PregnancyNCT01115413
The Effect of Teenage Maternity on Obstetrical and Perinatal Outcomes
An observational study of Pregnancy, run by University of Luebeck at 1 site in Germany.
Trial summary
The purpose of this study is to estimate the effect of maternal teenage on pregnancy and perinatal outcomes among Caucasian pregnant women. Read more about this study
- Who is it for?
- Ages 11 to 50 years, women only
- Conditions the study is for
- Pregnancy
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2010to Dec 2013
- 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 11 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: retrospective cohort analysis of all deliveries at the Schleswig-Holstein University Hospital Center in Lübeck from January 2000 through December 2009
Who may be able to join
- Nulliparity
- Maternal age of < 18 years for group A and
- Maternal age >/= 18 years for group B
Who cannot join
- Preterm delivery < 24 + 0 weeks of gestation post menstruation
- Confirmed multiple pregnancy
- Maternal and fetal co morbidity
- Presentation other than cephalic presentation and incomplete data
Trial locations and contacts
1 site in 1 country.
Germany1 site
Schleswig- Holstein University, Campus Lübeck, Department of Obstetrics and Gynecology
Lübeck, Schleswig-Holstein, D-23538
About this study
Official title: Influence of Young Maternal Age on Pregnancy Outcome in Central Europe
The purpose of this study is to estimate the effect of maternal teenage on pregnancy and perinatal outcomes among Caucasian pregnant women.
Read the detailed description
During the past decade in the United States, approximately 10 percent of teenage girls from 15 to 19 became pregnant. According to the National Vital Statistics Report 2009 seventy of one thousand births in the United States accounted to teenagers from 15 to nineteen years of age during in 2005 and fell to forty per 1,000 women in 2006. In contrary, the overall teenage birth rate lay at twenty- two per 1,000 births in Massachusetts in 2007 ranging from seventy to thirteen per 1,000 women for Hispanic vs. white women aged 15- 19 years. Central European data showed equal results for teenage pregnancy birth rates. According to the German National Institute of Vital Statistics thirty-four of one thousand births in Germany accounted to teenagers younger than 20 years of age. This pattern is a source of concern since teenage mothers have an increased risk of having low-birth- weight babies, premature babies, and babies who die during the first year of life. Additionally, teenage mothers are more likely to suffer from other concomitant pregnancy diseases such as preeclampsia or anemia.
Furthermore, teenage mothers are more likely than older mothers to be poor, less well educated, non- white, unmarried and they are less likely to have received early prenatal care. Dealing with pregnant adolescents therefore means a great challenge in modern obstetrics. Previous research has shown racial differences as well as weight differences for increased risk of adverse prenatal outcome among African Americans and teenagers. Taking into account the impact of race on pregnancy outcomes, our goal was to examine the relationship of young maternal age on obstetrical outcomes in a predominantly Caucasian central European teenaged population.
- Conditions
- Pregnancy
- Keywords
- teenage, pregnancy, obstetrical risk
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 |
|---|---|---|
| young maternal age | maternal age of < 18 years | |
| adult maternal age | maternal age >/= 18 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
mode of delivery
Measured: 9yrs
Secondary outcomes (3)
time of labor
Measured: 9yrs
maternal injury during labor and delivery
Measured: 9yrs
neonatal outcome
Measured: 9yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2013
- Study completionDec 2013
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 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Alexander Beyer, University of Luebeck
- Investigators
- Daniel A Beyer, M.D., Principal investigator, Lübeck University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115413
- Sponsor's protocol ID
- UKSH-HL-10-064
- Status last verified
- May 2018
- First submitted
- 30 Apr 2010
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Picklesimer AH, Jared HL, Moss K, Offenbacher S, Beck JD, Boggess KA. Racial differences in C-reactive protein levels during normal pregnancy. Am J Obstet Gynecol. 2008 Nov;199(5):523.e1-6. doi: 10.1016/j.ajog.2008.04.017. Epub 2008 Jun 9.
PubMed 18539258Steinfeld JD, Valentine S, Lerer T, Ingardia CJ, Wax JR, Curry SL. Obesity-related complications of pregnancy vary by race. J Matern Fetal Med. 2000 Jul-Aug;9(4):238-41. doi: 10.1002/1520-6661(200007/08)9:43.0.CO;2-5.
