Gestational DiabetesCAPONCT04219085
CAPO: Continuous Glucose Monitoring in A2 Gestational Diabetes and Pregnancy Outcomes
A study testing Continuous Glucose Monitor and Routine Care in people with Gestational Diabetes and Maternal Complication of Pregnancy, run by Yale University at 1 site in United States.
Trial summary
This study will utilize continuous glucose monitoring in women with A2 gestational diabetes. Women will be randomized to continuous glucose monitoring or routine care with fingersticks to check their blood glucose four times daily. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Gestational Diabetes, Maternal Complication of Pregnancy
- What is being tested?
- Continuous Glucose Monitor and Routine Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 30 Aug 2024
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women between 18-50 years old
- pregnant
- singleton gestation
- diagnosis of gestational diabetes requiring medication (A2) during the current pregnancy between 24-36 weeks' gestation
Who cannot join
- pregestational diabetes
- diagnosis with gestational diabetes < 24 weeks gestation or > 36 weeks gestation
- known fetal anomalies
- fetal growth restriction diagnosed during the current pregnancy
- diagnosis of polyhydramnios at time of randomization
- abnormal diagnostic genetic testing or genetic screening for the fetus in the current pregnancy prior to randomization
Show all 9Show fewer
- twin or higher order multiple gestation
- non-compliance with prenatal visits (missing ≥3 visits prior to enrollment) prior to diagnosis with A2 gestational diabetes
- maternal medical comorbidities including the following: lupus, chronic hypertension, cancer, ischemic cardiovascular disease
Trial locations and contacts
1 site in 1 country.
About this study
This study will utilize continuous glucose monitoring in women with A2 gestational diabetes. Women will be randomized to continuous glucose monitoring or routine care with fingersticks to check their blood glucose four times daily. It is hypothesized that women in the continuous glucose monitoring arm will have a lower incidence of the composite primary outcome, which includes the following variables: perinatal death, shoulder dystocia, birth weight greater than 4,000 grams, NICU admission for treatment of hypoglycemia (blood glucose level <40mg/dL) and birth trauma, including fracture or nerve palsy.
Read the detailed description
Diabetes complicates 6-7% of pregnancies annually and approximately 85% of these cases are women diagnosed with gestational diabetes (GDM).1,2 The prevalence of GDM varies within populations based on obesity rates, maternal age and ethnicity. GDM is diagnosed during the third trimester through a two-step process of a 50-gram oral glucose challenge screen and a subsequent 100-gram oral glucose challenge test if the woman screens positive. Once the diagnosis is confirmed women are asked to monitor their glucose levels with finger sticks at least four times a day (fasting and post-prandial) and medication is added when glucose target goals cannot be reached by diet and exercise alone. Approximately, 15% of women will not reach glucose target goals with diet and exercise alone and will require medication. These women are then diagnosed with class A2 GDM by the White classification of diabetes.
Identification of women with GDM who require treatment is essential in optimizing pregnancy outcomes for these women. Treatment of GDM results in lower neonatal morbidity, reduced incidence of large for gestational age infants (LGA), reduced incidence of preeclampsia and shoulder dystocia and a reduced need for cesarean delivery.3-5 Since LGA infants are at higher risk for hypoglycemia which may necessitate admission to the neonatal intensive care unit (NICU), treatment of GDM reduces the incidence of LGA infants resulting in less hypoglycemia and NICU admissions.
