An observational study in Discordance in Lung Maturity in Diamniotic Twins, sponsored by TriHealth Inc.. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-28.
Sponsored by TriHealth Inc. · Observational
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.
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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.
Diamniotic twin gestations
Exclusion Criteria:
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.
Also known as: diamniotic twins
FLM Index
FLM Index
Time frame: 3 years
Lamellar Body Counts
Lamellar Body Counts
Time frame: 3 years
Respiratory Distress Syndrome
Respiratory Distress Syndrome
Time frame: 3 years
Transient Tachypnea in newborns
Transient Tachypnea in newborns
Time frame: 3 years
Neonatal Death
Neonatal Death
Time frame: 3 years
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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TriHealth Inc.