PreeclampsiaPhase 3P-PATNCT04298034
Preeclampsia Postpartum Antihypertensive Treatment
A Phase 3 study testing Labetalol, Nifedipine in people with Preeclampsia and Hypertension in Pregnancy, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The goal of this study is to compare whether antihypertensive treatment in the postpartum period decreases postpartum hypertension and its associated maternal morbidity, including risk of readmission and healthcare utilization in comparison with no treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia, Hypertension in Pregnancy
- What is being tested?
- Labetalol, Nifedipine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2020to 30 Sep 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 years old
- Immediately postpartum (delivered in previous 96 hours)
- Diagnosed with preeclampsia during pregnancy, labor or immediately postpartum
- >30% of blood pressures in the postpartum period were elevated (systolic 140 or higher OR diastolic 90 or higher)
Who cannot join
- Chronic hypertension with superimposed preeclampsia
- Diagnosis of preeclampsia after discharge from delivery hospitalization
- Persistent severe range blood pressures after delivery requiring initiation of antihypertensive regimen by the care team
- >50% of blood pressures in the postpartum period were normal (systolic less than 140 AND diastolic less than 90)
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin-Froedtert Hospital
Milwaukee, Wisconsin, 53226
About this study
Official title: Randomized Controlled Trial for Postpartum Antihypertensive Treatment of Women With Preeclampsia
The goal of this study is to compare whether antihypertensive treatment in the postpartum period decreases postpartum hypertension and its associated maternal morbidity, including risk of readmission and healthcare utilization in comparison with no treatment. Women with preeclampsia diagnosed during the antepartum, intrapartum or postpartum period will be randomized to either initiate antihypertensive treatment or standard of care. We hypothesize that postpartum antihypertensive treatment of patients with preeclampsia will decrease risk of hospital readmission, healthcare utilization and the number of severe range blood pressures at postpartum follow-up visits.
Read the detailed description
This will be a randomized, controlled trial of 300 women with a diagnosis of preeclampsia at any point in their current pregnancy or immediately postpartum. Immediately postpartum is defined as preeclampsia diagnosed after delivery but prior to discharge from the hospital. The diagnosis of preeclampsia will be made using standardized definitions by the American College of Obstetrics and Gynecology. Preeclampsia is diagnosed with new-onset hypertension of blood pressure of greater than or equal to 140 systolic blood pressure or greater than or equal to 90 diastolic blood pressure recorded twice at least four hours apart AND proteinuria, defined as 300mg of protein in a 24hour urine collection or a protein/creatinine ratio of 0.3. If the above blood pressure criteria are met and there is not proteinuria, preeclampsia can still be diagnosed if there is thrombocytopenia with platelet count of less than 100,000, renal insufficiency with creatinine of greater than 1.1 or twice the patient's individual baseline, impaired liver function with AST or ALT twice normal or epigastric/right upper quadrant pain, pulmonary edema, new-onset headache unresponsive to medication, or visual disturbance. All of these findings should not be explained by an alternative diagnosis.
Women will be consented and randomized at the time of their diagnosis, within 96 hours of their delivery. The patients randomized to the treatment group will have an antihypertensive medication prescribed to them. The specific medication will be either labetalol, nifedipine or hydralazine based on allergies and clinically appropriateness of the medication. The patient will be instructed on the dosing, timing, and possible adverse effects. All subject's blood pressures will be monitored per standard postpartum protocols. As per standard practice, all patients with preeclampsia will be asked to return at 7-10 days for a blood pressure check and then again at 6 weeks for a complete postpartum assessment.
Consent of patients, review of blood pressures, data collection and storage, and statistical analysis will be performed at the Medical College of Wisconsin (MCW) through the Maternal Fetal medicine department. Women will be allowed to continue routine antenatal, intrapartum and postpartum care with their primary obstetrician. The research team will follow enrolled patients through the 6-week postpartum follow up.