Given that pregnancy outcomes are directly tied to blood glucose control, it is essential that women with GDM play an active role in the monitoring of their disease. The frequency of monitoring and frustration with diet can lead to issues with patient compliance and ultimately impact their pregnancy outcomes. One study found that just over half of women successfully tested their blood glucose via finger sticks ≥ 80% of the time. About 25% of the women in the same study had <90% of the values matching in their glucometer and their blood glucose log.6 Given these issues with compliance the need for a better and more convenient monitoring system is evident. Continuous glucose monitors (CGM) are a relatively new device that have yet to be fully explored for their utility in pregnancy. The current generation of CGM has had exponential growth in the clinical care of diabetes, driven primarily by the improved accuracy of these devices, longer duration sensor life (ranging from 7-14 days in currently available models), and the ability to collect these data without performing calibration of the sensors with fingerstick glucose readings. Continuous Glucose Monitoring in Women with Type 1 Diabetes in Pregnancy Trial (CONCEPTT), demonstrated the utility of CGM data to decrease the frequency of adverse neonatal outcomes in a pregestational diabetes population.7 A more recent trial of blinded CGM data in women with GDM showed mean sensor glucose was significantly higher in women who delivered LGA infants. The 24-hour mean glucose was different between groups in this study (112 mg/dL vs. 104 mg/dL, p=0.025), driven by higher overnight mean glucose levels (108 mg/dL vs. 99 mg/dL, p=0.005).8 Given that this is not a time that women with GDM would normally be monitoring their blood sugar it is evident that CGM may be useful, not only in increasing patient compliance by eliminating the need for measuring serum glucose via finger sticks and a glucometer four times a day but by allowing for monitoring of blood glucose levels at times that are not normally convenient for testing.
- Being tested
- Continuous Glucose Monitor, Routine Care
- Keywords
- gestational diabetes, fetal or neonatal outcomes, maternal morbidity
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose MonitorDevice
Wearing of a continuous glucose monitor to monitor blood glucose levels in women with gestational diabetes
Routine CareOther
Use of a glucometer to monitor blood glucose levels in women with gestational diabetes
| Study group | Role | What they receive |
|---|---|---|
| Routine Care | Active comparator | Monitoring of control of gestational diabetes with routine care and use of a glucometer and fingersticks 4 times a day Receives: Other: Routine Care |
| Continuous Glucose Monitor | Experimental | Monitoring of control of gestational diabetes with use of a continuous glucose monitor Receives: Device: Continuous Glucose Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Primary Outcome
The number of participants who have at least one of each of the following outcome measures occur: perinatal death, shoulder dystocia, birth weight less than 4,000 grams, NICU admission for treatment of hypoglycemia (blood glucose level <40mg/dL) and birth trauma, including fracture or nerve palsy. Any one of these would make the composite primary outcome positive and will be recorded as a categorical variable.
Measured: from enrollment up until delivery by 41 weeks gestation, up to 19 weeks total
Secondary outcomes (2)
Cesarean Delivery for an Arrest of Labor Disorder
The number of women who undergo a cesarean delivery for arrest of dilation or descent during labor or induction of labor. This will be recorded as a categorical (yes/no) variable. Data presented below is for the participants that had c-section for arrest.
Measured: during delivery by 40 weeks gestation
Hypertensive Disorders of Pregnancy.
The number of women who receive a diagnosis of a hypertensive disorder of pregnancy (gestational hypertension, preeclampsia, HELLP). This will be recorded as a categorical (yes/no) variable
Measured: from enrollment, through delivery by 41 weeks gestation and the immediate postpartum hospitalization up to 7 days postpartum, up to 20 weeks total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start1 Sep 2020
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
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 (8)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial, not blinded
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Audrey Merriam, MD, MS, Principal investigator, Assistant Professor; Assistant Professor, Department of Obstetrics, Gynecology and Reproductive Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219085
- Sponsor's protocol ID
- 2000027143
- Other IDs
- 000
- Acronym
- CAPO
- Status last verified
- Aug 2025
- First submitted
- 2 Jan 2020
- Last updated
- 28 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: no plan to share
Publications
Martin JA, Hamilton BE, Osterman MJK, Driscoll AK, Drake P. Births: Final Data for 2017. Natl Vital Stat Rep. 2018 Nov;67(8):1-50.
PubMed 30707672The American College of Obstetricians and Gynecologists Practice Bulletin Number 190. Gestational Diabetes Mellitus. February 2018.
Crowther CA, Hiller JE, Moss JR, McPhee AJ, Jeffries WS, Robinson JS; Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) Trial Group. Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. N Engl J Med. 2005 Jun 16;352(24):2477-86. doi: 10.1056/NEJMoa042973. Epub 2005 Jun 12.
