Pregnancy, High RiskPRiSMA-MNHNCT05904145
PRISMA Maternal and Newborn Health Study
An observational study of Pregnancy, High Risk, run by George Washington University at 5 sites in 5 countries.
Trial summary
Access to quality antenatal care (ANC) and postnatal care (PNC), including maternal, newborn, and infant services, is integral to reducing adverse pregnancy-related health outcomes and promoting positive birth experiences. The World Health Organization (WHO) recommends a total of eight ANC visits for pregnant women. Read more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, High Risk
- How many people
- 267,897 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 1 Aug 2022to 31 Dec 2028
- Phase
- Observational
- 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 15 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The investigators will identify, screen, and enroll pregnant participants through pregnancy surveillance systems, with a goal of identifying pregnancies prior to 20 weeks of pregnancy. Pregnant women will be assessed at <20, 20, 28, 32, and 36 weeks gestation, at labor and delivery, and at 3 days and 1, 4, 6, 26, and 52 weeks postpartum. Infants will similarly be assessed at 3 days and 1, 4, 6, 26, and 52 weeks of age.
A woman who meets the following inclusion criteria during screening may be enrolled:
- Lives within the study catchment area;
- Meets minimum age requirement in study site country:
- Ghana: 15 years of age;
- Kenya: 18 years of age or those who meet the criteria of emancipated minors;
- Pakistan: 15 years of age or those who meet the criteria of emancipated minors;
- Zambia: 15 years of age;
- India: 18 years of age
- Intrauterine pregnancy <20 weeks gestation verified via ultrasound;
- Provides informed consent.
A woman who meets the following exclusion criteria during screening may NOT be enrolled:
- Nonviable (e.g. ectopic or molar) pregnancy;
- Plans to relocate outside of the study catchment area during pregnancy and/or postpartum.
Trial locations and contacts
5 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
Bethany Freeman, MPH contact
5 sites in 5 countries
India1 site, 1 recruiting
- Recruiting
Christian Medical College (CMC) Vellore
Vellore
Santosh Benjamin, MD, sbenjamin@cmcvellore.ac.in
Anne George Cherian, MD, annegc@cmcvellore.ac.in
Kenya1 site
- Active, not recruiting
Kenya Medical Research Institute-Center for Global Health Research
Kisumu
Pakistan1 site, 1 recruiting
- Recruiting
Aga Khan University
Karachi
Zahra Hoodbhoy, PhD, zahra.hoodbhoy@aku.edu
Zambia1 site
- Completed
University of North Carolina-Global Projects Zambia
Lusaka
About this study
Official title: Pregnancy Risk, Infant Surveillance, and Measurement Alliance (PRiSMA) Maternal and Newborn Health (MNH) Study: A Multi-center, Prospective Cohort Study of Maternal, Newborn, and Infant Health
Access to quality antenatal care (ANC) and postnatal care (PNC), including maternal, newborn, and infant services, is integral to reducing adverse pregnancy-related health outcomes and promoting positive birth experiences. The World Health Organization (WHO) recommends a total of eight ANC visits for pregnant women. However, the ANC coverage rate remains considerably lower among more vulnerable populations, and the quality of care that women receive is inconsistent, often poor, and frequently fails to detect risks in a timely fashion or adequately prepare women for the birth process. While rates of facility-based delivery are on the rise worldwide, disparities persist and the quality of care across facilities remains uneven. Even less information is available on PNC, where services beyond routine immunizations may not be widely available, especially in resource-poor regions.
Additionally, limited evidence exists on innovative service delivery approaches and how to effectively scale tested maternal and newborn health (MNH) interventions. This coupled with the fragmented datasets from smaller studies limit our ability to advocate for policy change.
The Pregnancy Risk Stratification Innovation and Measurement Alliance (PRiSMA) is implementing a harmonized open cohort study that seeks to evaluate pregnancy risk factors and their associations with adverse pregnancy outcomes, including stillbirth, neonatal mortality and morbidity, and maternal mortality and severe morbidity. The goals are to develop a harmonized data set to improve understanding of pregnancy risk factors, vulnerabilities, and morbidity and mortality and to estimate the burden of these risk factors and outcomes in LMICs. Ultimately, these data will inform development of innovative strategies to optimize pregnancy outcomes for mothers and their newborns.
