Trial Outcomes & Findings for Determination of Abnormal Fetal Growth or Amniotic Fluid With Third Trimester Ultrasounds in Uncomplicated Pregnancies: A Randomized Trial (NCT NCT02702999)
NCT ID: NCT02702999
Last Updated: 2018-09-05
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
206 participants
Primary outcome timeframe
30 to 38 weeks gestational age
Results posted on
2018-09-05
Participant Flow
Participant milestones
| Measure |
Routine Third Trimester Care
Clinically-indicated ultrasound: Routine third trimester care with clinically-indicated ultrasound (control)
|
Serial Third Trimester Ultrasound
Serial third trimester ultrasound: Ultrasound evaluation for fetal growth and amniotic fluid will be performed every 4 weeks starting at 30 weeks. Thus, if they continue to term, there will be 3 additional ultrasounds exams (30, 34 and 38 weeks).
|
|---|---|---|
|
Overall Study
STARTED
|
102
|
104
|
|
Overall Study
COMPLETED
|
102
|
104
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Determination of Abnormal Fetal Growth or Amniotic Fluid With Third Trimester Ultrasounds in Uncomplicated Pregnancies: A Randomized Trial
Baseline characteristics by cohort
| Measure |
Routine Third Trimester Care
n=102 Participants
Clinically-indicated ultrasound: Routine third trimester care with clinically-indicated ultrasound (control)
|
Serial Third Trimester Ultrasound
n=104 Participants
Serial third trimester ultrasound: Ultrasound evaluation for fetal growth and amniotic fluid will be performed every 4 weeks starting at 30 weeks. Thus, if they continue to term, there will be 3 additional ultrasounds exams (30, 34 and 38 weeks).
|
Total
n=206 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
less than 20 years old
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Customized
20 to 34 years old
|
87 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
|
Age, Customized
greater than or equal to 35 years old
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
102 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
206 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black
|
32 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
27 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
102 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
206 Participants
n=5 Participants
|
|
Nulliparity (never given birth)
|
43 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Insurance
Medicaid
|
66 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Insurance
Private Insurance
|
36 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Body Mass Index (BMI) at first prenatal visit
less than 30 kg/m^2
|
74 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Body Mass Index (BMI) at first prenatal visit
30 to 39.9 kg/m^2
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Time of first ultrasound exam
|
12.9 weeks
STANDARD_DEVIATION 4.3 • n=5 Participants
|
12.9 weeks
STANDARD_DEVIATION 4.3 • n=7 Participants
|
12.9 weeks
STANDARD_DEVIATION 4.3 • n=5 Participants
|
|
Gestational Age at Randomization
|
29.2 weeks
STANDARD_DEVIATION 1.0 • n=5 Participants
|
29.0 weeks
STANDARD_DEVIATION 1.1 • n=7 Participants
|
29.1 weeks
STANDARD_DEVIATION 1.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: 30 to 38 weeks gestational ageOutcome measures
| Measure |
Routine Third Trimester Care
n=102 Participants
Clinically-indicated ultrasound: Routine third trimester care with clinically-indicated ultrasound (control)
|
Serial Third Trimester Ultrasound
n=104 Participants
Serial third trimester ultrasound: Ultrasound evaluation for fetal growth and amniotic fluid will be performed every 4 weeks starting at 30 weeks. Thus, if they continue to term, there will be 3 additional ultrasounds exams (30, 34 and 38 weeks).
|
|---|---|---|
|
Number of Participants With Fetal Growth Restriction
|
2 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: 30 to 38 weeks gestational ageOutcome measures
| Measure |
Routine Third Trimester Care
n=102 Participants
Clinically-indicated ultrasound: Routine third trimester care with clinically-indicated ultrasound (control)
|
Serial Third Trimester Ultrasound
n=104 Participants
Serial third trimester ultrasound: Ultrasound evaluation for fetal growth and amniotic fluid will be performed every 4 weeks starting at 30 weeks. Thus, if they continue to term, there will be 3 additional ultrasounds exams (30, 34 and 38 weeks).
|
|---|---|---|
|
Number of Participants With Large for Gestational Age Fetuses
|
2 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: 30 to 38 weeks gestational ageOligohydramnios is a condition in pregnancy characterized by a deficiency of amniotic fluid. Amniotic fluid was assessed using the amniotic fluid index (AFI) or maximum vertical pocket (MVP). Oligohydramnios was defined as AFI less than or equal to 5.0 cm or MVP less than or equal to 2.0 cm. AFI is the sum of the vertical length of the deepest, unobstructed pocket of amniotic fluid in each of the 4 quadrants of the pregnant uterus. An AFI of less than or equal to 5cm is considered low amniotic fluid, and an AFI greater than or equal to 24cm is considered high amniotic fluid. MVP is the vertical length of the single deepest pocket of amniotic fluid. An MVP less than or equal to 2cm is considered to be low amniotic fluid and an MVP of 8cm or greater is considered to be high amniotic fluid. Both low and high amniotic fluid levels are worse outcomes than having normal amniotic fluid levels.
