Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202307876581314 Date of Approval: 27/07/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Postpartum IV Iron to Treat Iron Deficiency Anemia Post Delivery Trial
Official scientific title Postpartum IV Iron to Treat Iron Deficiency Anemia Post Delivery (PRIORITY TRIAL). A Randomized Controlled Trial Of The Global Network For Women's and Children's Health Research Version 0.7 December 14, 2021
Brief summary describing the background and objectives of the trial Background: Anemia remains a major contributor to maternal morbidity and mortality and, despite numerous efforts, rates of anemia have not decreased, especially in low- and middle income countries. The most common cause of anemia worldwide is iron deficiency, and anemia due to this cause will be referred to as iron deficiency anemia (IDA). And while IDA during pregnancy increases the risk of adverse maternal, fetal, and neonatal outcomes, it is important to address other periods, particularly immediately after delivery when maternal hemoglobin values often drop precipitously. An intravenous (IV) iron infusion has been demonstrated to be a safe, effective intervention to reduce anemia during pregnancy but has not been adequately assessed during the postpartum period. To reduce anemia among women of reproductive age, new, effective interventions are needed. Thus, this trial, Postpartum IV Iron to Treat Iron-Deficiency Anemia (PRIORITY Trial), will determine if a single-dose intravenous (IV) infusion of iron is a more effective means of increasing prevalence of non anemia than standard of care of oral iron (folate will be given to all participants as per local guidelines) among postpartum women with Hb 7-9.9 g/dL. Primary Hypothesis: At 6 weeks post-delivery, achievement of non-anemic state (defined as Hb ≥11 g/dL) will be greater among women receiving IV iron (Arm 1) than among women receiving standard care with oral iron (Arm 2) (both treatments will be given with or without folate as per local guidelines). Primary outcome: Maternal non-anemic state (Hb >11 g/dL) at 6 weeks post-delivery
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PRIORITY
Disease(s) or condition(s) being studied Haematological Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/08/2023
Actual trial start date
Anticipated date of last follow up 03/08/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 600
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group IV IRON 1 Gram Once This study, Prevention of Iron Deficiency Anemia Post-delivery (PRIORITY) is designed as a 2-arm, randomized-controlled trial focused on postpartum women. If successful, its application can contribute to a reduction in anemia prevalence rates among women of reproductive age consistent with the resolution of the World Health Assembly. The trial will recruit women who are diagnosed with moderate anemia based on a blood sample taken 6-48 hours after childbirth. A total of 4,800 eligible women, or 600 women per research site, will be consented and enrolled in the trial by the research teams of eight international sites that, together with their US partners, participate in the Eunice Kennedy Shriver National Institute of Child Health and Human Development’s (NICHD’s) Global Network for Women’s and Children’s Health Research. Women with Hb concentration 7-9.9 g/dL at enrollment, following informed consent, will be randomized to one of two study arms and subsequently receive a single-dose intravenous (IV) iron infusion (± folate tablets as per local guidelines) within 6-48 hours of delivery and prior to discharge or be given standard care consisting of the provision of tablets containing 60 mg of elemental iron to be taken twice daily for 6 weeks post-delivery (± folate as per local guidelines). The trial’s primary outcome is maternal non-anemic state (Hb >11 g/dL) at 6 weeks post-delivery. It is expected that there will be a 30% relative difference in the prevalence of anemia between the two arms when hemoglobin is assessed at 6 weeks post-delivery (based on anemia defined as Hb <11 g/dL). Secondary outcomes include maternal and infant morbidity and mortality, maternal functional outcomes, and hematological/biochemical measures. Maternal depression, based on the score on the Edinburgh Postnatal Depression Scale (EPDS)5-7 will be assessed at 6 weeks and 6 months after delivery. We anticipate that some women will continue to have symptoms of depression at 6 months post-deli 300
Control Group Oral Iron and folate Twice a day 6 weeks This study, Prevention of Iron Deficiency Anemia Post-delivery (PRIORITY) is designed as a 2-arm, randomized-controlled trial focused on postpartum women. If successful, its application can contribute to a reduction in anemia prevalence rates among women of reproductive age consistent with the resolution of the World Health Assembly. The trial will recruit women who are diagnosed with moderate anemia based on a blood sample taken 6-48 hours after childbirth. A total of 4,800 eligible women, or 600 women per research site, will be consented and enrolled in the trial by the research teams of eight international sites that, together with their US partners, participate in the Eunice Kennedy Shriver National Institute of Child Health and Human Development’s (NICHD’s) Global Network for Women’s and Children’s Health Research. Women with Hb concentration 7-9.9 g/dL at enrollment, following informed consent, will be randomized to one of two study arms and subsequently receive a single-dose intravenous (IV) iron infusion (± folate tablets as per local guidelines) within 6-48 hours of delivery and prior to discharge or be given standard care consisting of the provision of tablets containing 60 mg of elemental iron to be taken twice daily for 6 weeks post-delivery (± folate as per local guidelines). The