Sickle Cell DiseasePhase 4ProTIPNCT06979492
Prophylactic Transfusion In Pregnant in Women With Sickle Cell Disease
A Phase 4 study testing Prophylactic Transfusion Intervention group: Transfusion in people with Sickle Cell Disease and Pregnancy Related, run by Emory University at 1 site in United States.
Trial summary
The goal of this study is to determine if there is a positive effect of prophylactic red blood cell (RBC) transfusion of leukoreduced, ABO, Rh (D/Cc/Ee) and Kell matched blood compared to standard of care on the number of episodes of acute sickle cell disease (SCD) manifestations or pregnancy-related complications… 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
- Sickle Cell Disease, Pregnancy Related
- What is being tested?
- Prophylactic Transfusion Intervention group: Transfusion
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to May 2028
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Female
- Diagnosis of SCD of any genotype (i.e., HbSS, HbSC, HbSβ thalassemia)
- 18 Years and older
- Currently pregnant at 6 weeks through 20 weeks of gestation.
- Ability to understand the purposes and risks of the study and willingly give informed consent.
- For participants with private health insurance, insurance pre-approval for blood transfusions
Who cannot join
- Currently on chronic transfusion therapy before pregnancy
- Prior history of DHTR with hyperhemolysis
- Red cell antibody history, which would prevent the provision of adequate red cell units to support chronic transfusions.
- Unable or unwilling to receive blood transfusion for social, religious, or clinical reasons
- Known current triplet pregnancy
- Current diagnosis of major medical or psychiatric comorbidity, which in the randomizing clinician's opinion renders them unable to enter a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to determine if there is a positive effect of prophylactic red blood cell (RBC) transfusion of leukoreduced, ABO, Rh (D/Cc/Ee) and Kell matched blood compared to standard of care on the number of episodes of acute sickle cell disease (SCD) manifestations or pregnancy-related complications requiring acute health care encounters (acute care/ER/Hospital visits) or resulting in death over the entirety of pregnancy until 2 months post-partum in women with SCD.
RBC transfusion is the only disease-modifying therapy for pregnant women with SCD, and it is considered a standard treatment option however, there exists no consensus on the role of transfusion therapy in preventing SCD-related pregnancy complications.
Participants will be randomly assigned to repeated red blood cell transfusions or the standard of care. Participants will be on study for about 8-10 months (Pregnancy through 2 months post-partum).
Read the detailed description
Sickle cell disease (SCD) is a common genetic disorder that results from the homozygous presence of abnormal β-globin chains (hemoglobin Hb SS, Hb SC, HbSβ thalassemia). SCD causes red blood cells to become rigid, leading to various acute and chronic manifestations: chronic hemolytic anemia, poor growth, acute vaso-occlusive pain crises (VOC), priapism (in men) acute ischemic stroke, acute chest syndrome (ACS), and chronic organ damage within the spleen, kidneys, liver, lungs and heart.
High rates of both maternal and fetal morbidity and mortality complicate pregnancy in patients affected by SCD. SCD pregnancies have been linked to higher rates of obstetrical complications, including preeclampsia, venous thromboembolism, intrauterine growth restriction, preterm delivery, and small-for-gestational-age infants. In addition, sickle-related maternal complications are common during pregnancy. More than 50% of women with SCD have a VOC in the antenatal period (76% for HbSS vs 27% for Hb SC). ACS in pregnancy is seen in 7% to 20% of women with HbSS and approximately 5% in women with HbSC. Prophylactic transfusion therapy has established benefits in stroke prevention and preoperative optimization in SCD patients, but its use in pregnancy has not been established. Because hydroxyurea (HU) may be teratogenic, RBC transfusion is the only disease-modifying therapy available for pregnant women with SCD.
The decision to put a pregnant woman with SCD on chronic transfusion therapy is entirely based on provider preference and patient willingness. RBC transfusions are considered a standard treatment option for pregnant women with SCD and transfusion therapy widely used, however there exists no consensus among providers on the role of chronic transfusion therapy in preventing SCD-related pregnancy complications and no prospective randomized controlled study investigating the role of prophylactic transfusion for prevention of both maternal and fetal morbidity has been done.
- Conditions
- Sickle Cell Disease, Pregnancy Related
- Being tested
- Prophylactic Transfusion Intervention group: Transfusion, Control group
- Keywords
- Blood transfusion, Anemia
- Medical subject headings
- Anemia, Sickle Cell, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic Transfusion Intervention group: TransfusionBiological
For participants randomized to the prophylactic transfusion intervention group, the first RBC transfusion will occur within 3 weeks of randomization. All transfusions will be managed per SOC.
SOC prophylactic RBC transfusion management is as follows: transfusions are performed at 3-6 week intervals with the intent to maintain a pre-transfusion hemoglobin S level at <30%. All participants will have a complete blood count, reticulocyte count, hemoglobin fractionation, complete metabolic profile with LDH, ferritin, and type/screen at baseline and within 3 days of all monthly transfusions. All RBC transfusions must be compatible between the recipient and the donor and antigen matched for Rh (D/Cc/Ee) and Kell antigens at a minimum. For participants with a previous history of RBC alloimmunization, extended matched RBCs will be provided (Rh, Kell, Duffy, Kidd, S/s) per NHLBI/ASH guidelines to minimize further alloimmunization.
Control groupOther
Participants randomized to the control group will be followed per SOC. SOC management for pregnant women with SCD includes but is not limited to
- Clinic appointments with an SCD provider every 2 months
- Lab draws - complete blood count, reticulocyte count, hemoglobin fractionation, complete metabolic profile with LDH and ferritin.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Other | Patients randomized to the control group will receive standard care for SCD alone. As part of the standard of care, women with SCD who become pregnant and who are on hydroxyurea (HU) will have the HU suspended by their primary SCD provider. Receives: Other: Control group |
| Red Blood Cell (RBC) Transfusion | Experimental | Participants will receive a blood transfusion between 6 and 20 weeks of gestation. It will be repeated at 3-6 week intervals, aiming to maintain HbS <30% Receives: Biological: Prophylactic Transfusion Intervention group: Transfusion |
| Normal health controls | No intervention | Research testing on discarded, deidentified samples (placentas) of up to 10 women whose placentas were deemed normal, healthy, and full term by a clinical pathologist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital admissions rate
Number of participants who require hospital admission during study participation divided by the total number of participants. Collected from medical records
Measured: Baseline (enrollment) up to 8 weeks post-partum
Number of maternal emergency department (ED)/Acute care visits
Collected from medical records
Measured: Baseline (enrollment) up to 8 weeks post-partum
Number of SCD-related complications per group
Sickle cell complications (vaso-occlusive crisis (VOC) / acute chest syndrome (ACS) / cerebral stroke) collected from medical records
Measured: Baseline (enrollment) up to 8 weeks post-partum
Number of participants with pregnancy related complications
Number of participants who will develop pregnancy-related complications (pre-eclampsia, venous thromboembolism, infection). Collected from medical records
Measured: Baseline (enrollment) up to 8 weeks post-partum
Maternal death
Number of women who die at any gestational age during pregnancy or within 8 weeks after delivery from any cause arising from the pregnancy or its management, but not from incidental or accidental causes, divided by the total number of participants.
Measured: From randomization up to 8 weeks post-partum
Secondary outcomes (12)
Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me)
The Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me) is a validated patient-reported outcome measure of physical, mental, and social health in adults with SCD. Patient-reported outcome measure of pain level in the past 7 days. The ASCQ-Me pain scale ranges from 0-100, with a standardized sickle cell disease population mean of 50 (standard deviation=10), where lower scores signify worse disease impact. A modified version of the validated ASCQ-Me will be used.
Measured: 2, 4, 6, 8 and 10 months post randomization.
