: 22088316 BACKGROUND

• 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.

  PMID: 25842790 BACKGROUND

Study Officials

• Şerif Aksin, Assoc.Prof

  Siirt University Medical Faculty Obstetrics and Gynecology Departmant

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: August 2, 2022
• Study Start: January 1, 2017
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: September 1, 2022

Record last verified: 2022-08