Fetal Lung Maturation in Twin Gestations

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

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.

Study Overview

• Status: Completed
• Conditions: Discordance in Lung Maturity in Diamniotic Twins
• Intervention / Treatment: Procedure: aspiration of amniotic fluid

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Good Samaritan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 Names: diamniotic twins

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FLM Index	FLM Index	3 years
Lamellar Body Counts	Lamellar Body Counts	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory Distress Syndrome	Respiratory Distress Syndrome	3 years
Transient Tachypnea in newborns	Transient Tachypnea in newborns	3 years
Neonatal Death	Neonatal Death	3 years

Collaborators and Investigators

• Sponsor: TriHealth Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: June 28, 2011
• First Submitted That Met QC Criteria: June 29, 2011
• First Posted (Estimate): June 30, 2011

Study Record Updates

• Last Update Posted (Actual): December 28, 2018
• Last Update Submitted That Met QC Criteria: December 27, 2018
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 08074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO