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Fetal Lung Maturation in Twin Gestations

Fetal Lung Maturation in Twin Gestations Based on Birth Order and Weight Discordance

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01385267
Enrollment
50
Registered
2011-06-30
Start date
2009-06-30
Completion date
2012-06-30
Last updated
2018-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Discordance in Lung Maturity in Diamniotic Twins

Brief summary

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.

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.

Interventions

PROCEDUREaspiration 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.

Sponsors

TriHealth Inc.
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
FLM Index3 yearsFLM Index
Lamellar Body Counts3 yearsLamellar Body Counts

Secondary

MeasureTime frameDescription
Respiratory Distress Syndrome3 yearsRespiratory Distress Syndrome
Transient Tachypnea in newborns3 yearsTransient Tachypnea in newborns
Neonatal Death3 yearsNeonatal Death

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026