PubMed 11048836Woods C. At-risk, pregnant youth and appropriate use of health care. Am Fam Physician. 2010 Mar 1;81(5):577. No abstract available.
PubMed 20187592
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Young Maternal Age on Pregnancy Outcome in Central Europe
- ClinicalTrials.gov ID
- NCT01115413
- Acronym / sponsor ID
- UKSH-HL-10-064
- Conditions
- Pregnancy
- Keywords
- teenage, pregnancy, obstetrical risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 4 May 2010 (estimated)
- 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.
The purpose of this study is to estimate the effect of maternal teenage on pregnancy and perinatal outcomes among Caucasian pregnant women.
Detailed description
During the past decade in the United States, approximately 10 percent of teenage girls from 15 to 19 became pregnant. According to the National Vital Statistics Report 2009 seventy of one thousand births in the United States accounted to teenagers from 15 to nineteen years of age during in 2005 and fell to forty per 1,000 women in 2006. In contrary, the overall teenage birth rate lay at twenty- two per 1,000 births in Massachusetts in 2007 ranging from seventy to thirteen per 1,000 women for Hispanic vs. white women aged 15- 19 years. Central European data showed equal results for teenage pregnancy birth rates. According to the German National Institute of Vital Statistics thirty-four of one thousand births in Germany accounted to teenagers younger than 20 years of age. This pattern is a source of concern since teenage mothers have an increased risk of having low-birth- weight babies, premature babies, and babies who die during the first year of life. Additionally, teenage mothers are more likely to suffer from other concomitant pregnancy diseases such as preeclampsia or anemia.
Furthermore, teenage mothers are more likely than older mothers to be poor, less well educated, non- white, unmarried and they are less likely to have received early prenatal care. Dealing with pregnant adolescents therefore means a great challenge in modern obstetrics. Previous research has shown racial differences as well as weight differences for increased risk of adverse prenatal outcome among African Americans and teenagers. Taking into account the impact of race on pregnancy outcomes, our goal was to examine the relationship of young maternal age on obstetrical outcomes in a predominantly Caucasian central European teenaged population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| young maternal age | – | –maternal age of < 18 years |
| adult maternal age | – | –maternal age >/= 18 years |
Who may qualify
- Ages
- 11 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- retrospective cohort analysis of all deliveries at the Schleswig-Holstein University Hospital Center in Lübeck from January 2000 through December 2009
Key inclusion criteria (3 listed)
- Nulliparity
- Maternal age of < 18 years for group A and
- Maternal age >/= 18 years for group B
Key exclusion criteria (4 listed)
- Preterm delivery < 24 + 0 weeks of gestation post menstruation
- Confirmed multiple pregnancy
- Maternal and fetal co morbidity
- Presentation other than cephalic presentation and incomplete data
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
mode of delivery
Time frame: 9yrs
3 secondary outcomes
time of labor
Time frame: 9yrs
maternal injury during labor and delivery
Time frame: 9yrs
neonatal outcome
Time frame: 9yrs
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 3 May 2018.
- Background: PubMed 18539258Picklesimer AH, Jared HL, Moss K, Offenbacher S, Beck JD, Boggess KA. Racial differences in C-reactive protein levels during normal pregnancy. Am J Obstet Gynecol. 2008 Nov;199(5):523.e1-6. doi: 10.1016/j.ajog.2008.04.017. Epub 2008 Jun 9.
- Background: PubMed 11048836Steinfeld JD, Valentine S, Lerer T, Ingardia CJ, Wax JR, Curry SL. Obesity-related complications of pregnancy vary by race. J Matern Fetal Med. 2000 Jul-Aug;9(4):238-41. doi: 10.1002/1520-6661(200007/08)9:43.0.CO;2-5.
- Background: PubMed 20187592Woods C. At-risk, pregnant youth and appropriate use of health care. Am Fam Physician. 2010 Mar 1;81(5):577. No abstract available.
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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.
Daniel A Beyer, M.D. principal investigator
Lübeck University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by University of Luebeck at 1 site in Germany.
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 3 inclusion and 4 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 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
mode of delivery (time frame: 9yrs). 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 NCT01115413, 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 3 May 2018.