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CompletedNCT01385267Updated Dec 28, 2018

Fetal Lung Maturation in Twin Gestations

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

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
Female
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Study 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.

Read the 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.

02

Conditions studied

  • Discordance in Lung Maturity in Diamniotic Twins
03

In context

Lead sponsor

TriHealth Inc. is the lead sponsor of 99 studies on the registry; 9 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (actual)
Biospecimen retention
Samples without dna

Groups and cohorts

  • Diamniotic twin gestations

    Procedure: aspiration of amniotic fluid

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.

    Also known as: diamniotic twins

06

What researchers measure

Primary outcomes

  1. FLM Index

    FLM Index

    Time frame: 3 years

  2. Lamellar Body Counts

    Lamellar Body Counts

    Time frame: 3 years

Secondary outcomes

  1. Respiratory Distress Syndrome

    Respiratory Distress Syndrome

    Time frame: 3 years

  2. Transient Tachypnea in newborns

    Transient Tachypnea in newborns

    Time frame: 3 years

  3. Neonatal Death

    Neonatal Death

    Time frame: 3 years

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Study locations

1 site
  • Good Samaritan Hospital
    Cincinnati, Ohio 45220, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 28, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01385267
Lead sponsor
TriHealth Inc.
Responsible party
Sponsor
First posted
Jun 30, 2011
Start date
Jun 2009
Primary completion
Jun 2012
Completion
Jun 2012
Last update
Dec 28, 2018

Study contacts

Donna Lambers, MD
principal investigator · TriHealth Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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