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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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine third trimester care | Active Comparator | Routine third trimester care with clinically-indicated ultrasound (control) |
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| Serial third trimester ultrasound | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinically-indicated ultrasound | Device | Routine third trimester care with clinically-indicated ultrasound (control) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 30 to 38 weeks gestational age |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olaide A Ashimi Balogun, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Physicians | Bellaire | Texas | 77401 | United States | ||
| University of Texas at Houston Health Science Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30399092 | Derived | Ashimi Balogun O, Sibai BM, Pedroza C, Blackwell SC, Barrett TL, Chauhan SP. Serial Third-Trimester Ultrasonography Compared With Routine Care in Uncomplicated Pregnancies: A Randomized Controlled Trial. Obstet Gynecol. 2018 Dec;132(6):1358-1367. doi: 10.1097/AOG.0000000000002970. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Routine Third Trimester Care | Clinically-indicated ultrasound: Routine third trimester care with clinically-indicated ultrasound (control) |
| FG001 | Serial Third Trimester Ultrasound |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 3, 2016 |
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| Serial third trimester ultrasound | Device | 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). |
|
| 30 to 38 weeks gestational age |
| From time of delivery to 28 days after delivery |
| 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. | From time of delivery to discharge (average time of discharge is 4 days after delivery) |
| Houston |
| Texas |
| 77030 |
| United States |
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).
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Routine Third Trimester Care | Clinically-indicated ultrasound: Routine third trimester care with clinically-indicated ultrasound (control) |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Nulliparity (never given birth) | Count of Participants | Participants |
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| Insurance | Count of Participants | Participants |
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| Body Mass Index (BMI) at first prenatal visit | Count of Participants | Participants |
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| Time of first ultrasound exam | Mean | Standard Deviation | weeks |
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| Gestational Age at Randomization | Mean | Standard Deviation | weeks |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Fetal Growth Restriction | Posted | Count of Participants | Participants | 30 to 38 weeks gestational age |
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| Primary | Number of Participants With Large for Gestational Age Fetuses | Posted | Count of Participants | Participants | 30 to 38 weeks gestational age |
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| 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. | Posted | Count of Participants | Participants | 30 to 38 weeks gestational age |
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| 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. | Posted | Count of Participants | Participants | 30 to 38 weeks gestational age |
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| 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. | One patient in the routine third trimester care group delivered in an outside hospital, and the data was not available. | Posted | Count of Participants | Participants | From time of delivery to 28 days after delivery |
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| 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. | One patient in the routine third trimester care group delivered in an outside hospital, and the data was not available. | Posted | Count of Participants | Participants | From time of delivery to discharge (average time of discharge is 4 days after delivery) |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Routine Third Trimester Care | Routine third trimester care with clinically-indicated ultrasound (control) Clinically-indicated ultrasound: Routine third trimester care with clinically-indicated ultrasound (control) | 1 | 102 | 1 | 102 | 25 | 102 |
| EG001 | 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). 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). | 0 | 104 | 0 | 104 | 22 | 104 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neonatal death | General disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| gestational hypertension (GHTN)/preeclampsia | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Decreased fetal movement | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Preterm labor | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Premature rupture of membranes (PROM) | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Cholestasis, pyelonephritis, fall, or fetal ventricular tachycardia | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Chorioamnionitis | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Cesarean delivery in labor | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Postpartum Hemorrhage | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Transfusion (maternal) | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Wound infection (maternal) | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Apgar score < 5 at 5 min | General disorders | Systematic Assessment |
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| Umbilical arterial pH < 7.00 | General disorders | Systematic Assessment |
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| Intubation over 24 hours (infant) | General disorders | Systematic Assessment |
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| Intraventricular hemorrhage (IVH) grade III or IV (infant) | Vascular disorders | Systematic Assessment |
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not powered to detect differences in neonatal outcomes; all sonographic exams were done by a Registered Diagnostic Medical Sonographer (RDMS), and thus findings may not apply to those with sonographic exams done by clinician
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Olaide Azizat Ashimi Balogun, MD | The University of Texas Health Science Center at Houston | (713) 500-6412 | Olaide.A.Ashimi@uth.tmc.edu |
| Jul 11, 2018 |
| Prot_SAP_000.pdf |
| greater than or equal to 35 years old |
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| Male |
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| White |
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| Hispanic |
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| Other |
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| Private Insurance |
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| 30 to 39.9 kg/m^2 |
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