- Conditions
- Pregnancy, High Risk
- Keywords
- Antenatal Care (ANC), Postnatal Care (PNC), Maternal Newborn Health
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Mortality
Death from any cause related to or aggravated by pregnancy or its management (excluding accidental or incidental causes) during pregnancy and childbirth or within 42 days of termination of pregnancy, irrespective of the duration and site of the pregnancy.
Measured: Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age), through delivery or termination of pregnancy, and then 42 days postpartum
Composite Severe Maternal Outcomes
Composite outcome of maternal deaths + near-miss cases + potentially life-threatening complications + critical intervention.
Measured: Assessed through 12 months postpartum
Maternal Anemia
Low hemoglobin levels throughout pregnancy and labor and delivery, classified as mild (10-10.9 g/dL), moderate (7-9.9 g/dL), or severe (<7 g/dL). Low hemoglobin levels in the postpartum period, classified as mild (11-11.9 g/dL), moderate (8-10.9 g/dL), or severe (<8 g/dL).
Measured: Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age) through 6 months postpartum
Stillbirth
Delivery of a fetus showing no signs of life, as indicated by absence of breathing, heartbeat, pulsation of the umbilical cord, or definite movements of voluntary muscles. The primary definition for the study is death prior to delivery of a fetus at >=20 weeks of gestation (or >350 g weight, if gestational age is unavailable). Additionally, we will analyze time-specific definitions: Early stillbirth (20-27 weeks), Late stillbirth (28-36 weeks), Term stillbirth (>=37 weeks), and WHO stillbirth (>=28 weeks).
Measured: Assessed at delivery
Neonatal Mortality
Death of a live-born baby during the first 28 days of life from any cause.
Measured: Assessed delivery to 28 days of life
Preterm Birth
Delivery prior to 37 completed weeks of gestation of a birth (live or stillbirth). Further classified as extremely preterm (<28 weeks), very preterm (28-32 weeks), and moderate to late preterm (32-37 weeks). For these, gestational age at birth will be determined by the best obstetric estimate: last menstrual period, Ultrasound (method to be determined), and ACOG algorithm.
Measured: Assessed at delivery
Low Birth Weight
Defined as birth weight <2500 g and very low birth weight <1500 g.
Measured: Assessed at delivery or within 72 hours for home births
Small-for-Gestational-Age (SGA)
Combined gestational age information and birthweight will be used to further categorize into: preterm-SGA, preterm-AGA, term-SGA, term-AGA.
Measured: Assessed at delivery
Secondary outcomes (20)
Late Maternal Mortality
Measured: Assessed from 42 days postpartum up to one year
Preeclampsia
Measured: Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age) through 42 days postpartum
Preterm Birth Indication
Measured: Assessed at delivery
Preterm Premature Rupture of Membranes (PPROM)
Measured: Assessed at <37 weeks of gestation
Gestational Hypertension
Measured: : Assessed from 20 weeks gestational age through delivery
Postpartum Hypertension
Measured: Assessed at delivery or time of pregnancy to 1 year postpartum
Gestational Diabetes
Measured: Assessed between 24 and 28 weeks gestation
Perinatal Depression, as measured using the Edinburgh Postnatal Depression Scale
The minimum value is 0 and the maximum value is 30. Higher scores indicate that more severe depression may be present.
Measured: Assessed at 20 and 32 weeks gestation and 6 weeks postpartum
Maternal Infection and Sepsis
Measured: Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age) through 42 days postpartum
Fetal Death
Measured: Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age) up until delivery
Cause of Neonatal Death
Measured: Assessed at <28 days of life
Cause of Stillbirth
Measured: : Assessed from 20 weeks gestational age through time of delivery
Timing of Stillbirth
Measured: : Assessed from 20 weeks gestational age through time of delivery
Timing of neonatal mortality
Measured: Assessed from delivery to 28 days of life
Infant Mortality
Measured: Assessed from delivery to 1 year of life
Hyperbilirubinemia
Measured: Assessed at birth, 3 days, and 7 days of age
Neonatal Sepsis
Measured: Assessed at delivery through 28 days
Possible Severe Bacterial Infection
Measured: Assessed from delivery to 59 days
Postnatal Weight Trajectory
Measured: Assessed collected at birth, 3 days, 7 days, and 28 days
Infant Growth
Measured: Assessed at birth, 4 weeks, 6 weeks, 6 months, 26 months, and 52 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Aug 2022
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pregnancy, High RiskStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 267,897 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- Kenya Medical Research Institute, University of North Carolina, Chapel Hill, Kintampo Health Research Centre, Ghana, Aga Khan University, Christian Medical College, Vellore, India, Centres for Disease Control and Prevention, Kenya., Vital Pakistan Trust
- Responsible party
- Principal investigator, Emily Smith, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904145
- Sponsor's protocol ID
- PRiSMA-MNH 2022
- Acronym
- PRiSMA-MNH
- Status last verified
- Jun 2026
- First submitted
- 14 Oct 2022
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pregnancy Risk, Infant Surveillance, and Measurement Alliance (PRISMA) Investigators. Pregnancy Risk, Infant Surveillance, and Measurement Alliance (PRISMA) Maternal and Newborn Health Study: protocol for a multisite, prospective, open cohort study of pregnancy and postpartum health outcomes in South Asia and sub-Saharan Africa. BMJ Open. 2026 Jan 20;16(1):e104512. doi: 10.1136/bmjopen-2025-104512.
PubMed 41558748Smith ER, Hoodbhoy Z, Hotwani A, Jehan F, Khan A, Nisar I, Yazdani N, Benjamin SJ, Cherian AG, Mohan VR, Varghese S, Vijayalekshmi B, Wylie BJ, Chatterjee L, Dang A, Venketeshwar R, Baumann SG, Mores C, Pan Q, Sudfeld CR, Akelo V, Mwebia WK, Otieno K, Ouma G, Owuor H, Were J, Adu-Gyasi D, Agyemang V, Newton S, Tawiah C, Jadaun AS, Mazumder S, Sharma N, Ugwu LG, Benneh-Akwasi Kuma A, Freeman B, Kasaro MP, Mbewe FM, Mwape H, Resop RS, Spelke MB, Asante KP; Redefining Maternal Anemia in Pregnancy and Postpartum (ReMAPP) Study Investigators. Protocol for the Redefining Maternal Anemia in Pregnancy and Postpartum (ReMAPP) study: A multisite, international, population-based cohort study to establish global hemoglobin thresholds for maternal anemia. PLoS One. 2025 Jul 28;20(7):e0321943. doi: 10.1371/journal.pone.0321943. eCollection 2025.
PubMed 40720446Naz S, Jaffar A, Yazdani N, Kashif M, Hussain Z, Khan U, Farooq F, Nisar MI, Jehan F, Smith E, Hoodbhoy Z. Cohort profile: the Pregnancy Risk Infant Surveillance and Measurement Alliance (PRISMA) - Pakistan. BMJ Open. 2023 Dec 10;13(12):e078222. doi: 10.1136/bmjopen-2023-078222.
PubMed 38072494
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy Risk, Infant Surveillance, and Measurement Alliance (PRiSMA) Maternal and Newborn Health (MNH) Study: A Multi-center, Prospective Cohort Study of Maternal, Newborn, and Infant Health
- ClinicalTrials.gov ID
- NCT05904145
- Acronym / sponsor ID
- PRiSMA-MNH / PRiSMA-MNH 2022
- Conditions
- Pregnancy, High Risk
- Keywords
- Antenatal Care (ANC), Postnatal Care (PNC), Maternal Newborn Health
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 267,897 participants (estimated)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- Kenya Medical Research Institute, University of North Carolina, Chapel Hill, Kintampo Health Research Centre, Ghana, Aga Khan University, Christian Medical College, Vellore, India, Centres for Disease Control and Prevention, Kenya., Vital Pakistan Trust
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 Jun 2023 (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.
Access to quality antenatal care (ANC) and postnatal care (PNC), including maternal, newborn, and infant services, is integral to reducing adverse pregnancy-related health outcomes and promoting positive birth experiences. The World Health Organization (WHO) recommends a total of eight ANC visits for pregnant women. However, the ANC coverage rate remains considerably lower among more vulnerable populations, and the quality of care that women receive is inconsistent, often poor, and frequently fails to detect risks in a timely fashion or adequately prepare women for the birth process. While rates of facility-based delivery are on the rise worldwide, disparities persist and the quality of care across facilities remains uneven. Even less information is available on PNC, where services beyond routine immunizations may not be widely available, especially in resource-poor regions.