- Conditions
- Preeclampsia, Hypertension in Pregnancy
- Being tested
- Labetalol, Nifedipine
- Medical subject headings
- Pre-Eclampsia, Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labetalol, NifedipineDrug
Also called Procardia, Trandate, Normodyne
Antihypertensive treatment that is safe and well studied in peripartum women.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | The patients randomized to the treatment group will have an antihypertensive medication prescribed to them. The specific medication will be either labetalol or nifedipine based on allergies and clinically appropriateness of the medication. The patient will be instructed on the dosing, timing, and possible adverse effects. Receives: Drug: Labetalol, Nifedipine |
| No-treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Readmission
Measured: Within 6 weeks from delivery
Secondary outcomes (4)
Rate of Healthcare Utilization
hospital readmissions, increased number of postpartum visits or phone calls, emergency room or urgent care visits, consultation with primary care (internal medicine, family medicine), cardiology, or maternal-fetal-medicine specialists
Measured: Within 6 weeks from delivery
percentage of severe range blood pressures at the 7-10 days postpartum visit
Measured: 7-10 days postpartum
percentage of severe range blood pressures at the 6 week postpartum visit
Measured: Approximately 6 weeks postpartum
compare mean systolic and mean diastolic blood pressure values at 7-10 days postpartum and at 6weeks postpartum
Measured: 6 weeks pospartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start17 Jul 2020
- Primary completion30 Jun 2025
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Palatnik, MD, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298034
- Sponsor's protocol ID
- PRO36760
- Acronym
- P-PAT
- Status last verified
- Oct 2025
- First submitted
- 4 Mar 2020
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sibai BM. Hypertensive disorders of pregnancy: the United States perspective. Curr Opin Obstet Gynecol. 2008 Apr;20(2):102-6. doi: 10.1097/GCO.0b013e3282f73380. No abstract available.
PubMed 18388806Mogos MF, Salemi JL, Spooner KK, McFarlin BL, Salihu HH. Hypertensive disorders of pregnancy and postpartum readmission in the United States: national surveillance of the revolving door. J Hypertens. 2018 Mar;36(3):608-618. doi: 10.1097/HJH.0000000000001594.
PubMed 29045342Tan LK, de Swiet M. The management of postpartum hypertension. BJOG. 2002 Jul;109(7):733-6. doi: 10.1111/j.1471-0528.2002.01012.x. No abstract available.
PubMed 12135206Ade-Conde JA, Alabi O, Higgins S, Visvalingam G. Maternal post natal hospital readmission-trends and association with mode of delivery. Ir Med J. 2011 Jan;104(1):17-20.
PubMed 21387880Clapp MA, Little SE, Zheng J, Robinson JN. A multi-state analysis of postpartum readmissions in the United States. Am J Obstet Gynecol. 2016 Jul;215(1):113.e1-113.e10. doi: 10.1016/j.ajog.2016.01.174.
PubMed 27829570Ferrazzani S, De Carolis S, Pomini F, Testa AC, Mastromarino C, Caruso A. The duration of hypertension in the puerperium of preeclamptic women: relationship with renal impairment and week of delivery. Am J Obstet Gynecol. 1994 Aug;171(2):506-12. doi: 10.1016/0002-9378(94)90290-9.