Outcome measures
| Measure |
Routine Third Trimester Care
n=102 Participants
Clinically-indicated ultrasound: Routine third trimester care with clinically-indicated ultrasound (control)
|
Serial Third Trimester Ultrasound
n=104 Participants
Serial third trimester ultrasound: Ultrasound evaluation for fetal growth and amniotic fluid will be performed every 4 weeks starting at 30 weeks. Thus, if they continue to term, there will be 3 additional ultrasounds exams (30, 34 and 38 weeks).
|
|---|---|---|
|
Number of Participates With Oligohydraminos
|
2 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 30 to 38 weeks gestational agePolyhydraminos is a condition in pregnancy characterized by an excess of amniotic fluid. Amniotic fluid was assessed using either the amniotic fluid index (AFI) or maximum vertical pocket (MVP). Polyhydramnios was defined as AFI greater than or equal to 24.0 cm or MVP greater than or equal to 8.0 cm. AFI is the sum of the vertical length of the deepest, unobstructed pocket of amniotic fluid in each of the 4 quadrants of the pregnant uterus. An AFI of less than or equal to 5cm is considered low amniotic fluid, and an AFI greater than or equal to 24cm is considered high amniotic fluid. MVP is the vertical length of the single deepest pocket of amniotic fluid. An MVP less than or equal to 2cm is considered to be low amniotic fluid and an MVP of 8cm or greater is considered to be high amniotic fluid. Both low and high amniotic fluid levels are worse outcomes than having normal amniotic fluid levels.
Outcome measures
| Measure |
Routine Third Trimester Care
n=102 Participants
Clinically-indicated ultrasound: Routine third trimester care with clinically-indicated ultrasound (control)
|
Serial Third Trimester Ultrasound
n=104 Participants
Serial third trimester ultrasound: Ultrasound evaluation for fetal growth and amniotic fluid will be performed every 4 weeks starting at 30 weeks. Thus, if they continue to term, there will be 3 additional ultrasounds exams (30, 34 and 38 weeks).
|
|---|---|---|
|
Number of Participates With Polyhydraminos
|
2 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: From time of delivery to 28 days after deliveryPopulation: One patient in the routine third trimester care group delivered in an outside hospital, and the data was not available.
Composite Neonatal Morbidity is defined as the presence of one or more of the following: 1) Apgar score \< 5 at 5 min; 2) umbilical arterial pH \< 7.00; 3) intraventricular hemorrhage grade III or IV; 4) periventricular leukomalacia; 5) intubation for over 24 hrs; 6) necrotizing enterocolitis grade 2 or 3; 7) stillbirth; or 8) death within 28 days of birth.
Outcome measures
| Measure |
Routine Third Trimester Care
n=101 Participants
Clinically-indicated ultrasound: Routine third trimester care with clinically-indicated ultrasound (control)
|
Serial Third Trimester Ultrasound
n=104 Participants
Serial third trimester ultrasound: Ultrasound evaluation for fetal growth and amniotic fluid will be performed every 4 weeks starting at 30 weeks. Thus, if they continue to term, there will be 3 additional ultrasounds exams (30, 34 and 38 weeks).
|
|---|---|---|
|
Number of Participants With Composite Neonatal Morbidity
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From time of delivery to discharge (average time of discharge is 4 days after delivery)Population: One patient in the routine third trimester care group delivered in an outside hospital, and the data was not available.
Composite Maternal Morbidity is defined as the presence of one of more of the following: 1) chorioamnionitis; 2) cesarean delivery in labor; 3) wound infection; 4) transfusion; 5) deep venous thrombus or pulmonary embolism; 6) admission to intensive care unit; 7) postpartum hemorrhage; or 8) death.
