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OpenTrials
Completed

NCT Number: NCT01385267

Fetal Lung Maturation in Twin Gestations

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aspiration of amniotic fluid

Procedure

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 names: diamniotic twins

Primary outcomes

  1. FLM Index

    Time frame: 3 years

    FLM Index

  2. Lamellar Body Counts

    Time frame: 3 years

    Lamellar Body Counts

Secondary outcomes

  1. Respiratory Distress Syndrome

    Time frame: 3 years

    Respiratory Distress Syndrome

  2. Transient Tachypnea in newborns

    Time frame: 3 years

    Transient Tachypnea in newborns

  3. Neonatal Death

    Time frame: 3 years

    Neonatal Death

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jun 30, 2011
Registry last updated
Dec 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.