PubMed 8059832Kassebaum NJ, Bertozzi-Villa A, Coggeshall MS, Shackelford KA, Steiner C, Heuton KR, Gonzalez-Medina D, Barber R, Huynh C, Dicker D, Templin T, Wolock TM, Ozgoren AA, Abd-Allah F, Abera SF, Abubakar I, Achoki T, Adelekan A, Ademi Z, Adou AK, Adsuar JC, Agardh EE, Akena D, Alasfoor D, Alemu ZA, Alfonso-Cristancho R, Alhabib S, Ali R, Al Kahbouri MJ, Alla F, Allen PJ, AlMazroa MA, Alsharif U, Alvarez E, Alvis-Guzman N, Amankwaa AA, Amare AT, Amini H, Ammar W, Antonio CA, Anwari P, Arnlov J, Arsenijevic VS, Artaman A, Asad MM, Asghar RJ, Assadi R, Atkins LS, Badawi A, Balakrishnan K, Basu A, Basu S, Beardsley J, Bedi N, Bekele T, Bell ML, Bernabe E, Beyene TJ, Bhutta Z, Bin Abdulhak A, Blore JD, Basara BB, Bose D, Breitborde N, Cardenas R, Castaneda-Orjuela CA, Castro RE, Catala-Lopez F, Cavlin A, Chang JC, Che X, Christophi CA, Chugh SS, Cirillo M, Colquhoun SM, Cooper LT, Cooper C, da Costa Leite I, Dandona L, Dandona R, Davis A, Dayama A, Degenhardt L, De Leo D, del Pozo-Cruz B, Deribe K, Dessalegn M, deVeber GA, Dharmaratne SD, Dilmen U, Ding EL, Dorrington RE, Driscoll TR, Ermakov SP, Esteghamati A, Faraon EJ, Farzadfar F, Felicio MM, Fereshtehnejad SM, de Lima GM, Forouzanfar MH, Franca EB, Gaffikin L, Gambashidze K, Gankpe FG, Garcia AC, Geleijnse JM, Gibney KB, Giroud M, Glaser EL, Goginashvili K, Gona P, Gonzalez-Castell D, Goto A, Gouda HN, Gugnani HC, Gupta R, Gupta R, Hafezi-Nejad N, Hamadeh RR, Hammami M, Hankey GJ, Harb HL, Havmoeller R, Hay SI, Pi IB, Hoek HW, Hosgood HD, Hoy DG, Husseini A, Idrisov BT, Innos K, Inoue M, Jacobsen KH, Jahangir E, Jee SH, Jensen PN, Jha V, Jiang G, Jonas JB, Juel K, Kabagambe EK, Kan H, Karam NE, Karch A, Karema CK, Kaul A, Kawakami N, Kazanjan K, Kazi DS, Kemp AH, Kengne AP, Kereselidze M, Khader YS, Khalifa SE, Khan EA, Khang YH, Knibbs L, Kokubo Y, Kosen S, Defo BK, Kulkarni C, Kulkarni VS, Kumar GA, Kumar K, Kumar RB, Kwan G, Lai T, Lalloo R, Lam H, Lansingh VC, Larsson A, Lee JT, Leigh J, Leinsalu M, Leung R, Li X, Li Y, Li Y, Liang J, Liang X, Lim SS, Lin HH, Lipshultz SE, Liu S, Liu Y, Lloyd BK, London SJ, Lotufo PA, Ma J, Ma S, Machado VM, Mainoo NK, Majdan M, Mapoma CC, Marcenes W, Marzan MB, Mason-Jones AJ, Mehndiratta MM, Mejia-Rodriguez F, Memish ZA, Mendoza W, Miller TR, Mills EJ, Mokdad AH, Mola GL, Monasta L, de la Cruz Monis J, Hernandez JC, Moore AR, Moradi-Lakeh M, Mori R, Mueller UO, Mukaigawara M, Naheed A, Naidoo KS, Nand D, Nangia V, Nash D, Nejjari C, Nelson RG, Neupane SP, Newton CR, Ng M, Nieuwenhuijsen MJ, Nisar MI, Nolte S, Norheim OF, Nyakarahuka L, Oh IH, Ohkubo T, Olusanya BO, Omer SB, Opio JN, Orisakwe OE, Pandian JD, Papachristou C, Park JH, Caicedo AJ, Patten SB, Paul VK, Pavlin BI, Pearce N, Pereira DM, Pesudovs K, Petzold M, Poenaru D, Polanczyk GV, Polinder S, Pope D, Pourmalek F, Qato D, Quistberg DA, Rafay A, Rahimi K, Rahimi-Movaghar V, ur Rahman S, Raju M, Rana SM, Refaat A, Ronfani L, Roy N, Pimienta TG, Sahraian MA, Salomon JA, Sampson U, Santos IS, Sawhney M, Sayinzoga F, Schneider IJ, Schumacher A, Schwebel DC, Seedat S, Sepanlou SG, Servan-Mori EE, Shakh-Nazarova M, Sheikhbahaei S, Shibuya K, Shin HH, Shiue I, Sigfusdottir ID, Silberberg DH, Silva AP, Singh JA, Skirbekk V, Sliwa K, Soshnikov SS, Sposato LA, Sreeramareddy CT, Stroumpoulis K, Sturua L, Sykes BL, Tabb KM, Talongwa RT, Tan F, Teixeira CM, Tenkorang EY, Terkawi AS, Thorne-Lyman AL, Tirschwell DL, Towbin JA, Tran BX, Tsilimbaris M, Uchendu US, Ukwaja KN, Undurraga EA, Uzun SB, Vallely AJ, van Gool CH, Vasankari TJ, Vavilala MS, Venketasubramanian N, Villalpando S, Violante FS, Vlassov VV, Vos T, Waller S, Wang H, Wang L, Wang X, Wang Y, Weichenthal S, Weiderpass E, Weintraub RG, Westerman R, Wilkinson JD, Woldeyohannes SM, Wong JQ, Wordofa MA, Xu G, Yang YC, Yano Y, Yentur GK, Yip P, Yonemoto N, Yoon SJ, Younis MZ, Yu C, Jin KY, El Sayed Zaki M, Zhao Y, Zheng Y, Zhou M, Zhu J, Zou XN, Lopez AD, Naghavi M, Murray CJ, Lozano R. Global, regional, and national levels and causes of maternal mortality during 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2014 Sep 13;384(9947):980-1004. doi: 10.1016/S0140-6736(14)60696-6. Epub 2014 May 2.
