Advanced Maternal Age PregnancyNCT05484869
Very Advanced Maternal Aged Pregnants and Early Adolescent Pregnant Women
An observational study of Advanced Maternal Age Pregnancy and Early Pregnancy, run by Siirt University.
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. Read more about this study
- Who is it for?
- Ages 15 to 47 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Advanced Maternal Age Pregnancy, Early Pregnancy
- How many people
- 297 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 30 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 47 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Pregnant on the age of 16 and below and on the age of 45 and above, control groups
Who may be able to join
- Pregnants under the age of 16 and younger
- pregnants over the age of 45 and older
Who cannot join
- history of chronic hypertension
- history of pre gestational diabetes
- history of chronic diseases
- excessive consumption of alcohol
- smoking pregnants
- kidney disorders
About this study
Official title: 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.
Read the 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.
- Conditions
- Advanced Maternal Age Pregnancy, Early Pregnancy
- Keywords
- age, pregnancy, adolescent, perinatal, neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start1 Jan 2017
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Advanced Maternal Age PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siirt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serif Aksin, Siirt University
- Investigators
- Şerif Aksin, Assoc.Prof, Study director, Siirt University Medical Faculty Obstetrics and Gynecology Departmant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484869
- Sponsor's protocol ID
- SiirtUNIVER
- Status last verified
- Aug 2022
- First submitted
- 22 Jul 2022
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 26169538Malabarey 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.
PubMed 22088316Traisrisilp 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.
PubMed 25842790
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Perinatal and Neonatal Outcomes of Very Advanced Maternal Aged Pregnants and Early Adolescent Pregnant Women
- ClinicalTrials.gov ID
- NCT05484869
- Acronym / sponsor ID
- SiirtUNIVER
- Conditions
- Advanced Maternal Age Pregnancy, Early Pregnancy
- Keywords
- age, pregnancy, adolescent, perinatal, neonatal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 297 participants (actual)
- Lead sponsor
- Siirt UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 2 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 15 to 47 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Pregnant on the age of 16 and below and on the age of 45 and above, control groups
Key inclusion criteria (2 listed)
- Pregnants under the age of 16 and younger
- pregnants over the age of 45 and older
Key exclusion criteria (6 listed)
- history of chronic hypertension
- history of pre gestational diabetes
- history of chronic diseases
- excessive consumption of alcohol
- smoking pregnants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
- Background: PubMed 26169538Brown 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.
- Background: PubMed 22088316Malabarey 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.
- Background: PubMed 25842790Traisrisilp 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Şerif Aksin, Assoc.Prof study director
Siirt University Medical Faculty Obstetrics and Gynecology Departmant
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Maternal Age Pregnancy and Early Pregnancy, run by Siirt University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: 1 month). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05484869, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2022.