Additionally, limited evidence exists on innovative service delivery approaches and how to effectively scale tested maternal and newborn health (MNH) interventions. This coupled with the fragmented datasets from smaller studies limit our ability to advocate for policy change.
The Pregnancy Risk Stratification Innovation and Measurement Alliance (PRiSMA) is implementing a harmonized open cohort study that seeks to evaluate pregnancy risk factors and their associations with adverse pregnancy outcomes, including stillbirth, neonatal mortality and morbidity, and maternal mortality and severe morbidity. The goals are to develop a harmonized data set to improve understanding of pregnancy risk factors, vulnerabilities, and morbidity and mortality and to estimate the burden of these risk factors and outcomes in LMICs. Ultimately, these data will inform development of innovative strategies to optimize pregnancy outcomes for mothers and their newborns.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The investigators will identify, screen, and enroll pregnant participants through pregnancy surveillance systems, with a goal of identifying pregnancies prior to 20 weeks of pregnancy. Pregnant women will be assessed at <20, 20, 28, 32, and 36 weeks gestation, at labor and delivery, and at 3 days and 1, 4, 6, 26, and 52 weeks postpartum. Infants will similarly be assessed at 3 days and 1, 4, 6, 26, and 52 weeks of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maternal Mortality
Time frame: Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age), through delivery or termination of pregnancy, and then 42 days postpartum
Death from any cause related to or aggravated by pregnancy or its management (excluding accidental or incidental causes) during pregnancy and childbirth or within 42 days of termination of pregnancy, irrespective of the duration and site of the pregnancy.
Composite Severe Maternal Outcomes
Time frame: Assessed through 12 months postpartum
Composite outcome of maternal deaths + near-miss cases + potentially life-threatening complications + critical intervention.
Maternal Anemia
Time frame: Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age) through 6 months postpartum
Low hemoglobin levels throughout pregnancy and labor and delivery, classified as mild (10-10.9 g/dL), moderate (7-9.9 g/dL), or severe (<7 g/dL). Low hemoglobin levels in the postpartum period, classified as mild (11-11.9 g/dL), moderate (8-10.9 g/dL), or severe (<8 g/dL).
Stillbirth
Time frame: Assessed at delivery
Delivery of a fetus showing no signs of life, as indicated by absence of breathing, heartbeat, pulsation of the umbilical cord, or definite movements of voluntary muscles. The primary definition for the study is death prior to delivery of a fetus at >=20 weeks of gestation (or >350 g weight, if gestational age is unavailable). Additionally, we will analyze time-specific definitions: Early stillbirth (20-27 weeks), Late stillbirth (28-36 weeks), Term stillbirth (>=37 weeks), and WHO stillbirth (>=28 weeks).
Neonatal Mortality
Time frame: Assessed delivery to 28 days of life
Death of a live-born baby during the first 28 days of life from any cause.
Preterm Birth
Time frame: Assessed at delivery
Delivery prior to 37 completed weeks of gestation of a birth (live or stillbirth). Further classified as extremely preterm (<28 weeks), very preterm (28-32 weeks), and moderate to late preterm (32-37 weeks). For these, gestational age at birth will be determined by the best obstetric estimate: last menstrual period, Ultrasound (method to be determined), and ACOG algorithm.
Low Birth Weight
Time frame: Assessed at delivery or within 72 hours for home births
Defined as birth weight <2500 g and very low birth weight <1500 g.
Small-for-Gestational-Age (SGA)
Time frame: Assessed at delivery
Combined gestational age information and birthweight will be used to further categorize into: preterm-SGA, preterm-AGA, term-SGA, term-AGA.