Patient reported outcomes measurement information system (PROMIS)
The patient-reported outcomes will be assessed using a health-related quality of life questionnaire, a modified version of the validated sickle-cell specific quality of life instruments, PROMIS
The PROMIS Short-Form scale is a generic measure of health-related quality of life (HRQL) that assesses physical, mental, and social health. It has a recall period of 7 days and yields separate Physical Health and Mental Health subscale scores, which range from 0 to 100 and are standardized to a US population mean of 50 and standard deviation (SD) of 10. Each question usually has five response options ranging in value from one to five. To find the total raw score for a short form with all questions answered, sum up the values of the responses to each question. For example, for the adult 8-item form, the lowest possible raw score is 8; the highest possible raw score is 40. For each subscale, a higher score connotes better functioning.
Measured: 2, 4, 6, 8 and 10 months post randomization.
Infant birth weight
Infant's birth weight from medical records.
Measured: At delivery up to 42 weeks of pregnancy
Preterm delivery
Number of women delivered before 37 weeks gestational age divided by the total number of participants randomized.
Measured: Up to delivery (36 weeks of pregnancy)
APGAR Scores
The Apgar score is a scoring system doctors and nurses use to assess newborns after delivery. At most, a child will receive an overall score of 10. A score of 7 to 10 five minutes after birth is reassuring, 4 to 7 is moderately abnormal, and 0 to 3 is concerning. The Apgar scoring system is divided into five categories. Each category receives a score of 0 to 2 points.
A: Activity/muscle tone P: Pulse/heart rate G: Grimace (response to stimulation, such as suctioning the baby's nose) A: Appearance (color) R: Respiration/breathing
Measured: 1 and 5 minutes after neonate's delivery
Number of neonatal intensive care unit/critical care admissions
The neonate's admission to the intensive care unit/critical care admission will be documented from medical records.
Measured: After neonate's delivery up to 1 week post-partum
Perinatal death
Number of babies who died from 28 weeks gestational age up to seven days post-delivery (comprising all still births and early neonatal deaths divided by total births.
Measured: From 28 weeks of pregnancy up to 1 week post-partum
Fetal demise/stillbirth
Fetal demise refers to the spontaneous intrauterine death of a fetus at any time during pregnancy.
Measured: From enrollment up to 42 weeks of pregnancy
Number of participants with new RBC alloantibodies
Participants who have been assigned to receive chronic simple blood transfusions will have monthly labs prior to their scheduled transfusion as per SOC to assess for new alloantibodies.
Measured: From enrollment up to 8 weeks post-partum
Number of participants with transfusion reactions
Participants will be carefully monitored for transfusion-related adverse events throughout the intervention phase of the study.
Measured: From enrollment up to 8 weeks post-partum
Number of participants with an increase in iron overload (serum ferritin)
Transfusion iron burden will be monitored with monthly serum ferritin levels during the study, which is standard of care monitoring for patients undergoing chronic transfusion therapy.
Measured: From enrollment up to 8 weeks post-partum
Number of participants with placental pathology
Per standard of care women with sickle cell disease routinely have their placentas sent to pathology for analysis. Once the routine testing is done placentas will undergo additional histopathological and biochemical analysis for research purposes.
Measured: Up to 5 days post-delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study startSep 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Why it stopped: The study was withdrawn due to no enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Emory 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ross Fasano, Emory University
- Investigators
- Ross Fasano, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979492
- Sponsor's protocol ID
- STUDY00007288
- Other IDs
- 2025P013305
- Acronym
- ProTIP
- Status last verified
- Oct 2026
- First submitted
- 13 May 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Transfusion In Pregnant in Women With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT06979492
- Acronym / sponsor ID
- ProTIP / STUDY00007288
- Conditions
- Sickle Cell Disease, Pregnancy Related
- Keywords
- Blood transfusion, Anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn due to no enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to determine if there is a positive effect of prophylactic red blood cell (RBC) transfusion of leukoreduced, ABO, Rh (D/Cc/Ee) and Kell matched blood compared to standard of care on the number of episodes of acute sickle cell disease (SCD) manifestations or pregnancy-related complications requiring acute health care encounters (acute care/ER/Hospital visits) or resulting in death over the entirety of pregnancy until 2 months post-partum in women with SCD.
