Antenatal Testing in Obese Woman, is it Really Necessary?

NCT02821988 | Unknown

• 1 other identifier: 16-04574-XP
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

It is well established that obese women are at an increased risk of stillbirth compared to non obese women. This has led many physicians to begin antenatal testing in obese women in the third trimester through either nonstress tests or biophysical profiles. However, there is little evidence that antenatal testing improves fetal outcomes in obese women. The aim of this study is to determine if antenatal testing improves outcomes in obese women and to determine the optimal mode of testing (either nonstress tests or biophysical profiles).

Conditions

Obesity in Pregnancy

Outcome Measures

Primary Outcomes (2)

• Stillbirth

  demise of infant prior to delivery as verified by ultrasonography

  until delivery, up to 41 weeks

• Mode of delivery

  whether the subject undergoes a vaginal delivery, cesarean delivery, or operative delivery will be recorded

  at delivery, up to 41 weeks

Secondary Outcomes (2)

• Neonatal intensive care unit admission admission

  at delivery, up to 41 weeks

• Apgar score of less than 7 at 5 minutes

  at delivery, up to 41 weeks

Study Arms (3)

Nonstress test

EXPERIMENTAL

Subjects will undergo weekly nonstress tests beginning at 32 weeks until delivery in addition to monitoring fetal kick counts. A nonstress test is a test in which an external fetal monitor is placed on the mother to defect the fetal heart rate for 20 to 40 minutes. A test is considered reactive if there are more than 2 accelerations in fetal heart rate defined as an increase of at least 15 beats per minute lasting at least 15 seconds in a 20 minute period.

Device: External fetal monitor for Nonstress test

Biophysical profile

EXPERIMENTAL

Subjects will undergo weekly biophysical profile testing beginning at 32 weeks until delivery in addition to monitoring fetal kick counts. A Biophysical profile is a test using real time ultrasonography to determine the presence of absence of certain components of fetal well being. There components include: an episode of fetal breathing lasting at least 30 seconds, 3 or more discrete body movements, 1 or more episodes of extension of a fetal extremity with return to flexion, and determination of amniotic fluid volume to detect a maximum vertical pocket of \>2cm. The duration of this test is no more than 30 minutes.

Device: Ultrasonography for Biophysical profile

Kick counts only

NO INTERVENTION

Subjects will monitor fetal kick counts only.

Interventions

External fetal monitor for Nonstress test DEVICE

Nonstress test

Ultrasonography for Biophysical profile DEVICE

Biophysical profile

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• less then 32 weeks gestation BMI \> 30kg/m2 English speaking

You may not qualify if:

• age \< 18 age \>45 medical comorbidity which requires antenatal testing other than obesity unwilling to consent Non-English speaking not pregnant Gestational age \>32 weeks

Sponsors & Collaborators

• University of Tennessee: lead
• Regional One Health: collaborator

MeSH Terms

Conditions

Pregnancy in Obesity

Interventions

Cardiotocography; Ultrasonography

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Fetal Monitoring; Diagnostic Techniques, Obstetrical and Gynecological; Monitoring, Physiologic; Diagnostic Imaging

Central Study Contacts

Laura Grese, MD

CONTACT

4235712990; lgrese@uthsc.edu

Luis Gomez, MD

CONTACT

lgomez2@uthsc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: July 4, 2016
• Study Start: July 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: July 4, 2016

Record last verified: 2016-06