PubMed 24797575ACOG Practice Bulletin No. 202: Gestational Hypertension and Preeclampsia. Obstet Gynecol. 2019 Jan;133(1):1. doi: 10.1097/AOG.0000000000003018.
PubMed 30575675Levine LD, Nkonde-Price C, Limaye M, Srinivas SK. Factors associated with postpartum follow-up and persistent hypertension among women with severe preeclampsia. J Perinatol. 2016 Dec;36(12):1079-1082. doi: 10.1038/jp.2016.137. Epub 2016 Sep 1.
PubMed 27583396American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin No. 203: Chronic Hypertension in Pregnancy. Obstet Gynecol. 2019 Jan;133(1):e26-e50. doi: 10.1097/AOG.0000000000003020.
PubMed 30575676Boffa RJ, Constanti M, Floyd CN, Wierzbicki AS; Guideline Committee. Hypertension in adults: summary of updated NICE guidance. BMJ. 2019 Oct 21;367:l5310. doi: 10.1136/bmj.l5310. No abstract available.
PubMed 31636059
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial for Postpartum Antihypertensive Treatment of Women With Preeclampsia
- ClinicalTrials.gov ID
- NCT04298034
- Acronym / sponsor ID
- P-PAT / PRO36760
- Conditions
- Preeclampsia, Hypertension in Pregnancy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 17 Jul 2020 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 6 Mar 2020 (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 compare whether antihypertensive treatment in the postpartum period decreases postpartum hypertension and its associated maternal morbidity, including risk of readmission and healthcare utilization in comparison with no treatment. Women with preeclampsia diagnosed during the antepartum, intrapartum or postpartum period will be randomized to either initiate antihypertensive treatment or standard of care. We hypothesize that postpartum antihypertensive treatment of patients with preeclampsia will decrease risk of hospital readmission, healthcare utilization and the number of severe range blood pressures at postpartum follow-up visits.
Detailed description
This will be a randomized, controlled trial of 300 women with a diagnosis of preeclampsia at any point in their current pregnancy or immediately postpartum. Immediately postpartum is defined as preeclampsia diagnosed after delivery but prior to discharge from the hospital. The diagnosis of preeclampsia will be made using standardized definitions by the American College of Obstetrics and Gynecology. Preeclampsia is diagnosed with new-onset hypertension of blood pressure of greater than or equal to 140 systolic blood pressure or greater than or equal to 90 diastolic blood pressure recorded twice at least four hours apart AND proteinuria, defined as 300mg of protein in a 24hour urine collection or a protein/creatinine ratio of 0.3. If the above blood pressure criteria are met and there is not proteinuria, preeclampsia can still be diagnosed if there is thrombocytopenia with platelet count of less than 100,000, renal insufficiency with creatinine of greater than 1.1 or twice the patient's individual baseline, impaired liver function with AST or ALT twice normal or epigastric/right upper quadrant pain, pulmonary edema, new-onset headache unresponsive to medication, or visual disturbance. All of these findings should not be explained by an alternative diagnosis.
Women will be consented and randomized at the time of their diagnosis, within 96 hours of their delivery. The patients randomized to the treatment group will have an antihypertensive medication prescribed to them. The specific medication will be either labetalol, nifedipine or hydralazine based on allergies and clinically appropriateness of the medication. The patient will be instructed on the dosing, timing, and possible adverse effects. All subject's blood pressures will be monitored per standard postpartum protocols. As per standard practice, all patients with preeclampsia will be asked to return at 7-10 days for a blood pressure check and then again at 6 weeks for a complete postpartum assessment.