RBC transfusion is the only disease-modifying therapy for pregnant women with SCD, and it is considered a standard treatment option however, there exists no consensus on the role of transfusion therapy in preventing SCD-related pregnancy complications.
Participants will be randomly assigned to repeated red blood cell transfusions or the standard of care. Participants will be on study for about 8-10 months (Pregnancy through 2 months post-partum).
Detailed description
Sickle cell disease (SCD) is a common genetic disorder that results from the homozygous presence of abnormal β-globin chains (hemoglobin Hb SS, Hb SC, HbSβ thalassemia). SCD causes red blood cells to become rigid, leading to various acute and chronic manifestations: chronic hemolytic anemia, poor growth, acute vaso-occlusive pain crises (VOC), priapism (in men) acute ischemic stroke, acute chest syndrome (ACS), and chronic organ damage within the spleen, kidneys, liver, lungs and heart.
High rates of both maternal and fetal morbidity and mortality complicate pregnancy in patients affected by SCD. SCD pregnancies have been linked to higher rates of obstetrical complications, including preeclampsia, venous thromboembolism, intrauterine growth restriction, preterm delivery, and small-for-gestational-age infants. In addition, sickle-related maternal complications are common during pregnancy. More than 50% of women with SCD have a VOC in the antenatal period (76% for HbSS vs 27% for Hb SC). ACS in pregnancy is seen in 7% to 20% of women with HbSS and approximately 5% in women with HbSC. Prophylactic transfusion therapy has established benefits in stroke prevention and preoperative optimization in SCD patients, but its use in pregnancy has not been established. Because hydroxyurea (HU) may be teratogenic, RBC transfusion is the only disease-modifying therapy available for pregnant women with SCD.
The decision to put a pregnant woman with SCD on chronic transfusion therapy is entirely based on provider preference and patient willingness. RBC transfusions are considered a standard treatment option for pregnant women with SCD and transfusion therapy widely used, however there exists no consensus among providers on the role of chronic transfusion therapy in preventing SCD-related pregnancy complications and no prospective randomized controlled study investigating the role of prophylactic transfusion for prevention of both maternal and fetal morbidity has been done.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Other | Other: Control groupPatients randomized to the control group will receive standard care for SCD alone. As part of the standard of care, women with SCD who become pregnant and who are on hydroxyurea (HU) will have the HU suspended by their primary SCD provider. |
| Red Blood Cell (RBC) Transfusion | Experimental | Biological: Prophylactic Transfusion Intervention group: TransfusionParticipants will receive a blood transfusion between 6 and 20 weeks of gestation. It will be repeated at 3-6 week intervals, aiming to maintain HbS <30% |
| Normal health controls | No intervention | –Research testing on discarded, deidentified samples (placentas) of up to 10 women whose placentas were deemed normal, healthy, and full term by a clinical pathologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female
- Diagnosis of SCD of any genotype (i.e., HbSS, HbSC, HbSβ thalassemia)
- 18 Years and older
- Currently pregnant at 6 weeks through 20 weeks of gestation.
- Ability to understand the purposes and risks of the study and willingly give informed consent.
Key exclusion criteria (6 listed)
- Currently on chronic transfusion therapy before pregnancy
- Prior history of DHTR with hyperhemolysis
- Red cell antibody history, which would prevent the provision of adequate red cell units to support chronic transfusions.
