PRIORITY: Prevention of Iron Deficiency Anemia Post-delivery

Sponsor

NICHD Global Network for Women's and Children's Health (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05590260

Collaborator

Thomas Jefferson University (Other), University of North Carolina (Other), Kinshasa School of Public Health (Other), University of Alabama at Birmingham (Other), University Teaching Hospital, Lusaka, Zambia (Other), University of Colorado, Denver (Other), Institute of Nutrition of Central America and Panama (Other), University of Virginia (Other), International Centre for Diarrhoeal Disease Research, Bangladesh (Other), Columbia University (Other), Aga Khan University (Other), Boston University (Other), Lata Medical Research Foundation, Nagpur (Other), Indiana University (Other), Moi University (Other), RTI International (Other), Bill and Melinda Gates Foundation (Other), KLE University Jawaharlal Nehru Medical College (Other)

4,800

Enrollment

Locations

Arms

Anticipated Duration (Months)

600

Patients Per Site

17.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Postpartum Anemia	Drug: IV iron infusion Drug: Oral iron tablets	Phase 3

Detailed Description

PRIORITY is a 2-arm, randomized-controlled trial 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

4800 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Study participation will be individually randomized and allocated 1:1 to one of two arms stratified by site. A computer algorithm generated by the data coordinating center (DCC) will create the random assignment to one of the treatment arms based on randomly permuted block design with randomly varied block sizes. Randomization will be stratified based on delivery mode (Cesarean section vs. vaginal birth) and site. The block sizes will be known only by the DCC personnelStudy participation will be individually randomized and allocated 1:1 to one of two arms stratified by site. A computer algorithm generated by the data coordinating center (DCC) will create the random assignment to one of the treatment arms based on randomly permuted block design with randomly varied block sizes. Randomization will be stratified based on delivery mode (Cesarean section vs. vaginal birth) and site. The block sizes will be known only by the DCC personnel

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Prevention of Iron Deficiency Anemia Post-delivery (PRIORITY Trial): A Randomized Controlled Trial of the Global Network for Women's and Children's Health Research

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IV iron arm 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.	Drug: IV iron infusion single-dose IV iron infusion
Active Comparator: Oral iron comparator arm 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.	Drug: Oral iron tablets 60 mg of elemental iron

Arm

Intervention/Treatment

Experimental: IV iron arm

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.

Drug: IV iron infusion

single-dose IV iron infusion

Active Comparator: Oral iron comparator arm

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.

Drug: Oral iron tablets

60 mg of elemental iron

Outcome Measures

Primary Outcome Measures

Number of women with non-anemic hemaglobin levels (Hb >11 g/dL) [6 weeks post-delivery]
Hemoglobin measure

Secondary Outcome Measures

Number of maternal deaths [From delivery to 6 months post-delivery]
Maternal death from any cause
Number of women who receive a blood transfusion post-discharge [through 6 months post-delivery]
Blood transfusion given to mother enrolled in study after randomization
Number of women who experience a postpartum hemorrhage requiring transfusion or major surgery [from intervention through 6 weeks post-delivery]
PPH defined as those requiring transfusion of surgery
Number of women with hospitalization [through 6 months post-delivery]
Hospital admission for any reason after randomization until 6 months postpartum
Number of women with documentation of postpartum complications [Randomization through 6 weeks post delivery]
Maternal postpartum clinical complications
Number of women screening positive for postpartum depression [6 weeks and 6 months]
EPDS will be used as post-partum depression screening tool
Number of women with severe fatigue [6 weeks, 6 months]
Fatigue severity score (utilizing 9 question survey with a scale from 1-7 for each item; the lower the total score is the better the outcome)
Differences between treatment groups in infant-mother bonding scale scores [6 weeks]
Will utilize mother-infant (MIBS) tool
Differences in quality of life assessment scores [6 weeks, 6 months]
Will utilize WHO QOL tool
Prevalence of severe/moderate/mild anemia among women [At 6 weeks and 6 months]
Use Hemocue hemoglobin measure to categorize anemia
Maternal - Change resulting in severe/moderate/mild anemia by treatment arm [6 months]
Evaluate individual changes in maternal anemia levels from randomization to 6 months
Maternal - Hemoglobin concentration by mode of delivery [6 months]
Evaluate hemoglobin stratified by Cesarean delivery vs. Vaginal delivery
Maternal - Differences in ferritin and inflammatory markers by treatment group [6 weeks, 6 months]
Using centralized testing, evaluate differences by treatment group
Number of neonatal infant deaths [birth to 6 months]
Neonatal or infant death from any cause post-randomization
Number of infants with hospitalization [birth to 6 months]
Neonatal or infant hospitalization for any reason
Number of women exclusive breastfeeding rate and intend to continue breastfeeding through 12 months post-delivery [6 weeks, 6 months]
Self report of breastfeeding

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 49 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ICDDRB	Dhaka		Bangladesh	1212
2	Kinshasa School of Public Health	Kinshasa		Congo, The Democratic Republic of the
3	INCAP	Guatemala City		Guatemala
4	KLE Society's Jawaharlal Nehru Medical College	Belgaum	Karnataka	India	590 010
5	Lata Medical Research Foundation	Nagpur		India
6	Moi University School of Medicine	Eldoret		Kenya	30100
7	The Aga Khan University	Karachi		Pakistan	74800
8	University Teaching Hospital	Lusaka		Zambia