Uncomplicated PregnancyUPNCT02702999

Determination of Abnormal Fetal Growth or Amniotic Fluid With Third Trimester Ultrasounds in Uncomplicated Pregnancies: A Randomized Trial

A study testing Clinically-indicated ultrasound and Serial third trimester ultrasound in people with Uncomplicated Pregnancy and Abnormal Fetal Growth or Fluid, run by The University of Texas Health Science Center, Houston at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Uncomplicated Pregnancy, Abnormal Fetal Growth or Fluid
What is being tested?: Clinically-indicated ultrasound and Serial third trimester ultrasound
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 206 participants
Where: 2 sitesUnited States
Study dates: Jun 2016to Aug 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Maternal age of 18 at the time of consent
Singleton gestation

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

UT Physicians
Bellaire, Texas, 77401
University of Texas at Houston Health Science Center
Houston, Texas, 77030

Other trials in United States

About this study

Official title: Determination of Abnormal Fetal Growth or Amniotic Fluid With Third Trimester Ultrasounds in Uncomplicated Pregnancies: A Randomized Trial (UP Trial)

Conditions: Uncomplicated Pregnancy, Abnormal Fetal Growth or Fluid
Being tested: Clinically-indicated ultrasound, Serial third trimester ultrasound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Clinically-indicated ultrasoundDevice
Routine third trimester care with clinically-indicated ultrasound (control)
Serial third trimester ultrasoundDevice
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).

Study groups in NCT02702999
Study group	Role	What they receive
Routine third trimester care	Active comparator	Routine third trimester care with clinically-indicated ultrasound (control) Receives: Device: Clinically-indicated ultrasound
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). Receives: Device: Serial third trimester ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Fetal Growth Restriction
Measured: 30 to 38 weeks gestational age
Number of Participants With Large for Gestational Age Fetuses
Measured: 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.
Measured: 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.
Measured: 30 to 38 weeks gestational age

Secondary outcomes (2)

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.
Measured: 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.
Measured: From time of delivery to discharge (average time of discharge is 4 days after delivery)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2016Aug 2017

First posted9 Mar 2016 (estimated)
Study startJun 2016
Primary completionAug 2017
Study completionAug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Uncomplicated PregnancyStudies of the same condition, open and under way.
More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 206 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02702999
Sponsor's protocol ID: HSC-MS-16-0084
Acronym: UP
Status last verified: Aug 2018
First submitted: 25 Feb 2016
Last updated: 5 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 30399092

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Determination of Abnormal Fetal Growth or Amniotic Fluid With Third Trimester Ultrasounds in Uncomplicated Pregnancies: A Randomized Trial (UP Trial)
ClinicalTrials.gov ID: NCT02702999
Acronym / sponsor ID: UP / HSC-MS-16-0084
Conditions: Uncomplicated Pregnancy, Abnormal Fetal Growth or Fluid
Study type: Interventional
Recruitment status: Completed
Enrolment: 206 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Study start: Jun 2016
Primary completion: Aug 2017 (actual)
Study completion: Aug 2017 (actual)
First posted: 9 Mar 2016 (estimated)
Results: Posted 7 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Routine third trimester care	Active comparator	Device: Clinically-indicated ultrasoundRoutine third trimester care with clinically-indicated ultrasound (control)
Serial third trimester ultrasound	Experimental	Device: Serial third trimester ultrasoundUltrasound 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).

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Maternal age of 18 at the time of consent
Singleton gestation

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Clinically-indicated ultrasoundRoutine third trimester care with clinically-indicated ultrasound (control)	Device	Routine third trimester care
Serial third trimester ultrasoundUltrasound 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).	Device	Serial third trimester ultrasound

Primary outcome

Number of Participants With Fetal Growth Restriction
Time frame: 30 to 38 weeks gestational age
Number of Participants With Large for Gestational Age Fetuses
Time frame: 30 to 38 weeks gestational age
Number of Participates With Oligohydraminos
Time frame: 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
Time frame: 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.

2 secondary outcomes

Number of Participants With Composite Neonatal Morbidity
Time frame: From time of delivery to 28 days after delivery
Number of Participants With Composite Maternal Morbidity
Time frame: From time of delivery to discharge (average time of discharge is 4 days after delivery)

Results and safety

Results posted to the registry on 7 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Routine Third Trimester Care	102	102
Serial Third Trimester Ultrasound	104	104

Primary outcome: Number of Participants With Fetal Growth Restriction

Time frame: 30 to 38 weeks gestational age. Count of participants. Unit: Participants

Measure	Routine Third Trimester Care n = 102	Serial Third Trimester Ultrasound n = 104
Value	2	8

Routine Third Trimester Care vs Serial Third Trimester Ultrasound: Risk Ratio (RR): 3.9 (95% CI 0.9 to 18.0)

Primary outcome: Number of Participants With Large for Gestational Age Fetuses

Time frame: 30 to 38 weeks gestational age. Count of participants. Unit: Participants

Measure	Routine Third Trimester Care n = 102	Serial Third Trimester Ultrasound n = 104
Value	2	8

Routine Third Trimester Care vs Serial Third Trimester Ultrasound: Risk Ratio (RR): 3.9 (95% CI 0.9 to 18.0)

Primary outcome: Number of Participates With Oligohydraminos

Time frame: 30 to 38 weeks gestational age. Count of participants. Unit: Participants

Measure	Routine Third Trimester Care n = 102	Serial Third Trimester Ultrasound n = 104
Value	2	4

Routine Third Trimester Care vs Serial Third Trimester Ultrasound: Risk Ratio (RR): 1.9 (95% CI 0.4 to 10.5)

Primary outcome: Number of Participates With Polyhydraminos

Time frame: 30 to 38 weeks gestational age. Count of participants. Unit: Participants

Measure	Routine Third Trimester Care n = 102	Serial Third Trimester Ultrasound n = 104
Value	2	11

Routine Third Trimester Care vs Serial Third Trimester Ultrasound: Risk Ratio (RR): 5.4 (95% CI 1.2 to 23.7)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From time of delivery to discharge (average time of discharge is 4 days after delivery). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Routine Third Trimester Care	1 of 102 (1%)	25 of 102 (24.5%)	1 of 102
Serial Third Trimester Ultrasound	0 of 104 (0%)	22 of 104 (21.2%)	0 of 104

Limitations and caveats (from the sponsor): 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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30399092Ashimi 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Olaide A Ashimi Balogun, MD principal investigator

The University of Texas Health Science Center, Houston

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Fetal Growth Restriction (time frame: 30 to 38 weeks gestational age). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02702999, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.