- Unable or unwilling to receive blood transfusion for social, religious, or clinical reasons
- Known current triplet pregnancy
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 |
|---|---|---|
| Prophylactic Transfusion Intervention group: TransfusionFor participants randomized to the prophylactic transfusion intervention group, the first RBC transfusion will occur within 3 weeks of randomization. All transfusions will be managed per SOC. SOC prophylactic RBC transfusion management is as follows: transfusions are performed at 3-6 week intervals with the intent to maintain a pre-transfusion hemoglobin S level at <30%. All participants will have a complete blood count, reticulocyte count, hemoglobin fractionation, complete metabolic profile with LDH, ferritin, and type/screen at baseline and within 3 days of all monthly transfusions. All RBC transfusions must be compatible between the recipient and the donor and antigen matched for Rh (D/Cc/Ee) and Kell antigens at a minimum. For participants with a previous history of RBC alloimmunization, extended matched RBCs will be provided (Rh, Kell, Duffy, Kidd, S/s) per NHLBI/ASH guidelines to minimize further alloimmunization. | Biological | Red Blood Cell (RBC) Transfusion |
| Control groupParticipants randomized to the control group will be followed per SOC. SOC management for pregnant women with SCD includes but is not limited to * Clinic appointments with an SCD provider every 2 months * Lab draws - complete blood count, reticulocyte count, hemoglobin fractionation, complete metabolic profile with LDH and ferritin. | Other | Standard of Care |
Primary outcome
Hospital admissions rate
Time frame: Baseline (enrollment) up to 8 weeks post-partum
Number of participants who require hospital admission during study participation divided by the total number of participants. Collected from medical records
Number of maternal emergency department (ED)/Acute care visits
Time frame: Baseline (enrollment) up to 8 weeks post-partum
Collected from medical records
Number of SCD-related complications per group
Time frame: Baseline (enrollment) up to 8 weeks post-partum
Sickle cell complications (vaso-occlusive crisis (VOC) / acute chest syndrome (ACS) / cerebral stroke) collected from medical records
Number of participants with pregnancy related complications
Time frame: Baseline (enrollment) up to 8 weeks post-partum
Number of participants who will develop pregnancy-related complications (pre-eclampsia, venous thromboembolism, infection). Collected from medical records
Maternal death
Time frame: From randomization up to 8 weeks post-partum
Number of women who die at any gestational age during pregnancy or within 8 weeks after delivery from any cause arising from the pregnancy or its management, but not from incidental or accidental causes, divided by the total number of participants.
12 secondary outcomes
Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me)
Time frame: 2, 4, 6, 8 and 10 months post randomization.
Patient reported outcomes measurement information system (PROMIS)
Time frame: 2, 4, 6, 8 and 10 months post randomization.
Infant birth weight
Time frame: At delivery up to 42 weeks of pregnancy
Preterm delivery
Time frame: Up to delivery (36 weeks of pregnancy)
APGAR Scores
Time frame: 1 and 5 minutes after neonate's delivery
Number of neonatal intensive care unit/critical care admissions
Time frame: After neonate's delivery up to 1 week post-partum
Perinatal death
Time frame: From 28 weeks of pregnancy up to 1 week post-partum
Fetal demise/stillbirth
Time frame: From enrollment up to 42 weeks of pregnancy
Number of participants with new RBC alloantibodies
Time frame: From enrollment up to 8 weeks post-partum
Number of participants with transfusion reactions
Time frame: From enrollment up to 8 weeks post-partum
Number of participants with an increase in iron overload (serum ferritin)
Time frame: From enrollment up to 8 weeks post-partum
Number of participants with placental pathology
Time frame: Up to 5 days post-delivery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Sickle Cell Disease
Active, not recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat
Sickle Cell Disease, Hemolytic Anemia
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
RecruitingPhase 1
Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease
Sickle Cell Disorders, Sickle Cell Disease
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingPhase 1
Buprenorphine for the Management of Pain in Children With Sickle Cell Disease
Sickle Cell Disease (SCD), Sickle Cell Disease Vaso-occlusive Crisis
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.
Ross Fasano, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prophylactic Transfusion Intervention group: Transfusion in people with Sickle Cell Disease and Pregnancy Related, run by Emory 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 6 inclusion and 6 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: withdrawn, as of the sponsor's last update on 19 Oct 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Hospital admissions rate (time frame: Baseline (enrollment) up to 8 weeks post-partum). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2026.