PubMed 15951574Landon MB, Spong CY, Thom E, Carpenter MW, Ramin SM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade G, Lain KY, Sorokin Y, Peaceman AM, Tolosa JE, Anderson GB; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. A multicenter, randomized trial of treatment for mild gestational diabetes. N Engl J Med. 2009 Oct 1;361(14):1339-48. doi: 10.1056/NEJMoa0902430.
PubMed 19797280Hartling L, Dryden DM, Guthrie A, Muise M, Vandermeer B, Donovan L. Benefits and harms of treating gestational diabetes mellitus: a systematic review and meta-analysis for the U.S. Preventive Services Task Force and the National Institutes of Health Office of Medical Applications of Research. Ann Intern Med. 2013 Jul 16;159(2):123-9. doi: 10.7326/0003-4819-159-2-201307160-00661.
PubMed 23712381Cosson E, Baz B, Gary F, Pharisien I, Nguyen MT, Sandre-Banon D, Jaber Y, Cussac-Pillegand C, Banu I, Carbillon L, Valensi P. Poor Reliability and Poor Adherence to Self-Monitoring of Blood Glucose Are Common in Women With Gestational Diabetes Mellitus and May Be Associated With Poor Pregnancy Outcomes. Diabetes Care. 2017 Sep;40(9):1181-1186. doi: 10.2337/dc17-0369. Epub 2017 Jul 19.
PubMed 28724718Law GR, Alnaji A, Alrefaii L, Endersby D, Cartland SJ, Gilbey SG, Jennings PE, Murphy HR, Scott EM. Response to Comment on Law et al. Suboptimal Nocturnal Glucose Control Is Associated With Large for Gestational Age in Treated Gestational Diabetes Mellitus. Diabetes Care 2019;42:810-815. Diabetes Care. 2019 Jul;42(7):e123-e124. doi: 10.2337/dci19-0018. No abstract available.
PubMed 31221709Feig DS, Donovan LE, Corcoy R, Murphy KE, Amiel SA, Hunt KF, Asztalos E, Barrett JFR, Sanchez JJ, de Leiva A, Hod M, Jovanovic L, Keely E, McManus R, Hutton EK, Meek CL, Stewart ZA, Wysocki T, O'Brien R, Ruedy K, Kollman C, Tomlinson G, Murphy HR; CONCEPTT Collaborative Group. Continuous glucose monitoring in pregnant women with type 1 diabetes (CONCEPTT): a multicentre international randomised controlled trial. Lancet. 2017 Nov 25;390(10110):2347-2359. doi: 10.1016/S0140-6736(17)32400-5. Epub 2017 Sep 15.
PubMed 28923465
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAPO: Continuous Glucose Monitoring in A2 Gestational Diabetes and Pregnancy Outcomes
- ClinicalTrials.gov ID
- NCT04219085
- Acronym / sponsor ID
- CAPO / 2000027143
- Keywords
- gestational diabetes, fetal or neonatal outcomes, maternal morbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 6 Jan 2020 (actual)
- Results
- Posted 28 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will utilize continuous glucose monitoring in women with A2 gestational diabetes. Women will be randomized to continuous glucose monitoring or routine care with fingersticks to check their blood glucose four times daily. It is hypothesized that women in the continuous glucose monitoring arm will have a lower incidence of the composite primary outcome, which includes the following variables: perinatal death, shoulder dystocia, birth weight greater than 4,000 grams, NICU admission for treatment of hypoglycemia (blood glucose level <40mg/dL) and birth trauma, including fracture or nerve palsy.
Detailed description
Diabetes complicates 6-7% of pregnancies annually and approximately 85% of these cases are women diagnosed with gestational diabetes (GDM).1,2 The prevalence of GDM varies within populations based on obesity rates, maternal age and ethnicity. GDM is diagnosed during the third trimester through a two-step process of a 50-gram oral glucose challenge screen and a subsequent 100-gram oral glucose challenge test if the woman screens positive. Once the diagnosis is confirmed women are asked to monitor their glucose levels with finger sticks at least four times a day (fasting and post-prandial) and medication is added when glucose target goals cannot be reached by diet and exercise alone. Approximately, 15% of women will not reach glucose target goals with diet and exercise alone and will require medication. These women are then diagnosed with class A2 GDM by the White classification of diabetes.
