Prevention of Iron Deficiency Anemia Post-delivery (PRIORITY)

NICHD Global Network for Women's and Children's Health

Status and phase

Enrolling

Phase 3

Conditions

Postpartum Anemia

Treatments

Drug: Oral iron tablets

Drug: IV iron infusion

Study type

Interventional

Funder types

Other

NETWORK

Identifiers

NCT05590260

CP PRIORITY

Details and patient eligibility

About

PRIORITY is designed as a 2-arm, randomized-controlled trial focused on postpartum women. 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. The study hypothesizes that at 6 weeks post-delivery, prevalence of the non-anemic state in women in that received a single-dose IV iron infusion between 6 and 48 hours after delivery and prior to discharge from the facility will be greater than that of women given a supply of oral iron tablets taken twice daily for 6 weeks.

Full description

PRIORITY is a 2-arm, randomized-controlled trial (RCT) that will be implemented at 8 sites in 7 countries: Bangladesh, Democratic Republic of the Congo, Guatemala, India (Nagpur and Belagavi), Kenya, Pakistan, and Zambia. The research team for each site will enroll approximately 600 women who deliver at a hospital or other facility such as a health center with delivery services. Participants will be randomized to receive a single-dose IV iron infusion between 6 and 48 hours after delivery prior to discharge from the facility or oral iron tablets taken twice daily for 6 weeks. They will then be assessed by research staff at an appropriate health facility at 6 weeks and 6 months post-delivery by providing a maternal blood sample that will be analyzed to determine Hb concentration. At each study visit, trained staff will also measure serum ferritin, serum transferrin receptor, C-reactive protein (CRP) and alpha 1 acid glycoprotein (AGP). Additionally, in the African research sites, a rapid diagnostic test (RDT) for malaria will be administered upon admission to the birthing facility, and at 6 weeks and 6 months postpartum. The Edinburgh Postnatal Depression Scale (EPDS), The World Health Organization Quality-of-Life (QOL) scale, The Maternal Fatigue Severity Scale (FSS-5R), and The Mother-to-infant Bonding Scale (MIBS) will also be used at the 6 weeks and 6 months postpartum follow up appointments to collect data for secondary study aims.The study hypothesizes that at 6 weeks post-delivery, the prevalence of the non-anemic state in women in that received a single-dose IV iron infusion between 6 and 48 hours after delivery and prior to discharge from the facility will be greater than that of women given a supply of oral iron tablets taken twice daily for 6 weeks. Secondary study aims will look at the effects of postpartum depression on maternal quality of life, fatigue, and breastfeeding initiation and retention rates. Depression is also a risk factor for reducing infant-mother bonding.

The PRIORITY RCT will include an implementation research (IR) sub-study to complement the findings of the RCT trial and provide evidence about facilitators, barriers, and costs of implementation to inform global guidelines on the use of IV iron in postpartum women in Low-Middle Income Countries (LMIC). This Implementation Research (IR) sub-study will build upon the PRIORITY trial as well as other research projects to assess IV iron that are being conducted by the Jawaharlal Nehru Medical College research team in Belagavi, India, Thomas Jefferson University (TJU) and by the Aga Khan University team in Pakistan. The IR will utilize a mixed methods approach, employing both quantitative and qualitative data collection to better understand the potential barriers and facilitators to IV iron use in India and Pakistan. The implementation research will be harmonized with the timeline of the main PRIORITY trial, enabling the investigators to collect the IR data in parallel with the trial. The mixed methods IR study for the PRIORITY trial in India and Pakistan will be guided by the Consolidated Framework for Implementation Research (CFIR) and by Proctor's implementation outcomes framework. CFIR and Proctor's framework are complementary and provide a structure for guiding the types of questions and target groups for the implementation research data collection during the trial.

Enrollment

4,800 estimated patients

Sex

Female

Ages

15 to 49 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Established pregnancy >20 weeks 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 hour 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

Exclusion criteria

IV Iron infusion received in past 3 weeks
Contraindication to iron supplementation (some examples may include hemolytic anemia, allergy, severe infection)
Blood transfusion already received or scheduled during 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

4,800 participants in 2 patient groups

IV iron arm

Experimental group

Description:

Which will result in receipt of a single-dose IV iron infusion between 6 and 48 hours after delivery and prior to discharge from the facility; folate tablets per local guidelines.

Treatment:

Drug: IV iron infusion

Oral iron comparator arm

Active Comparator group

Description:

Oral iron tablets (containing 60 mg of elemental iron (± folate as per local guidelines)) to be taken at a treatment dose of twice daily for 6 weeks.

Treatment:

Drug: Oral iron tablets