Consent of patients, review of blood pressures, data collection and storage, and statistical analysis will be performed at the Medical College of Wisconsin (MCW) through the Maternal Fetal medicine department. Women will be allowed to continue routine antenatal, intrapartum and postpartum care with their primary obstetrician. The research team will follow enrolled patients through the 6-week postpartum follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Labetalol, NifedipineThe patients randomized to the treatment group will have an antihypertensive medication prescribed to them. The specific medication will be either labetalol or nifedipine based on allergies and clinically appropriateness of the medication. The patient will be instructed on the dosing, timing, and possible adverse effects. |
| No-treatment | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >= 18 years old
- Immediately postpartum (delivered in previous 96 hours)
- Diagnosed with preeclampsia during pregnancy, labor or immediately postpartum
- >30% of blood pressures in the postpartum period were elevated (systolic 140 or higher OR diastolic 90 or higher)
Key exclusion criteria (4 listed)
- Chronic hypertension with superimposed preeclampsia
- Diagnosis of preeclampsia after discharge from delivery hospitalization
- Persistent severe range blood pressures after delivery requiring initiation of antihypertensive regimen by the care team
- >50% of blood pressures in the postpartum period were normal (systolic less than 140 AND diastolic less than 90)
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 |
|---|---|---|
| Labetalol, NifedipineAlso: Procardia, Trandate, NormodyneAntihypertensive treatment that is safe and well studied in peripartum women. | Drug | Treatment |
Primary outcome
Hospital Readmission
Time frame: Within 6 weeks from delivery
4 secondary outcomes
Rate of Healthcare Utilization
Time frame: Within 6 weeks from delivery
percentage of severe range blood pressures at the 7-10 days postpartum visit
Time frame: 7-10 days postpartum
percentage of severe range blood pressures at the 6 week postpartum visit
Time frame: Approximately 6 weeks postpartum
compare mean systolic and mean diastolic blood pressure values at 7-10 days postpartum and at 6weeks postpartum
Time frame: 6 weeks pospartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Background: PubMed 18388806Sibai BM. Hypertensive disorders of pregnancy: the United States perspective. Curr Opin Obstet Gynecol. 2008 Apr;20(2):102-6. doi: 10.1097/GCO.0b013e3282f73380. No abstract available.
- Background: PubMed 29045342Mogos MF, Salemi JL, Spooner KK, McFarlin BL, Salihu HH. Hypertensive disorders of pregnancy and postpartum readmission in the United States: national surveillance of the revolving door. J Hypertens. 2018 Mar;36(3):608-618. doi: 10.1097/HJH.0000000000001594.
- Background: PubMed 12135206Tan LK, de Swiet M. The management of postpartum hypertension. BJOG. 2002 Jul;109(7):733-6. doi: 10.1111/j.1471-0528.2002.01012.x. No abstract available.
- Background: PubMed 21387880Ade-Conde JA, Alabi O, Higgins S, Visvalingam G. Maternal post natal hospital readmission-trends and association with mode of delivery. Ir Med J. 2011 Jan;104(1):17-20.
- Background: PubMed 27829570Clapp MA, Little SE, Zheng J, Robinson JN. A multi-state analysis of postpartum readmissions in the United States. Am J Obstet Gynecol. 2016 Jul;215(1):113.e1-113.e10. doi: 10.1016/j.ajog.2016.01.174.
- Background: PubMed 8059832Ferrazzani S, De Carolis S, Pomini F, Testa AC, Mastromarino C, Caruso A. The duration of hypertension in the puerperium of preeclamptic women: relationship with renal impairment and week of delivery. Am J Obstet Gynecol. 1994 Aug;171(2):506-12. doi: 10.1016/0002-9378(94)90290-9.
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- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Labetalol, Nifedipine in people with Preeclampsia and Hypertension in Pregnancy, run by Medical College of Wisconsin 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 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: under way, not looking for participants, as of the sponsor's last update on 20 Jul 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 Readmission (time frame: Within 6 weeks from delivery). 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 NCT04298034, which also lists 11 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 20 Jul 2026.