20 secondary outcomes
Late Maternal Mortality
Time frame: Assessed from 42 days postpartum up to one year
Preeclampsia
Time frame: Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age) through 42 days postpartum
Preterm Birth Indication
Time frame: Assessed at delivery
Preterm Premature Rupture of Membranes (PPROM)
Time frame: Assessed at <37 weeks of gestation
Gestational Hypertension
Time frame: : Assessed from 20 weeks gestational age through delivery
Postpartum Hypertension
Time frame: Assessed at delivery or time of pregnancy to 1 year postpartum
Gestational Diabetes
Time frame: Assessed between 24 and 28 weeks gestation
Perinatal Depression, as measured using the Edinburgh Postnatal Depression Scale
Time frame: Assessed at 20 and 32 weeks gestation and 6 weeks postpartum
Maternal Infection and Sepsis
Time frame: Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age) through 42 days postpartum
Fetal Death
Time frame: Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age) up until delivery
Cause of Neonatal Death
Time frame: Assessed at <28 days of life
Cause of Stillbirth
Time frame: : Assessed from 20 weeks gestational age through time of delivery
Timing of Stillbirth
Time frame: : Assessed from 20 weeks gestational age through time of delivery
Timing of neonatal mortality
Time frame: Assessed from delivery to 28 days of life
Infant Mortality
Time frame: Assessed from delivery to 1 year of life
Hyperbilirubinemia
Time frame: Assessed at birth, 3 days, and 7 days of age
Neonatal Sepsis
Time frame: Assessed at delivery through 28 days
Possible Severe Bacterial Infection
Time frame: Assessed from delivery to 59 days
Postnatal Weight Trajectory
Time frame: Assessed collected at birth, 3 days, 7 days, and 28 days
Infant Growth
Time frame: Assessed at birth, 4 weeks, 6 weeks, 6 months, 26 months, and 52 months
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 11 Jun 2026.
- Background: PubMed 41558748Pregnancy Risk, Infant Surveillance, and Measurement Alliance (PRISMA) Investigators. Pregnancy Risk, Infant Surveillance, and Measurement Alliance (PRISMA) Maternal and Newborn Health Study: protocol for a multisite, prospective, open cohort study of pregnancy and postpartum health outcomes in South Asia and sub-Saharan Africa. BMJ Open. 2026 Jan 20;16(1):e104512. doi: 10.1136/bmjopen-2025-104512.
- Derived from this study: PubMed 40720446Smith ER, Hoodbhoy Z, Hotwani A, Jehan F, Khan A, Nisar I, Yazdani N, Benjamin SJ, Cherian AG, Mohan VR, Varghese S, Vijayalekshmi B, Wylie BJ, Chatterjee L, Dang A, Venketeshwar R, Baumann SG, Mores C, Pan Q, Sudfeld CR, Akelo V, Mwebia WK, Otieno K, Ouma G, Owuor H, Were J, Adu-Gyasi D, Agyemang V, Newton S, Tawiah C, Jadaun AS, Mazumder S, Sharma N, Ugwu LG, Benneh-Akwasi Kuma A, Freeman B, Kasaro MP, Mbewe FM, Mwape H, Resop RS, Spelke MB, Asante KP; Redefining Maternal Anemia in Pregnancy and Postpartum (ReMAPP) Study Investigators. Protocol for the Redefining Maternal Anemia in Pregnancy and Postpartum (ReMAPP) study: A multisite, international, population-based cohort study to establish global hemoglobin thresholds for maternal anemia. PLoS One. 2025 Jul 28;20(7):e0321943. doi: 10.1371/journal.pone.0321943. eCollection 2025.
- Derived from this study: PubMed 38072494Naz S, Jaffar A, Yazdani N, Kashif M, Hussain Z, Khan U, Farooq F, Nisar MI, Jehan F, Smith E, Hoodbhoy Z. Cohort profile: the Pregnancy Risk Infant Surveillance and Measurement Alliance (PRISMA) - Pakistan. BMJ Open. 2023 Dec 10;13(12):e078222. doi: 10.1136/bmjopen-2023-078222.
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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.
Bethany Freeman, MPH contact
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, High Risk, run by George Washington University at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Ghana, India, Kenya, Pakistan, Zambia. 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?
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?
Contact Emily R Smith, ScD, MPH (12029943589, emilysmith@gwu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Mortality (time frame: Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age), through delivery or termination of pregnancy, and then 42 days postpartum). The study lists 8 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 NCT05904145, which also lists 3 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 11 Jun 2026.