trial’s primary outcome is maternal non-anemic state (Hb >11 g/dL) at 6 weeks post-delivery. It is expected that there will be a 30% relative difference in the prevalence of anemia between the two arms when hemoglobin is assessed at 6 weeks post-delivery (based on anemia defined as Hb <11 g/dL). Secondary outcomes include maternal and infant morbidity and mortality, maternal functional outcomes, and hematological/biochemical measures. Maternal depression, based on the score on the Edinburgh Postnatal Depression Scale (EPDS)5-7 will be assessed at 6 weeks and 6 months after delivery. We anticipate that some women will continue to have symptoms of depression at 6 months post-deli 300 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Established pregnancy >20 wk gestation by LMP and/or clinical assessment and/ Or USG • Age: 15 years (or lower limit age eligible*) to 49 years • Confirmed moderate anemia (Hb 7.0 to 9.9 g/dL, 6-48 hr after delivery based on a venous blood sample on Hemocue®) • Deliver in participating study hospital or health facility • Able to provide informed consent • Plans to remain in study area for duration of the study IV Iron infusion already received in past 3 weeks • Contraindication to iron supplementation (some examples may include hemolytic anemia, allergy, severe infection) • Blood transfusion already received or scheduled in the current hospital admission • Known diagnosis of pre-existing depression or other psychiatric illness • Stillbirth, major congenital anomaly, or neonatal loss prior to randomization • Women testing positive and previously untreated for malaria • Presenting with symptomatic anemia with dyspnea or fatigue and need for immediate correction • Women with known hemoglobinopathy (sickle cell disease or thalassemia) • Presence of severe allergic conditions such as severe asthma or known drug allergies • Women presenting with any illness/condition requiring immediate medical care per physician’s assessment Adult: 19 Year-44 Year 18 Year(s) 49 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/10/2022 MTRHMU INSTITUTIONAL RESEARCH AND ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
Nandi road Eldoret 30100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Maternal non-anemic state (Hb >11 g/dL) at 6 weeks post-delivery 6 weeks post delivery
Secondary Outcome Maternal mortality (from delivery to 6 mo post-delivery) • Post-discharge blood transfusion through 6 mo post-delivery • Postpartum hemorrhage (from intervention through 6 wk post-delivery) requiring transfusion or major surgery • Hospitalization (as an indicator to capture infection through 6 mo post-delivery) • Documentation of intrapartum complications (diabetes, preeclampsia, fetal demise) • Rate of screening for postpartum depression (6 wk, 6 mo) • Maternal fatigue severity scores (6 wk, 6 mo) • Infant-mother bonding scale scores (6 wk • Quality of life assessment scores (6 wk, 6 mo) • Prevalence of severe/moderate/mild anemia (also at time of recruitment and at 6 mo) 5 • Change resulting in severe/moderate/mild anemia by treatment arm (6 mo) • Hemoglobin concentration by mode of delivery (6 mo) • Differences in ferritin and inflammatory markers on all randomized patients (delivery, 6 wk, 6 mo) • Hb concentration and ferritin measured in first trimester of an intercurrent pregnancy Infant • Neonatal/infant mortality (birth to 6 mo) • Infant hospitalization (birth to 6 mo) • Exclusive breastfeeding rate (6 wk, 6 mo) and intent to continue breastfeeding through 12 mo post-delivery (6 mo) 6 weeks post delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Busia County Referral Hospital Off Bumala road Busia 50400 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institute of Child Health and Development Rockville Maryland United States of America
Bill and Melinda Gates Foundation Fifth Avenue Seattle United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Institute of Child Health and Development Rockville Maryland United States of America Funding Agency
Secondary Sponsor Bill and Melinda Gates Foundation Fifth Avenue Seattle United States of America Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Indiana University 10th Street Indianapolis United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Fabian Esamai fesemai2007@gmail.com 254724400189 Nandi road
City Postal code Country Position/Affiliation
Eldoret Kenya Moi University College of Health Sciences
Role Name Email Phone Street address
Public Enquiries Elizabeth Mc lure mclure@rti.org +254724400189 Cornwallis
City Postal code Country Position/Affiliation
Raleigh United States of America Data Coordinating Center
Role Name Email Phone Street address
Scientific Enquiries Richard Derman Richard.Derman@jefferson.edu 254724400189 Henry Avenue
City Postal code Country Position/Affiliation
Philadelphia United States of America International Principal Investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data collected in this study shall be analyzed and a primary publication shall done. Once the primary publication has been done, the data will be available on NDASH after 36months. After de identification, raw data in form of text figures and tables will be available upon request to NIH. This will include the study protocol, statistical analysis plan that was used, the informed consent and clinical report. Parties interested in this data shall apply to NIH to request for in as prescribed by NIH data sharing policy. This can be found at https://sharing.nih.gov/ Informed Consent Form,Statistical Analysis Plan,Study Protocol 4 years This will be done as per NICHD policy on data sharing. Instructions can be found at https://sharing.nih.gov/accessing-data/accessing-scientific-data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
gn.rti.org No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information