Fetal Lung Maturation in Twin Gestations

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TriHealth Inc.
ClinicalTrials.gov Identifier:
NCT01385267
First received: June 28, 2011
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Discordance in Lung Maturity in Diamniotic Twins
Procedure: aspiration of amniotic fluid

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Fetal Lung Maturation in Twin Gestations Based on Birth Order and Weight Discordance

Further study details as provided by TriHealth Inc.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Biospecimen Retention:   Samples Without DNA

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.


Enrollment: 50
Study Start Date: June 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Diamniotic twin gestations 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01385267

Locations
United States, Ohio
Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
TriHealth Inc.
Investigators
Principal Investigator: Donna Lambers, MD TriHealth Inc.
  More Information

No publications provided

Responsible Party: TriHealth Inc.
ClinicalTrials.gov Identifier: NCT01385267     History of Changes
Other Study ID Numbers: 08074
Study First Received: June 28, 2011
Last Updated: February 17, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 19, 2014