NCT04180566

Brief Summary

The purpose of study is to evaluate whether weekly antenatal testing in pregnant women with body mass index (BMI) 30-40 in the third trimester is associated with earlier delivery when compared to growth ultrasounds every 4 weeks. The investigators will also assess the differences in maternal and neonatal outcomes between the groups.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 27, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

February 4, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2021

Completed
Last Updated

July 7, 2021

Status Verified

July 1, 2021

Enrollment Period

1.1 years

First QC Date

November 26, 2019

Last Update Submit

July 2, 2021

Conditions

Obesity Complicating Childbirth

Keywords

PregnantPregnancyUltrasoundAntepartum testingNeonatal outcomeAntenatal complications

Outcome Measures

Primary Outcomes (1)

  • Average gestational age at delivery of participating women's babies

    This is to measure the number of weeks that the baby has been in the uterus. It is measured from the first day of the woman's last menstrual cycle to the date of delivery. A normal pregnancy can range from 38 to 42 weeks. A significant delay in gestational age of delivery would be \> 7 days out of this range.

    At time of delivery

Secondary Outcomes (4)

  • Average birth weight of participating women's babies

    At time of delivery

  • Number of participating women who experienced composite maternal morbidity

    At time of delivery

  • Number of participating women whose babies experienced composite neonatal morbidity

    At time of delivery

  • Number of participating women whose babies experienced composite of abnormalities of fluid volume and growth

    At time of delivery

Study Arms (2)

Weekly antenatal testing

OTHER

Women with BMI 30-40 between 20 and 34.6 weeks of gestation will receive weekly antenatal testing (biophysical profile) starting at 34 weeks as well as growth ultrasound every 4 weeks.

Other: Antenatal Testing (biophysical profile)

Growth ultrasound examination every 4 weeks

OTHER

Women with BMI 30-40 between 20 and 34.6 weeks of gestation will receive ultrasound examination (growth ultrasound) every 4 weeks starting at 34 weeks.

Other: Ultrasound Examination

Interventions

Ultrasound ExaminationOTHER

Includes a regular growth ultrasound examination.

Growth ultrasound examination every 4 weeks
Antenatal Testing (biophysical profile)OTHER

Includes weekly ultrasounds with a biophysical profile, which measures fetal tone, fetal movements, fetal breathing and amount of amniotic fluid (water around baby).

Weekly antenatal testing

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women at or over 18 years of age
  • Singleton pregnancy with no major fetal anomalies
  • Pregnancies and gestational age will be well dated
  • Obese with BMI 30-40kg/m2

You may not qualify if:

  • Women with any complications at time of randomization that would require antenatal testing in the third trimester as per ACOG guidelines including: hypertension, systemic lupus erythematosus, chronic renal disease, antiphospholipid syndromes, hyperthyroidism poorly controlled, hemoglobinopathies, cyanotic heart disease, gestational hypertension, pre-eclampsia, gestational diabetes medication controlled, oligohydramnios, intrauterine growth restriction before randomization, isoimmunization, history of fetal demise
  • Women with indication for weekly testing as per local protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia Univeristy Irving Medical Center

New York, New York, 10032, United States

Location

Study Officials

  • Cynthia Gyamfi-Bannerman, MD, MSc

    Professor of Obstetrics/Gyn, Columbia University

    PRINCIPAL INVESTIGATOR

  • Maria Andrikopoulou, MD, PhD

    Postdoctoral Clinical Fellow in the Department of Obstetrics

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2019

First Posted

November 27, 2019

Study Start

February 4, 2020

Primary Completion

March 10, 2021

Study Completion

March 10, 2021

Last Updated

July 7, 2021

Record last verified: 2021-07

Locations

US(1)