Fetal Lung Maturation in Twin Gestations
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Discordance in Lung Maturity in Diamniotic Twins |
Procedure: aspiration of amniotic fluid |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Fetal Lung Maturation in Twin Gestations Based on Birth Order and Weight Discordance |
- FLM Index [ Time Frame: 3 years ] [ Designated as safety issue: No ]FLM Index
- Lamellar Body Counts [ Time Frame: 3 years ] [ Designated as safety issue: No ]Lamellar Body Counts
- Respiratory Distress Syndrome [ Time Frame: 3 years ] [ Designated as safety issue: No ]Respiratory Distress Syndrome
- Transient Tachypnea in newborns [ Time Frame: 3 years ] [ Designated as safety issue: No ]Transient Tachypnea in newborns
- Neonatal Death [ Time Frame: 3 years ] [ Designated as safety issue: No ]Neonatal Death
Biospecimen Retention: Samples Without DNA
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.
| Estimated Enrollment: | 50 |
| Study Start Date: | June 2009 |
| Study Completion Date: | June 2012 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| 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 Name: diamniotic twins
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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:
- 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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Donna Lambers MD, Trihealth |
| ClinicalTrials.gov Identifier: | NCT01385267 History of Changes |
| Other Study ID Numbers: | 08074 |
| Study First Received: | June 28, 2011 |
| Last Updated: | October 30, 2012 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on June 18, 2013