Identification of women with GDM who require treatment is essential in optimizing pregnancy outcomes for these women. Treatment of GDM results in lower neonatal morbidity, reduced incidence of large for gestational age infants (LGA), reduced incidence of preeclampsia and shoulder dystocia and a reduced need for cesarean delivery.3-5 Since LGA infants are at higher risk for hypoglycemia which may necessitate admission to the neonatal intensive care unit (NICU), treatment of GDM reduces the incidence of LGA infants resulting in less hypoglycemia and NICU admissions.
Given that pregnancy outcomes are directly tied to blood glucose control, it is essential that women with GDM play an active role in the monitoring of their disease. The frequency of monitoring and frustration with diet can lead to issues with patient compliance and ultimately impact their pregnancy outcomes. One study found that just over half of women successfully tested their blood glucose via finger sticks ≥ 80% of the time. About 25% of the women in the same study had <90% of the values matching in their glucometer and their blood glucose log.6 Given these issues with compliance the need for a better and more convenient monitoring system is evident. Continuous glucose monitors (CGM) are a relatively new device that have yet to be fully explored for their utility in pregnancy. The current generation of CGM has had exponential growth in the clinical care of diabetes, driven primarily by the improved accuracy of these devices, longer duration sensor life (ranging from 7-14 days in currently available models), and the ability to collect these data without performing calibration of the sensors with fingerstick glucose readings. Continuous Glucose Monitoring in Women with Type 1 Diabetes in Pregnancy Trial (CONCEPTT), demonstrated the utility of CGM data to decrease the frequency of adverse neonatal outcomes in a pregestational diabetes population.7 A more recent trial of blinded CGM data in women with GDM showed mean sensor glucose was significantly higher in women who delivered LGA infants. The 24-hour mean glucose was different between groups in this study (112 mg/dL vs. 104 mg/dL, p=0.025), driven by higher overnight mean glucose levels (108 mg/dL vs. 99 mg/dL, p=0.005).8 Given that this is not a time that women with GDM would normally be monitoring their blood sugar it is evident that CGM may be useful, not only in increasing patient compliance by eliminating the need for measuring serum glucose via finger sticks and a glucometer four times a day but by allowing for monitoring of blood glucose levels at times that are not normally convenient for testing.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled trial, not blinded
| Arm | Type | Receives |
|---|---|---|
| Routine Care | Active comparator | Other: Routine CareMonitoring of control of gestational diabetes with routine care and use of a glucometer and fingersticks 4 times a day |
| Continuous Glucose Monitor | Experimental | Device: Continuous Glucose MonitorMonitoring of control of gestational diabetes with use of a continuous glucose monitor |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- women between 18-50 years old
- pregnant
- singleton gestation
- diagnosis of gestational diabetes requiring medication (A2) during the current pregnancy between 24-36 weeks' gestation
Key exclusion criteria (9 listed)
- pregestational diabetes
- diagnosis with gestational diabetes < 24 weeks gestation or > 36 weeks gestation
- known fetal anomalies
- fetal growth restriction diagnosed during the current pregnancy
- diagnosis of polyhydramnios at time of randomization
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 |
|---|---|---|
| Continuous Glucose MonitorWearing of a continuous glucose monitor to monitor blood glucose levels in women with gestational diabetes | Device | Continuous Glucose Monitor |
| Routine CareUse of a glucometer to monitor blood glucose levels in women with gestational diabetes | Other | Routine Care |
Primary outcome
Composite Primary Outcome
Time frame: from enrollment up until delivery by 41 weeks gestation, up to 19 weeks total
The number of participants who have at least one of each of the following outcome measures occur: perinatal death, shoulder dystocia, birth weight less than 4,000 grams, NICU admission for treatment of hypoglycemia (blood glucose level <40mg/dL) and birth trauma, including fracture or nerve palsy. Any one of these would make the composite primary outcome positive and will be recorded as a categorical variable.
2 secondary outcomes
Cesarean Delivery for an Arrest of Labor Disorder
Time frame: during delivery by 40 weeks gestation
Hypertensive Disorders of Pregnancy.