Outcome measures
| Measure |
Routine Third Trimester Care
n=101 Participants
Clinically-indicated ultrasound: Routine third trimester care with clinically-indicated ultrasound (control)
|
Serial Third Trimester Ultrasound
n=104 Participants
Serial third trimester ultrasound: Ultrasound evaluation for fetal growth and amniotic fluid will be performed every 4 weeks starting at 30 weeks. Thus, if they continue to term, there will be 3 additional ultrasounds exams (30, 34 and 38 weeks).
|
|---|---|---|
|
Number of Participants With Composite Maternal Morbidity
|
9 Participants
|
9 Participants
|
Adverse Events
Routine Third Trimester Care
Serious events: 1 serious events
Other events: 25 other events
Deaths: 1 deaths
Serial Third Trimester Ultrasound
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Routine Third Trimester Care
n=102 participants at risk
Routine third trimester care with clinically-indicated ultrasound (control)
Clinically-indicated ultrasound: Routine third trimester care with clinically-indicated ultrasound (control)
|
Serial Third Trimester Ultrasound
n=104 participants at risk
Ultrasound evaluation for fetal growth and amniotic fluid will be performed every 4 weeks starting at 30 weeks (intervention group). Thus, if they continue to term, there will be 3 additional ultrasounds exams (30, 34 and 38 weeks).
Serial third trimester ultrasound: Ultrasound evaluation for fetal growth and amniotic fluid will be performed every 4 weeks starting at 30 weeks (intervention group). Thus, if they continue to term, there will be 3 additional ultrasounds exams (30, 34 and 38 weeks).
|
|---|---|---|
|
General disorders
Neonatal death
|
0.98%
1/102 • Number of events 1 • From time of delivery to discharge (average time of discharge is 4 days after delivery)
None of the below-reported adverse events were deemed to be related to the study interventions.
|
0.00%
0/104 • From time of delivery to discharge (average time of discharge is 4 days after delivery)
None of the below-reported adverse events were deemed to be related to the study interventions.
|
Other adverse events
| Measure |
Routine Third Trimester Care
n=102 participants at risk
Routine third trimester care with clinically-indicated ultrasound (control)
Clinically-indicated ultrasound: Routine third trimester care with clinically-indicated ultrasound (control)
|
Serial Third Trimester Ultrasound
n=104 participants at risk
Ultrasound evaluation for fetal growth and amniotic fluid will be performed every 4 weeks starting at 30 weeks (intervention group). Thus, if they continue to term, there will be 3 additional ultrasounds exams (30, 34 and 38 weeks).
Serial third trimester ultrasound: Ultrasound evaluation for fetal growth and amniotic fluid will be performed every 4 weeks starting at 30 weeks (intervention group). Thus, if they continue to term, there will be 3 additional ultrasounds exams (30, 34 and 38 weeks).
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
gestational hypertension (GHTN)/preeclampsia
|
14.7%
15/102 • Number of events 15 • From time of delivery to discharge (average time of discharge is 4 days after delivery)
None of the below-reported adverse events were deemed to be related to the study interventions.
|
20.2%
21/104 • Number of events 21 • From time of delivery to discharge (average time of discharge is 4 days after delivery)
None of the below-reported adverse events were deemed to be related to the study interventions.
|
|
Pregnancy, puerperium and perinatal conditions
Decreased fetal movement
|
3.9%
4/102 • Number of events 4 • From time of delivery to discharge (average time of discharge is 4 days after delivery)
None of the below-reported adverse events were deemed to be related to the study interventions.
|
2.9%
3/104 • Number of events 3 • From time of delivery to discharge (average time of discharge is 4 days after delivery)
None of the below-reported adverse events were deemed to be related to the study interventions.
|
|
Pregnancy, puerperium and perinatal conditions
Preterm labor
|
4.9%
5/102 • Number of events 5 • From time of delivery to discharge (average time of discharge is 4 days after delivery)
None of the below-reported adverse events were deemed to be related to the study interventions.
|
2.9%
3/104 • Number of events 3 • From time of delivery to discharge (average time of discharge is 4 days after delivery)
None of the below-reported adverse events were deemed to be related to the study interventions.
|
|
Pregnancy, puerperium and perinatal conditions
Premature rupture of membranes (PROM)
|
0.98%
1/102 • Number of events 1 • From time of delivery to discharge (average time of discharge is 4 days after delivery)
None of the below-reported adverse events were deemed to be related to the study interventions.
|
2.9%
3/104 • Number of events 3 • From time of delivery to discharge (average time of discharge is 4 days after delivery)
None of the below-reported adverse events were deemed to be related to the study interventions.
