Fetal Lung Maturation in Twin Gestations

This study has been completed.
Sponsor:
Information provided by:
TriHealth Inc.
ClinicalTrials.gov Identifier:
NCT01385267
First received: June 28, 2011
Last updated: October 30, 2012
Last verified: January 2011

June 28, 2011
October 30, 2012
June 2009
Not Provided
  • FLM Index [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    FLM Index
  • Lamellar Body Counts [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Lamellar Body Counts
Same as current
Complete list of historical versions of study NCT01385267 on ClinicalTrials.gov Archive Site
  • Respiratory Distress Syndrome [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Respiratory Distress Syndrome
  • Transient Tachypnea in newborns [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Transient Tachypnea in newborns
  • Neonatal Death [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Neonatal Death
Same as current
Not Provided
Not Provided
 
Fetal Lung Maturation in Twin Gestations
Fetal Lung Maturation in Twin Gestations Based on Birth Order and Weight Discordance

Objectives:

To evaluate discordance in lung maturity in diamniotic twins based on birth order, sex and body weight. If we find discordance in fetal lung maturity in twin gestations this will change current practice of sampling only one amniotic sac for evaluation of fetal lung maturity.

Objectives:

To evaluate discordance in lung maturity in diamniotic twins based on birth order, sex and body weight. If we find discordance in fetal lung maturity in twin gestations this will change current practice of sampling only one amniotic sac for evaluation of fetal lung maturity.

Hypotheses:

Lung maturation within twin pairs is weakly correlated based on presentation and estimated fetal weight.

Research Methods:

This study will be prospective cohort study of women with twin diamniotic intrauterine gestations who will be delivered at a Good Samaritan or Bethesda North Hospital. Patients will be counseled and informed consent for participation in the study will be obtained prior to enrollment in study.

At the time of Cesarean delivery or in the event of amniocenteses for FLM, a sample of amniotic fluid will be drawn from the amniotic sac of Twin A and Twin B. Each amniotic sac will be aspirated by the obstetrician and sent to the laboratory for determination of fetal lung maturity index and lamellar body count. Fetal lung maturity index and lamellar body count will be correlated to see if there is an association between Twin A and Twin B.

Fetal Lung Maturity index and lamellar body count will be calculated and compared based on fetal weight, sex, zigosity, and birth order. Demographic information, maternal obstetrical and medical history, newborn/fetal data, indications for cesarean section and twin A and B outcomes will be obtained through OB Traceview or patient chart.

Study population:

Participants will include pregnant patients, greater than 24 completed weeks with diamniotic twin gestations, at Good Samaritan and Bethesda North Hospitals. Patients will be scheduled for a cesarean section by their primary MD prior to being approached for inclusion into the study.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

A sample of amniotic fluid will be drawn from the amniotic sac of Twin A and Twin B. Each amniotic sac will be aspirated by the obstetrician and sent to the laboratory for determination of fetal lung maturity index and lamellar body count. Fetal lung maturity index and lamellar body count will be correlated to see if there is an association between Twin A and Twin B.

Fetal Lung Maturity index and lamellar body count will be calculated and compared based on fetal weight, sex, zigosity, and birth order. Demographic information, maternal obstetrical and medical history, newborn/fetal data, indications for cesarean section and twin A and B outcomes will be obtained through OB Traceview or patient chart.

Non-Probability Sample

Participants will include pregnant patients, greater than 24 completed weeks with diamniotic twin gestations, at Good Samaritan and Bethesda North Hospitals. Patients will be scheduled for a cesarean section by their primary MD prior to being approached for inclusion into the study.

Discordance in Lung Maturity in Diamniotic Twins
Procedure: aspiration of amniotic fluid
a sample of amniotic fluid will be drawn from the amniotic sac of Twin A and Twin B. Each amniotic sac will be aspirated by the obstetrician and sent to the laboratory for determination of fetal lung maturity index and lamellar body count.
Other Name: diamniotic twins
Diamniotic twin gestations
Intervention: Procedure: aspiration of amniotic fluid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
June 2012
Not Provided

Inclusion Criteria:

Diamniotic twin gestations

  • Twenty-four completed weeks gestation with dating calculated by their sure last menstrual period or utilizing a first trimester crown rump length ultrasound.
  • English Speaking
  • Scheduled cesarean section by patient's primary MD

Exclusion Criteria:

  • Monoamniotic twins
  • Presence of gross blood in amniotic sample
  • Presence of meconium amniotic fluid
  • Known/diagnosed fetal or newborn anomaly
  • Twin to Twin Transfusion Syndrome (TTTS)
  • Vaginal delivery
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01385267
08074
Yes
Donna Lambers MD, Trihealth
TriHealth Inc.
Not Provided
Principal Investigator: Donna Lambers, MD TriHealth Inc.
TriHealth Inc.
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP