An RCT Study Between WHO and RCOG Based Practices

Официальное название

A Randomized Controlled Trial Comparing WHO- and RCOG-Based Practices for Routine Iron Supplementation in Postpartum Women With Normal Hemoglobin Level

Обзор

Investigator is doing this study to understand the best way to give iron supplements to mothers after delivery who already have a normal blood level (hemoglobin). Some guidelines recommend one approach, while others recommend a different approach. In this study, investigator will compare these two methods to see which one is more helpful and suitable for mothers. Participants participation will help us improve care for women after childbirth in the future. Taking part is participants choice, and all participants information will be kept private.

Подробное описание

Postpartum women may be at risk of developing iron deficiency and postpartum anemia due to blood loss during childbirth. Iron supplementation after delivery is commonly used to prevent anemia; however, the benefit of routine iron supplementation in postpartum women who already have normal hemoglobin levels remains an area of discussion.

This randomized controlled trial aims to compare routine iron supplementation with no iron supplementation in postpartum women with normal hemoglobin levels.

Eligible postpartum women with normal hemoglobin levels will be randomly allocated into two groups. The intervention group will receive Polymalt F (iron polymaltose complex with folic acid), one tablet daily for 6 weeks postpartum. The control group will not receive routine iron supplementation during the study period and will receive standard postpartum care.

Participants will be followed up at 6 weeks postpartum. Maternal outcomes will be assessed, including hemoglobin level, development of postpartum anemia, fatigue level,compliance with supplementation, and any reported side effects among participants receiving iron.

The primary outcome of this study is to determine whether routine iron supplementation prevents postpartum anemia in women with normal hemoglobin levels. The findings may help provide evidence regarding the need for routine iron supplementation after childbirth and improve postpartum care practices.

Вмешательства

• Препарат Iron Polymaltose Complex with folic acid
  Participants in the intervention group will receive drug Polymalt F (iron polymaltose complex with folic acid), one tablet orally once daily for 6 weeks after delivery. The purpose of this intervention is to evaluate whether routine iron supplementation helps prevent postpartum anemia in women with normal hemoglobin levels.

Первичные конечные точки

• Change in postpartum hemoglobin levels /development of postpartum anemia [Срок оценки: 6week]

Критерии участия

Критерии включения

• Women aged 18-40 years
• Single Term Vaginal delivery
• Hemoglobin ≥10.5 g/dL at 24hour of delivery
• Willing for follow-up

Критерии исключения

• Postpartum hemorrhage
• Hemoglobin <10.5 g/dL
• Blood transfusion received
• Known hematological disease
• Chronic liver or kidney disease
• Cesarian section

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Пакистан · 1 центр

• Regional headquarters hospital chilas — Chilas

Идентификаторы

NCT: NCT07708090 · 2026-15583

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