Abnormal Fetal Growth or Fluid, Uncomplicated Pregnancy
Conditions
Brief summary
The purpose of this study is to see whether women at a gestational age of 30 weeks or more without comorbidities, does performance of serial 3rd trimester growth ultrasounds increase the frequency of identifying abnormalities in fetal growth or amniotic fluid, when compared with women who only receive indicated ultrasounds?
Interventions
DEVICEClinically-indicated ultrasound
Routine third trimester care with clinically-indicated ultrasound (control)
DEVICESerial 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).
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Maternal age of 18 at the time of consent * Singleton gestation
Exclusion criteria
* First sonographic examination after 20 weeks * Women with any of the following co-morbidities: Autoimmune disorders (antiphospholipid antibody, lupus, rheumatoid arthritis, scleroderma), Cerclage in the index pregnancy, Diabetes mellitus-gestational or pre-gestational, Hematologic disorders (coagulation defects, sickle cell disease, thrombocytopenia, thrombophilia), Hypertension (chronic or pregnancy induced) before enrollment, HIV (human immunodeficiency virus), Institutionalized individuals (prisoners), Prior obstetric history of: \[1) intrauterine growth restriction, 2) preterm birth before 34 weeks, 3) severe preeclampsia\], eclampsia, HELLP syndrome, and 4) stillbirth after 24 weeks or neonatal death, Preterm labor or ruptured membranes before enrollment, Psychiatric disorder (bipolar, depression) on medication, Placenta previa / 3rd trimester bleeding, Renal insufficiency (serum creatinine \> 1.5 mg/dL), Restrictive lung disease, Fetal red blood cell isoimmunization, Seizure disorder on medication, Thyroid disease on medication, Body Mass Index (BMI) above 40 kg/m2 * Major fetal Anomaly including: anencephaly, spina bifida, bilateral renal agenesis, cystic hygroma with hydrops, diaphragmatic hernia, or congenital heart defects * Unable to understand consent in English or Spanish
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Fetal Growth Restriction | 30 to 38 weeks gestational age | — |
| Number of Participants With Large for Gestational Age Fetuses | 30 to 38 weeks gestational age | — |
| Number of Participates With Oligohydraminos | 30 to 38 weeks gestational age | Oligohydramnios 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. |
| Number of Participates With Polyhydraminos | 30 to 38 weeks gestational age | Polyhydraminos 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Composite Neonatal Morbidity | From time of delivery to 28 days after delivery | 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. |
| Number of Participants With Composite Maternal Morbidity | From time of delivery to discharge (average time of discharge is 4 days after delivery) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Routine Third Trimester Care Clinically-indicated ultrasound: Routine third trimester care with clinically-indicated ultrasound (control) | 102 |
| 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). | 104 |
| Total | 206 |
Baseline characteristics
| Characteristic | Routine Third Trimester Care | Total | Serial Third Trimester Ultrasound |
|---|---|---|---|
| Age, Customized 20 to 34 years old | 87 Participants | 169 Participants | 82 Participants |
| Age, Customized greater than or equal to 35 years old | 10 Participants | 22 Participants | 12 Participants |
| Age, Customized less than 20 years old | 5 Participants | 15 Participants | 10 Participants |
| Body Mass Index (BMI) at first prenatal visit 30 to 39.9 kg/m^2 | 28 Participants | 55 Participants | 27 Participants |
| Body Mass Index (BMI) at first prenatal visit less than 30 kg/m^2 | 74 Participants | 151 Participants | 77 Participants |
| Gestational Age at Randomization | 29.2 weeks STANDARD_DEVIATION 1 | 29.1 weeks STANDARD_DEVIATION 1.1 | 29.0 weeks STANDARD_DEVIATION 1.1 |
| Insurance Medicaid | 66 Participants | 135 Participants | 69 Participants |
| Insurance Private Insurance | 36 Participants | 71 Participants | 35 Participants |
| Nulliparity (never given birth) | 43 Participants | 82 Participants | 39 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black | 32 Participants | 66 Participants | 34 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 20 Participants | 42 Participants | 22 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 27 Participants | 50 Participants | 23 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 23 Participants | 48 Participants | 25 Participants |
| Region of Enrollment United States | 102 Participants | 206 Participants | 104 Participants |
| Sex: Female, Male Female | 102 Participants | 206 Participants | 104 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Time of first ultrasound exam | 12.9 weeks STANDARD_DEVIATION 4.3 | 12.9 weeks STANDARD_DEVIATION 4.3 | 12.9 weeks STANDARD_DEVIATION 4.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 102 | 0 / 104 |
| other Total, other adverse events | 25 / 102 | 22 / 104 |
| serious Total, serious adverse events | 1 / 102 | 0 / 104 |
Outcome results
Primary
Number of Participants With Fetal Growth Restriction
Time frame: 30 to 38 weeks gestational age
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Routine Third Trimester Care | Number of Participants With Fetal Growth Restriction | 2 Participants |
| Serial Third Trimester Ultrasound | Number of Participants With Fetal Growth Restriction | 8 Participants |
95% CI: [0.9, 18]
Primary
Number of Participants With Large for Gestational Age Fetuses
Time frame: 30 to 38 weeks gestational age
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Routine Third Trimester Care | Number of Participants With Large for Gestational Age Fetuses | 2 Participants |
| Serial Third Trimester Ultrasound | Number of Participants With Large for Gestational Age Fetuses | 8 Participants |
95% CI: [0.9, 18]
Primary
Number of Participates With Oligohydraminos
Oligohydramnios 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.
Time frame: 30 to 38 weeks gestational age
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Routine Third Trimester Care | Number of Participates With Oligohydraminos | 2 Participants |
| Serial Third Trimester Ultrasound | Number of Participates With Oligohydraminos | 4 Participants |
95% CI: [0.4, 10.5]
Primary
Number of Participates With Polyhydraminos
Polyhydraminos 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.
Time frame: 30 to 38 weeks gestational age
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Routine Third Trimester Care | Number of Participates With Polyhydraminos | 2 Participants |
| Serial Third Trimester Ultrasound | Number of Participates With Polyhydraminos | 11 Participants |
95% CI: [1.2, 23.7]
Secondary
Number of Participants With Composite Maternal Morbidity
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Routine Third Trimester Care | Number of Participants With Composite Maternal Morbidity | 9 Participants |
| Serial Third Trimester Ultrasound | Number of Participants With Composite Maternal Morbidity | 9 Participants |
95% CI: [0.4, 2.3]
Secondary
Number of Participants With Composite Neonatal Morbidity
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.
Time frame: From time of delivery to 28 days after delivery
Population: One patient in the routine third trimester care group delivered in an outside hospital, and the data was not available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Routine Third Trimester Care | Number of Participants With Composite Neonatal Morbidity | 4 Participants |
| Serial Third Trimester Ultrasound | Number of Participants With Composite Neonatal Morbidity | 1 Participants |
95% CI: [0.03, 2.1]