Time frame: from enrollment, through delivery by 41 weeks gestation and the immediate postpartum hospitalization up to 7 days postpartum, up to 20 weeks total
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30707672Martin JA, Hamilton BE, Osterman MJK, Driscoll AK, Drake P. Births: Final Data for 2017. Natl Vital Stat Rep. 2018 Nov;67(8):1-50.
- BackgroundThe American College of Obstetricians and Gynecologists Practice Bulletin Number 190. Gestational Diabetes Mellitus. February 2018.
- Background: PubMed 15951574Crowther CA, Hiller JE, Moss JR, McPhee AJ, Jeffries WS, Robinson JS; Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) Trial Group. Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. N Engl J Med. 2005 Jun 16;352(24):2477-86. doi: 10.1056/NEJMoa042973. Epub 2005 Jun 12.
- Background: PubMed 19797280Landon MB, Spong CY, Thom E, Carpenter MW, Ramin SM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade G, Lain KY, Sorokin Y, Peaceman AM, Tolosa JE, Anderson GB; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. A multicenter, randomized trial of treatment for mild gestational diabetes. N Engl J Med. 2009 Oct 1;361(14):1339-48. doi: 10.1056/NEJMoa0902430.
- Background: PubMed 23712381Hartling L, Dryden DM, Guthrie A, Muise M, Vandermeer B, Donovan L. Benefits and harms of treating gestational diabetes mellitus: a systematic review and meta-analysis for the U.S. Preventive Services Task Force and the National Institutes of Health Office of Medical Applications of Research. Ann Intern Med. 2013 Jul 16;159(2):123-9. doi: 10.7326/0003-4819-159-2-201307160-00661.
- Background: PubMed 28724718Cosson E, Baz B, Gary F, Pharisien I, Nguyen MT, Sandre-Banon D, Jaber Y, Cussac-Pillegand C, Banu I, Carbillon L, Valensi P. Poor Reliability and Poor Adherence to Self-Monitoring of Blood Glucose Are Common in Women With Gestational Diabetes Mellitus and May Be Associated With Poor Pregnancy Outcomes. Diabetes Care. 2017 Sep;40(9):1181-1186. doi: 10.2337/dc17-0369. Epub 2017 Jul 19.
- Background: PubMed 31221709Law GR, Alnaji A, Alrefaii L, Endersby D, Cartland SJ, Gilbey SG, Jennings PE, Murphy HR, Scott EM. Response to Comment on Law et al. Suboptimal Nocturnal Glucose Control Is Associated With Large for Gestational Age in Treated Gestational Diabetes Mellitus. Diabetes Care 2019;42:810-815. Diabetes Care. 2019 Jul;42(7):e123-e124. doi: 10.2337/dci19-0018. No abstract available.
- Background: PubMed 28923465Feig DS, Donovan LE, Corcoy R, Murphy KE, Amiel SA, Hunt KF, Asztalos E, Barrett JFR, Sanchez JJ, de Leiva A, Hod M, Jovanovic L, Keely E, McManus R, Hutton EK, Meek CL, Stewart ZA, Wysocki T, O'Brien R, Ruedy K, Kollman C, Tomlinson G, Murphy HR; CONCEPTT Collaborative Group. Continuous glucose monitoring in pregnant women with type 1 diabetes (CONCEPTT): a multicentre international randomised controlled trial. Lancet. 2017 Nov 25;390(10110):2347-2359. doi: 10.1016/S0140-6736(17)32400-5. Epub 2017 Sep 15.
- Individual participant dataSharing planned: No. no plan to share
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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.
Audrey Merriam, MD, MS principal investigator
Assistant Professor; Assistant Professor, Department of Obstetrics, Gynecology and Reproductive Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Glucose Monitor and Routine Care in people with Gestational Diabetes and Maternal Complication of Pregnancy, run by Yale University at 1 site in United States.
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 4 inclusion and 9 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 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 28 Aug 2025). 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?
Composite Primary Outcome (time frame: from enrollment up until delivery by 41 weeks gestation, up to 19 weeks total). 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 NCT04219085, which also lists 8 linked publications.
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 28 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.