|
|
Pregnancy, puerperium and perinatal conditions
Cholestasis, pyelonephritis, fall, or fetal ventricular tachycardia
|
8.8%
9/102 • Number of events 9 • From time of delivery to discharge (average time of discharge is 4 days after delivery)
None of the below-reported adverse events were deemed to be related to the study interventions.
|
1.9%
2/104 • Number of events 2 • From time of delivery to discharge (average time of discharge is 4 days after delivery)
None of the below-reported adverse events were deemed to be related to the study interventions.
|
|
Pregnancy, puerperium and perinatal conditions
Chorioamnionitis
|
3.9%
4/102 • Number of events 4 • From time of delivery to discharge (average time of discharge is 4 days after delivery)
None of the below-reported adverse events were deemed to be related to the study interventions.
|
4.8%
5/104 • Number of events 5 • From time of delivery to discharge (average time of discharge is 4 days after delivery)
None of the below-reported adverse events were deemed to be related to the study interventions.
|
|
Pregnancy, puerperium and perinatal conditions
Cesarean delivery in labor
|
5.9%
6/102 • Number of events 6 • From time of delivery to discharge (average time of discharge is 4 days after delivery)
None of the below-reported adverse events were deemed to be related to the study interventions.
|
4.8%
5/104 • Number of events 5 • From time of delivery to discharge (average time of discharge is 4 days after delivery)
None of the below-reported adverse events were deemed to be related to the study interventions.
|
|
Pregnancy, puerperium and perinatal conditions
Postpartum Hemorrhage
|
2.9%
3/102 • Number of events 3 • From time of delivery to discharge (average time of discharge is 4 days after delivery)
None of the below-reported adverse events were deemed to be related to the study interventions.
|
1.9%
2/104 • Number of events 2 • From time of delivery to discharge (average time of discharge is 4 days after delivery)
None of the below-reported adverse events were deemed to be related to the study interventions.
|
|
Pregnancy, puerperium and perinatal conditions
Transfusion (maternal)
|
2.9%
3/102 • Number of events 3 • From time of delivery to discharge (average time of discharge is 4 days after delivery)
None of the below-reported adverse events were deemed to be related to the study interventions.
|
0.96%
1/104 • Number of events 1 • From time of delivery to discharge (average time of discharge is 4 days after delivery)
None of the below-reported adverse events were deemed to be related to the study interventions.
|
|
Pregnancy, puerperium and perinatal conditions
Wound infection (maternal)
|
0.00%
0/102 • From time of delivery to discharge (average time of discharge is 4 days after delivery)
None of the below-reported adverse events were deemed to be related to the study interventions.
|
0.96%
1/104 • Number of events 1 • From time of delivery to discharge (average time of discharge is 4 days after delivery)
None of the below-reported adverse events were deemed to be related to the study interventions.
|
|
General disorders
Apgar score < 5 at 5 min
|
0.98%
1/102 • Number of events 1 • From time of delivery to discharge (average time of discharge is 4 days after delivery)
None of the below-reported adverse events were deemed to be related to the study interventions.
|
0.00%
0/104 • From time of delivery to discharge (average time of discharge is 4 days after delivery)
None of the below-reported adverse events were deemed to be related to the study interventions.
|
|
General disorders
Umbilical arterial pH < 7.00
|
2.0%
2/102 • Number of events 2 • From time of delivery to discharge (average time of discharge is 4 days after delivery)
None of the below-reported adverse events were deemed to be related to the study interventions.
|
0.00%
0/104 • From time of delivery to discharge (average time of discharge is 4 days after delivery)
None of the below-reported adverse events were deemed to be related to the study interventions.
|
|
General disorders
Intubation over 24 hours (infant)
|
0.98%
1/102 • Number of events 1 • From time of delivery to discharge (average time of discharge is 4 days after delivery)
None of the below-reported adverse events were deemed to be related to the study interventions.
|
0.96%
1/104 • Number of events 1 • From time of delivery to discharge (average time of discharge is 4 days after delivery)
None of the below-reported adverse events were deemed to be related to the study interventions.
|
|
Vascular disorders
Intraventricular hemorrhage (IVH) grade III or IV (infant)
|
0.98%
1/102 • Number of events 1 • From time of delivery to discharge (average time of discharge is 4 days after delivery)
None of the below-reported adverse events were deemed to be related to the study interventions.
|
0.00%
0/104 • From time of delivery to discharge (average time of discharge is 4 days after delivery)
None of the below-reported adverse events were deemed to be related to the study interventions.
|
Additional Information
Olaide Azizat Ashimi Balogun, MD
The University of Texas Health Science Center at Houston
Phone: (713) 500-6412
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place