NCT01115413

Brief Summary

The purpose of this study is to estimate the effect of maternal teenage on pregnancy and perinatal outcomes among Caucasian pregnant women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 4, 2010

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

May 3, 2018

Status Verified

May 1, 2018

Enrollment Period

3.7 years

First QC Date

April 30, 2010

Last Update Submit

May 2, 2018

Conditions

Pregnancy

Keywords

teenagepregnancyobstetrical risk

Outcome Measures

Primary Outcomes (1)

  • mode of delivery

    9yrs

Secondary Outcomes (3)

  • time of labor

    9yrs

  • maternal injury during labor and delivery

    9yrs

  • neonatal outcome

    9yrs

Study Arms (2)

young maternal age

maternal age of \< 18 years

adult maternal age

maternal age \>/= 18 years

Eligibility Criteria

Age11 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

retrospective cohort analysis of all deliveries at the Schleswig-Holstein University Hospital Center in Lübeck from January 2000 through December 2009

You may qualify if:

  • Nulliparity
  • Maternal age of \< 18 years for group A and
  • Maternal age \>/= 18 years for group B

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schleswig- Holstein University, Campus Lübeck, Department of Obstetrics and Gynecology

Lübeck, Schleswig-Holstein, D-23538, Germany

Location

Related Publications (3)

  • 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.

    PMID: 18539258BACKGROUND

  • Steinfeld 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.

    PMID: 11048836BACKGROUND

  • Woods C. At-risk, pregnant youth and appropriate use of health care. Am Fam Physician. 2010 Mar 1;81(5):577. No abstract available.

    PMID: 20187592BACKGROUND

Study Officials

  • Daniel A Beyer, M.D.

    Lübeck University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. D. A. Beyer

Study Record Dates

First Submitted

April 30, 2010

First Posted

May 4, 2010

Study Start

April 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

May 3, 2018

Record last verified: 2018-05

Locations

DE(1)